SUMMARY STATEMENT ( Privileged Communication ) Release Date: 03/10/2014

Transcription

1 PROGRAM CONTACT: Paul Cotton Principal Investigator ATRICIA PHD Applicant Organization: NURSING PROFESSOR, LLC SUMMARY STATEMENT ( Privileged Communication ) Release Date: 03/10/2014 Review Group: ZRG1 RPHB-C (10) Center for Scientific Review Special Emphasis Panel Small Business: Risk, Prevention and Health Behavior Meeting Date: 02/27/2014 Council: MAY 2014 Requested Start: 07/05/2014 Application Number: 1 R43 NR A1 RFA/PA: PA PCC: DSBPC Dual PCC: P146SS Dual IC(s): GM Project Title: Telehealth Nursing: Managing Risks for Multiple Chronic Conditions SRG Action: Impact Score: 39 Next Steps: Visit Human Subjects: 30-Human subjects involved - Certified, no SRG concerns Animal Subjects: 10-No live vertebrate animals involved for competing appl. Gender: 1A-Both genders, scientifically acceptable Minority: 1A-Minorities and non-minorities, scientifically acceptable Children: 3A-No children included, scientifically acceptable Clinical Research - not NIH-defined Phase III Trial Project Year 1 TOTAL Direct Costs Requested 163, ,020 Estimated Total Cost 167, ,820 ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by Institute grants management staff based on the recommendations outlined below in the COMMITTEE BUDGET RECOMMENDATIONS section.

2 1 R43 NR A1 2 ZRG1 RPHB-C (10) 1R43NR A1 Camillo, Patricia RESUME AND SUMMARY OF DISCUSSION: This resubmitted Phase I application proposes to develop a program for patient self-management of risk of comorbidity among those with multiple chronic conditions. Nurse practitioners (NPs) will deliver this program to rural patients from virtual rooms. The innovation is in the use of the virtual room delivery system and the focus is on training the NPs to implement the program. It is unclear who the market for this service will be, and if health systems or insurance companies, the use of NPs may be unwarranted. Currently, the investigators are not connected with any health care system, and identification of the sample may be problematic. The investigators were responsive to initial review and the team of investigators is strong. There is a good theoretical framework and high potential impact. These strengths were, however, offset by the question of commercial potential, a remaining issue of access to sufficient internet in rural areas, and a number of issues concerning the study sample. There was some disagreement among reviewers about the overall significance of the study but in sum, the balance of strengths and weaknesses led to an assessment by the panel of a good, but not outstanding application. DESCRIPTION (provided by applicant): The increasing prevalence of chronic diseases and the associated high costs of care are a priority concern for public health. The time and effort required to prevent comorbidities in this population is difficult to offer in the current system given the significant shortage of providers, the growing number of new patients and the level of disability resulting from multiple chronic conditions (MCC's). The latter often presents a significant barrier in accessing care, especially in rural areas. Since most chronic care is a function of self-management, the proposed intervention, delivered by nurse practitioners (NP's) is an innovative complement to traditional care with the long-term goal of preventing additional comorbidities. A six week program, with a core focus on three conditions common to chronic illness (inactivity, chronic pain and sleep disruption) will be offered to twelve small groups of eight participants residing in rural Minnesota and Mississippi. Using HIPPA secured virtual rooms, specially trained NP's will engage participants in face-to-face, real time interactions, helping them to assess, understand and manage their personal risks. The group process will be used to enhance understanding of these risks and provide social support in learning new skills to mitigate them. The first aim of this study is to evaluate the practical application of this virtual space. The second aim is to evaluate the effect of this intervention on patient reported outcomes, specifically related to health status, health behaviors to modify risks, and self-efficacy. These aims will be accomplished using a mixed method approach that includes a randomized controlled trial, participant observation and focus groups. The outcomes will be measured using NIH PROMIS-57 and selected tools from the Stanford Chronic Disease Self Management Program (SCDSMP). The theoretical basis for these sessions is drawn from the situated-information-motivation-behavior Model of Care Initiation and Maintenance (simb-cim) to increase engagement in care for chronic medical conditions. Different from other chronic disease self management programs, this intervention brings together participants with a shared chronic illness profile using a situated approach that includes individual risk assessments and preventive action plans guided by the expertise of an NP facilitator in a virtual face-to-face room. Participants involved in Phase I will have a diagnosis of moderate to severe arthritis along with high cholesterol, identified as one of the five most common chronic disease dyads among Medicare beneficiaries. Managing risks associated with MCC's requires time, accurate information, motivation, social support, skill building and professional expertise. The proposed intervention extends NP practice using an innovative approach which makes it possible to provide these critical components of chronic disease care to an at risk population. PUBLIC HEALTH RELEVANCE: Millions of people in the United States are living with a chronic illness that causes inactivity, chronic pain and sleep disturbances. These three conditions, if not successfully managed, can increase the risk for additional chronic diseases. The proposed six week, small group,

3 1 R43 NR A1 3 ZRG1 RPHB-C (10) virtual intervention, facilitated by a nurse practitioner, offers participants the knowledge and skills to help reduce these risks, resulting in improved health status and increased self-efficacy. CRITIQUE 1: Significance: 3 Investigator(s): 3 Innovation: 5 Approach: 5 Environment: 2 Overall Impact: Proposing a 6 week program with a core focus on three conditions (inactivity, chronic pain, and sleep disruption) offered to 12 small groups of 8 residents in rural Minnesota and now Mississippi in response to initial reviewer concerns. Will use virtual rooms, specially trained NPs to help ensure assess, understand, and risks and provide social support in learning new skills 1. Significance: Addressing common, preventable health problems in the US is a significant issue to address. There lacks adequate discussion of the commercialization plan who and why will someone pay for this program, potential partners or customers There still lacks an adequate justification for why only nurse practitioners are the right personnel to conduct this work. In addition, given that in many states NPs have their own panels, the likelihood of NPs to staff this program and be reimbursed is not clear. Legislation on clinical practices of NPs varies state by state but this is not acknowledged. 2. Investigator(s): Dr. Camillo has a strong educational background, but appears has limited research and business experience. Have legal guidance from Ms. Buppert Strong clinical support, but there lacks adequate expertise in commercialization. The roles of many of the participants (e.g., Mary Atkinson Smith, Rita Morgan) are not clear. 3. Innovation: Addresses a potentially important topic Not clear how different or innovative the proposed program is. The Investigator argues that what differentiates the program is it brings together participants with a shared chronic illness

4 1 R43 NR A1 4 ZRG1 RPHB-C (10) approach using a individualize risk assessment and preventive action plans guided by a nurse practitioner in a virtual face-to-face room. While there are some differences proposed between the proposed project (e.g., smaller groups) these differences seem minor and not clear they will significantly differentiate the product from other well-established programs. Prior programs developed using similar telehealth technology; however, while primary care NP s may not have embraced the use of this technology, this may reflect more the legal and business problems of the program 4. Approach: Propose a mixed method approach to asses patient outcomes. Will use NIH PROMIS 57 and the Stanford Chronic disease self management program. Includes a theoretical framework - situated-information-motivation-behavior model of care initiation and maintenance. While pilot data is not necessarily required as indicated by the investigators, indications regarding proof of concept, engagement, and participation would be helpful. Without adequate data, the proposed project is not likely to be feasible in the allotted time. Concern remains regarding the feasibility and commercialization of the product if one NP works with only 16 participants. While creating a distribution of effort, the scalability of the program is questionable. Propose to enroll individuals with moderate to severe arthritis along with high cholesterol it is not clear how these individuals will be identified, how severe arthritis and high cholesterol will be operationalized. There are also concerns that if cholesterol is the disease of focus, the outcome assessment of inactivity, chronic pain, and sleep disturbance will not likely link to improvements in the intervention for cholesterol The expected outcomes are not clearly operationalized and/or rely on the interventionist to record which may Given the use of multiple interventionists, there lacks details regarding intervention fidelity 5. Environment: Significant clinical expertise The feasibility of enrollment is not clear Protections for Human Subjects: Acceptable Risks and Adequate Protections Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Not Applicable (No Clinical Trials)

5 1 R43 NR A1 5 ZRG1 RPHB-C (10) Inclusion of Women, Minorities and Children: G1U - Both Genders, Unacceptable M1U - Minority and Non-minority, Unacceptable C3A - No Children Included, Acceptable It is not clear how the investigators will meet the proposed recruited numbers Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Not Applicable (No Biohazards) Resubmission: Responsive to the concern regarding a lack of minority representative and added Mississippi as a site Budget and Period of Support: Recommend as Requested The budget lacks details CRITIQUE 2: Significance: 3 Investigator(s): 1 Innovation: 3 Approach: 6 Environment: 2 Overall Impact: This is a resubmission. The investigators propose a 6 week intervention delivered to allow patients to interact with NPs via a secure virtual room. Focus is on 3 common symptoms -- inactivity, chronic pain and sleep disruption common in chronic illnesses. The investigators propose a mixed method approach. The project is only moderately innovative using telehealth and in a not very unique way. The application is unclear about eligibility criteria, should presence of the 3 symptoms facilitate patient access all 3 or 1? The generalizability is problematic in today s health system. The intervention approach with one NP for 16 participants is unclear. The team is qualified to carry out the study. It is important to help patients get access to care but picking out selected symptoms in a chronic illness still presents a fragmented approach. Unsure if it would have an impact if the project is as described. 1. Significance: Conditions are major problems for those with chronic illness

6 1 R43 NR A1 6 ZRG1 RPHB-C (10) Should enable rural patients to have access It is important to help rural patients with chronic illnesses have access to care for symptoms and selected symptoms are important. Concerned about, and not clear if patients have to have needs still promotes a fragmented approach. How will rurality of patients be determined? Concern over internet access not really addressed 2. Investigator(s): Dr. Camillo has skills to carry out study, is an NP specializing in gerontology and has ethnographic experience, statistics, focus group, methods, and rural health back ground. Principal Investigator has published; Roles of team members seem clarified. Has focus group expert and a statistician. Why so many group facilities? 3 from Minnesota and 3 from Mississippi? There are a small number of patients only 192 with 6 interveners. 3. Innovation: Seeks focus on chronic disease and management of symptoms/using a chat room. Approach is not innovative Unclear what the rurality of the application is other than location Primary Care use is not documented or an area of concern. Use of video chat room not unique or innovative. 4. Approach: Inactivity, chronic pain and sleep disruption Have specified outcomes Qualitative and quantitative data, triangulation methods used Using known measures for variables Has a theoretical framework to guide study Information, Motivation, Behavioral Skills Model Has an analysis plan Can reach rural patients will the patients participate? Nurse meets with participants for 90 minutes over 6 weeks.

7 1 R43 NR A1 7 ZRG1 RPHB-C (10) What comorbidities are the focus? How does rural relate to the study? Says an RCT but then under recruitment says convenience sample No confirmation of diagnosis for patients to participate, nor confirmation of a problem No screening of participants. Unclear how different from existing programs used for symptoms Seem to have large sample required in the study without clarity as the ability to recruit. Will they be able to recruit patients? Unclear how each patient is engaged to participate, what about follow-up? Reasons for including lipidemia with persons with arthritis unclear how associated with pain, sleep and inactivity is not clear, what is the rationale? Why are no outcomes related to this? The investigator needs to better define outcomes. Will rural areas have adequate numbers of NPs? What are NPs to do to advance their practice? They will be able to suggest behavioral skills, but where does this come from? Unclear why NP skills needed for the activity What is a fully functional virtual room (what used to measure)? What is active engagement? Aim 2 is evaluating outcomes Increase in health behaviors how measured? How do comorbidities relate Investigator says it is critical and indicates that pain is an outcome yet not obvious, what about sleep and activity? Increased health status what measure is used? Increase arthritis self efficacy 5. Environment: Resources are adequate Clinical source of patients not described. Protections for Human Subjects: Acceptable Risks and Adequate Protections Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Acceptable Principal Investigator will monitor participants, but not a clinical trial

8 1 R43 NR A1 8 ZRG1 RPHB-C (10) Inclusion of Women, Minorities and Children: G1A - Both Genders, Acceptable M1A - Minority and Non-minority, Acceptable C3A - No Children Included, Acceptable Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Not Applicable (No Biohazards) Resubmission: Has addressed comments. In particular they are in Minnesota - appears they have now added Mississippi as a site. Budget and Period of Support: Recommended budget modifications or possible overlap identified: All of the incentive money for patients is a problem - not generalizable or realistic CRITIQUE 3: Significance: 1 Investigator(s): 1 Innovation: 1 Approach: 2 Environment: 1 Overall Impact: This resubmission of an application to develop an intervention that builds on the situated--information--motivation--behavioral Skills Model of Care Initiation and Maintenance and the Stanford chronic disease self-management program addresses all of the major concerns expressed by prior reviewers in the first round, resulting in a much stronger application. These included lack of ethnic and racial diversity, an unrealistic Aim moved to Phase II, and explanations of the use of nurse practitioners, the sample size and other issues. By using virtual internet video chat rooms instead of face-to-face meetings, the study team will make the interventions available to patients who do not normally have good access to care. This is an innovative combination of existing, proven interventions that leverages technology to extend their reach. Protections for Human Subjects: Acceptable Risks and Adequate Protections The risks are minimal and appropriately addressed Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):

9 1 R43 NR A1 9 ZRG1 RPHB-C (10) Acceptable As above, low risk and appropriate plan Inclusion of Women, Minorities and Children: G1A - Both Genders, Acceptable M1A - Minority and Non-minority, Acceptable C3A - No Children Included, Acceptable The diseases addressed are not typically pediatric Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Not Applicable (No Biohazards) Resubmission: Response to prior critique Budget and Period of Support: Recommend as Requested THE FOLLOWING RESUME SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE ON THE FOLLOWING ISSUES: PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE Although the panel considered the plan acceptable, one reviewer was considered about how the planned enrollment would be reached. INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE Although the panel considered the plan acceptable, one reviewer was considered about how the planned enrollment would be reached. INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE COMMITTEE BUDGET RECOMMENDATIONS: The budget was recommended as requested.

10 1 R43 NR A1 10 ZRG1 RPHB-C (10) NIH has modified its policy regarding the receipt of resubmissions (amended applications). See Guide Notice NOT-OD at html. The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10. The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score. Some applications also receive a percentile ranking. For details on the review process, see

11 MEETING ROSTER Center for Scientific Review Special Emphasis Panel CENTER FOR SCIENTIFIC REVIEW Small Business: Risk, Prevention and Health Behavior ZRG1 RPHB-C (10) B February 27, February 28, 2014 CHAIRPERSON ROBINSON, RICHARD C, PHD ASSOCIATE PROFESSOR DEPARTMENT OF PSYCHIATRY UT SW MEDICAL CENTER DALLAS, TX MEMBERS ALLEN, REBECCA S, PHD PROFESSOR DEPARTMENT OF PSYCHOLOGY CENTER FOR MENTAL HEALTH AND AGING UNIVERSITY OF ALABAMA TUSCALOOSA, AL BECKER, BRUCE M, MPH ASSOCIATE PROFESSOR SCHOOL OF MEDICINE BROWN UNIVERSITY PROVIDENCE, RI BOSWORTH, HAYDEN B, PHD PROFESSOR CENTER FOR HEALTH SERVICES RESEARCH IN PRIMARY CARE DURHAM VAMC RESEARCH PROFESSOR DUKE UNIVERSITY SCHOOL OF MEDICINE DURHAM, NC CASTRO, CYNTHIA M, PHD SENIOR RESEARCH SCIENTIST STANFORD PREVENTION RESEARCH CENTER STANFORD UNIVERSITY STANFORD, CA DELAMATER, ALAN M, PHD PROFESSOR, DIRECTOR, CLINICAL PSYCHOLOGY DEPARTMENT OF PEDIATRICS UNIVERSITY OF MIAMI SCHOOL OF MEDICINE MIAMI, FL DIGNAN, MARK B, PHD PROFESSOR DEPARTMENT OF INTERNAL MEDICINE PREVENTION RESEARCH CENTER MARKEY CANCER CENTER UNIVERSITY OF KENTUCKY LEXINGTON, KY DODGE, KAREN C, PHD DIRECTOR OF RESEARCH HANLEY CENTER, INCORPORATED CO-AFFILIATE MILLER SCHOOL OF MEDICINE UNIVERSITY OF MIAMI WEST PALM BEACH, FL EAKIN, MICHELLE N, PHD ASSISTANT PROFESSOR DIVISION OF PULMONARY AND CRITICAL CARE MEDICINE, DEPARTMENT OF MEDICINE JOHNS HOPKINS UNIVERSITY BALTIMORE, MD FENTON, SUSAN H, PHD ASSISTANT DEAN FOR ACADEMIC AFFAIRS UTHEALTH SCHOOL OF BIOMEDICAL INFORMATICS HOUSTON, TX GARDNER, REED M, PHD EMERITUS PROFESSOR AND FORMER CHAIRMAN SCHOOL OF MEDICINE UNIVERSITY OF UTAH SALT LAKE CITY, UT GIVEN, BARBARA A, FAAN, RN, PHD PROFESSOR COLLEGE OF NURSING MICHIGAN STATE UNIVERSITY EAST LANSING, MI GORDON, DONALD, PHD PRESIDENT FAMILY WORKS INC. ATHENS, OH HAHN, JEROME, BSME PRESIDENT AND VICE CHAIRMAN TELEHEALTH HOLDINGS, LLC LEXINGTON, KY HOLLAND, JOHN K SENIOR VICE PRESIDENT ADVANCED MONITORED CAREGIVING, INC. NEW YORK, NY JOHNSON, RENEE M, PHD ASSISTANT PROFESSOR DEPARTMENT OF MENTAL HEALTH JOHN HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH BALTIMORE, MD MCGAVOCK, JONATHAN, PHD ASSISTANT PROFESSOR MANITOBA INSTITUTE OF CHILD HEALTH UNIVERSITY OF MANITOBA WINNIPEG, MB R3E3P4 CANADA MCGILLICUDDY, NEIL B, PHD SENIOR RESEARCH SCIENTIST RESEARCH INSTITUTE ON ADDICTIONS STATE UNIVERSITY OF NEW YORK BUFFALO, NY 14203

12 MEYERS, EMILY, MA PRESIDENT EYES OF THE WORLD MEDIA GROUP CULVER CITY, CA PAN, YANG, MD, PHD SCIENTIFIC AND REGULATORY AFFAIRS MANAGER OMEGA PROTEIN CORPORATION HOUSTON, TX PHAM, RICHARD H, PHMD SENIOR ENTERPRISE ARCHITECT OFFICE OF INFORMATICS AND ANALYTICS DEPARTMENT OF VETERANS AFFAIRS RENO, NV GRANTS TECHNICAL ASSISTANT WATTS, MELISSA D EXTRAMURAL SUPPORT ASSISTANT CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTE FOR HEALTH BETHESDA, MD Consultants are required to absent themselves from the room during the review of any application if their presence would constitute or appear to constitute a conflict of interest. SANTAMORE, WILLIAM P, PHD PROFESSOR DEPARTMENT OF MEDICINE AND PHYSIOLOGY TEMPLE UNIVERSITY PHILADELPHIA, PA SHEGOG, ROSS, PHD ASSOCIATE PROFESSOR CENTER FOR HEALTH PROMOTION AND PREVENTION RESEARCH SCHOOL OF PUBLIC HEALTH UNIVERSITY OF TEXAS HOUSTON, TX SWARTZ, ANN M, PHD ASSOCIATE PROFESSOR DEPARTMENT OF KINESIOLOGY UNIVERSITY OF WISCONSIN-MILWAUKEE MILWAUKEE, WI WOLPIN, SETH, PHD ASSOCIATE PROFESSOR DEPARTMENT OF BIOBEHAVIORAL NURSING SCHOOL OF NURSING UNIVERSITY OF WASHINGTON SEATTLE, WA ZILL, NICHOLAS, PHD VICE PRESIDENT (RETIRED) WESTAT CHILD AND FAMILY STUDIES WASHINGTON, DC MAIL REVIEWER(S) SPRINGER, JOHN F, PHD RESEARCH DIRECTOR EMT ASSOCIATES, INC. FOLSOM, CA SCIENTIFIC REVIEW ADMINISTRATOR GUTKIN, CLAIRE E, MPH, PHD SCIENTIFIC REVIEW OFFICER CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH BETHESDA, MD 20892