Hepatitis C: Perspectives on Chronic Care in Constanța, Romania

Transcription

1 Ana-Maria Schweitzer Mihaela Bogdan Hepatitis C: Perspectives on Chronic Care in Constanța, Romania Constanța, 2015

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3 Hepatitis C: Perspectives on Chronic Care in Constanța, Romania

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5 Ana-Maria Schweitzer Mihaela Bogdan Hepatitis C: Perspectives on Chronic Care in Constanța, Romania

6 Desktop Publishing: Dan Crăciun, Square Media

7 The qualitative assessment Hepatitis C: Perspectives on Chronic Care in Constanta, Romania has been prepared by: The team is grateful for their generous support to: 5

8 Acknowledgments The Baylor Black Sea Foundation is grateful to all people living with hepatitis C who have participated in the focus group discussions, as well as to health care professionals who have shared their experiences, problems and potential solutions to chronic care for people affected by this health condition. We appreciate the participants willingness, honesty and true interest in providing quality information about the subject. A team of five young researchers, employed by the Baylor Black Sea Foundation, has carried out the field activity and helped to collect the materials analyzed in this report. The Baylor team appreciates their efforts. 6

9 About Baylor Black Sea Foundation Baylor Black Sea Foundation is the only representative of the Baylor College of Medicine International Pediatric AIDS Initiative (BIPAI) network in Romania that offers medical and psychosocial services at the Center of Clinical Excellence in Constanţa to people in Dobrogea region affected by infectious diseases. Since 2001 Baylor Romania has added to the already existing services (dentistry, infectious diseases, obstetrics-gynecology, pulmonology, rapid testing and psychosocial) new ones: family planning and primary cardiology services and most recently viral hepatitis care. The hepatitis care program of Baylor Black Sea Foundation aims to give hepatitis C patients and their families the power and courage to face the changes happening in their lives due to their health problems and to prove that, despite the chronic condition that they are fighting, there are structures that encourage them to move forward and support them to improve their quality of life. The Baylor Foundation also strives to develop among patients and their families abilities to navigate within the medical system, and to catalyze and stimulate the organization of patient-centred health systems. Further information can be found at: and 7

10 Executive summary Developing and strengthening the capacity of health systems to handle hepatitis C in Romania is a public health priority. This paper brings into focus the role of chronic care delivery design in the management of hepatitis C. The current organization of the Romanian health system and the current level of organization of authorities response to the public health issue raised by hepatitis C are presented in the first part of this report. Stress is laid on the immediate need to structure an integrated approach that efficiently meets the healthcare needs of hepatitis C patients. A future healthcare program should be structured based on good practice and evidence. In this context, Baylor foundation set to investigate what is the current organizational model of care for patients with hepatitis C in a region of Romania, namely Constanţa County, in order to identify strengths, existent capacity and areas of improvement. The results of this qualitative assessment describe the chronic care delivery system for hepatitis C available in Constanţa, Romania, in the context where the work of the public health system is complimented by the programs and services of Baylor Foundation. The research design is a qualitative investigation, using focus groups and interviews, based on the Chronic Care Theoretical Model. This framework is an evidence-based guide that indicates where the efforts of changing health systems should be directed. Fifty six persons (patients with hepatitis C and healthcare professionals) participated in this research. Thematic analysis was used to interpret the data by matching the Chronic Care Model Assessment tool categories. Findings indicate that there is some existent local capacity, especially regarding the organization of healthcare and delivery design, on which a more chronic patient-centered approach can be built. The qualitative assessment also reveals the importance of community linkages and civil society resources in improving the quality of care, especially in supplementing self-management interventions that state run programs do not usually incorporate. Special capacity building efforts need to be made and specific resources to be allocated in order to compensate for the lack of development of important clinical decision support components and clinical information systems. At the end of the qualitative assessment, specific recommendations are 8

11 suggested regarding interventions that can assist health planners in redesigning the current care program for patients with hepatitis C in this region of Romania. 9

12 Section A: Delivery of Healthcare Services for Hepatitis C in the Context of the Health System in Romania 10

13 Chapter I. Characteristics of the Romanian Health System Health systems around the world face various challenges and critical situations for which they need to find a solution by developing coherent and integrated actions. Efficient health systems have the capacity to deal promptly with crises and immediate demands, and, moreover, they are capable of developing proactive mechanisms by anticipating and planning population health programs. Much of the burden of disease can be prevented or cured with known, affordable technologies. The problem is getting drugs, vaccines, information and other forms of prevention, care or treatment on time, reliably, in sufficient quantity and at reasonable cost to those who need them 1. Stable funding mechanism Adequate and skilled health workforce Adequate costing of health services Resilient health systems Sound risk ajustment methods Good governance Information ows in the system Figure 1. Elements of a resilient health system, European Commission, 2014 Health systems are defined by the World Health Organization as a means of organizing institutions, human resources and other types of resources (fi- 1 World Health Organization. (2007). Everybody s business: Strengthening health systems to improve health outcomes: WHO s framework for action. Geneva: WHO Press. Available from htttp:// int/healthsystems/strategy/everybodys_business.pdf. 11

14 nancial, informational etc.) that meet the healthcare needs of a target group, being responsible both for the actions aimed at influencing health determining factors, and for carrying out direct health improvement activities. The resilience of health systems is a new concept that has been defined by experts as a result of unexpected challenges that health systems need to tackle under such limitations as shortage of resources (economic crisis), unexpected surges in demand (epidemics) etc. Resilience indicates the level of development of the system s capacity to adapt effectively to changing environments by applying innovative solutions 2. The elements that make up a health system include services, human resources, health-related informational issues, necessary products (drugs, vaccines, access to recent technologies), financial resources, and managementand good governance-related issues. Organization of health services in Romania The health system includes the sum of healthcare structures, public and private organizations, institutions, and resources empowered to prevent, maintain, improve and provide health to the population. In Romania, public healthcare includes individual health services, health services that address the population or certain population groups, and activities aimed at influencing the policies and actions of other sectors that address the social-economic and environmental determinants of health 3. Public healthcare is guaranteed by the state, and is financed from the Ministry of Health budget, from the state budget or from own revenues, local government budgets, health insurance budgets and other sources, as applicable, pursuant to the law. The public health system is managed and coordinated by the Ministry of Health and its specialized structures, which are organized by competencies and responsibilities at a national and regional level. 2 European Commission Communication from the Commission on effective, accessible and resilient health systems, Brussels, COM (2014)215 final 3 Law regulating the organization and operation of the health system in Romania, Article 1, Public Health 12

15 In Romania, the health system is built around the central administration and, subsidiarily, around the medical staff, with the patient or their representatives having very few possibilities to influence the system for which they pay. The single major change made in the past 30 years has been the implementation of the health insurance system whose organizational purpose was to clarify and re-enforce the responsibility of the main buyer of health services the National Health Insurance Agency (Casa Naţională pentru Asigurări de Sănătate CNAS) through direct election of management structures at a local level. The bodies with a determining role in planning, coordinating and financing the Romanian health system are the following: the Ministry of Health and County Public Health Directorates; the National Health Insurance Agency, County Health Insurance Agencies and the Insurance Agencies of ministries that have their own network of healthcare units; the Romanian College of Physicians and County Colleges of Physicians, as well as other similar professional organizations; individual healthcare providers: healthcare offices, hospitals, diagnosis and treatment centers, pharmacies and laboratories. The Romanian health system supported by the EU Representation in Bucharest, the World Bank, USAID, John Snow Institute, WHO, UNFPA, UNICEF, and UNAIDS has made progress in the period , which can be seen in the evolution of several health indicators for the said period: increase in life expectancy from to years, reduction of infant mortality from to 9.79, of incidence of tuberculosis from to 79.23%000, of syphilis from to 10.85%000, and of hepatitis B from 12.2 to 2% The principles that define primary care family medicine as a specialty with a separate profile show that it provides first contact care throughout the patient s life, at both family and community level, in direct relation with the patient s environment 5. The family physician has complex duties. They include delivery of prevention services: immunization, family planning, pregnancy monitoring, home healthcare services, palliative care, directly observed therapy, social assistance, and also administrative and management activities. The services delivered by family physicians include the management of chronic diseases (high blood pressure, diabetes), short term treatments, immunization, prenatal care, family planning, regular check-ups for neonates, basic laboratory tests with the use of urine test strips, ECG devices and sometimes 4 Politici de Sănătate magazine, July-August 2013, page 12 5 Clujul medical, 2010 Vol. LXXXIII - Supliment 1 13

16 ultrasound devices. The latter are highly required by patients, and many general practitioners try to acquire competencies in imaging diagnosis 6. People who do not have health insurance benefit from three types of health services from the family physician. These are: emergency healthcare, consultations for infectious and contagious diseases, and check-ups for pregnant and lately confined women 7. The infectious and contagious diseases for which uninsured persons may benefit from health services also include viral hepatitis (note should be taken that the law does not clearly specify whether it refers to acute and/or chronic viral hepatitis). However, uninsured patients will bear the costs of all clinical and paraclinical investigations recommended, as well as of medications prescribed by family physicians. The only health service offered by the family physician to uninsured chronic patients is a medical consultation and referral to a specialist. For insured patients, the duties of the family physician include referral to screening services, complex medical investigations in the secondary system, and registration of test results or of other recommendations made by the consulting physician through medical letters sent with the patient. In 2007, the competencies and responsibilities of family physicians were reviewed and improved, which led to better outcomes through more consultations and home visits, care for more registered patients and better coverage for emergency healthcare 8. Primary healthcare is insufficiently used. The referral rate is of 9% among family physicians in the rural area, and of 12% among family physicians in the urban area, which is the higher limit of the range compared to other countries. Most of referrals are motivated by the legal obligation of referring patients to consulting physicians with a view to obtaining permission to prescribe specific medicines. A report by NICE International for the Ministry of Health shows that: The relative underfunding inherent to the family medicine and outpatient care sectors, combined with structural and financing anomalies, seem to have led to an apparent underuse of family medicine, to an apparent overuse of inpatient care and, as a result, to an extensive transfer of costs and occurrence of perverse 6 Strategy for primary healthcare , Oxford Policy Management/Problems with service provision/quality of services NIVEL/CPSS. Evaluation of the structure and delivery of primary care services in Romania study-based project. WHO Europe 14

17 incentives 9. The secondary healthcare level consists of healthcare units belonging to the local public authorities, which deliver inpatient-specific healthcare services. The tertiary healthcare level refers to services delivered by clinics and specialized institutions (research and educational institutions). The health services related to the secondary health level are delivered through a network of healthcare units (hospitals, policlinics, health centers and other institutions) belonging to the public and private sectors. In Romania, there are currently 360 public hospitals (decentralized to local authorities, except for tertiary hospitals, which are still managed by the Ministry of Health) from university hospitals delivering highest standard services (located in Bucharest and other six university centers) to small hospitals with two three specialties or even one. The health system is still responding inefficiently to major health problems of the Romanian population, as the current design focuses on curative and mainly inpatient care, laying stress on emergency services at the expense of outpatient and primary care. In the longer term, the risk that emergency care might replace regular care should not be underestimated. Emergencies are becoming the de facto entry point to the health system for most of the population, particularly the poor, and after the planned cuts in hospital beds, emergency hospitals will contain about three-quarters of all hospital beds 10. The connection between the two system sectors primary and tertiary is not clear enough. The communication between family physicians and consultants aimed at managing certain diseases (in particular, chronic diseases) requires immediate integration. Poor development of guidelines for family physicians, the lack of use of existing ones and the complete absence of guidelines for nurses are aspects that contribute to an unclear distribution of responsibilities within this category of professionals, and even to a limitation of their role to auxiliary tasks, such as those related to bureaucracy 11. These barriers could be overcome because there are also facilitators. Thus, the Strategy for primary healthcare shows that Almost all family physicians, except for those from remote areas, have a fast Internet connection and are able to access evidence-based electronic resources and even share opinions online 9 Final report by NICE International for the Ministry of Health, January 2012http:// upload/ Ministerul%20Sanatatii%20NICE%20R0MANIA%20FINAL%20REP0RT.D0C 10 World Bank Functional review of the health sector in Romania - Final Report, 25 May Strategy for primary healthcare , Oxford Policy Management/Problems with service provision/quality of services 15

18 with their colleagues, if necessary 12. The tertiary sector consists of healthcare units that include research and educational institutions that also deliver specialized and highly specialized healthcare for the entire population. Inpatient services Specialized outpatient care Family medicine services Community care services Figure 2. Performance of the health system according to the national health strategy Both public and private healthcare providers may be directly contracted by National Health Insurance bodies for the delivery of medical services covered by the mandatory health insurance. A large number of parallel healthcare services are also delivered through public medical institutions belonging to other branches of the government, which are financed from the state budget through their respective ministries, but they can also contract with the National Health Insurance bodies. 12 Strategy for primary healthcare prepared by Oxford Policy Management for the Ministry of Health with funds from the World Bank, published on 23 March

19 Health-Related Human Resources The availability of a highly qualified and motivated health workforce of adequate capacity and with the right skills is a component that has been facing serious challenges in the past decade, a problem identified both in Romania, and in other EU Member States. Significant gaps have been identified in Member States capacity to plan for future health workforce resource requirements, relating to both overall volume and required skills mixes, in order to meet expected healthcare needs efficiently 13. Figure 3. Availability of physicians and nurses in 2009 in Europe, source European Health for All Database European Commission Communication from the Commission on effective, accessible and resilient health systems, Brussels, COM (2014)215 final 17

20 The issues related to health workforce concern both educational-qualitative aspects, and numerical-quantitative aspects. The numerical imbalance occurs under various aspects in terms of specialties breakdown or regional breakdown. Romania ranks among the last European countries (31 out of 33) in terms of professional density related to the number of inhabitants (1.9 physicians per 1,000 inhabitants), according to the statistical yearbook 14. As regards the geographic breakdown, an overcrowding of human resources is noticed in the urban area at the expense of the rural area, where a vulnerable, poor and uninsured population lives. In this context, the system is obsolete and unable to adequately cover the specific needs of sub-groups or regions. The staff training process could solve part of the human resources-related problem in the system. Unfortunately, it is characterized by many experts as being centered more on learning by heart and less on developing evidence-based analytical skills 15. This educational system discourages team work, and is not centered on patients and their needs. At least as discouraging as the process is the remuneration and promotion system, as well as the working conditions. Having an effective structure of incentives is vital to improving the performance of health professionals and ensuring the focus on direct provision of healthcare 16. The small number of healthcare employees in Romania following its accession to the EU is also the result of a massive migration of the workforce to other Member States. According to the Romanian College of Physicians, the demand for specialists was higher in family medicine, general practice, surgery, anesthesiology, and intensive care. The number of people who have chosen to work abroad is of almost 20,000. The migration of physicians has continued through 2014 as well. The College of Physicians has spoken about an exodus of physicians ever since We issued warnings at least several times a year. However, nothing has been done to prevent the collapse of the health system due to the lack of qualified staff. Moreover, the decision to classify physicians as public servants decision made by the Supreme Court without regard to the legislative and legal framework is nothing but another reason for physicians to migrate. Especially since there is no country in the European Union, in the European area, in Canada or USA where the physician is a public servant Report of the Presidential Commission A health system based on citizens needs 15 Report of the Presidential Commission A Health System Based on Citizens Needs 16 European Commission Communication from the Commission on effective, accessible and resilient health systems, Brussels, COM (2014)215 final

21 Almost 2,500 physicians have requested professional certificates from the Romanian College of Physicians in order to work abroad. Currently, 39,000 practitioners are registered with the Romanian College of Physicians, and, according to the data submitted by the College, 3,000 physicians enter the system and almost 3,500 leave the system (through migration, retirement or death). 18 Information and Research Systems The systematic collection and dissemination of information within the system (at various levels, from the patient history, needs, pathway, costs to institution or types of health conditions) are vital elements for supporting evidence-based decisions. E-health systems have been used on a larger scale in Romania as well, due to pressures from the European Union, and an electronic health card for insured people was introduced in In whole, the capacity of the system used to collect, process, analyze and report data into existing IT or information systems, and the capacity of using the data and information from public policies are insufficient whilst communication/access to information that is relevant for the patient and population is insufficiently developed 19. Furthermore, the most recent national strategy on population health prepared by the Ministry of Health shows that in terms of its monitoring and evaluation systems, Romania is still a beginner: we need to promote an organizational and system framework that is favorable to monitoring and evaluation, that helps us achieve expected results through active co-participation from the various relevant institutional stakeholders. Currently, the responsibility of surveilling communicable diseases (including viral hepatitis) rests with the National Centre for the Surveillance of Communicable Diseases, which centralizes data received from Public Health Directorates. The duties of County Public Health Directorates, more precisely of the Department for the control of primary healthcare services, also include control of compliance with the provisions regarding the reporting and monitoring of communicable and chronic diseases by family physicians who carry out their activity in both public offices, and private offices; control of management of primary healthcare 18 The Romanian College of Physicians

22 records and medical information, including for the supply of data related to county/regional/national vaccination and chronic disease records regulated through implementing regulations 20. Besides improving data collection mechanisms, it is recommended to immediately enhance the efforts for carrying out investigations, studies and operational quality and quantity research in order to make sure that health interventions have a measurable impact. The Ministry of Health states that: In 2011, Romania spent 0.5% of the GDP for research and development (Eurostat), the lowest percent among EU Member States (except for Cyprus). There is no information available about health expenditure. Besides insufficient funding, there are many other health research problems related to health visibility as a research priority, to the adequacy of defined research priorities, to the transfer and efficient use of research results in medical practice, to the existing research institutional capacity, and to the complexity of the accreditation process for research, at least for non-public entities. Existing Medical Products Romania has a wide range of medicines, which is considered to be satisfactory and permanently growing (e.g. there were more than 7,000 medicines in 2009 on the Romanian market, and in 2013 their number reached 8, ). The authority that verifies and approves medicines and medical devices in Romania is ANMDM (Agenţia Naţională a Medicamentului şi Dispozitivelor Medicale National Agency for Medicines and Medical Devices). It was established 50 years ago, and reports directly to the Ministry of Health. Its name has been changed several times, however its duties have remained the same. Romania aligned to the European standards with respect to medicines after Medicines are sold to patients through a closed network of pharmacies (in hospitals), through a network of private community pharmacies or through health centers. It is forbidden in Romania to sell prescription drugs over the Internet. The growth seen by the private sector has led to an increase in the number of pharmacies and pharmaceutical units; thus, in 2011, there 20 Organisational and Operational Rules, Public Health Division in Constanţa 21 Activity Report for National Agency for Medicines and Medical Devices anmdm/_/raport%20actlvltate/raport_anmdm_2013.pdf 20

23 were 8,240 units, 1,025 more than in 2008; approximately 15% of them are part of the same chain. For medicines sold as part of national programs, prices are regulated by the Government and do not allow for too large variations; however, among closed networks of pharmacies, the competition market is free 22. Access to pharmaceutical products is a problem for insured patients who live in rural areas. According to the Health Law (Law no. 95/2006, Article 383 and Article 788) and to the Pharmacy Law (Law no. 266/2008, Article 2), family physicians are not allowed to sell medicines. Many rural areas lack pharmacies, and accreditation requirements for a pharmacy limit the possibility to establish smaller rural pharmacies. Currently, several ideas are being issued with respect to the funds owned for primary healthcare medicines. However, a decision for authorizing physicians in remote areas to keep limited stocks of pharmaceutical products has not been adopted yet (according to the Primary Healthcare Strategy ). There is a complex process in place for establishing prices for prescription drugs, and for reimbursing such prescriptions by Insurance Agencies. Usually, the medicine inclusion process is considered by the population as non-transparent, incoherent and seldom adapted to the actual needs of the population 23. There is widespread lack of confidence in generic drugs, which is enhanced by physicians practice of prescribing new, top medicines promoted by pharmaceutical companies, thus avoiding the obligation to prescribe generic drugs. The Romanian legislation makes no reference as to the pharmacists duty to inform patients about the cheapest medicine containing the active ingredient prescribed by their physician. Requiring pharmacies to have a permanent stock of generic drugs has also remained a mere intention 24. The European Union has imposed Romania to significantly increase the volume of generic drugs on the free market, however its targets have not been reached. The situation is due to investments made by pharmaceutical companies, who have innovative products, in visiting physicians and pharmacists directly to promote and advocate for the qualities of the original drug. For example, in 2007, these investments accounted for half of the marketing budget of pharmaceutical companies Global Forum on Competition- Competition Issues in the Distribution of Pharmaceuticals Contribution from Romania, february 2014, DAF/CONP/GF/WD (2014)30 23 Romania Functional Review Health Sector Final Report May 25, 2011, The World Bank Europe 24 Central Asia Region, page Global Forum on Competition- Competition Issues in the Distribution of Pharmaceuticals Contribution from Romania, February 2014, DAF/CONP/GF/WD (2014)30, pages

24 Sustainable Funding and Social Protection According to Law no. 145/1997 and to the Health Reform Law as of 2006, the Romanian health system is based on social health insurances that include similar benefits for all tax payers (the basic package of health services made available through a framework contract). The funds are collected by a body of the Ministry of Finance, and county insurance agencies collect taxes from freelancers. Insurance premiums are mandatory (except for pupils, students and retirees), and they are dependent on income and individual risks. Social health insurance contributions are paid by both the employer (5.2% of the salary), and the employee (5.5% of the salary). The money for the health system come from the following sources: 60% from social insurances mandatory contributions, 10 15% from taxes and specific fees, 10% from private insurances, and 10 15% from payments made by patients. Almost half of the Romanian population does not contribute directly to the public insurance budget 26. Besides, the forecast on the ratio between active people and socially assisted people in Romania is rather dark: in 2060 there will be only two people aged between 15 and 64 for each person of more than 65. This ratio will have a visible negative impact on the budget of the national health system. The health system financing is still evaluated as inadequate and inefficiently used. Compared to most European countries, Romania allocates a significantly lower budget from the Gross National Product to health expenditure. 26 Romania Functional Review Health Sector Final Report May 25, 2011, The World Bank Europe and Central Asia Region, pag 11 22

25 Figure 4. Income sources of the National Health Insurance Agency Romania Germany France Hungary Bulgaria Figure 5. Health-related expenditure, percentage from GDP, source: World Bank ( The monthly expenditure of the Romanian Government is of approximately 27 Euro per capita compared to those of the German Government, which allocates more than 230 Euro/month per capita Forbes, Romania,

26 Figure 6. Health-related expenditure correlated to the number of physicians available, European Health for All Database Apart from underfunding, an arbitrary use of resources among various regions and types of services can also be noticed. There is limited access, characterized by inequities, to high quality health services, with the main differences occurring between the rural and urban areas: the mortality rate in the rural area is twice the rate recorded in the urban area, and the number of physicians is three times smaller in the rural area than in the urban area, according to a report of the presidential health commission 28. Furthermore, the current payment systems create financial incentives that are contrary to the government s stated policy of reducing the use of inpatient services and increasing the use of family medicine and specialized outpatient services 29. Financial barriers have a direct negative impact on patients. A survey requested by the World Health Organization shows that most of respondents complain about difficulties related to finding medicines, the lack of medicines, costs and copayment. One fifth of the patients surveyed declared that they pay for home medical visits, and one fifth that they pay to see a consultant after they get a referral. 10% of the respondents declared that they refuse or postpone their visit in the primary care system for financial reasons 30. Informal payments are widespread in Romania, ranging from 63% 28 Report of the Presidential Commission A health system based on citizens needs, presidency.ro/ static/ordine/comisiasanatate/un_sistem_sanitar_centrat_pe_nevoi- LE_CETATEAN- ULUI.pdf 29 World Bank Functional review of the health sector in Romania - Final Report, 25 May World Health Organization: final report Evaluation of the structure and primary healthcare delivery in Romania ; Primary healthcare in the European region of the WHO; WHO Europe;

27 among the poor to 88% among families with a better financial condition 31. The data from the World Bank (see Figure 7) show that the level of out-of-pocket payments has been high and steady in time Romania Germany France Hungary Figure 7. Percentage of informal (out-of-pocket) payments, source: World Bank ( The poor have limited access to health services. Many of those who need medical care do not seek health services. This is the case for almost 50% of the poor. The gap between rich and poor is particularly large in the treatment of chronic disease because 42% of the poor who suffer from a chronic disease do not seek care compared to 17% of the rich. The actual gap is even larger as many of the poor with chronic conditions are not aware of their need for care. Simulations show that the need for chronic care is not similar among rich and poor, and estimate that a whopping 85% of the poor who need chronic care are not receiving it. 32 Even the Ministry of Health states that, although the subsidies for health services and the partial reimbursement of medicines are aimed at protecting vulnerable populations, the financial protection fails to render the expected outcomes as long as: three out of four poor patients pay from their pocket for the medical care they need, 62% of the poor who need medicines pay for them from their pocket, average reimbursement rates are the same for the rich and the poor while subsidized services are underused by the poor. Thus, the benefits of subsi- 31 Romania Functional Review Health Sector Final Report may 25, 2011, The World Bank Europe and Central Asia Region, pag Functional review of the health sector in Romania, World Bank,

28 dies are directed more towards the rich or middle class 33. A survey conducted in 2014 at a national level by Asociaţia pentru Implementarea Democraţiei (Association for Democracy Implementation), coordinated by the Ministry of Health, shows that the phenomenon of corruption in the healthcare sector relates to healthcare service providers, and to the management and administrative staff, and that patients also encourage this phenomenon by offering gifts or money. More than a quarter of the people who sought medical care in the public sector in the previous year admit that they offered gifts or money to the medical staff. The same survey shows that more than 50% of the patients have willfully offered gifts and money. According to the findings of the research, willfully offered or requested incentives for the medical staff can be avoided through the implementation of an insurance system that is able to provide comfort to the patient in the public health system 34. Management and Good Governance Good governance in the health sector is a process that was accelerated in Romania following its integration into the European Union through the development of common policies and common regulatory structures. The transition from a centralized administration to a decentralized one, and the development of the regionalization process are the most important changes made in the past decade with respect to management in the health sector. The decentralization process has been continuously amended and changed, which is evidence for the lack of predictability and stability of the Romanian political environment (the reform approved by Ordinance no. 162/2008 was amended through emergency ordinances and decisions more than ten times by 2013). The legislative and institutional framework propitious to the integration of community healthcare services with the social services is still under development, which deprives vulnerable groups of the support they need. At least for chronic conditions, the prevalent design of healthcare is focused rather on treating flares than on managing the disease by detecting it as 33 Ministry of Health, Annex 1 to the National Health Strategy The research was conducted on a three-stage sample, which is representative at a national level for the Romanian adult population, made up of 1,076 respondents. The maximum error of the survey is of +/-2.8% with a confidence index of 95% 26

29 early as possible and delivering intermittent, systematic and quality care in order to reduce the risk of progress into more severe forms and complications 35. Ensuring continuous care is a priority for the national strategy, as the Ministry of Health is going to prepare the methodology and treatment procedures for the first 20 most frequent pathologies, including to define the service plans for specialized outpatient care as part of the local health service plans. The aspects related to monitoring quality, focusing on the physician-patient relation and respecting patients rights will continue at the stage of intentions and strategic action directions for now. All these aspects are included in a program document, Strategy of the Ministry of Health Until all mentioned strategy plans are put into place, most of the policies are implemented ad-hoc due to a lack of evidence and data which should underlie the decisions made 36. The collection and analysis of health-related key indicators are not centralized at the level of a single agency/body, but duties are divided among several institutions; some of the data are not available free of charge, and others do not return into the system to change current practices. The relation with the civil society is still weak and incoherent. Although non-profit organizations have expertise in the medical field and they make significant investments in the health sector (in the form of equipment, medicines, continuing medical education or even healthcare service delivery), their efforts are parallel to rather than integrated with the efforts of the Ministry of Health. As a matter of fact, there are no non-governmental organizations supported from public funds, which means they are self-supported. Patients are organized into associations and coalitions, and they are approached and involved by health authorities when required by law. The formal consultation process requires continuity, and the partnership between public institutions and the civil society needs to be improved. There are few good practice models related to the delivery of prevention-testing-treatment services for patients in public-private partnership with non-governmental organizations. 35 Ministry of Health, Annex 1 to the National Health Strategy , page World Bank (October 15, 2010) Romania. Functional Review Center of Government. Final Report, p. 7 27

30 Chapter II. Current Level of Development of Care for Hepatitis C Patients in Romania There is a lack of knowledge and awareness about viral hepatitis among at-risk populations, members of the public, and policy-makers; there is a lack of knowledge and awareness about viral hepatitis even on the part of healthcare and social-service providers. 37 The Context of Health Policies with Respect to Hepatitis C No clear targets have been set at a global level with respect to HCV, that is why the WHO is seeking to prompt a debate in 2015 over a Global Hepatitis Strategy However, recent steps have been taken towards structuring the response against hepatitis C, among which it is worth mentioning the Guidelines for identifying, treating and managing people with HCV, published in April 2014, and the Hepatitis C Resolution, in the World Health Assembly held in May 2014, signed by all member states. Such guidelines should be adopted by all signatory states at a national level; WHO states that only 37% of its member states reported the existence of a national strategy that focuses on the control of hepatitis C, and almost half of them also have clinical care guidelines 38. It is recommended that new testing strategies for identifying people with HCV who are not aware of the infection be immediately developed, because the number of infected people is continuously increasing 39. Referring reactive cases and taking them over for treatment and care 37 IOM (Institute of Medicine). Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Washington, DC: The National Academies Press; Global policy report on the prevention and control of viral hepatitis. Geneva: World Health Organization;

31 is the next step. Currently, the pathway of the hepatitis C patient within the health system, if any, is poorly structured, most of the countries in the European region reporting exclusive referral of the HCV patient to a hospital or specialist 40. In most European countries, patients access to treatment is dependent on insurance 41. Since there are significant similarities between the HIV pandemia and the one caused by HCV, in 2014 the World Health Organization (WHO) included the Global Hepatitis Program alongside the HIV Department. The optimization and standardization of the HIV care continuum (testing, treatment, monitoring, adherence support etc.) are aspects that can also be used when addressing HCV infection. Epidemiological Facts about Hepatitis C in Romania The hepatitis C virus (HCV) was discovered more than twenty five years ago (in 1989) 42, however not earlier than in the past years has the infection caused by this virus been acknowledged as a public health problem. Approximately 3% of the world population ( million) is infected with HCV. Due to an asymptomatic period of more than 2 3 decades, 75% of the people infected with HCV are diagnosed late, when complications, such as cirrhosis or hepatocellular carcinoma, are difficult to treat. Between 1996 and 2006, cirrhosis prevalence has doubled, and that of hepatocellular carcinoma has increased twenty times. These figures are not the peak of the endemia, as the forecast for 2030 shows a three times increase in the number of people infected (and diagnosed) with HCV. For a comparative understanding of the magnitude of the problem, we outline that there are currently approximately 2.2 million people infected with HIV and more than 28 million people affected by viral hepatitis in Europe World Hepatitis Alliance, Viral hepatitis: Global policy, 2010, World Hepatitis Alliance. p Central and Eastern European Harm Reduction Network, Hepatitis C Among Injecting Drug Users in the New EU Member States and Neighboring Countries: Situation, Guidelines and Recommendations, UNITAID. Hepatitis C Medicines: Technology and Market Landscape. 2015; images/marketdynamics/publications/hcv_meds_landscape_feb2015.pdf 43 Global access to hepatitis drugs and diagnostics consultation with pharmaceutical and diagnostics companies- 16 June 2014, Geneva, Switzerland, meeting report. World Health Organization/ HIV/

32 In Europe, most of the people infected with HCV are injection drug users, whose prevalence ranges from 21% in Finland and over 90% in Estonia. The World Health Organization (WHO) has identified injection drug users as the main target group for HCV prevention and treatment programs 44. Many years ago, a website accredited by WHO (World Health Organization) Safe Injection Global Network drew attention to the persistence of this problem in Romania: Romania An European home of hepatitis 45. Most probably exaggerated, the figures quoted estimated that 6 to 8% of the population was infected with the B hepatitis virus (HBV), and 8 to 12% with the C hepatitis virus (HCV). Most of the ill have been infected before 1990 due to poor conditions in hospitals and policlinics, and to a lack of compliance with the proper practices for parenteral treatments or transfusion security. In Romania, viral chronic hepatitis is the main cause for inpatient care. The genetic heterogeneity of HCV is important because it has to do with the differences among the effects of the disease, as well as with HCV infected people s response to treatment. In Europe, the most prevalent genotypes of HCV are 1 and 3 (European Parliament 2014: 8). In Romania, 93% of people living with hepatitis C are genotype 1b, which indicates that the HCV was primarily transmitted through blood transfusion 46. Incidence: According to the National Health Strategy , subject to non-homogenous national reports, in terms of incidence of the infection with the B (HBV) and C (HCV) hepatitis viruses, Romania ranked second in Europe in 2011 and 2010, respectively, even if the incidence of infectious hepatitis has decreased significantly between 2000 and 2010, reaching 1/5 of the hepatitis B incidence for 2000 and 1/4 of the initial value for hepatitis C. However, the burden of hepatic infection goes beyond the incident cases of clinically evident diseases that are detected by healthcare providers. The hidden prevalence of the viral infection in population is highly important, as the risk of infection and transmission to the healthy population is actually dependent upon it. 44 World Health Organization (2010). Resolution A63/15: Viral hepatitis. 63rd World Health Assembly Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of hepatitis C virus infection in adult population in Romania: a nationwide survey J Gastrointestin Liver Dis Dec;19(4): PubMed PMID:

33 7 6 number of cases / population Year Figure 8. Hepatitis C incidence in Romania, , according to the National Centre for the Surveillance and Control of Communicable Diseases 47 Data from the past four years about the incidence of viral hepatitis reveal a steady trend in detecting and reporting new cases, and also a low level of testing and diagnosis, according to epidemiologic studies: Number of new cases reported by family physicians in Source: INS SAN109B New cases of infected people Prevalence: Available prevalence studies show that Romania is a high risk country for HBV and HCV infection (second highest prevalence in the EU for HVB and highest prevalence for HCV). The problem posed by the disease among the population is also amplified by a severe chronic secondary pathology (cirrhosis and liver cancer). In Romania, the burden of the chronic disease is double 48, due to both high prevalence of noncommunicable diseases, and high interference rates of infectious diseases. The Ministry of Health states that the prevalence of present anti-hcv antibodies is of 4.3% in the overall population, and of 3.3% in new blood donors 49. In the period of , a team of specialists from the Clinical In- 47 European Centre for Disease Prevention and Control, 2011, Country mission Romania: HIV, sexually transmitted infections, and hepatitis B and C, Stockholm, ECDC 48 Bygbjerg IC, Double burden of noncommunicable and infectious diseases in developing countries. Science Sep 21;337(6101): National Health Strategy , Ministry of Health, Romania 31

34 stitute Fundeni conducted an epidemiologic 50 study on more than 13,000 subjects, which revealed a national prevalence of 3.23%. Differences among regions and/or counties were significant, and ranged from 0.56% to 7.19%. The screening data of the Baylor Black Sea Foundation 51, reveal annual prevalence rates of approximately 3% for HCV in the period of for Constanţa and Tulcea Counties. Findings of the screening program conducted in Dobrogea on the overall population by the Baylor Foundation 3.30% 3.20% 3.10% 3.00% 2.90% 2.80% 2.70% 2.60% 2.50% year 2010 year 2010, 2.96% year 2011, 3.16% year 2011 year 2012, 2.85% year 2012 year 2013, 3.21% year 2013 year 2014, 2.77% year 2014 Figure 9. Baylor Black Sea Foundation HCV Screening Program: prevalence among overall population in Dobrogea Transmission paths: HCV transmission paths are similar to HIV, however, in terms of infectiousness, HCV blood transmission is 10 times more efficient than HIV transmission 52. HCV transmission is associated with a set of behavioral practices, such as the use of drugs with non-sterile tools, re-use of medical tools in the healthcare setting, performing tattoos and piercing with contaminated tools, or incorrect transfusion practices. HCV can also be transmitted through sexual contact, in particular among men who have sex with men. Unlike HIV, 50 Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of hepatitis C virus infection in adult population in Romania: a nationwide survey J Gastrointestin Liver Dis Dec;19(4): PubMed PMID: De la lansarea sa în 2007, au fost testate peste de persoane în cabinetele de testare și consiliere gratuită din orașele Constanța și Tulcea și de către echipa mobilă. Sursă: uploads/2014/10/raport-anual-2013-ro-web.pdf 52 Taylor L, Swan T, Mayer K. HIV coinfection with hepatitis C virus: evolving epidemiology and treatment paradigms. Clinical Infectious Diseases. 2012;55(Supp. 1):S33 S42 32

35 sexual penilo-vaginal transmission seldom occurs, and mother-to-infant infection is, also, less frequent 53. HCV cannot be transmitted through breastfeeding or daily shared activities. HCV infects hepatic cells, with the acute infection stage occurring in a period ranging from two weeks to six months after onset of the infection; only 20% of the persons in acute stage show symptoms, and less than half of infected people develop natural immunity to the virus 54. The remainder develop chronic hepatitis, a long-term infection that leads to a severe condition of the liver 55 (liver cancer or cirrhosis). HIV-HCV coinfection is quite frequent, which is due to a similarity between transmission paths, and to a common behavioral context (approximately a quarter of HIV infected people are also infected with HCV 56 ). IHIV infection accelerates progression of hepatic disease 57 and increases the risk of monther-to-infant HCV transmission. Other conditions associated with disease progression include hepatitis B virus infection, alcohol consumption and hepatic steatosis 58. Treatment: Not treated, hepatitis can lead to cirrhosis and cancer, and it can cause severe secondary conditions. Most of the patients are not aware of the infection they have. Morbidity caused by chronic HCV infection goes beyond hepatology, as it is also associated with autoimmune diseases, diabetes, lymphoproliferative diseases, depression and other cognitive distortions. The scientific community has had a gradual response to this disease, as interferon became available in 1991, and the double therapy with interferon and ribavirin was first initiated in The therapies available in Romania are free of charge for insured patients, and are based on a treatment scheme consisting of two medicines (peginterferon alpha and ribavirin). Studies have shown that achieving sustained viral response is greatly dependent on the viral genotype, not only on the treatment scheme. The genotype present in Romanian patients (1b) guarantees therapy success in 40 50% of them. 53 Guidelines for the screening, care and treatment of persons with hepatitis C infection. Geneva: World Health Organization; Hepatitis C. Fact sheet No 164. Geneva: World Health Organization; Hepatitis C FAQs for the Public. Atlanta (GA): US Centers for Disease Control and Prevention; HCV global prevalence HCV map. Louisville (CO): Center for Disease Analysis; 2013 ( Joshi D, O Grady J, Dieterich D, Gazzard B, Agarwal K. Increasing burden of liver disease in patients with HIV infection. Lancet. 2011;377(9772): Mahajan R, Xing J, Liu SJ, Ly KN, Moorman AC, Rupp L, Xu F, Holmberg SD; Chronic Hepatitis Cohort Study (CHeCS) Investigators. Mortality among persons in care with hepatitis C virus infection: the Chronic Hepatitis Cohort Study (CHeCS), Clin Infect Dis Apr;58(8):

36 Anti-VHC immunoenzymatic screening = positive result Absent anti-vhc to be repeated Risk factors assessment Present aminopherase Increased aminopherase - PCR Normal aminopherase to be retested every 6 months Qualitative PCR Quantitative PCR Normal aminopherase to be retested every 6 months Figure 10. Algorithm to diagnose HCV infectionc 59 In 2011, more efficient medicines were launched, that lack interferon and are able to eradicate this infection 60. In January 2014, the European Commission approved the first exclusively oral treatments against HCV with a curing rate during clinical tests of up to 98% 61. The treatments received marketing authorizations from the National Agency for Medicines in Unfortunately, no promising vaccine against HCV was available as of the date of this report. 59 Cernescu C. Actualități în tratamentul hepatitelor virale Bși C, Editura Medicală, București 2014, pg Thomas DL. Global control of hepatitis C: where challenge meets opportunity. Nat Med Jul;19(7): European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) (2014). Perspectives on Drugs: Hepatitis C Treatment for Injecting Drug Users. 34

37 Costs of Hepatitis C in Romania The recently published study Burden of Hepatitis C in Romania the Case of France and Romania 62 determined that currently for around 580,000 persons with HCV Romania allocates about 5 billion Euro (these costs covering healthcare system costs, medication and indirect costs). Cases with little or moderate symptomatology represent about 80% of the cases and the costs to treat these patients raise up to 40% in Romania. The rest of the costs are covering expenses for patients with cirrhosis and liver cancer associated with HCV. If the current conditions are to be maintained, it is estimated that the costs of the health system will double by 2040 in the context of a decrease in prevalence; this is mainly due to complications associated with untreated hepatitis C. For example, it is estimated that the number of patients with decompensated cirrhosis will increase from 20,000 to 40,000 by 2040; the number of liver cancers is expected to increase from 2,000 to 4,500 and the annual mortality is expected to increase from 1,200 to 3,500. The economic modeling has indicated that in the context where the number of patients successfully treated for HCV increases, the overall treatment costs are expected to decrease by 30% until 2040 and the annual mortality rate is expected to decrease by 50%

38 The Level of Organization of the Romanian Health System s Response to the Challenges Raised by Hepatitis C Although Romania has more than 25 years of experience in assisting chronic patients infected with HIV, and although progress has been made in terms of programs to control this health condition which is quite similar to hepatitis C, the lessons taken with HIV have not been learned and transferred to the HCV AREA. Chronic hepatitis-related issues are posing serious challenges to the health system in terms of care integration plans, monitoring, follow-up, communication between medical specialties involved etc. The report of the presidential health commission 63 outlines the lack of integration of the health services with the system so that care is guaranteed on a continuous basis. The sectors of the Romanian health system are operated separately. Primary care has no functional connections with inpatient care, and health promotion and disease prevention activities are not related with curative care. According to the European hepatitis index, Romania ranks 25th out of 27, with 453 points out of 1,000 in terms of structuring its response to HCV pandemia. The score refers to indicators such as prevention and screening, access to treatment, and national programs. This classification ranks Romania as the penultimate in HCV management within the global public health system. Without funds from the government, it is difficult to perform HCV testing. Under such conditions, great part of infections is detected late, which is why prevention is not possible in small communities (couples, families etc.). According to the same index, France and Scotland are in the front rank. This is mainly due to their hepatitis patient management systems, which were structured at an early stage by classifying hepatitis as a public health issue ever since 1990 (France). Romania is also behind with structuring a viral hepatitis prevention and control strategy, and it has also failed to answer external fora with respect to the stage of development of such strategy: 63 TRAT_PE_NEVOILE_CETATEANULUI.pdf 36

39 Responses to the question, Is there a written national strategy or plan that focuses exclusively or primarily on the prevention and control of viral hepatitis? 37

40 Figure 11. Existence/Absence of national strategies focused exclusively on the prevention and control of viral hepatitis C, 2013 As shown in the chart of the World Health Organization, in the Global policy report on the prevention and control of viral hepatitis C, conducted in 2013 among the member states of WHO, Romania is in the No response area, as there are no data about our country. Concerning surveillance and notification, in 2011, the European Centre for Disease Prevention and Control noted that the Romanian system for viral hepatitis notification should be restructured because its current organization does not enable understanding of the epidemiology of viral hepatitis, or continuous data monitoring 64. In the past two years, a series of steps have been taken in structuring response to challenges raised by HCV. Thus, according to the order of the minister no. 657/2014, the National Hepatitis Registry was created in 2014, which is subject to scientific coordination from the Infectious Disease Commission of the Ministry of Health, and to technical coordination from the Infectious Disease Institute Matei Bals in Bucharest. The same institute is in charge for making the electronic data system available to professionals (infectious disease specialists, gastro-enterologists and hepatologists) who deliver healthcare services to patients with viral etiology hepatitis, as the HepaReg. The order regulates aspects related to software administration, data collection and management, reporting, frequency for reporting stages, and reported data analysis and transfer to the Ministry of Health. The registry includes five important components: screening which rests with the family physician. They will have 64 European Centre for Disease Prevention and Control, 2011, Country mission Romania: HIV, sexually transmitted infections, and hepatitis B and C, Stockholm, ECDC, available at: europa.eu/en/publications/publications/mer-romania-2010-country-mission.pdf 38

41 a patient exposure risk assessment questionnaire which will help them to decide whether they need detailed evaluations. The other components are: infection staging, therapeutic recommendations, monitoring and follow-up 65. The strategic directions of the Ministry of Health for the next seven years are targeted exclusively towards strengthening prevention, early detection of new cases, clinical and biologic monitoring and antiviral treatment in compliance with national guidelines, minimizing occupational biologic risk for the system staff, and researching the epidemiologic profile of chronic infections. The treatment plan and active monitoring are not listed among indicators 66, as it is necessary to perform a subsequent review of the way services are delivered to patients with chronic conditions. The national strategy is aimed at organizing public events and awareness raising campaigns, testing people voluntarily and anonymously for HBV and HCV, preparing and reviewing clinical guidelines, treating patients with specific antiviral treatment, and creating a functional registry for hepatitis B and C. The costs for the national strategy are estimated at 4,812, RON, and the available budget is of 3,347, RON. The creation and implementation of national strategies that address certain public health issues have a measurable impact on the health level of the population. For instance, as regards hepatitis C, the first country to develop its own national strategy was Australia 67, in The implementation of the national strategy, together with all its proposals for improvement, has led to a significant decrease in new infections (incidence reduction from 105 cases for 100,000 persons in 2000 to only 51 in ). The success of such programs is however dependent upon the creation of evidence-based implementation recommendations that have clear and measurable targets staged in action calendars. Such an approach was chosen by the Scottish authorities, who, in only three years ( ), managed to achieve a 34% increase in cases diagnosed with HCV, and to double the number of successfully treated persons 69. Romania failed to prepare such a plan despite being a WHO member, and a signatory of the World Health Assembly since Order no. 657/2014 to create and operate the national viral hepatitis registry, in force since Strategia Națională de Sănătate National Centre in HIV Epidemiology and Clinical Research. HIV/AIDS, viral hepatitis and sexually transmissible infections in Australia Annual Surveillance Report (Sydney, NSW: University of New South Wales. 2002). 68 Australia, Commonwealth Government of. Third National Hepatitis C Strategy , Commonwealth of Australia, Morris, K. Tackling hepatitis C: a tale of two countries. Lancet 337: 9973 (2011)

42 A strategic action plan for viral hepatitis was created by an international coalition of patient associations (APAH, ELPA) in It was submitted to the Romanian Government. Its provisions sum up the concerns of both patients and professionals, and refer in particular to the creation of an advisory group for the Romanian decision making bodies, to the preparation and implementation of a viral hepatitis surveillance system, and, not the least, to the preparation of prevention policies. Unfortunately, the plan is still in the stage of proposal. Neither this, nor other plans prepared by ministries or by the Government have been adopted by now, although pressure is made from international bodies, and warnings are issued internally by patient associations. In Romania, there are general patient associations (such as COPAC - Coaliţia Organizaţiilor Pacienţilor cu Afecţiuni Cronice Coalition of Patients with Chronic Diseases), as well as organizations that represent the interests of patients with hepatitis (APAH, SANOHEP). Their actions are aimed at informing and raising awareness among the general public through media campaigns, online petitions, marches occasioned by various international events, patient fora and, to a lower extent, lobby or advocacy. 40

43 The current pathway of patients affected by HCV According to statements made by the president of the National Health Insurance Agency on the World Hepatitis Day in 2014, more than 32,000 patients benefited from hepatitis C treatment in 2013, the total value of the funds allocated being of million RON. For 2014, the National Health Insurance Agency allocated for six months 86.7 million RON for the treatment of approximately 10,000 patients with hepatitis C, and allocations of up to 470 million RON are estimated for the treatment of approximately 40,000 patients for the entire year 2014, according to the same statements (press conference organized in Bucharest by Mediafax) 70. The figures revealed are comparable to the level of access to treatment for patients in the period of For hepatitis C patients, the treatment for insured persons is also made available by means of state-owned or private pharmacies. Access to treatment is possible based on a record prepared by the specialist physician, submitted to the County Health Insurance Agency and approved by the National Health Insurance Agency. The investigations required to prepare the record are partly reimbursed by the insurance system, while the personal contribution of the patient is in most of the cases between 200 and 225 RON (antibody tests ~ 45 RON, fibrosis test contribution 90/120 RON, other tests ~ 70 RON). These are added transportation costs, given that the specialists who treat these infections work in county hospitals, costs with other approvals/investigations, if the treating physician asks them from other specialists (psychiatrist, cardiologist, endocrinologist etc.) for cases when the patient diagnosed with hepatitis has a history of conditions where interferon is not indicated. The process for referring patients for specialized diagnosis and treatment services begins with a test whereby the level of anti-hcv antibodies is detected. However, testing indications are missing for this infection, and the family physician refers the patient based exclusively on their obligation to fill in a risk sheet once every three years for people under 40 years of age, and annually for those older than 40 years (see Framework Contract ). These provisions are however quite new, and hepatitis has been diagnosed

44 randomly so far. There are also situations of severe chronic disease when high values of liver enzymes can trigger an alarm, and help the physician to recommend tests for the presence of a virus. Once antibodies are detected by the test, the patient is encouraged to continue investigations, being known that part of infected people can go through a spontaneous viral clearance, in which case the antibodies are still present without a detectable viral activity. According to the Surveillance and Control Guide, having all these results, the patient is eligible to receive treatment recommendations. To benefit from free therapy, the patient will submit with the County Health Insurance Agency a record with the above tests, a medical report and the informed consent form signed by the patient. The pathway of the record, which takes between 1 2 years (between 2010 and 2012) and a few months (less than six months since ) is between the approving commissions of CJAS and CNAS. CJAS sends its response directly to the patient, who receives a letter from the agency regarding its decision. If the record is approved, the patient submits the document to the specialist physician, who issues monthly treatment prescriptions. Medicines are obtained from the network of state-owned/private pharmacies based on the prescription issued by the specialist. The duration of a standard treatment is of 48 weeks, however recommendations are highly dependent on the virus genotype. Thus, there is a possibility to have a 6 months treatment (half the standard period) if the baseline viral load (VL) is below 600,000 copies/ml, VL on first evaluation 4 weeks is undetectable, and is maintained through weeks 12 and 24. For persons with a VL higher than 600,000 copies/ml, the first VL evaluation following the initiation of treatment is performed after 12 weeks and, irrespective of the resulting value, the treatment continues up to week 48 if no adverse events render the use of the medicine impossible. As a matter of fact, the VL is a test made four times during the treatment as follows: week 12, 24, 48 and 6 months after the therapy is completed. Week 54 VL (from baseline) is the control key to a successful treatment. If it continues to be undetectable, it is deemed that the sustained viral response has been achieved and the patient is declared cured. 42

45 Figure 12. HCV Patient s Pathway in the Health System If intermediary LV values (week 12, 24) are not detectable or do not decrease sufficiently (min. 2log10 compared to the reference value) this is an indication that the therapy will fail, and the treatment is discontinued. Throughout the therapy, the treating physician will periodically check (every 2 weeks in the first month and monthly by the end of the third month) the complete blood count and the transaminases in order to adjust on the way the quantity of ribavirin and to avoid potential decreases in hemoglobin down to the limit where hepatitis treatment can no longer be given. The therapeutic protocol in assisting chronic hepatitis is a document that regulates aspects related to patient inclusion criteria, medical monitoring during treatment, therapy dosage etc. As part of its program entitled Surveillance and control of communicable diseases, the Ministry of Health classified acute viral hepatitis as a priority. The chronic viral hepatitis surveillance document was prepared by the Ministry of Health and published in the Official Gazette in 2010, and reviewed in

46 Section B: Qualitative Research Hepatitis C: Opinions of Patients and Specialists on Chronic Care Delivery in Constanța, Romania 44

47 Part I. Research brief Systems are perfectly designed to get the results they achieve Don Berwick Motivation and applicability of the qualitative assessment The importance of an effective care system for patients with hepatitis C is becoming a priority in Romania during the past years. Thousands of patients are being treated annually for HCV and thus a system of care is already set in place. Baylor foundation set to investigate what is the current organizational model of care for patients with hepatitis C in a region of Romania, namely Constanta County. The present evaluation describes the chronic care delivery system for hepatitis C available in Constanta, Romania, in the context where the work of the public health system is complimented by the programs and services of Baylor Foundation. The current evaluation does not apply to other counties in Romania; a separate study is needed to assess the situation in other counties, taking into consideration local availability of supplemental resources and community linkages. One of the most recognized and established theoretical maps that can be used in this descriptive process is the Chronic Care Model. This model was elected to analyze and understand the current format of delivering care for patients with hepatitis C and to draw a series of recommendations. The model offers the possibility of future comparing of our findings across systems and across conditions by interested researchers and stakeholders. 45

48 Organization of the research related reading material The research paper describes the theoretical dimension of the assessment in order to allow the reader to better understand the concepts of the model and its interpretation. Several evidence based materials regarding the relevance of the model are also presented in this section. After the theoretical considerations, the paper presents the methodology, the content analysis and the findings. Annexes offer supplemental materials to understand the procedures and findings. 46

49 Part II. Chronic care model Theoretical and conceptual aspects During the past decades there has been an increasing pressure on improving outcomes of chronic illness and finding the most effective disease management approaches. In 2001 the Institute of Medicine published the report Crossing the Quality Chasm: A New Health System for the 21st Century 71 and it strongly recommended changing the current system of care so that it incorporates the needs of patients with chronic illness, as doing the same over and over again and trying harder will not work. The relationship between chronic care and the actual organization of the health care system is described as follows 72 : The models that are most useful in caring for the chronically ill are very different from our current delivery system models. Providing high-quality care to chronically ill individuals requires well designed care processes focused on information that meets the self-management needs of patients and their families. Patients with chronic illnesses require multidisciplinary care from teams of physicians, nurses, social workers, aides, and others. Team care is essential for high quality care. Our current health care delivery system, which is organized around professionals and types of institutions, grew out of a need to provide primarily acute care rather than chronic care. This is one kind of chasm we have to cross. The health care delivery system must be reorganized to meet the real needs of patients. Frameworks to guide efforts of changing the systems with the immediate aim of improving chronic care systems have been developed and adopted by various international Strategic Health Authorities, Quality Assurance Commissions and have also been embraced by the World Health Organization (see WHO global report, Innovative Care for Chronic Conditions: Building Blocks for Action, published in 2002). 71 IOM (Institute of Medicine) Washington, D.C: National Academy Press; Crossing the Quality Chasm: A New Health System for the 21st Century 72 National Academy of Engineering (US) and Institute of Medicine (US) Committee on Engineering and the Health Care System; Reid PP, Compton WD, Grossman JH, et al., editors. Building a Better Delivery System: A New Engineering/Health Care Partnership. Washington (DC): National Academies Press (US); Crossing the Quality Chasm. Available from: 47

50 One of the best known broad frameworks was developed at the end of the nineties by Edward Wagner and his team in U.S. and this model has been adopted in many settings 73 and for various diseases 74. Currently, most chronic care policies are based in various extents on the chronic care model (CCM) 75. The theoretical model hypothesizes than an effective care for persons with chronic issues involve creating a system that is able to 76 : Mobilize the community resources to meet the needs of people with long-term conditions Create mechanisms that promote safe, high quality care Actively prepare people to manage their health and healthcare, Ensure efficient self-management support, Promote care that is consistent with research evidence and patient preferences, Organize patient and population data to facilitate effective care. Briefly, the model states that the delivery of services that improve the clinical outcomes of chronic illness can only be assured if there are productive interactions between the patients and the practice teams of health care professionals 77. The productive interactions call on having the two parties involved in these interactions in special states, called activated states. In other words, patients need to be informed, motivated to act and prepared (have the health related skills and confidence in their efficacy to use their skills), while practice teams need to be prepared and proactive (with access to information, decision support and all the resources needed to deliver care). The model clearly emphasizes that the healthcare system is not an isolated entity and that healthcare delivery is not limited to various medical settings, rather a substantial part of chronic care happens outside the formal health settings. Productive interactions are defined as those that allow for the delivery of evidenced-base disease care in a systematic care so that the patients needs are met. They are described as being in contrast with the current interaction model that is unsatisfactory for both the patient and the provider. Interactions can be: face to face, phone interactions and/ or communication. 73 Stroebel RJ, Gloor B, Freytag S et al. Adapting the chronic care model to treat chronic illness at a free medical clinic. J Health Care Poor Underserved 2005; 16(2): , 74 Siminerio LM, Piatt G, Zgibor JC. Implementing the chronic care model for improvements in diabetes care and education in a rural primary care practice. Diabetes Educ 2005; 31(2): Ham C, Singh D. Improving care for people with Long Term Conditions: a review of UK and International framework.2006 ISBN X - HSMC, University of Birmingham. 76 Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract 1998; 1: Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A Survey of Leading Chronic Disease Management Programs: Are They Consistent with the Literature? Managed Care Quarterly.1999;7(3):

51 Figure 13. The chronic care model. Apud Wagner, reproduced with permission of the American College of Physicians (ACP) The Chartbook of Chronic Care Model, developed by Improving Chronic Illness Care group 78 lists that the productive interactions can be operationalized in a system by the existence of the following elements: Assessment of the self management skills and conficence, as well as clinical status Tailoring of clinical management by stepped care protocols Collaborative goal-setting and problem solving resulting in a shared care plan Active and sustained follow-up The productive interactions described by the chronic care model arise in the context of changed practices that call for redesign of operations and procedures on four main areas: self-management support, delivery system design, decision support and clinical information systems

52 Self-management support emphasizes the central role of the patient in the care relationship and it is supported by evidenced based recommendations stating that the likelihood of achieving optimal outcomes in chronic care increase when the patients are partners in the process of managing the illness. By providing self management support patients and families receive from the health provider (and the larger system) the needed help in order to cope with the challenges associated with the specific health problem they face 79. The collaborative relationship involves patient s involvement in setting the care goals, choosing the treatment plans and identifying ways to solve problems that arise while implementing the care plan. Self management support can be delivered in the context where there are appropriate educational tools, programs for skills training and services of psychosocial support, including behavioral interventions. The system can incorporate such services by participatory processes such as focus groups, advisory boards and expert panels. The results of these processes are to be incorporated into the design of the support services for patients and families. Delivery system design refers to the structure of the care team and the predefined pathways of interaction between the team and the patients; the design of the delivery system directly contributes to the effectiveness of the care process (both clinical outcomes and the self management level). This component of the model descibes the need for well defined tasks among team members (clinical, non-clinical) and a clear intention for structured and planned interactions. Unlike the acute care design, the chronic care delivery system is more effective if they are based on a planned interaction 80, that uses an agenda and a structured communication plan (such as the SBAR 81 communication structure: situation- background- assessment-recommendation). The use of a case manager (not necessarly the treating physician) that is able to intergrate information about the patient and create a coherent care plan is of utmost importance for a patient with longer term needs. It has been evidenced that the use of a case manager and/or health educator is effective 82 in several chronic conditions especially when the plan is associated with follow-up 83 ; creativity 79 Von Korff, M., et al. Collaborative Management of Chronic Illness. Annals of Internal Medicine127, no. 12 (1997): McCulloch et al. Effective Clinical Practice 1998; 1:12-22 and Disease Management 2000; 3(2): Dunsford, Jennifer (October 2009). Structured Communication: Improving Patient Safety with SBAR. Nursing for Women s Health 13 (5): Simon et al. Randomized trial of monitoring, feedback, and management of care by telephone to improve treatment of depression in primary care. BMJ. 2000; 320: Piette et al. Impact of automated phone calls and nurse calls on diabetes in the VA, Diabetes Care

53 is required in order to implement follow up, and research has been suggesting that planned group visits 84 and telephone follow up 85 are efficient and time efficient methods. Efficient case management involves the regular assessment of the following elements: Level of disease control/ symptoms, adherence and self-mangement status Immmediate action based on the results of the assessment: change treatment, inform primary care providers about changed needs Provide self-management support: reffer for psychosocial services, support group, educational sessions etc Ensure temporary sustained follow up, until the problem is stabilised Decrease barriers associated with navigating the healthcare system. Decision support is a component of the chronic care model that refers to assuring for the providers the access to the expertise necessary to offer effective care to the patients. In other words, the system needs to allow practitioners to easily identify the best care that can be offered (as suggested by guidelines and best practices) and to translate the guideline recommendations into usual care in the chronic care system. Decision support allows to promote clinical care that is consistent with scientific evidence and compatible with patient preferences. It is also suggested to share guidelines and information with patietns, so that they can understand why a particular decision or procedure is being performed. Clinical information systems indicates to organize patients and population data to facilitate efficient care. This imply to set up a disease registry that describes performance and results of health care and allows to identify and target specific interventions for populations that are at risk. For example, an electronic medical record should provide reminders for providers, facilitate individual patient care planning,share information on performance and so on. Community resources and policies refers to taking into account the entire offer of resources and services for patients that are not part of the medical system, but can offer complementary support for the care goals of patients. 84 Beck, A., et al. A Randomized Trial of Group Outpatient Visits for Chronically Ill Older HMO Members: The Cooperative Health Care Clinic. Journal of the American Geriatric Society45 (1997): Wasson, J., et al. Telephone Care as a Substitute for Routine Clinic Follow-up. Journal of the American Medical Association267, no. 13 (1992):

54 Examples include services offered by humanitarian organizations, exercise facilities, spiritual and faith based organizations etc. The model emphasizes the importance of mapping community services, partnering with those (formally and informally) and connecting patients with the auxiliary services in order to ensure a continuum of care. The linkages with the community includes also the common action, such as advocacy efforts to support patients and the elaboration of common strategies and workplans, with coordinated actions. The health system organization component of the chronic care model refers to the establishment of an organizational culture that is focused on quality care for patients with chronic issues and the organizational mechanisms that allows to achieve the measurable care goals. The health system must have in place the leadership, incentives and resources to help practices change to meet the needs of chronically ill patients 86. To summarize the above components, the chronic care model involves the existence of the following aspects 87 : Self management support: Patient education Patient activation and psychosocial support Self-management assessment Self- management resources and tools Collaborative decision making with patients Guidelines available to patients Delivery system design: Care management roles Team practice Care delivery coordination Proactive follow-up Planned visit Visit system change Decision support: Institutionalization of guidelines and use of prompts to use guideline Provider education Expert consultation support 86 Wagner EH, Davis C, Schaefer J, Von Korff M, Austin B. A Survey of Leading Chronic Disease Management Programs: Are They Consistent with the Literature? Managed Care Quarterly.1999;7(3): Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care2005; 11(8):

55 Clinical information systems: Patient registry system Use of information for care management Feedback on performance data Community resources For patients For community Health care organization: Leadership support Provider participation Coherent system improvement and spread The chronic care theoretical model (CCM) was tested and based on the published evidence it was revised to include cultural competency, patient safety, care coordination, community policies, and case management (see below). Figure 14. The care model, developed by the Maccoll Center 53

56 The published reviews 88 have proven that the CCM improves the delivery of care and patient health outcomes when practices are designed in accordance with its principles and recommendations. Moreover, the practice redesign is efficient when it takes into account most or all of the components of the model. Cochrane reviews regarding interventions that improve outcomes of chronic care 89 have proven that no single intervention seems to make a major difference (ie: interventions to change the typical behaviour of the clinician, interventions that were directed at the patient involvement, interventions targeting the design of the practice or improvement of the clinical information systems). However, as the number of interventions in different components of the model increased, the effectiveness of the program increased. In contrast, when looking at the studies of practice interventions that involved changes in all four categories 90, there was a positive impact on both process and outcome measures, including reduced costs of health care delivery. Canadian policy makers have adapted the CCM 91, since their analysis showed that the model was focused on clinically oriented systems, making it difficult to apply to prevention and health promotion activities. The model was further enriched to include population health promotion components such as the social determinants of health and enhanced community participation and it was renamed the Expanded Chronic Care Model (see below). As defined by the World Health Organization health promotion is the process of enabling people to increase control over, and to improve their health 92, changing the focus of responsibility from the health sector to the larger society. By integrating the population health with the prevention and management of chronic disease, the expanded model tackles simultaneously the determinants of health as well as the delivery of high quality health services. While the clinical outcomes result from productive interactions, the population health outcomes result from productive interactions among community representatives. The new model provides more details regarding the roles of the community (building policies, creating supportive environments, initiating community action) and also the influence of the community in shaping the main compo- 88 Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new millennium. Health Aff (Millwood) Jan-Feb;28(1): Renders et al, Diabetes Care, 2001; 24: Bodenheimer T, Wagner EH, Grumbach K. Improving Primary Care for Patients With Chronic Illness: The Chronic Care Model, Part 2. JAMA. 2002;288(15): Barr VJ, Robinson S, Marin-Link B et al. The expanded chronic care model: an integration of concepts and strategies from population health promotion and the chronic care model. Hosp Q2003; 7(1): World Health Organization, The Ottawa Charter for Health Promotion, 1986, healthpromotion/conferences/previous/ottawa/en/ 54

57 nents of the model (self-management, delivery system, decision support and information systems). The model is useful for development of coordinated and effective prevention and management of the chronic conditions, but currently the model is still to be tested in practice. Figure 15. The expanded chronic care model, developed by Virgina Barr et al,

58 Assessment of chronic illness care the ACIC tool The components of the CCM can be evaluated using a tool that was developed to measure current level of development of the six components as well as tracking changes over time, by recording the progress made on any component as a result of a redesign process 93. The ACIC questionnaire has of 34 items measuring strengths and weaknesses of the six areas of the CCM: health care organization (6 items); community linkages (3); self-management support (4); delivery system design (6); decision support (4); clinical information systems (5). The ACIC also covers integrating the six components, such as linking patients self-management goals to information systems (6 items) 94. A shorter 21 item version was recently developed by a Dutch research group 95. The items of the ACIC tool request from the respondent to score on a scale from 1 to 10 the level of development in their organization/ health facility of the following elements: Organization of the Healthcare Delivery System 1. Overall organizational leadership in chronic illness care 2. Organizational goals for chronic care 3. Improvement strategy for chronic illness care 4. Incentives and regulations for chronic illness care 5. Senior leaders 6. Benefits Community linkages 7. Linking patients to outside resources 8. Partnership with community organizations 9. Regional health plans Self-management support 93 Bonomi AE, Wagner EH, Glasgow RE, VonKorff M: Assessment of Chronic Illness Care (ACIC): A Practical Tool to Measure Quality Improvement. BMC Health Serv Res2002,37(3): MacColl Center for Healthcare Innovation:Assessment of Chronic Illness Care Version 3.5.[ acic_v3.5a.pdf], 95 Cramm, Jane M., et al. Development and validation of a short version of the Assessment of Chronic Illness Care (ACIC) in Dutch Disease Management Programs. Health Qual Life Outcomes 9.49 (2011):

59 10. Assessment and documentation of self-management needs and activities 11. Self-management support 12. Addressing concerns of patients and families 13. Effective behavior change interventions and peer support Decision support 14. Evidence-based guidelines 15. Involvement of specialists in improving primary care 16. Providing education for chronic illness care 17. Informing patients about guidelines Delivery system design 18. Practice team functioning 19. Practice team leadership 20. Appointment system 21. Follow-up 22. Planned visits for chronic illness care 23. Continuity of care Clinical information systems 24. Registry (list of patients with specific conditions) 25. Reminders to providers 26. Feedback 27. Information about relevant subgroups of patients needing services 28. Patient treatment plans Integration of chronic care components 29. Informing patients about guidelines 30. Information systems/registries 31. Community programs 32. Organizational planning for chronic illness care 33. Routine follow-up for appointments patient assessments and goal planning 34. Guidelines for chronic illness care ACIC is a tool that can be applied in various health-care systems, including hospital based settings, community health centers or for profit medical providers. 57

60 Recommendations to improve care based on CCM The Institute for Healthcare Improvement establishes a series of practical recommendations and changes for improvement that are to be implemented by systems interested to plan and implement a theoretically sound and evidenced based change process 96. The recommendations are listed below, per each CCM component: Change recommendations regarding self-management: Train Providers and Other Key Staff on How to Help Patients with Self-Management Goals Use Self-Management Tools That Are Based on Evidence of Effectiveness Use Group Visits to Support Self-Management Set and Document Self-Management Goals Collaboratively with Patients Follow Up and Monitor Self-Management Goals Change recommendations regarding delivery system design: Use Planned Interactions to Support Evidence-Based Care Ensure Regular Follow-Up by the Care Team Define Roles and Distribute Tasks Among Team Members Change recommendations regarding decision support: Embed Evidence-Based Guidelines into Daily Clinical Practice Integrate Specialist Expertise and Primary Care Use Proven Provider Education Methods Share Evidence-Based Guidelines and Information with Patients to Encourage Their Participation Change recommendations regarding clinical information systems: Share Information with Patients and Providers to Coordinate Care Provide Timely Reminders for Providers and Patients Change recommendations regarding healthcare organization: Make Sure the Senior Leaders and Staff Visibly Support and Promote the

61 Effort to Improve Chronic Care Encourage the senior leader to: ÕÕ Visit the clinical team. ÕÕ Speak about the improvement effort in all-staff meetings. ÕÕ Participate in writing the aims and goals of the initiative and provide guidance for the clinical team. ÕÕ Make monthly updates to the community. ÕÕ Present local morbidity/mortality data to the Board of Directors to make a compelling case for the need to change current practice. Have the physician champion share tested tools and interventions at provider meetings to engage interest and involvement. Have team members present improvement activities at staff meetings. Have the senior leader help identify the most enthusiastic and respected clinician to be on the improvement team and test changes in his/her practice. Change recommendations regarding community support: Encourage Patients to Participate in Effective Community Programs Form Partnerships with Community Organizations to Support and Develop Interventions That Fill Gaps in Needed Services Final comments regarding the CCM usefulness and limitations The CCM has been extensively researched in various observational studies and consistent evidence has been gathered about each component of the model. There is evidence that single and multiple elements of the CCM leads to better care, improved clinical outcomes and more effective resource use. There is not enough evidence whether all components of the model are equally effective or essential for improving care. There is no comparative evidence whether this framework is better than other frameworks, mainly because there are no many other models formulated already Ham C, Singh D. Improving care for people with Long Term Conditions: a review of UK and International framework.2006 ISBN X - HSMC, University of Birmingham. 59

62 Part III. Qualitative assessment findings Aim of the qualitative assessment Baylor Foundation set up to evaluate the current structure of the care available for patients affected by hepatitis C virus (HCV) in Constanta, Romania against the components of the Chronic Care Model, in order to identify areas for improvement, gaps and possible recommendations for increasing the quality of care. This was done in the context where services for HCV care are provided by the public sector and by Baylor foundation. A secondary objective was to identify priority areas of service development and improvement for Baylor Foundation s HCV development strategy. Methods To collect the data for the evaluation, qualitative collection methods were selected, in order to ensure enough information that will help understand the current issues specific for the description of strengths and challenges embedded in the structure of the current care for HCV. Qualitative evaluation is also most appropriate where little is already known about the subject of interest or where specific details are required from individual participants 98. The following methods were chosen by the team: focus groups group interviews with people sharing similar characteristics, led by 1 or 2 facilitators, based on a group interview guide 99 ; individual interviews to explore experiences, beliefs and attitudes of the stakeholders in regard to the topic of the level organization of the HCV care in the region. Both methods were applied using semi-structured interviews, since this 98 Gill P, Stewart K, Treasure E, Chadwick B. Methods of data collection in qualitative research: interviews and focus groups. Br Dent J Mar 22;204(6): Barnett J. Focus Group Tips for Beginners. Texas Center for the Advancement of Literacy and Learning. 60

63 type of guided data collection allows for the identification or elaboration of information that is important to participants, but may not have previously been anticipated of as relevant or important to include by the research team. Focus groups and one to one interviews were carried out by an independent organization commissioned by Baylor to conduct the fieldwork during 9-12 September 2014 in Constanta and 1-20 October in Bucharest. The average duration of focus groups and interviews was of ~90 minutes. All interviews were recorded on an audio-recorder and were later transcripted verbatim. The semi-structured interviews guides covered the following categories of information: Information systems: epidemiologic information, registries, information about relevant subgroups of patients needing services Examples of questions: What is the prevalence of hepatitis C in Romania? Is there a National Registry for people affected by hepatitis C? How people at risk, insured and uninsured, are identified and directed to testing services? To whom do you recommend testing for hepatitis C? Are there any groups of population that systematically are less likely to receive treatment in the public health system? Which are these groups? Why are they less likely to receive treatment in the public health system? Decision support: information about modalities of taking clinical decisions collaboration between practitioners, level of provider education, informing patients about guidelines Examples of questions: Who recommends and establishes the treatment scheme? How do you collaborate with other specialists (infectious, internists, psychiatrists, etc.)? Which are the categories of personnel involved in the detection, treatment and monitoring patients with hepatitis C? Are they properly trained? What is the time interval the patients (with and without treatment) are evaluated at? What does the monitoring and evaluation imply? How long does this stage take? How do you explain to the patients the results of the reactive rapid test? How do you explain to the patients the positive results? What do you recommend in each situation? Delivery system design: use of an appointment system, follow-up, planned visits, continuity of care Examples of questions: How do you keep in touch with patients (communication system)? Out of the total number of patients how many follow the monitoring and evaluation program and visit you 61

64 periodically? What is the general practitioner role during this phase? What support do you offer in putting together the treatment required documents? Are there waiting lists? How many persons are on these waiting lists? Questions for patients: Please describe how was the interaction with the health system (public and / or private) during the screening process until monitoring (interaction with the system and medical staff at different levels of the system) and the main barriers encountered in accessing medical services; Please make the history of doctors and places You went in the public or private sector? How long did it last from identifying symptoms and diagnosis to getting treatment? How often do you visit the doctor for check-ups? What does the check-up implies? Self-management support: addressing concerns of patients and families, ensuring access to effective behavior change interventions and peer support: Examples of questions: Do you (patient) have a delegated person/ a case manager/ medical staff (nurse, doctor, and specialist) that you can talk to about the disease? What type of support provides you? Which is the best source of support for you (patient)? How do you (practitioner) support patients embracing a healthy lifestyle? Do you (practitioner) think it would be useful to implement a personalized plan for encouraging a healthy lifestyle for your patients? Questions for patients: Did you received counseling before / after testing? What information did you received about the disease (about the widespread of hepatitis C, impact and evolution of the disease, possible treatments, where you can find more information and get support, etc.)? Who gave you this information? How did you communicate with the medical staff? Organization of healthcare system: existence of organizational goals for HCV care, regulations, incentives, leadership Examples of questions: Which are the national priorities regarding hepatitis C? Is there a national strategy to combat hepatitis C? What is the legislative context? What is the budget allocated by the state to cover the costs of treatment for hepatitis C? What should a national program for hepatitis C include? Are there any prevention programs? What should they include? During the lasts years, were there any national awareness/ information campaigns regarding hepatitis C? If so, 62

65 what was their impact? If not, would you consider them useful? How should they be conducted? Which are the main recommendations to improve the situation of patients with hepatitis C? Community linkages: partnerships with community organizations, regional health plans Examples of questions: Are you (practitioner) aware if there are alternatives to state run services in the private / NGO sectors? Are there any NGOs active in this field? What is the involvement of NGOs working in the field, of patients associations etc.? Participants Convenience sampling was used to recruit participants. Phone calls were made to invite participants and those were followed by written invitations explaining more about the purpose of the assessment, the time demands as well as the facilitators of the data collection. 59 patients were invited to participate, 43 accepted to participate, finally, 36 did attend the focus groups. The reasons why the persons that had the intention to participate, did not attend the meeting are not known; the patients that declined the invitation were mainly not able to attend due to schedule conflicts, including travelling. 16 family doctors were invited to participate in focus groups and all have expressed their intention to attend the meeting; 10 have actually been present, the reasons for those skipping the meeting are not known. 13 specialists and service providers were invited to participate in interviews; 3 specialists have declined the invitation (Ministry of Health, diabetes specialist and psychiatrist) for various reasons: not knowledgeable about the hepatitis C issue or busy schedule. A total of fifty-six persons (patients and professionals) accepted to be part of the interviews/ focus groups and were included in the qualitative assessment; the main groups targeted were: patients with hepatitis C (in various stages of the disease), from Constanta County, who have benefited of services provided by the Baylor Foundation; clinicians, including medical specialists and psychologists from public 63

66 hospitals and general practitioners (GPs), from Constanta and Bucharest; specialists in the health policies sector, both at local and national levels; representatives of civil society organizations active in the field, from Constanta and Bucharest. Data collection was based on semi-structured interviews with specialists and organizations of patients and focus groups with patients and GPs. The interviews and focus groups discussions followed five semi-structured guides, which are included in Annexes. No. of interviews/ Focus groups Interviews, of which: Patient organizations Medical specialists Specialists in the health policies sector 3 3 Focus groups, of which: Patients General Practitioners 2 10 Table 13. Distribution of interviews / focus groups and respondents No. of participants service providers patients with hepatitis C Total number of interviewees, of which: Medical professionals 15 - Policy specialists 3 - Patient organizations 2 - Women Men 1 14 Rural 3 5 Urban Age: years - 9 Age: years - 16 Age: >65 years - 11 Table 14. Distribution of interviews / focus groups and respondents 64

67 Analysis of the qualitative data Verbatim transcripts in Romanian were analyzed by two researchers (AMS and MB) using thematic analysis 100. Using the theoretical components of the Chronic Care Model (CCM), the procedures of performing the qualitative analysis of the verbatim transcripts were established. A coding manual was elaborated using the items of the ACIC tool and codes were established for all six components of the CCM. In order to precisely identify the constructs of each component of the model, the ACIC evaluation tool was examined and item content was associated with a specific subtheme. The code was also analyzed on wheatear it indicates the absence, the relative development or the presence of the feature that was examined. For example, a text coded for the domain community linkages could be ranked as little support, basic support, good support or full support, thus showing not only the existence of the theme, but also the level of development of that specific feature. Codes for items in the ACIC tool that were not identified in the themes of the verbatim transcripts were also highlighted in the final analysis. The two researchers have individually coded the transcripts using the coding manual. The codes allocated were afterwards compared; disagreements were solved using consensus and comparative analysis was used re-iteratively. Each summary table also groups the issues associated with the statements from the participants as: current needs (aspects that participants consider should be developed in the future) current capacity (aspects that are currently in place, on which services can be built on, as suggested by participants) proposed solutions and ideas generated by the participants during the interviews and focus groups 100 Paillé P:Qualitative par théorisation.in Dictionnaire des methods qualitatives en sciences humaines et sociales.edited by Mucchielli A. Paris: Armand Colin; 2009:

68 Results The interviews and focus groups allowed for the collection of a wealth of data that were organized on all six components of the CCM. Assessment per each component is summarized below, together with general comments regarding the integration of all the components. Regarding the healthcare system organization among the issues that are well defined the interviews revealed the following aspects: financial resources mobilized for the treatment: the hepatitis C treatment is completely subsidized by the National Insurance Fund, for all patients that have a health insurance; however, there is not a fixed budget allotted for HCV treatment, each county s Health Insurance Fund being responsible for the level of prioritization of the disease and for the number of patients that can be treated per year. good detection of hepatitis C among pregnant women thus making it the most systematically implemented recommendation. This recommendation is usually being made by family doctors or gynecologists. However, testing for pregnant women is now always subsidized, but most women in Constanta region are able to pay for their blood tests or to use a community resource, such as Baylor s free of charge rapid testing program or other temporary free of charge campaigns. partnership in place between various pharma companies and Romanian Health Insurance Fund allows for subsidized detection of HCV viral loads for patients with approval for treatment. This is managed exclusively based on vouchers distributed by pharma to specialists. The most prominent aspect that results from the qualitative analysis is the fragmentation of healthcare. Patients have to understand, master and manage the relationships between at least 3 different institutions/organizations: 1. the organization that provides the specialized HCV care ( where the specialist is affiliated) 2. the National Insurance Fund (where the file for treatment is submitted, the approval for treatment is obtained and the renewal of every monthly prescription is requested) 3. the family physician office (who is supposed to integrate all information about patients and ensure follow-up). Starting from the file [for treatment approval] you start running first 66

69 this doctor than you go to the other doctor.than from that doctor, you run to the other. Ok, I can accept that, but when you get the approval [to get free treatment], every month you go to ask for the prescription go hand over the prescription stamp me this piece of paper, stamp me that This experience [treatment approval files] is for the patients like Purgatory There is insufficient coordination between the actions and interventions developed between the 3 organizations listed above, and this creates discontinuities in care. Interviews revealed the following issues that are listed from up level of the system to the bottom one: Current needs leadership in chronic HCV care needs to be defined; there is no national program, nor national strategy to support the prevention, treatment and care of persons affected by HCV, nor the integration of these components. Individual initiatives or isolated projects do exist, but efforts are not connected with each other. goals and strategies for hepatitis detection focused on patients with symptoms that may flag the existence of HCV need to be set need to identify cases in a more systematic way, instead of by chance Statements [physician] There has been more than 2 years since we hear about promises about a national program; no one knows yet how it will actually look like [physician] There are no specific actions in this direction, and this is my short answer regarding the HCV policies [physician] I am sorry, maybe one can consider that I talk ill about my fellow doctors, but I believe that we need to have a durable national program to detect HCV; because now one detects it only by chance and it is such a pity to die because of this these days [ physician] Here at the hospital, we do not actively look for patients with HCV; not even when their transaminases level is high, we still do not test for the virus; we can order an echo graph or other investigations, just to stay within the budget.there is always the issue of funding [physician] The majority of patients in my care has been diagnosed completely by hazard, usually because they came to the hospital for other illnesses. Were there HCV screening programs? At the hospital where I work, never! No? Unfortunately, no 67

70 need for timely detection of new cases need to expand the network of specialty doctors (gastro-enterologists, infectious diseases specialists, hepatologists, internal medicine specialist) need to develop incentives and regulations to increase HCV screening in the primary care network need to allocate appropriate resources for timely followup of patients need to decrease financial burdens for hospitalized, insured patients [Patient] I had no symptoms whatsoever I simply saw the testing announcement on the street [regarding Baylor free of charge screening program] and I made an appointment and took the test [ physician] As a specialist I see very many patients that are diagnosed at very advanced stages of diseases progression.many are not diagnosed at all. [patient association representative] There are counties where there are very few doctors that are specialized in treating hepatitis, so patients have to travel to big cities or to university centers. [public health representative/] Family doctors have a very important role in prevention of HCV. When they encounter a situation of hepatic cytolysis, they should immediately think about screening that patient. And, again, when they identify risk situations, he should recommend testing for HCV. Screening everyone is not feasible, but one can educate, sensitize the family of the patient. So, yes, family doctors should play a very important role [ physician] I talk about the problems at the hospital where I work: it has been more than a year since we have not been able to detect the hepatitis viruses B and C, due to technical and financial reasons. Bio molecular and echo graphic tests suggest hepatitis, but we cannot run the confirmatory tests. [patient association] For example, one is hospitalized for an affection. During the hospitalization one does not receive any prescription from the family doctor and he has to buy the medication from the commercial pharmacies. The hospitals do not provide the medication because the pharmacy might not have the medication. 68

71 Current capacity free of charge testing is partially available easier referral process for those potentially exposed is available, but limited to the NGO community provider Statements [patient] One gets tested for free [in the public system] if he goes to donate blood; it is free of charge then and here, at this foundation [Baylor] otherwise, everywhere you go, to any other laboratory you have to pay [Baylor project manager] We encourage the patients with confirmed HCV to refer their families for testing as well. Our procedure allows to family members of patients exposed to HCV to come at our center and get tested without a prior appointment (no waiting time). Proposed solutions system organized around specialty doctors needs to include additional support, such as by increasing the role of family doctors in the HCV care prevention of hepatitis C at the primary care level should be tailored, instead of having a one measure fits all protocol Statements [HCV specialist] I believe that family doctors should be the ones that would gather all the information about the patient and manage it, make sure to follow up on the patient and refer him to other specialists, if necessary It is not the task of any specialist to integrate the HCV patient, even if we are doing it many a times. I am aware that family doctors also have very many patients and they are very busy too, but in my mind this would be a normal situation, to have a higher responsibility of the family doctor in the management of the HCV patients [public health representative] It is the responsibility of the family doctor to explain to the patients about prevention of various affections, including hepatitis C, when patients come for their annual visit. This is something new that has been introduced into the contract [between the doctor and the Health Fund]. Once a year, patients meet with their doctor and he presents everything. 69

72 inter-disciplinary consults need to become the norm [Patient 1] I was not sent to the endocrinologist [Patient 2] And they did not sent you also to the cardiologist? [Patient 1] No, no Did you? [Patient 2] Yes, I was referred to the endocrinologist, I was also sent to check my heart [endocrinologist] I always refer my [HCV] patients to my colleagues that are specialized in this disease Note: by December 2014, the Romanian authorities have released a document regarding the surveillance procedure for the reporting of hepatitis cases 101, in order to be able to identify trends of hepatitis, vulnerable groups and risk factors specific to Romania. Regarding community linkages the general observation is that its development is at an incipient stage and this makes sense with the situation where the healthcare organization of HCV care as a chronic disease is also still at an incipient stage. Community linkages domain requires a great deal of program design and development regarding the prevention and chronic care of hepatitis C. There are only two HCV patient organizations in Romania, who act especially on advocacy, policy development and general education; at the stage of this report, their activities were not correlated and one patient organization has been known to activate in Constanta, but only for specific, single time events- such as sensitization days. NGOs that directly offer services are limited in number and scattered. Community linkages are limited to Baylor foundation- in the region, most partnerships being created ad-hoc, between private practitioners and support organizations, out of the desire of helping patients

73 Current needs need to ensure a supportive environment so that vulnerable groups can access health care timely. need to create regional health plans and more coordination between key players, including NGOs and patients associations Statements [public heath representative] First of all, those that are uninsured would never go to the family doctor in the first place there are also costs associated with going there, so this is a huge barrier. [public heath representative] The fact that an organization, such as Baylor, has become involved in this campaign, it is proof that the support of an NGO is required, to support family doctors and the population in general, because there are not national programs right now. [public heath representative] The only thing that we truly need is the counseling part. To help the patient understand what is going to happen to him, to understand the risks and I think it is important to discuss with Baylor and think about distributing some first line information to the family doctors; also some training are necessary, to help family doctors do counselling about HCV. I think organizing some discussion groups with Baylor about next steps in counselling patients that are already diagnosed with HCV give family doctors some tools, how to do such a counseling in ten minutes or so that will make things easier for the doctors. need for improved mapping of community resources and easier ways to connect between the institutions Are you aware of any NGOs that are active in the area of HCV? Do you work with any of those? [physician] I do not collaborate with any organization. But do you know about any organizations? I don t even know they exist. This is the first time when I hear. I am not sure there is anything they can do about hepatitis [ specialist] If my friend, who is a family doctor, wants to refer someone to the foundation [Baylor, for testing], how can the patient have access. I am asking because I do not know. How does he send the patient? With a referral letter? Here, at the hospital, we send to Baylor office [within the hospital] the patient, with the nurse and his hospitalization document. But, what is the procedure for the family doctor? 71

74 need to raise awareness regarding the added value of community resources to the healthcare process How about the role of NGOs in offering counselling services? [specialist] I have to admit, I did not think about this before. Yes, we are always chased from one task to another, we never have time, so many a times the patient remains with less information then he actually would need yes, counselling would be quite helpful. Current capacity once established, community linkages create improved pathways for patients referral partnerships between public health organizations and NGOs compliments and support the work of healthcare specialists follow up support for vulnerable patients is limited Statements How did you [patient] find out about the foundation? My doctor has sent me here. I went to the family doctor, I asked for blood tests and she explained how to come to the foundation. [patient statement]: I think that private offices should collaborate with [Baylor] foundation. I found out about the foundation from another patient, my doctor did not send me here, like the family doctors of other persons did. For me, personally, as a doctor, when patients come prepared by the foundation [i.e. counseled at Baylor] it is a huge help. I am relieved when I hear them say I know, I know about hepatitis, I know what to expect. They [the patients] come already sensitized, educated and I am really grateful when I get such a patient. [Public Health representative] If you are diagnosed with HCV but uninsured you don t get care [Baylor project manager] The treatment is free of charge for those insured; when we have a patient that is uninsured we teach him the steps he needs to take to obtain an insurance he can pay an insurance fee retroactively Self-management component refers to a system s ability to perform routine assessment of patients needs and to provide to patients access to self-management and behavioral change programs. The analysis of the transcripts has revealed that there are frustrations on both sides of the interactions: On the one side, patients feel neglected, not heard and thrown away 72

75 from one unpleasant situation to another; On the other side, the health care providers, are also frustrated as a result of the interaction and they come to describe patients as coming forward with stupid questions or as being at fault. The behavioral results of these communication barriers lead to various situations. For example, patients turn to self-education, and moreover to self-medication, or they simply abandon treatment. Also, healthcare providers turn to ultimata or to fear arousal strategies, thus risking to lose the relationship with the patient and thus a chance for healing someone. Both parties, patients and healthcare providers, acknowledge the importance of education and emotional support, and this represents a positive foundation on which it can be built upon. The role of psychologists and support persons is also being recognized, although since these type of practitioners are not generally part of the traditional public health system, there is more a theoretical desire to collaborate with this type of experts, than a practical, at hand option to include them in the team or referral network. The concept of patient self-management per se was not identified during the analysis of the transcripts; active building of patients skills regarding their own health is still a concept to which the medical community that was interviewed need to be introduced to. Shared decision making, collaborative goal settings and planned behavioral change interventions are only incidentally formulated as formal care objectives, the intuitive implementation of such strategy being mostly reported by those included in this qualitative assessment. Orientation tools, health literacy materials and educational support were rarely mentioned and not routinely used. Current needs need to increase patients knowledge or skills to navigate the healthcare system (to obtain and go through the entire treatment). Statements [ Health Fund representative] Generally speaking, everywhere one looks around in the medical system, patients don t know what to do and their lack of knowledge is transformed into aggressiveness against the medical personnel. There are patients that come to the Health Fund with their treatment file and then they do not come back for one or two years; when they return, and they have lost their turn to get the medication, they are the ones that get upset. 73

76 -So, getting the treatment is not an issue of access to treatment? - No, it is not! It is all about management! To keep the pace with the system once you entered it. To be perseverant. To be focused to achieve your goal. clinicians perform alone all clinical functions: The HCV specialist bears the exclusive responsibility of the entire management chain of the patient, from the entry point until the exit point. This involves, potentially being over-burdened taken that he is the only one responsible with all the self-management issues, such as the assessment and documentation of self-management needs and activities, providing self-management support, addressing concerns of patients and families and implementing behavior change interventions. [Baylor project manager] The HCV screening program that we unfold make sense only if we manage to help patients to access the treatment. It is not enough to give him the bad news [that he is infected], but it is important to help him manage the new situation that he is in. So, one-two or three months after he [the patient] starts the treatment he feels weak and he comes and tell me that he can t go on anymore. And I have to use all my convincing skills. This is a hard work. And who is also in charge with this entire work of clarification with the patient? Only I, as a specialist. Always? Yes, always. How about the family doctor? No, they rely on me too. I have no idea what the family doctor actually tells to the patient. 74

77 Current capacity patients who receive simple interventions that ensure support and follow up, better manage their health process. Proposed solutions emotional and peer support for patients has potential to be effective both in views of the patients themselves and of the health providers. Statements [patient] In March 2012 I have submitted my file [to the Health Fund] and my approval arrived in August. I managed to remember because the ladies from Baylor telephoned me; they asked me if I have called at Bucharest to ask about the status of my approval. And I said to myself: BINGO! Let s do that. So, without their help, I wouldn t have remembered, I would have expected for the approval to be sent at my home. [Baylor project manager] Because patients need support to adhere to the treatment, because it is important to accept the diagnosis and go through the whole process, we have initiated support groups and other complimentary services that are not offered by the [public] system. Statements [ specialist] I believe that sessions with persons that are just diagnosed or are in the process [of being treated] would do them a lot of good. [ public health representative] Some kind of a group, led by a foundation would be great to share experiences, understand the steps that are to be followed [patient] Like there are abroad, some support groups for people with similar diseases [Baylor project manager] I would say that the critical moment is when the person is communicated the diagnosis. At the point, the madness starts: why me? Where did I get it from? How will I cope with the treatment? 75

78 patients need competent and trusted self-education sources; when information provided in the healthcare setting is evaluated as non-satisfactory, patients turn to other sources, mainly to the experience of other persons (neighbors, acquaintances, and relatives), internet forums and similar online sources. [patient] The doctor will not explain anything to you. So you d better start reading right now! He is busy. If you do not start to read about your problem, you are up in the air You need a lot of patience to watch shows, read leaflets if you find any... If you come here [at Baylor], take one of the leaflets too, it should stick to your hand. This way you will eventually learn something. I checked an online forum and I read that there were others that have taken less pills. So I did the same, Instead of taking 6 pills a day, I was taking 5 pills a day. And I felt better.i still have those pills at home As described in the theoretical part of the chronic care model, the decision support component refers to identifying the best care that can be provided to patients and searching for modalities of translating those recommendation into routine, day to day standard operating procedures. Our assessment aimed to evaluate the general perception among healthcare practitioners that were interviewed, regarding the existence and usability of evidence based guidelines and recommendations that support their clinical decision. Guidelines and procedures were mainly mentioned as those who regulate the approval of dual treatment by the National Health Fund. There were accounts with a lot of details regarding the criteria that the commission that approves the file takes into consideration, thus focusing mainly on a bureaucratic process to access treatment. This is the most prominent and most structured dimension regarding decision support. However, the HCV treatment guideline published in the Official Monitor in 2010 describes in only 5 pages the therapeutic management of patients with hepatitis C (patients not treated, patients with co-morbidities, relapses and the management of side effects). It does not provide any guidance about the implementation procedures, thus leaving at the latitude of the individual sub-systems to create their own processes. For example, the guide briefly lists when various HCV related blood tests should be performed, but in practice only some of the tests are reimbursed by the insurance. This leads to limited possibilities to implement the guideline recommendations in real life; this leaves providers with having to find ad-hoc solutions. Also, quality improvement cannot happen spon- 76

79 taneously in any settings, without a planned approach and eventually, with external practice support. There was no information regarding the process of revision/ amending the guidelines during the interviews from any participant. No participant in the qualitative assessment has mentioned any best practices that they are aware of regarding integrated chronic care. Most health providers are creating their own set of rules, tweaking around the edges of an acute care system not capable of handling needs of chronic illness 102. Current needs limited involvement of specialists in primary care. need to improve patients understanding regarding guidelines and procedures need to improve training on the evidence behind the care, especially among the primary (family) doctors. need to increase guideline based practices, rather than those based by preferences or ad-hoc practices. Statements Do your patients have to come with a medical letter from the family doctor? [specialist] Yes, but I generally manage my patients alone [without the involvement of the family doctor]. My patients can continue to keep in touch with their primary carer, but I am a responsible doctor and I like to do my job well. So, if I know that my patient will come this Monday, I simply write down what tests he needs to take [without referring for that to the family doctor] [specialist] I have not been talking with a family doctor for a long time. I do not know if they can order anti-hcv tests [patient 1] So, is it easy to prepare the file or not? [patient 2] The doctor does it, you just sign it! [patient 3] oh, so you have to agree [patient 2] many times they will not inform you. Do you have patients at your offices [with hepatitis C] that are not currently on treatment? [family doctor] Yes, the majority of them, Is this because they are not eligible? [family doctor] Honestly, we do not know what is going on in the mind of the specialist that evaluates the case [HCV specialist] I, personally, prefer to ask my patients with low fibroses to return for an evaluation. I expect at some point to see increased fibrosis. Not everyone does it

80 Proposed solutions evidence based guideline for primary care could guide everyday practice outdated and limited therapeutic options (at the date of the report, only interferon based dual therapy available free of charge in Romania for insured patients). statements [family doctor] Guidelines should state who the population at risk [in Romania] is, so we know it! Whether they want to be investigated or not, we will find solutions somehow, we will convince them! At least a temporary screening initiative might be required. [ specialist] Having the triple therapy would be in the advantage of the patient. There are less side effects to manage. Delivery design component details who is part of the health team and what are the ways of interaction with patients (ideally based on planned visits, follow up and continuity of care). The analysis revealed a general trend of working separately (all heath providers in the interviews and focus groups): each institution with its rules, each professional with his own practice habits, with its own human and health resources etc.; thus it can be inferred that multidisciplinary teams involved in the management of HCV patients are rare, linkages between various professionals being more common. The lack of such teams leads to the inadequate development of the delivery design, since it is not focused on chronic care. The authors could not detect any indications regarding planned visits, rather the majority of patients with chronic conditions are assisted in a very similar way with those with acute conditions. Moreover, continuity of care depends on the doctor s interpersonal and human skills and on his availability to create communication bridges with other specialties. 78

81 Current needs leadership regarding the delivery design needs to be clarified appointment system with specialists for patients with chronic health problems in public hospitals settings is not common practice need to improve continuity of care very limited situations where teams include psychosocial personnel Statements [family doctors] Where is the leadership for the management of the disease, in terms of talking with the patients about what the treatment implications are, how it is going to be Ah! That is the job of the specialist The infectious diseases doctor No, we all do it. We do it and the hospital [infectious diseases] does it too.. [patient] I would wait in front of the doctor s door from 8 AM just to get the prescription. If I insisted to be seen, he would explain to me how busy he is, that he has an entire ward with many patients with problems so around 4 PM I would actually get my prescription. [patient] When I go to renew my prescription, I never see the doctor, only the resident if I want to ask him something, he [the resident] doesn t know what to say. Did you have any side effects [due to the treatment]? Did you go to see another specialist? - [patient] Oh, naturally, I did! I went to the neurologist. Did your doctor send you there? [patient] No, I went there by my own decision. Because I was fainting. I wanted to find out why I was fainting so suddenly. [endocrinologist] Generally speaking I have a good relationship with my patients, and after they are seen [by the HCV specialist], they came by themselves to tell me if they started the treatment, how they are feeling [ family doctor] It is hard to find a psychologist. Is there any working in both state policlinics here in Constanta? [Baylor project manager] our team is made of doctors, nurses, psychologists and counselors 79

82 limited awareness about the roles of some support team members [family doctor] What can a psychologist do for a patient? There is nothing he can say to change things for him. Believe me! The only thing that matters is when the patient sees his viral load result as undetectable Proposed solutions support personnel directly involved in case management statements [Baylor project manager] Our case managers [psychologists] ensure patients follow-up, until they are registered with a specialist and the diagnosis is confirmed... we buffer the relationship between the doctor and the patient The final component, clinical information systems, covers the aspects that encompass data management that allows for targeted interventions for those in care. As stated above, at the date of the data collection there was no official surveillance system available in Romania. At the end of the year 2014, the surveillance forms and procedures of data collection were published by the NATIONAL INSTITUTE OF PUBLIC HEALTH. However, in the spirit of the CCM we were mainly interested to identify the clinical information systems that are used for micro-management (for smaller clinics, offices, hospitals), or for local/regional collaborations, and not specifically for the country wide system. This part of the assessment is supposed to see if clinicians are actively organizing their work using registries, reminders to perform specific clinical tasks and if they use some specific technology to plan the treatment. As a general comment, it can be observed that there was very little evidence in the data collected regarding the organization of clinical information systems for care management and treatment plans purposes. The majority of reporting and data collection is being requested by higher order institutions and feed-back is rarely integrated back into the current practice. Providers would need to make a special search effort to find out information regarding subgroups of patients. 80

83 Current needs need to increase awareness about program impact and results key information regarding the prevalence of HCV needs to be identified Statements [ physician] I am just a practicing doctor, so I do my job as a doctor, I am not a statistician. Probably there is [somewhere] a situation, a report about patients with HCV We simply do what everybody else does: we just report the data of the hospital. Now, if the data is further centralized, that I wouldn t know to tell you [representative of Public Health Authority] We do not collect data about the prevalence of hepatitis, not at the country level and not at the national level. Right now specialists are working to create a national registry of patients with HCV. -Can you tell us anything about at risk groups? [representative of Public Health Authority] I have no statistics at the level of the institution, to be able to Current capacity National database in preparation Statements [ patient association representative] Currently the Matei Bals National Infectious Diseases Institute is developing a national database of patients [ever treated for hepatitis] more than 35 thousands persons are listed there Proposed solutions Prompts and alerts relevant to the physicians need to be interpreted/ communicated to the patient. Statements [patient] You know what? The doctor should be alerted immediately. When he took all those tests for my liver, he knew that my transaminases where very high. He should have alerted me also! I have had these result for over a year now. My doctor should have alerted me and say Mister, something is wrong with your liver. 81

84 Wrapping it up all together Mapping the content analysis against the ACIC assessment tool The results of the qualitative assessment provide an evaluation of the HCV chronic care delivery system available in Constanta, Romania, where Baylor foundation runs its main operations as well. The above results revealed by the content analysis have been further mapped and summarized to draw the qualitative assessment s conclusions. In this respect, two researchers (AMS and MB) have classified the indications revealed by the transcripts on the 4 level scale of the ACIC assessment form (see table 3 below to understand the coding procedure). The scale classifies the development of a key element of a component as having little support, basic support, good support or full support. The sub-components for which the researchers did not find any proof during the thematic analysis were not coded (marked as blank, see legend). The researchers have collected all the codes associated with qualitative text data and analyzed the following elements: presence or absence of codes related to the ACIC items current level of development of the features identified among the themes. 82

85 coding Community resources Community partnerships Components Little support Basic support Good support Full support Linking Patients to Outside Resources is not done systematically. is limited to a list of identified community resources in an accessible format. is accomplished through a designated staff person or resource responsible for ensuring providers and patients make maximum use of community resources. is accomplished through active coordination between the health system, community service agencies, and patients. Partnerships with Community Organizations do not exist. are being considered but have not yet been implemented. are formed to develop supportive programs and policies. are actively sought to develop formal supportive programs and policies across the entire system. Coordinated community Regional Health Plans do not coordinate chronic illness guidelines, measures, or care resources at the practice level. would consider some degree of coordination of guidelines, measures or care resources at the practice level but have not yet implemented changes. currently coordinate guidelines, measures, or care resources in one or two chronic illness areas. currently coordinate chronic illness guidelines, measures, and resources at the practice level for most chronic illnesses. Table 15. Coding procedure based on the ACIC tool Community Linkages Linkages between the health system and community resources play important roles in chronic illness management. It should be noted that maximum values at all scores, indicating an excellent level of development and integration of chronic care interventions, are an ideal situation towards which health systems should strive for. In real life, identifying current weaknesses of a system should guide the development of interventions to improve the delivery of care for patients affected by chronic conditions. The evaluation based on CCM can be used for strategic planning of system change and/ or redesign. The findings are summarized on the next table: 83

86 The observed strengths of the current HCV care system in Constanta region refer to the existence of the evidence based guidelines, especially regarding the eligibility of patients for treatment and the treatment administration; the other components that have a good development refer to community linkages and self-management support, this underscoring the importance of increasing the community involvement during all the episodes of care, within 84

87 and between institutions and organizations. There is existent capacity, especially regarding the organization of health care and the delivery design on which a more chronic patient centered approach can be built: in Constanta region there are dedicated healthcare professionals, struggling to find creative solutions to respond to their patients needs in spite of severe limitations, there are various partnerships with companies in order to decrease the financial burden on patients, the international context pushes towards an increased attention regarding HCV care and this has echoes at the national level as well Baylor foundation s HCV program ensures alignment of own services with various international initiatives ( such as the Word Hepatitis Alliance) and with local institutions ( National Health Fund, Public Health Authorities, local hospitals etc) although the reach of Baylor support services for patients and families with HCV is limited, there local expertise to increase the self-management support delivered in the region the specialists directly involved in the medical management of patients with HCV work within a delivery design environment that ensures follow up in accordance with guidelines and tend to plan visits only for complicated cases in order to ensure continuity of care, the preferred communication system within the public health institutions remain the written referral and medical letter There is a long road ahead in terms of areas for improvement, some suggestions and recommendations being listed below. 85

88 Part IV. Recommendations for Interventions to Improve the Care of Hepatitis C in Constanța region The recommendations formulated below suggest areas of improvement that can be targeted by interventions to increase the quality of care delivered in Constanta region to patients with chronic hepatitis C. Systems cannot redesign and change all the components in the same time, usually various practices having to choose only some areas of improvement that are consider a priority. There is growing body of evidence that isolated interventions to improve only one element of the care system do not impact the overall quality of care. However, interventions that tend to address several component at the same time (not necessary all of them), do induce measurable results, both in terms of patients clinical outcomes and self-management results. Recommendations to improve the organization of healthcare system: create a local body of stakeholders that is able to coordinate and plan the improvement of care transitions of patients and the efficient transfer of information between providers and institutions develop formal agreements and partnerships that facilitate care coordination align the coordination plan with strategic objectives as suggested by international bodies and forums, such as World Health Organization, European Liver Patient Association and World Hepatitis Alliance advocate to find solutions in order to compensate for the insufficient number of human resources with roles in the care of patients with HCV, including the increased role of primary care practices create procedures and practices that encourage the early detection and enrollment of new cases create and maintain screening programs for HCV, such as Baylor s free of charge, rapid testing screening program increase the opportunities for testing in other primary care settings, in order to actively detect new cases 86

89 Recommendations to improve the community linkages: sensitize the health institutions about the importance of community linkages stimulate the health institutions to actively seek for community partnerships in order to expand the access to timely detection and the access to healthcare of vulnerable populations, including those from underserved areas strengthen community action, by coordinating plans of NGOs with other local agencies create simple, straight forward referral pathways between public health institutions and community based organizations educate health providers on the importance of increasing patients health literacy level and give opportunities for trainings in this respect increase the capacity of community linkages already in place, by actively reviewing common chronic care goals ensure access to external practice support programs to help practices and health institutions to deliver more effective care Recommendations to improve the patients self-management level: disseminate evidence that recognizes the importance of assessing clinical state in tandem in self-management status in the context of chronic care create local expertise on self-management and offer access to tools about how patients self-management level can be assessed and developed as part of the clinical care goals develop locally relevant health literacy tools for providers and patients help practices create health literacy friendly clinical environments provide skills building opportunities for health care professionals regarding the development and implementation of simple self-management interventions in the context of their own practice create opportunities for exchanges regarding the successful implementation of self-management programs in the context of other health systems and practices assign and re-assign self-management tasks to other team members, partner providers or support personnel ensure consensus among providers and develop pathways for patients, including designated contact persons at each key provider tailor self-management interventions to match the patients needs in 87

90 each episode of care create patients toolkits and workbooks to assist them with self-management issues, such as lifestyle and health habits, adherence etc make available to clinicians questionnaires, surveys and checklists that can help them quickly asses self-management barriers and priorities for action Recommendations to improve decision support create avenues for structured interactions of specialist with primary care providers, to identify pathways for care transitions create expert panels to develop consensus regarding locally relevant strategies to identify appropriate patients for referral and follow up make guidelines available to patients at an appropriate health literacy level, to increase patients buy-in regarding treatment decisions increase the access to the evidence behind the guidelines for primary care providers in order to ease the understanding of patients treatment plans consider the possibility of comparing current practices against established guidelines in specific settings and at the level of individual practices in order to determine local improvements that can be easily implemented make available to practicing professionals involved in the care of HCV, easy to use standardized assessments and checklists to identify measures to ensure disease control and risks for complications Recommendations to improve delivery design: make a public agenda about the importance of designing a chronic care model, separate from the acute care system in place coordinate the use registries to implement a planned visits approach ( special times allotted for consultations, use of agenda regarding the content of the planned visits etc) assemble teams that can work together to implement the planned visits system use community resources to expand the staff capabilities ( interns, volunteers, partner NGOs) 88

91 Recommendations to improve clinical information systems: enable clinicians to use clinical information systems in order to guide the delivery of planned care ( generate lists of high risk patients, patients missing appointments or missing prescriptions etc) advocate for the design of databases that are able to provide feedback that indicates the needed services for specific categories of patients invest in data-bases that use prompts and alerts that help to monitor performance and stages in treatment plan disseminate feedback regarding the results suggested by data gathered through a network of interested providers The above recommendations should be aligned with higher, national level recommendations regarding hepatitis C policies that are to be drafted and regulated by central agencies and Ministry of Health. The general recommendations for Romania in the area of viral hepatitis policies and implementation include: Drafting a national strategy to tackle viral hepatitis, incorporating the existing prevention and treatment programs and, alongside this, enhancing screening, referral and treatment to prevent further infections. Ensuring timely and continuous access to treatments, especially for patients facing the highest unmet need, and develop treatment protocols that improve adherence to treatment. Raising awareness especially among risk groups, socially excluded groups, to test for viral hepatitis, and ensure easy access to diagnosis. Developing diagnostic and therapeutic protocols and train general practitioners and nurses to better detect and care for viral hepatitis. Establishing Centers of Excellence for epidemiological surveillance, treatment and research, as well as developing a national registry for viral hepatitis to enable better management of patients. Developing a national and regional network to better inform patients and practitioners about epidemiological data and best strategies (balkanhep.eu) 89

92 The qualitative assessment s limitations The research team recognizes a series of limitations regarding to the results of this qualitative assessment. First of all, the geographical limitations should be stated. Secondly, the partnership between Baylor foundation and the local health care providers is not the norm in the rest of the country, and some of the results regarding self-management and community linkages should be understood as describing a somehow atypical situation of Constanta Country compared with other places in Romania. The number of participants in the sample of health care professionals are rather small, but this is also explainable due to the fact that there is a shortage of specialists involved in the management of HCV prevention, treatment and care. Regarding the characteristics of patients enrolled in this qualitative assessment, in should be noted that the patients were exclusively persons that at some point during their diagnosis and treatment pathway were beneficiaries of services provided by Baylor Foundation. The research team did not have access to patients that were outside this group (ie: patients that were exclusively managed by the public health system). It is possible that the challenges that the patients face when they are not at all supported by a community organization to be different or more intense, but this avenue was not investigated comparatively in this qualitative assessment. Some of the dimensions in the ACIC tool could not be ascertained, due to the lack of information about the issues of the participants in the qualitative assessment. It is possible that the cause it is not only the fact that participants were not knowledgeable about some aspects, but also because the system does not currently pay attention to those components. The topic investigated in this qualitative assessment was very complex, therefore in spite the fact that the researchers tried to have a comprehensive approach it was rather discovered that not everything could be investigated to the depth intended during the time framework that the participants had available (for example, topics such as the management skills practices need to run planned visits or topics about types of trainings that providers are interested to attend annually were insufficiently explored). With the perspective of the availability of interferon free treatments that offer very high cure rate in a short while, the importance of system redesign to accommodate chronic care of patients with hepatitis C should also consider 90

93 the emergence of coordinated episodes of care. However long or short the duration of treatments available in Romania, a system redesign is called upon urgently. 91

94 Section C: Annexes 92

95 The ACIC tool 103 Organization of the Health Care Delivery System. Chronic illness management programs can be more effective if the overall system (organization) in which care is provided is oriented and led in a manner that allows for a focus on chronic illness care. Components Little support Basic support Good support Full support Overall Organizational Leadership in Chronic Illness Care does not exist or there is little interest. is reflected in vision statements and business plans, but no resources are specifically earmarked to execute the work. exist but are not actively reviewed. is reflected by senior leadership and specific dedicated resources (dollars and personnel). is part of the system s long term planning strategy, receive necessary resources, and specific people are held accountable. Organizational Goals for Chronic Care do not exist or are limited to one condition. are measurable and reviewed. are measurable, reviewed routinely, and are incorporated into plans for improvement. include a proven improvement strategy and are used proactively in meeting organizational goals. are used to motivate and empower providers to support patient care goals. visibly participate in improvement efforts in chronic care. are specifically designed to promote better chronic illness care. Improvement Strategies for Chronic Illness Care are ad hoc and not organized or supported consistently. utilize ad hoc approaches for targeted problems as they emerge. utilize a proven improvement strategy for targeted problems. Incentives and Regulations for Chronic Illness Care are not used to influence clinical performance goals. are used to influence utilization and costs of chronic illness care. do not make improvements to chronic illness care a priority. neither encourage nor discourage patient self-management or system changes. are used to support patient care goals. Senior Leaders discourage enrollment of the chronically ill. encourage improvement efforts in chronic care. Benefits discourage patient self-management or system changes. encourage patient self-management or system changes. 103 Adapted from The Assessment of Chronic Illness Care (ACIC), Copyright 2000 MacColl Institute for Healthcare Innovation, Group Health Cooperative 93

96 Community Linkages. Linkages between the health system and community resources play important roles in chronic illness management. Components Little support Basic support Good support Full support Linking Patients to Outside Resources Partnerships with Community Organizations Regional Health Plans is not done systematically. do not exist. do not coordinate chronic illness guidelines, measures, or care resources at the practice level. is limited to a list of identified community resources in an accessible format. are being considered but have not yet been implemented. would consider some degree of coordination of guidelines, measures or care resources at the practice level but have not yet implemented changes. is accomplished through a designated staff person or resource responsible for ensuring providers and patients make maximum use of community resources. are formed to develop supportive programs and policies. currently coordinate guidelines, measures, or care resources in one or two chronic illness areas. is accomplished through active coordination between the health system, community service agencies, and patients. are actively sought to develop formal supportive programs and policies across the entire system. currently coordinate chronic illness guidelines, measures, and resources at the practice level for most chronic illnesses. 94

97 Self-Management Support. Effective self-management support can help patients and families cope with the challenges of living with and treating chronic illness and reduce complications and symptoms. Components Limited support Basic support Good support Full support Assessment and Documentation of Self-Management Needs and Activities Self-Management Support Addressing Concerns of Patients and Families Effective Behavior Change Interventions and Peer Support are not done. are expected. are completed in a standardized manner. is limited to the distribution of information (pamphlets, booklets). is not consistently done. are not available. is available by referral to self-management classes or educators. is provided for specific patients and families through referral. are limited to the distribution of pamphlets, booklets, or other written information. is provided by trained clinical educators who are designated to do self-management support, are affiliated with each practice, and see patients on referral. is encouraged, and peer support, groups, and mentoring programs are available. are available only by referral to specialized centers staffed by trained personnel. are regularly assessed and recorded in standardized form linked to a treatment plan available to practice and patients. is provided by clinical educators affiliated with each practice, trained in patient empowerment and problem-solving methodologies, and see most patients with chronic illness. is an integral part of care and includes systematic assessment and routine involvement in peer support, groups, or mentoring programs. are readily available and an integral part of routine care. 95

98 Decision Support. Effective chronic illness management programs assure that providers have access to evidence-based information necessary to care for patients decision support. This includes evidence-based practice guidelines or protocols, specialty consultation, provider education, and activating patients to make provider teams aware of effective therapies. Components Limited support Basic support Good support Full support Evidence-Based Guidelines Involvement of Specialists in Improving Primary Care Provider Education for Chronic Illness Care Informing Patients about Guidelines are not available. is primarily through traditional referral. is provided sporadically. is not done. are available but are not integrated into care delivery. is achieved through specialist leadership to enhance the capacity of the overall system to routinely implement guidelines. is provided systematically through traditional methods. happens on request or through system publications. are available and supported by provider education. includes specialist leadership and designated specialists who provide primary care team training. is provided using optimal methods (e.g. academic detailing). is done through specific patient education materials for each guideline. are available, supported by provider education and integrated into care through reminders and other proven provider behavior change methods. includes specialist leadership and specialist involvement in improving the care of primary care patients. includes training all practice teams in chronic illness care methods such as population-based management, and self-management support. includes specific materials developed for patients which describe their role in achieving guideline adherence. 96

99 Delivery System Design. Evidence suggests that effective chronic illness management involves more than simply adding additional interventions to a current system focused on acute care. It may necessitate changes to the organization of practice that impact provision of care. Components Practice Team Functioning Practice Team Leadership Appointment System Follow-up Planned Visits for Chronic Illness Care Continuity of Care Limited support is not addressed. is not recognized locally or by the system. can be used to schedule acute care visits, follow-up and preventive visits. is scheduled by patients or providers in an ad hoc fashion. are not used. is not a priority. Basic support Good support Full support is addressed by assuring the availability of individuals with appropriate training in key elements of chronic illness care. is assumed by the organization to reside in specific organizational roles. assures scheduled follow-up with chronically ill patients. is scheduled by the practice in accordance with guidelines. are occasionally used for complicated patients. depends on written communication between primary care providers and specialists, case managers, or disease management companies. is assured by regular team meetings to address guidelines, roles and accountability, and problems in chronic illness care. is assured by the appointment of a team leader but the role in chronic illness is not defined. is flexible and can accommodate innovations such as customized visit length or group visits. is assured by the practice team by monitoring patient utilization. are an option for interested patients. between primary care providers and specialists and other relevant providers is a priority but not implemented systematically. is assured by teams who meet regularly and have clearly defined roles including patient self-management education, proactive follow-up, and resource coordination and other skills in chronic illness care. is guaranteed by the appointment of a team leader who assures that roles and responsibilities for chronic illness care are clearly defined includes organization of care that facilitates the patient seeing multiple providers in a single visit. is customized to patient needs, varies in intensity and methodology (phone, in person, ) and assures guideline follow-up. are used for all patients and include regular assessment, preventive interventions, and attention to self-management support is a high priority and all chronic disease interventions include active coordination between primary care, specialists, and other relevant groups. 97

100 Clinical Information Systems. Timely, useful information about individual patients and populations of patients with chronic conditions is a critical feature of effective programs, especially those that employ population-based approaches. Components Limited support Basic support Good support Full support Registry (list of patients with specific conditions) is not available. allows queries to sort sub-populations by clinical priorities. Reminders to Providers Feedback Information about Relevant Subgroups of Patients Needing Services Patient Treatment Plans are not available. is not available or is non-specific to the team. is not available. are not expected. includes name, diagnosis, contact information, and date of last contact either on paper or in a computer database. include general notification of the existence of a chronic illness, but do not describe needed services at time of encounter. is provided at infrequent intervals and is delivered impersonally. can only be obtained with special efforts or additional programming. are achieved through a standardized approach. include indications of needed service for populations of patients through periodic reporting. occurs at frequent enough intervals to monitor performance and is specific to the team s population. can be obtained upon request but is not routinely available. are established collaboratively and include self-management as well as clinical goals. is tied to guidelines which provide prompts and reminders about needed services. include specific information for the team about guideline adherence at the time of individual patient encounters. is timely, specific to the team, routine, and personally delivered by a respected opinion leader to improve team performance. is provided routinely to providers to help them deliver planned care. are established collaboratively and include self management as well as clinical management. Follow-up occurs and guides care at every point of service 98

101 Interview guide for medical specialists Assessing the needs of patients with chronic hepatitis C in order to integrate them into medical and psychosocial services provided by Baylor Black Sea Foundation. Name: Function: Institution: _ Interview date: _ Phone no: Fax: _ Hour: 1. Introductory discussion Short presentation of the project and of the research team. What do you know about Baylor? 2. General information about hepatitis C Which is the prevalence of hepatitis C in Romania and globally? Is there a National Registry of people affected by hepatitis C? Is there a National Program for hepatitis C? Which are the main groups with disproportionate risk of hepatitis C in Romania? Which are the main transmission paths? Which are the main symptoms? How do they manifest? What are the main causes of the disease? How does the disease progresses? What are the complications of the disease? Which are the main prevention methods? Which are the main problems of patients of hepatitis C (management of the disease, access to treatment, poverty, discrimination, lack of help)? 3. Identification of persons at risk and diagnosis How are people at risk, insured and uninsured, identified and directed to testing services? What do you think is the role of the general practitioner in identifying / prevention / education / support for people at risk of hepatitis C? 99

102 Are there any screening programs? How many hepatitis C patients do you have? How do patients get to you? What types of services do you offer? Are there any other medical specialities that can provide the same services as you? Please name those. How much do the tests needed to diagnose hepatitis C cost? What is the route the patient has to follow in order to receive a diagnosis? How long does it takes to establish the diagnosis and which are the costs for the patient? 4. Treatment Is hepatitis C treatment available in Romania? Does it complies with the European standards? Is the treatment accessible to everyone, free of major charges? Are there waiting lists? How many persons are on these waiting lists? Which are the latest treatment schemes available in Europe? Which are the latest treatment schemes available in Romania? Who recommends and establishes the treatment scheme? How can the patient benefit of the treatment? Which is the procedure (for example, how long does it take to prepare the necessary documents, which are the costs)? Are there any groups of population that systematically are less likely to receive treatment in the public health system? Which are these groups? Why are the less likely to receive treatment in the public health system? Overall, how much does a patient (insured/uninsured) pays to receive proper treatment? What is the role of family practitioners and / or specialists in providing care for the patients? What methods should be used to encourage patient adherence to treatment and a corresponding lifestyle to slow the progression of the disease? How do you collaborate with other specialists (infectious, internists, psychiatrists, etc.)? What support do you offer in putting together the treatment required documents? 5. Monitoring and Evaluation What is the time interval the patients (with and without treatment) are evaluated at? What does the monitoring and evaluation imply? Out of the total number of patients how many respect the monitoring 100

103 and evaluation program and visit you periodically? How do you support patients embracing a healthy lifestyle? 6. Development needs of the health services available / public policies / priorities Which are the main factors hampering the access to health services in the public health system? Are there alternatives in the private / NGO sectors? Which are the unmet needs of patients with hepatitis C? Which are the categories of personnel involved in the detection, treatment and monitoring patients with hepatitis C? Are they properly trained? Which are the national priorities regarding hepatitis C? Is there a national strategy to combat hepatitis C? What is the legislative context? Is there a special budget allocated by the state to cover the costs of treatment for hepatitis C? If yes, what is the budget? What should a national program for hepatitis C include? Are there any prevention programs? What should they include? During the lasts years, were there any national awareness/ information campaigns regarding hepatitis C? If so, what was their impact? If not, would you consider them useful? How should they be conducted? Are there any NGOs active in this field? What is the involvement of NGOs working in the field, of patients associations etc.? Which are the main recommendations to improve the situation of patients with hepatitis C? What do you think needs to be done? Who should be involved? 101

104 Interview guide for policy makers Assessing the needs of patients with chronic hepatitis C in order to integrate them into medical and psychosocial services provided by Baylor Black Sea Foundation. Name: Function: Institution: _ Interview date: _ Phone no: Fax: _ Hour: 1. Introductory discussion Short presentation of the project and of the research team. 2. General information about hepatitis C Which is the prevalence of hepatitis C in Romania and globally? Is there a National Registry of people affected by hepatitis C? Is there a National Program for hepatitis C? Are there any screening programs? How are people at risk, insured and uninsured, identified and directed to testing services? Which are the main groups with disproportionate risk of hepatitis C in Romania? 3. Problems of hepatitis C patients Which are the main problems of hepatitis C patients? What is the route the patient has to follow in order to receive a diagnosis? How much does the diagnosis cost, how long does it take and who establishes the diagnosis. What is the role of the general practitioner in identifying / prevention / education / support for people at risk of hepatitis C? Hepatitis C treatment is available in Romania? Is the treatment accessible to everyone, free of major charges? Are there waiting lists? How many persons are on these waiting lists? Which are the latest treatment schemes available in Europe? Which are 102

105 the latest treatment schemes available in Romania? How can the patient benefit of the treatment? Which is the procedure (for example, how long does it take to prepare the necessary documents, which are the costs)? Which are groups of population that systematically are less likely to receive treatment in the public health system? Why are they less likely to receive treatment in the public health system? Overall, how much does a patient (insured/uninsured) pays to receive proper treatment? 4. Development needs of the health services available / public policies / priorities Which are the national priorities regarding hepatitis C? Is there a national strategy to combat hepatitis C? What is the legislative context? What is the budget allocated by the state to cover the costs of treatment for hepatitis C? What should a national program for hepatitis C include? Are there any prevention programs? What should they include? During the lasts years, were there any national awareness/ information campaigns regarding hepatitis C? If so, what was their impact? If not, would you consider them useful? How should they be conducted? Which are the main recommendations to improve the situation of patients with hepatitis C? 103

106 Interview guide for patient organizations Assessing the needs of patients with chronic hepatitis C in order to integrate them into medical and psychosocial services provided by Baylor Black Sea Foundation. Name: Function: Institution: _ Interview date: _ Phone no: Fax: _ Hour: 1. Introductory discussion Short presentation of the project and of the research team. What do you know about Baylor? 2. General information about hepatitis C Which is the prevalence of hepatitis C in Romania and globally? Is there a National Registry of people affected by hepatitis C? Is there a National Program for hepatitis C? Are there any screening programs? How are people at risk, insured and uninsured, identified and directed to testing services? Which are the main groups with disproportionate risk of hepatitis C in Romania? 3. Problems of hepatitis C patients Which are the main problems of hepatitis C patients regarding: Management of the disease Access to treatment Keeping constant the income Poverty Discrimination Lack of support etc. What is the route the patient has to follow in order to receive a diagnosis? How long does it takes to establish the diagnosis and which are the costs 104

107 for the patient? What is the role of the general practitioner in identifying / prevention / education / support for people at risk of hepatitis C? Hepatitis C treatment is available in Romania? Is the treatment accessible to everyone, free of major charges? Are there waiting lists? How many persons are on these waiting lists? Which are the latest treatment schemes available in Europe? Which are the latest treatment schemes available in Romania? How can the patient benefit of the treatment? Which is the procedure (for example, how long does it take to prepare the necessary documents, which are the costs)? Which are groups of population that systematically are less likely to receive treatment in the public health system? Why are they less likely to receive treatment in the public health system? Overall, how much does a patient (insured/uninsured) pays to receive proper treatment? 4. Services Which are the main factors hampering the access to health services in the public health system? Are there alternatives in the private / NGO sectors? Which are the unmet needs of patients with hepatitis C? What services do you provide for hepatitis C patients? Do these services cover their needs? What type of support do you offer to encourage a healthy lifestyle? Do you have trained personnel in managing hepatitis C (disseminating information, diagnosis, treatment)? 5. Development needs of the health services available / public policies / priorities Which are the national priorities regarding hepatitis C? Is there a national strategy to combat hepatitis C? What is the legislative context? What is the budget allocated by the state to cover the costs of treatment for hepatitis C? What should a national program for hepatitis C include? Are there any prevention programs? What should they include? During the lasts years, were there any national awareness/ information campaigns regarding hepatitis C? If so, what was their impact? If not, would 105

108 you consider them useful? How should they be conducted? Which are the main recommendations to improve the situation of patients with hepatitis C? 106

109 Focus group guide for patients Assessing the needs of patients with chronic hepatitis C in order to integrate them into medical and psychosocial services provided by Baylor Black Sea Foundation. Participants: Total Age years Women years Men > 65 years Date: Hour: 1. Introductory discussion Short presentation of the project and of the research team. 2. Personal experience with hepatitis CTests and diagnosis Tests and diagnosis When did you first noticed symptoms and in what context? Which were the symptoms? Who did you talk first about the symptoms? (a family member, a general practitioner, a specialist, other medical representative, another person) How were you diagnosed? (for example: During a routine medical examinations, you felt ill one day and consulted a doctor, you felt ill for a period of time and consulted a doctor, you got tested because another family member was diagnosed) How advanced was the disease when you got diagnosed? How long did it take for you to get tested since you first thought about it? How long did it take for you to consult a specialist for the first time? How long did it take to receive a diagnosis? Before you get ill, did you received any information or have taken any preventive actions? What did you know about hepatitis C before being diagnosed? Did you received counseling before / after testing? What information did you received about the disease (about the widespread of hepatitis C, impact and evolution of the disease, possible treatments, where you can find more information and get support, etc.)? Who gave you this information? How did you communicate with the medical staff? 107

110 Disclosing the disease Who were the persons you spoke about the disease? From who did you received support (any kind of support: emotional, information, financial, etc.)? Have you encountered problems in disclosing that you have this disease? What is the perception of family / friends / co-workers / neighbors / community regarding this disease? Do you abstain in talking about the disease? How did you overcome the detection of the disease? Managing the disease How did your life changed after diagnosis? Did the disease affected in any way your professional life, family life, social life, diet, lifestyle, etc.? To what extent do you have information about: Transmission paths Main symptoms and their manifestation Effects of the disease (before and after treatment) Causes and evolution of the disease Prevention Management of the disease what to do after being diagnosed Treatment options in Romania and in Europe Have you tried naturist treatments? Please describe your experience during treatment: side effects, adverse effects, how did you responded to treatment, who helped you during treatment, if you completed the treatment, whether there was an alternative to treatment (if advised of other treatment or research programs at certain institutions conducting research on patients). 3. Experiences with the healthcare system Access to health services Please describe how was the interaction with the health system (public and / or private) during the screening process until monitoring (interaction with the system and medical staff at different levels of the system) and the main barriers encountered in accessing medical services. Please make the history of doctors and places You went in the public or private sector? How long did it last from identifying symptoms and diagnosis to getting treatment? Did you paid (formal or informal) for any necessary tests (for diagnosis)? How much did you pay? Have you been hospitalized for diagnosis? How 108

111 many days? And how much did it cost? Did you asked for a second opinion? Do you think that you have been diagnosed correctly and on time or, incorrect and/ or late, fact that affected your health? Have you had time to ask for clarification during the visit? Were you encouraged to ask questions? How long was on average the interaction with the specialist? After diagnosis, how much time did you spent in a hospital / public clinic? Did you went to a private clinics or abroad? Health services received at the clinic / hospital were free? Did you had to pay medical staff to receive proper care? Did you had to pay for laboratory tests done at the clinic / hospital? Did you had to pay for medication received at the clinic / hospital? Access to treatment What was the procedure for accessing treatment (for example, the elaboration of the application to receive treatment, duration, required documents, costs)? What type of treatment did you follow? Did you had access to treatment? If not, why? Are you on the waiting list? Which are the treatment costs (formal and informal)? Monitoring How often do you visit the doctor for check-ups? What does the checkup implies? Is the distance from your home to the clinic / hospital acceptable? 4. Development needs of the health, social and support services The need for information and education How informed do you consider yourself about hepatitis C? What type of information do you need? Through what channels would you like to be informed? Who would you like to provide you the information? Which are the trustable sources of information? Support services needs Do you consider that you received adequate support to manage the disease? What type of support do you need? Who should provide it? Who helped you in taking decisions on: changing the diet, ameliorating symptoms, alternative therapies, treatment? Do you use specialized sites to get information about hepatitis C? 109

112 Do you have a delegated person/ a case manager/ medical staff (nurse, doctor, specialist) that you can talk to about the disease? What type of support provides you? Which is the best source of support? Are you a part of a support group? If yes, What needs are covered by the support group? How useful is this group in helping you tackling the disease? What are your expectations regarding this group? If not, why not? There are no such groups in your city? You don t want to be part of such a group? Medical services needs What type of medical services do you need? What medical services do you think should be improved? Social and psychosocial services needs What type of social/psychosocial services do you need? Did you benefited of any services provided by NGOs? Are there such NGOs in your city? Did you ever heard of services provided by NGOs regarding hepatitis C? Do you know anyone who benefited of such services? 110

113 Focus groups guide for GPs Assessing the needs of patients with chronic hepatitis C in order to integrate them into medical and psychosocial services provided by Baylor Black Sea Foundation. Participants: Total Age years Women years Men > 65 years Date: Hour: 1. Introductory discussion Short presentation of the project and of the research team. 2. General information about hepatitis C What is the prevalence of hepatitis C in Romania and globally? Is there a National Registry of people affected by hepatitis C? Is there a National Program for hepatitis C? Which are the main groups with disproportionate risk of hepatitis C in Romania? Which are the main transmission paths? Which are the main symptoms? How do they manifest? What are the main causes of the disease? How does the disease progresses? What are the complications of the disease? Which are the main prevention methods? Do you have patients with hepatitis C? If so, how many? At what stage of the disease are they? How long after the first infection they discovered the disease? From your experience, what percentage of patients: accidentally discover the infection; discover the infection after participation in a screening program or discover it during the late stages? Which are the main problems of patients of hepatitis C (management of the disease, access to treatment, poverty, discrimination, lack of help)? What are the main problems you face in relation to these patients? 111

114 3. Identification of persons at risk and diagnosis How people at risk, insured and uninsured, are identified and directed to testing services? To whom do you recommend testing for hepatitis C? Where do you sent the patients to get tested? How do you explain to the patients the results of the reactive rapid test? How do you explain to the patients the positive results? What do you recommend in each situation? What do you think is the role of the general practitioner in identifying / prevention / education / support for people at risk of hepatitis C? Are there any screening programs? Do you think that they are necessary? What is the route the patient has to follow in order to receive a diagnosis? Who establishes the diagnostic? Is hospitalization required in order to establish a diagnosis? How long does it takes to establish the diagnosis? How much do the tests needed to diagnose hepatitis C cost? 4. Treatment Hepatitis C treatment is available in Romania? Does it complies with the European standards? Which are the latest treatment schemes available in Europe? Which are the latest treatment schemes available in Romania? Is the treatment accessible to everyone, free of major charges? Are there waiting lists? How many persons are on these waiting lists? Who recommends and establishes the treatment scheme? How can the patient benefit of the treatment? Which is the procedure (for example, how long does it take to prepare the necessary documents, which are the costs)? Are there any groups of population that systematically are less likely to receive treatment in the public health system? Which are these groups? Why are they less likely to receive treatment in the public health system? Overall, how much does a patient (insured/uninsured) pays to receive proper treatment? Do you think that the liver-protective treatment is efficient? Should it be financially supported by the state? How can the general practitioner and/or the specialist to increase the treatment compliance of patients? What methods should be used to encourage patient adherence to treatment and a corresponding lifestyle to slow the progression of the disease? How do you collaborate with other specialists (infectious, internists, 112

115 psychiatrists, etc.)? What support do you offer in putting together the treatment required documents? 5. Monitoring and Evaluation What is the time interval the patients (with and without treatment) are evaluated at? What does the monitoring and evaluation imply? How long does this stage take? How do you keep in touch with patients (communication system)? Out of the total number of patients how many respect the monitoring and evaluation program and visit you periodically? What is the general practitioner role during this phase? How do you support patients embracing a healthy lifestyle? Do you think it would be useful to implement a personalized plan for encouraging a healthy lifestyle? 6. Development needs of the health services available / public policies / priorities Which are the main factors hampering the access to health services in the public health system? Are there alternatives in the private / NGO sectors? Which are the unmet needs of patients with hepatitis C? Do you think there is a fair territorial distribution of resources - rural patients have easy access to resources? Which are the categories of personnel involved in the detection, treatment and monitoring patients with hepatitis C? Are they properly trained? Which are the national priorities regarding hepatitis C? Is there a national strategy to combat hepatitis C? What is the legislative context? Is there a special budget allocated by the state to cover the costs of treatment for hepatitis C? If yes, what is the budget? What should a national program for hepatitis C include? Are there any prevention programs? What should they include? During the lasts years, were there any national awareness/ information campaigns regarding hepatitis C? If so, what was their impact? If not, would you consider them useful? How should they be conducted? Are there any NGOs active in this field? What is the involvement of NGOs working in the field, of patients associations etc.? Which are the main recommendations to improve the situation of patients with hepatitis C? What do you think needs to be done? Who should be involved? 113

116 Hepatitis C Lived Experiences as revealed by focus groups When have the interviewed patients been diagnosed? The patients with hepatitis C who attended the group discussions fall into five categories depending on the way in which they have been diagnosed with hepatitis C. Most of them had no symptom whatsoever before being diagnosed. 1. They tested out of curiosity The first category consists of the patients who tested out of curiosity at the Baylor test centre or at the caravans with free testing. So, no symptom, I just went there (Baylor Foundation), I saw the note about rapid testing, went in and did it. (...) You didn t feel bad, didn t have anything at all? Nothing, nothing at all, I really don t know what it means to be ill, nothing hurts me. (Focus Group Patients with Hepatitis C) I had my mother at Fundeni (a hospital in Bucharest). It was a caravan for the free HIV, B and C hepatitis tests. B and HIV were negative, C was reactive. Then I started to move, I filed my medical record and so on. (Focus Group Patients with Hepatitis C) 2. They tested because they need annual medical tests for their job Another category consists of the patients who work in areas which require blood counts annually. Since they monitor periodically their health state, it is easier for them to realise how they got infected. Hence, many think they were infected at the dentist. I m in the army, I do a medical check every year, blood analyses and all. I did it last year, in December, early December. I went to the dentist, me, my daughter and my wife. Me and my daughter were treated for our teeth, I had a small crown done, and at the blood test from May they found me with C hepatitis. (Focus Group Patients with Hepatitis C) 114

117 3. They tested within the national health evaluation program from There are patients who tested positive for hepatitis C virus in , when there was a national program for health state evaluation of the population, the so-called Nicolaescu program, by the name of the ministry of health at that moment. Although the test for hepatitis C was not on the list of compulsory tests within that program, some family doctors had their patients checked because other medical indicators showed liver problems. Accidentally, in 2008, it was that health check program started by minister Nicolaescu, and I tested positively for C. Why did your family doctor ask you to make that test? I was eating disorderly my lipid profile was busted and I did the transaminases too, and with a cholesterol close to 400, she told me to try that one too. And it tested positive in (Focus Group Patients with Hepatitis C) 4. They tested because they felt sick or had other medical indicators altered Another category of patients positive for hepatitis C virus consists of the people who had some symptoms or whose indicators for liver functions had been repeatedly detected to be outside the normal ranges. Generally, for these patients, the family doctors or the medical specialists considered it necessary to run a test for the presence of the virus for hepatitis C. I have diabetes and every six months I make analyses and TGP was high each time. One day, the nutritionist sent me down to the hospital to do a test. I asked, well, a month, one year, this year, next year, will they always be higher? Not very high, but higher. And I went downstairs and I did that test and this is how I discovered it, in spring. (Focus Group Patients with Hepatitis C) 5. They tested during the pregnancy Theoretically, all the pregnant women should do a test for virus C, so even in the lack of symptoms, some had tested positive for hepatitis C on this occasion. 115

118 Table of Contents Acknowledgments... 6 About Baylor Black Sea Foundation... 7 Executive summary... 8 Section A: Delivery of Healthcare Services for Hepatitis C in the Context of the Health System in Romania Chapter I. Characteristics of the Romanian Health System...11 Organization of health services in Romania Health-Related Human Resources Information and Research Systems Existing Medical Products Sustainable Funding and Social Protection Management and Good Governance Chapter II. Current Level of Development of Care for Hepatitis C Patients in Romania...28 The Context of Health Policies with Respect to Hepatitis C Epidemiological Facts about Hepatitis C in Romania Incidence Prevalence Transmission paths Treatment Costs of Hepatitis C in Romania The Level of Organization of the Romanian Health System s Response to the Challenges Raised by Hepatitis C The current pathway of patients affected by HCV Section B: Qualitative Research Hepatitis C: Opinions of Patients and Specialists on Chronic Care Delivery in Constanța, Romania Part I. Research brief...45 Motivation and applicability of the qualitative assessment Organization of the research related reading material Part II. Chronic care model...47 Theoretical and conceptual aspects Assessment of chronic illness care the ACIC tool

119 Recommendations to improve care based on CCM Final comments regarding the CCM usefulness and limitations Part III. Qualitative assessment findings...60 Aim of the qualitative assessment Methods Participants Analysis of the qualitative data Results Wrapping it up all together Mapping the content analysis against the ACIC assessment tool Part IV. Recommendations for Interventions to Improve the Care of Hepatitis C in Constanța region...86 The qualitative assessment s limitations Section C: Annexes The ACIC tool Interview guide for medical specialists Interview guide for policy makers Interview guide for patient organizations Focus group guide for patients Focus groups guide for GPs Hepatitis C Lived Experiences as revealed by focus groups

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124 Ana-Maria Schweitzer, senior clinical psychologist, has been active in the healthcare area since 1999, being part of the Baylor Black Sea Foundation that has set up the multidisciplinary services at the Spitalul Clinic de Boli Infecţioase Constanţa Baylor College of Medicine Texas Children s Hospital Abbott Fund Clinical Centre of Excellence in Constanţa, Romania. Since 2005, she has been serving as the executive director of the Baylor Black Sea Foundation that focuses on developing prevention, testing and care programs for people affected by chronic infectious diseases, such as HIV infection or viral hepatitis. Through her professional activity, she strives to mitigate the psychological impact of chronic diseases and to develop patient centered health projects. Mihaela Bogdan has experience in healthcare organizations of more than 15 years. She started her career as a volunteer working in prevention projects. She has progressively embraced different other roles, such as health counselor, trainer and program manager. In 2006 she joined the Baylor Black Sea Foundation. At the Centre of Excellence she was a key player in establishing the voluntary counselling and testing project for HIV and viral hepatitis. As the project director, Mihaela strives to ensure the team s professional level and the alignment with the best practices of service delivery for people affected by chronic illnesses. ISBN: