Home-based Primary Care for Homebound Seniors
Home-based Primary Care for Homebound Seniors: a Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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Aktiv komparator: Usual Care Arm
Participants in this arm will receive the usual care at office based visits
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Office based care
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Incidence of Hospitalization
Tidsramme: at 12 months
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at 12 months
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Incidence of ED visits
Tidsramme: at 12 months
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at 12 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alex Federman, MD, MPH, Icahn School of Medicine at Mount Sinai
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GCO 15-0950
- R01AG052557 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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