Home-based Primary Care for Homebound Seniors

NCT02965508 | Terminated DMC

• 2 other identifiers: GCO 15-0950R01AG052557
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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

Conditions

Home-bound Adults

Keywords

Home-bound; home-based primary care

Outcome Measures

Primary Outcomes (2)

• Incidence of Hospitalization

  at 12 months

• Incidence of ED visits

  at 12 months

Study Arms (2)

Home-based Primary Care Arm

EXPERIMENTAL

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

Usual Care Arm

ACTIVE COMPARATOR

Participants in this arm will receive the usual care at office based visits

Other: Usual Care

Interventions

Home-based Primary Care OTHER

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.

Home-based Primary Care Arm

Usual Care OTHER

Office based care

Usual Care Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator
• NYU Langone Health: collaborator
• University of California, San Francisco: collaborator
• Visiting Nurse Service of New York: collaborator
• The New Jewish Home: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Alex Federman, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Geriatrics and Palliative Medicine

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: February 8, 2017
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)