Session Code A4, B4 The presenters have nothing to disclose Can Improvement Cause Harm: Ethical Issues in QI William Nelson, PhD Greg Ogrinc, MD, MS Daisy Goodman, CNM. DNP, MPH December 6, 2016 #IHIFORUM Session Objectives P2 Identify the components of an ethical framework for quality improvement Describe a structured approach for reviewing healthcare quality improvement Identify ethical challenges in healthcare quality improvement through analyzing examples of improvement projects 1
Today s Flow Introduction to session Highlight the relationship of ethics to quality improvement Discussion of Case 2, Distinguishing QI From research Discussion of Case 1, Applying an ethical framework to QI Session wrap-up Ethics and Quality Linkage P4 Ethical principles are the foundation for the concept and need for health care quality 2
Ethics and Quality Linkage P5 Ethical principles are the foundation for the concept and need for health care quality Ethics is the foundation for IOM s 6 aims of quality care that need improvement Ethics and Quality Linkage Nelson WA, Ethics: A Foundation for Quality. Healthcare Executive 2011; 26(6):46-49. Basic Ethics Principles and Concepts Autonomy Beneficence Applications of Ethics Principles to Quality Care Supporting, facilitating, and respecting self-determination in shared decision-making Promoting the patient s beneficial health care and best interest Institute of Medicine s Quality Aims Patient-centered Effective, safe, timely, patientcentered Non-maleficence Distributive and social justice Avoiding and protecting patient from actions that cause harm Allocating fairly the benefits and burdens to health care, promoting access in an equitable manner, ensuring value for service provided Safe, effective, patient-centered Equitable, efficient, safe, patientcentered 3
Ethics and Quality Linkage P7 Ethical principles are the foundation for the concept and need for health care quality Ethics is the foundation for IOM s 6 aims of quality care that need improvement Due to potential harms caused by Quality improvement interventions should reflect ethical standards Ethics in Quality Improvement Lynn J et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann Int Med 2007; 46 (9): 666-673. Ethics Concept Description Quality improvement activity should be sought to answer specific question(s) to justify Scientific and/or use of time and resources. The project seeks to answer or clarify needed questions to Social Question improve health care delivery. Valid Scientific Methods Improvement activity employs a valid method to answer the identified aim. Promoting beneficial and effective health care while using resources appropriately. Fair Participant Selection The improvement participant selection is without bias Participants Respected QI activity designed to respect all participants, including the privacy and confidentially of participants. The QI allocates fairly the benefits and burdens of participating in the QI activity. 4
Ethics in Quality Improvement (continued) Lynn J et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann Int Med 2007; 46 (9): 666-673. Ethics Concept Description Benefits Outweigh Risks/Burden The improvement method offers potential benefits greater than harms/burden. Patients and/or staff are protected from harms/burden/risks. Participants Involvement The improvement activity assumes that patient and staff have an ethical responsibility to participate in QI to enhance the quality of care. All participants (patients and staff) have been given basic information of the QI activity. The extent of disclosure should be proportionate to the potential harms/burdens to participants. Independent Review The improvement activity fostering public and organizational accountability; promoting the avoidance of conflicts of interest through an effective review and supervision process. Sharing and Disseminating QI Results The results of the improvement activity are appropriately shared to implement the outcomes and findings. CASE 1 P10 Big City Hospital: Applying Ethical Principles to Improvement Work https://www.amazon.com/lego-duplo-5795-city-hospital/dp/b005fos2m4 5
Improving Vital Signs Monitoring Big City Hospital is a tertiary care facility in a major metropolitan area A sentinel event occurred when a young person who became critically ill did not receive timely intervention Case Background For patients not ill enough for continuous cardiorespiratory monitoring, vital signs are assessed by nursing staff, with frequency determined by the patient s condition Vital signs provide early warning of changes in patient status. When followed by timely action, there is potential to reduce mortality, morbidity, length of stay and cost 6
ViEWS Track and Trigger Protocol http://www.patientsafetyfederation.nhs.uk/medialibrary/downloads/harm%20 Death/5.-Escalation-protocol-for-deteriorating-patient.pdf Case Background According to the protocol, escalating scores should trigger interventions and more frequent monitoring However, vital signs observations are not always increased appropriately, especially during shifts which are sparsely staffed The hospital recently underwent cost cutting measures which resulted in a significant reduction in nursing staff 7
Methods The hospital initiated a quality improvement program to ensure that frequency of vital signs monitoring was reflective of patient acuity Baseline frequency was studied by unit, across shifts, and on specified days of the week Nurses and patients were not advised of the baseline data collection period This activity was reviewed by the hospital s research ethics committee and found to be quality improvement not requiring review Results The nurse: patient ratio at night averaged 1:10, compared to 1: 6 during day and evening shifts The improvement team reported that there was an observed failure of our staff to follow the hospital s clinical vital signs monitoring protocol Date and shift-specific results were shared with unit managers As a result, low performers on each ward were identified by managers and received personal feedback 8
Applying Lynn, et al. s Framework: What are the ethical concerns that arise from this case? Ethics Concept Description Scientific and/or Social Question Quality improvement activity should be sought to answer specific question(s) to justify use of time and resources. The project seeks to answer or clarify needed questions to improve health care delivery. Valid Scientific Methods Improvement activity employs a valid method to answer the identified aim. Promoting beneficial and effective health care while using resources appropriately. Fair Participant Selection The improvement participant selection is without bias Participants Respected QI activity designed to respect all participants, including the privacy and confidentially of participants. The QI allocates fairly the benefits and burdens of participating in the QI activity. Lynn J et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann IntMed 2007; 46 (9): 666-673. Applying Lynn et al. s Framework: What are the ethical concerns that arise from this case? Ethics Concept Description Benefits Outweigh Risks/Burden Participants Involvement The improvement method offers potential benefits greater than harms/burden. Patients and/or staff are protected from harms/burden/risks. The improvement activity assumes that patient and staff have an ethical responsibility to participate in QI to enhance the quality of care. All participants (patients and staff) have been given basic information of the QI activity. The extent of disclosure should be proportionate to the potential harms/burdens to participants. Independent Review The improvement activity fostering public and organizational accountability; promoting the avoidance of conflicts of interest through an effective review and supervision process. Sharing and Disseminating QI Results The results of the improvement activity are appropriately shared to implement the outcomes and findings. Lynn J et al. The Ethics of Using Quality Improvement Methods in Health Care. Ann IntMed 2007; 46 (9): 666-673. 9
Case 2 19 Distinguishing between Improvement Work and Research Addressing QI vs Research A clear framework for QI ethics Institutional review boards (IRBs) do not always understand the intent, methods, and analysis of QI work. Develop a practical instrument for institutional review boards (IRBs), researchers, and improvers to differentiate between QI and clinical research activities 10
Along The Continuum of Care Research Quality Improvement Research Quality Improvement Direct Patient Care Retrospective cohort analysis of cardiac catheterization and current medical therapy Randomized controlled trial of a new medication for acute MI Multi-institution study of a checklist for cardiac catheritization Medical center makes several changes to improve the efficiency of door to balloon time for AMI Mr. Johnson receives acute cardiac catheritization within 82 minutes of arriving at the ED with symptoms Attribute Intent and Background QI-Research Instrument Part 1 Quality Improvement Describes the nature and significance of the local problem. Focus is to improve a specific aspect of health or healthcare delivery that is currently NOT consistently and appropriately being implemented at this site Mechanisms of the intervention are expected to change over time (i.e., an iterative activity) in response to ongoing feedback Clinical Researchwith Human Subjects Identifies a specific deficit in scientific knowledge from the literature Proposes to address or identify specific hypotheses in order to develop new knowledge or advance existing knowledge Specific protocol defines the intervention, interaction, and use of collected data and tissues, plus project may rely on the randomization of individuals to enhance confidence in differences Methods Plan for intervention and analysis includes an assessment of the system (i.e., process flow diagram, fishbone, etc) and the context Statistical methods evaluate system level processes and outcomes over time with statistical process control or other methods May use qualitative or quantitative methods to make observations, make comparisons between groups, or generate hypotheses Statistical methods primarily compare differences between groups or correlate observed differences with a known health condition Ogrinc G, Nelson W, Adams SM, O Hara E. A Tool to Differentiate Quality Improvement from Clinical Research. IRB: Ethics and Human Research. 2013: 35(5), 1-8 11
QI-Research Instrument Part 2 Attribute Quality Improvement Clinical Research with Human Subjects Intended Benefit Risk Intervention would be considered within the usual clinician-patient therapeutic relationship Direct benefit to participants is indicated (e.g., decrease in risk by receiving a vaccination or by creating a safer institutional system) Potential local institutional benefit is specified (e.g., increased efficiency or decreased cost) Primary risk is to privacy or the confidentiality of health information Risk may be described as higher for patients by not participating in this activity Intervention, interaction, or use of identifiable private information occurs outside of the usual clinician-patient therapeutic relationship Direct benefit to each individual participant or for the institution is not typically the intent or is not certain Potential societal benefit in developing new or advancing existing generalizable knowledge Risks may be minimal, but may include physical, psychological, emotional, social, or financial risks, as well as risk to privacy or the confidentiality of health information from participation in the project The informed consent process describes the risks to participants, who individually and voluntarily decide whether to participate or an IRB grants an alteration or waiver of the consent process Ogrinc G, Nelson W, Adams SM, O Hara E. A Tool to Differentiate Quality Improvement from Clinical Research. IRB: Ethics and Human Research. 2013: 35(5), 1-8 QI-Research Instrument Part 3 Attribute Quality Improvement Clinical Research with Human Subjects Applicability of Results Implementation is immediate so that review of results occurs throughout the process and may be used for next QI activity Results and analysis may be delayed or periodic throughout the duration of the project, except to protect patient safety. The results will primarily be used to inform further investigations, but may be implemented directly into clinical practice. Extrapolation of results to other settings is possible, but not the main intent of the activity Results are intended to generalize beyond the study population Sharing& Disseminating Results System level outcomes, processes, refinement of the intervention, and the applicability of the intervention in specific settings/contexts may be shared through peer-reviewed publication and presentation outside the institution. It is expected that results will be published or presented to others through a peer-reviewed process Ogrinc G, Nelson W, Adams SM, O Hara E. A Tool to Differentiate Quality Improvement from Clinical Research. IRB: Ethics and Human Research. 2013: 35(5), 1-8 12
Case #2: Lab Testing 25 Local standard of practice at a hospital is to check both erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) to monitor patients with rheumatoid arthritis (RA) Multiple research studies have established that only one test is required Retrospective chart review of laboratory results for ESR and CRP and patients symptoms Goal is to assess discordance of test results and determine relationship between test results and disease severity for local population of patients Submitted as QI project to improve care for patients with RA Concluding Thoughts Need to recognize QI can cause harms Implementing an ethical framework can foster the quality of QI activities Ethical review and oversight of QI through an appropriate mechanism is essential Ethically grounded QI builds institutional, professional, and public support and trust in QI 13