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Home-based Primary Care for Homebound Seniors

14. Oktober 2020 aktualisiert von: Alex D Federman, Icahn School of Medicine at Mount Sinai

Home-based Primary Care for Homebound Seniors: a Randomized Controlled Trial

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

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

230

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Icahn School of Medicine at Mount Sinai

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: 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.
Aktiver Komparator: Usual Care Arm
Participants in this arm will receive the usual care at office based visits
Sonstiges: Usual Care
Office based care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Incidence of Hospitalization
Zeitfenster: at 12 months
at 12 months
Incidence of ED visits
Zeitfenster: at 12 months
at 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Icahn School of Medicine at Mount Sinai

Mitarbeiter

NYU Langone Health
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of California, San Francisco
Visiting Nurse Service of New York
The New Jewish Home

Ermittler

  • Hauptermittler: Alex Federman, MD, MPH, Icahn School of Medicine at Mount Sinai

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Februar 2017

Primärer Abschluss (Tatsächlich)

10. Juli 2020

Studienabschluss (Tatsächlich)

10. Juli 2020

Studienanmeldedaten

Zuerst eingereicht

14. November 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. November 2016

Zuerst gepostet (Schätzen)

16. November 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • GCO 15-0950
  • R01AG052557 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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