Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
230 participants
INTERVENTIONAL
2017-02-08
2020-07-10
Brief Summary
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Detailed Description
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Over one million seniors in the U.S. have functional limitations that prevent them from receiving office-based primary care. As a result, home-bound adults typically experience poor disease control, high rates of hospitalization, and large healthcare expenditures resulting for hospitalizations and emergency department use. Few modes of healthcare delivery designed specifically for the home-bound have been studied, but observational data suggest that home-based primary care could improve outcomes and reduce spending for these highly vulnerable patients.
The investigators propose a pragmatic randomized controlled trial of home-based primary care vs. office-based primary care for home-bound older adults, with 3 Specific Aims: to compare the impact of home-based primary care and office-based primary care 1) on hospitalization and emergency department visit rates, symptom control and quality of life, and satisfaction with care among home-bound elders; 2) on care-giving burden among informal caregivers (e.g., family and friends); and 3) on healthcare expenditures for the home-bound. The hypothesis is that patients in home-based primary care and their caregivers will have better outcomes compared to office-based primary care patients.
The study embraces the concepts of a pragmatic trial design to facilitate the translation of study findings for practical clinical, systems, and health policy applications. The study team includes experts in aging related health services research, health economics, health policy, randomized clinical trials, and the medical and nursing care of home-bound older adults.
The proposed study would be the largest prospective study of home-bound older adults and the only randomized trial of home-based primary car for the home-bound. It would fill important knowledge gaps in our understanding of the effects of home-based primary care for the home-bound. The study is consistent with the Institute of Medicine's call for expanded research on comprehensive models of chronic care, including the multidisciplinary management of chronic diseases and the medical home concept.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Home-based Primary Care Arm
Participants in this arm will be assigned a Mount Sinai Visiting Doctors primary care physician who makes a home based primary care visit.
Home-based Primary Care
Care in the programs is inter-professional and team-based. Each physician leads a team charged with the care of a panel of patients and directs the team's activities. New patients are assigned a Mount Sinai Visiting Doctors (MSVD) primary care physician or the Chelsea Village House Calls Program (CVHCP) who makes an initial visit within 2 weeks of the patient's enrollment in the program. The primary care physician completes a comprehensive medical history and physical exam during the initial visit including standardized assessments of physical functioning and cognition. The primary care physician then provides ongoing management of the patients' acute and chronic health problems, including palliative and home hospice care when needed, every 2 to 12 weeks as determined on a case-by-case basis.
Usual Care Arm
Participants in this arm will receive the usual care at office based visits
Usual Care
Office based care
Interventions
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Home-based Primary Care
Care in the programs is inter-professional and team-based. Each physician leads a team charged with the care of a panel of patients and directs the team's activities. New patients are assigned a Mount Sinai Visiting Doctors (MSVD) primary care physician or the Chelsea Village House Calls Program (CVHCP) who makes an initial visit within 2 weeks of the patient's enrollment in the program. The primary care physician completes a comprehensive medical history and physical exam during the initial visit including standardized assessments of physical functioning and cognition. The primary care physician then provides ongoing management of the patients' acute and chronic health problems, including palliative and home hospice care when needed, every 2 to 12 weeks as determined on a case-by-case basis.
Usual Care
Office based care
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent (patient or proxy)
* Permanently requires assistance in ≥2 activities of daily living
* Patient or proxy reports that patient is home-bound (leaves the home infrequently for non-medical purposes or cannot leave the home without assistance)
* ≥1 hospitalization in past 12 months
* Speaks English or Spanish
* Willingness to accept a home-based primary care physician as their primary care physician.
Exclusion Criteria
* If there is any active drug use/sale or firearms in home, we exclude for safety reasons
* A 2-week prognosis will be based on the opinion of the patient's primary care provider or by consensus among physicians on the research team
* Patients in hospice at baseline
65 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
NYU Langone Health
OTHER
University of California, San Francisco
OTHER
Visiting Nurse Service of New York
OTHER
The New Jewish Home
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Alex D Federman
Professor, Geriatrics and Palliative Medicine
Principal Investigators
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Alex Federman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Other Identifiers
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GCO 15-0950
Identifier Type: -
Identifier Source: org_study_id
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