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Home-based Primary Care for Homebound Seniors

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ClinicalTrials.gov Identifier: NCT02965508
Recruitment Status : Terminated (The Data Safety Monitoring Board determined that the serious adverse event rate was higher among patients awaiting enrollment in the home-based primary care intervention compared to those who had initiated home-based primary care.)
First Posted : November 16, 2016
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
NYU Langone Health
University of California, San Francisco
Visiting Nurse Service of New York
The New Jewish Home
Information provided by (Responsible Party):
Alex D Federman, Icahn School of Medicine at Mount Sinai

Brief Summary:
The objective of this pragmatic randomized controlled trial is to compare the impact of physician directed home-based primary care with office-based primary care on hospitalizations, symptom control, caregiver burden, healthcare costs and other outcomes for older homebound adults and to conduct a dissemination and implementation evaluation to support future home-based primary care adoption

Condition or disease Intervention/treatment Phase
Home-bound Adults Other: Home-based Primary Care Other: Usual Care Not Applicable

Detailed Description:

The objective of this study is to evaluate the impact of home-based primary care on outcomes for home-bound older adults, including hospitalization and emergency department (ED) visits, quality of life and symptom control, costs of care, and burden of care for their informal caregivers. A mixed methods dissemination and implementation evaluation of home-based primary care will also be conducted.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Home-based Primary Care for Homebound Seniors: a Randomized Controlled Trial
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Active Comparator: Usual Care Arm
Participants in this arm will receive the usual care at office based visits
Other: Usual Care
Office based care




Primary Outcome Measures :
  1. Incidence of Hospitalization [ Time Frame: at 12 months ]
  2. Incidence of ED visits [ Time Frame: at 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥65 years with Medicare
  • 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:

  • Patients must live in Manhattan, have access to a telephone 24 hours a day, 7 days a week, not be on hemodialysis, agree to open the door and allow access to the members of the team
  • 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
  • Standard MSVD and CVHCP exclusion criteria also apply :(1) Patients must live in Manhattan, have access to a telephone 24/7, not be on hemodialysis, agree to open the door and allow access to the members of the team; (2) If there is any active drug use/sale or firearms in home, will exclude for safety reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965508


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institutes of Health (NIH)
National Institute on Aging (NIA)
NYU Langone Health
University of California, San Francisco
Visiting Nurse Service of New York
The New Jewish Home
Investigators
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Principal Investigator: Alex Federman, MD, MPH Icahn School of Medicine at Mount Sinai
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Responsible Party: Alex D Federman, Professor, Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02965508    
Other Study ID Numbers: GCO 15-0950
R01AG052557 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alex D Federman, Icahn School of Medicine at Mount Sinai:
Home-bound
home-based primary care