Longitudinal, Interdisciplinary Home Visits Versus Usual Care for Homebound People With Advanced Parkinson Disease: Protocol for a Controlled Trial

Background The current understanding of advanced Parkinson disease (PD) and its treatment is largely based on data from outpatient visits. The most advanced and disabled individuals with PD are disconnected from both care and research. A previous pilot study among older, multimorbid patients with advanced PD demonstrated the feasibility of interdisciplinary home visits to reach the target population, improve care quality, and potentially avoid institutionalization. Objective The aim of this study protocol is to investigate whether interdisciplinary home visits can prevent a decline in quality of life of patients with PD and prevent worsening of caregiver strain. The protocol also explores whether program costs are offset by savings in health care utilization and institutionalization compared with usual care. Methods In this single-center, controlled trial, 65 patient-caregiver dyads affected by advanced PD (Hoehn and Yahr stages 3-5 and homebound) are recruited to receive quarterly interdisciplinary home visits over 1 year. The 1-year intervention is delivered by a nurse and a research coordinator, who travel to the home, and it is supported by a movement disorder specialist and social worker (both present by video). Each dyad is compared with age-, sex-, and Hoehn and Yahr stage–matched control dyads drawn from US participants in the longitudinal Parkinson’s Outcome Project registry. The primary outcome measure is the change in patient quality of life between baseline and 1 year. Secondary outcome measures include changes in Hoehn and Yahr stage, caregiver strain, self-reported fall frequency, emergency room visits, hospital admissions, and time to institutionalization or death. Intervention costs and changes in health care utilization will be analyzed in a budget impact analysis to explore the potential for model adaptation and dissemination. Results The protocol was funded in September 2017 and approved by the Rush Institutional Review Board in October 2017. Recruitment began in May 2018 and closed in November 2019 with 65 patient-caregiver dyads enrolled. All study visits have been completed, and analysis is underway. Conclusions To our knowledge, this is the first controlled trial to investigate the effects of interdisciplinary home visits among homebound individuals with advanced PD and their caregivers. This study also establishes a unique cohort of patients from whom we can study the natural course of advanced PD, its treatments, and unmet needs. Trial Registration ClinicalTrials.gov NCT03189459; http://clinicaltrials.gov/ct2/show/NCT03189459. International Registered Report Identifier (IRRID) PRR1-10.2196/31690

The panel noted that Dr. Fleisher's research focuses upon an area of tremendous interest since it has the potential to create a new model of interdisciplinary home care. More specifically, three aims will determine whether a telemedicine-enhanced home visit program improves quality of life, caregiver strain, and cost-effectiveness for patients with advanced PD. In addition, the proposed research leverages an existing infrastructure that is already led by Dr. Fleisher, and also features a peer mentor intervention to improve quality of life ratings and mood among caregivers. Power calculations were noted to be satisfactory, and appropriate scientific rigor is demonstrated in Dr. Fleisher's methods. The premise was felt to be adequately addressed. If proven effective, this innovative model of in-home care could change clinical practice. Minor concerns included the feasibility of recruitment, the short one-year time period for follow-up testing, and limited assessments in Aims 2 and 3. Regarding the proposed one-year follow-up period, some panel members indicated it may be too short to detect meaningful differences in quality of life, care and mood. These same panel members acknowledged that the concern is minor since it is probably unavoidable due to potential attrition if the time frame between testing is set to longer than one year. Another concern for some was that the preliminary data indicate that the quality of life numbers improve despite evidence of disease progression. Thus, it was unclear if the improved quality of life ratings are clinically meaningful. It also was noted that it was difficult to understand which quality of life numbers were for the patient or for the caregiver. Overall, the review panel had high enthusiasm not only for Dr. Fleisher, but for the proposed research which has potential for high-impact and should prepare Dr. Fleischer to be competitive for future independent funding.

K23 NS097615-01A1
3 NST-1 FLEISHER, J caregiver strain rises, resulting in 100-200,000 US patients becoming homebound. This population loses access to care despite overwhelming need. Evidence supports interdisciplinary and home-based models of care in other elderly cohorts, and the use of telehealth in earlier stages of PD; however, none of these have been formally tested in advanced PD. The long-term goals of this K23 are 1) to develop the candidate into a leader in the fields of movement disorders and health services research, and 2) to develop, test, and disseminate models of care and related interventions to improve access to care, quality of care, and quality of life for patients with advanced PD and their caregivers. The aims of this project are 1) to test the efficacy of an interdisciplinary home visit program for patients with advanced PD on patient quality of life and caregiver strain when compared with usual care; 2) to compare the effects of home visits with and without caregiver peer mentoring on caregiver health; and 3) to conduct a budget impact analysis of the model. We will prospectively study 60 patient-caregiver pairs matched with subjects receiving usual care within the National Parkinson Foundation Parkinson's Outcome Project (POP); we will enroll 36 experienced past caregivers as peer mentors. The K23 candidate is an Assistant Professor of Neurology and Population Health at New York University School of Medicine, and completed a movement disorders fellowship and NINDS T32-supported Master's of Science in Clinical Epidemiology at the University of Pennsylvania. She has conducted clinical and health services research in geriatrics, neurology, and PD, identifying health literacy and medication beliefs as barriers to care. She has demonstrated the feasibility of a pilot interdisciplinary home visit program for homebound individuals with PD. The candidate is committed to a career in patient-oriented research and proposes an comprehensive five-year plan of mentorship, formal training, self-directed learning, and research. She will develop expertise and skills in: 1) Implementation and dissemination science; 2) Comparative and cost effectiveness research; and 3) Palliative care skills and research. The results of this K23 will inform future R01 applications that will test the efficacy and cost effectiveness of this model for advanced PD in other settings, and adapt this model to other chronic neurologic conditions. By identifying, testing, and disseminating effective therapies and models of care for this previously understudied population, we can minimize morbidity and unnecessary healthcare utilization. Dr. Fleisher's mentorship team includes expertise in PD, implementation and dissemination of interdisciplinary care models, telehealth, cost effectiveness, and the POP. The outstanding institutional support, and proposed training, career development, and research plans will ensure Dr. Fleisher's successful transition to an independent clinical investigator dedicated to improving the health outcomes of patients with advanced Parkinson's Disease and other neurodegenerative conditions. PUBLIC HEALTH RELEVANCE: Advanced Parkinson's Disease is a debilitating, costly, and understudied condition. Improving access to comprehensive, specialized, in-home patient care and caregiver support offers the potential to minimize the downward spiral of morbidity and preventable healthcare utilization. The aim of this proposal is to test whether and to what degree an interdisciplinary home visit program, with and without peer mentoring for caregivers, will improve patient-and caregiverreported outcomes and reduce healthcare costs when compared with usual care in advanced Parkinson's Disease.

NOTE:
The critiques and criterion scores from individual reviewers are provided below in an essentially unedited form. These were prepared prior to the review meeting and may not have been updated or revised subsequent to the discussion at the meeting. Therefore, they may not fully reflect the final opinions of the individual reviewers at the close of group discussion or the final majority opinion of the group. The Resume and Summary of Discussion above summarizes the final outcome of the group discussion. Overall Impact: This is a resubmission of a K23 application by a promising candidate with strong research and clinical training in geriatrics and neurology, movement disorders, and Parkinson's disease research. The candidate is highly motivated and has a goal of becoming an independent health services researcher in movement disorders. In addition to her clinical training, she has a MS in clinical epidemiology and has already worked on number of healthcare projects including development of an interdisciplinary home visit program (funded by the Edmond J. Safra Foundation). Her work is now recognized by several other foundations and is garnering increasing interest. Although her publication record remains modest, she has had 2 recent publications of note. Her career goals are well detailed and better identify gaps in training. The coursework outlined appears appropriate, but concern is raised regarding the ambitious nature of her training plan including coursework, committees, task force, and meetings. She has created a solid mentoring team at NYU and outstanding advisory committee that will help ensure her success. Her environment is outstanding and institutional support strong. Her research focuses on an area of tremendous interest in advanced PD and has the potential to create a new model of interdisciplinary home care incorporating a mentoring team and telemedicine. Prior concerns included differentiation of her project, but these have been addressed. Minor concerns include the feasibility of mentor recruitment, time period for follow-up, and limited assessments in Aims 2 and 3. Overall, this project is met with enthusiasm and has potential for high-impact and launching the candidate's career. 1 K23 NS097615-01A1 5 NST-1 FLEISHER, J  Plan for mentorship is solid and includes experts in her field (Primary: Dr. Chodosh) with regular meeting. She has put together an outstanding advisory committee to oversee her progress.

Weaknesses
 Amount of coursework, local and national career development opportunities, committee work, task force, may be overambitious.

Research Plan:
Strengths  The candidate's proposed research focuses on an area of great need and tremendous interest in advanced PD and has the potential to forward an innovative model of (in-home) care, and change practice, for many patients with PD. The goals of her project fit well with her background, expertise, and long-term interests.
 Based on successful pilot Interdisciplinary Home Visit Program  Candidate addressed gaps in her approach to advanced PD: targeting caregiver strain, added peer mentoring, and telemedicine.
 Rigor is demonstrated and power calculations included.

Weaknesses
 1-year follow-up period may be too short to detect meaningful differences in quality of care and impact of patients, caregivers, and mood. This concern may be minor and unavoidable due to attrition and confound of increase in comorbid conditions.
 Aims 2 and 3 rely on one outcome measure: MCSI, and HADS, respectively.
 Preliminary data and feasibility of mentor recruitment and capability is lacking.

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s):
Strengths  Primary mentor, Dr. Chodosh, though relatively new to NYU is outstanding. He has expertise in the candidate's field of interest, is well-funded, and has a proven track record of successfully mentoring. Strong letter.
 Co-mentors, Drs. Di Rocco and Gold, are excellent and provide expertise in advanced PD care, health disparities, dissemination of health care technologies, and cost-effectiveness analyses.

Weaknesses
 Dr. Chodosh has not mentored a K-awardee before, but this is a minor weakness as he has trained many other junior faculty.

Environment and Institutional Commitment to the Candidate:
Strengths  The candidate is in an outstanding environment that fosters collaboration and support.
 Strong support expressed by her Chair. 80% protected time stipulated, start-up funds, department resources, and support for her mentor team.

K23 NS097615-01A1
8 NST-1 FLEISHER, J  Difficult to understand when patient QOL and caregiver QOL is the focus in the preliminary data.
 Despite the updated interest in implementation science, the rigor of this approach in the preliminary data is limited.

Weaknesses
 No significant concerns.

Environment and Institutional Commitment to the Candidate:
Strengths  The environment is strong.

Weaknesses
 No significant concerns.  Footnotes for 1 K23 NS097615-01A1; PI Name: Fleisher, Jori Erin NIH has modified its policy regarding the receipt of resubmissions (amended applications). See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.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 1 K23 NS097615-01A1 Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant investigators and institutional officials must not communicate directly with study section members about an application before or after the review. All questions should be directed to the Scientific Review Officer in charge of the study section. Failure to observe this policy will create a serious breach of integrity in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.html, including removal of the application from immediate review. 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.