Skilled Nursing Facility at Home Trial

Part of paid clinical trials in Springfield, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06547645
Status
Recruiting

Conditions

  • Home Based Care
  • Rehabilitation
  • Skilled Nursing Facility

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sub-Acute Rehab at Home — OTHER
    Patients randomized to the intervention group will receive skilled nursing and rehabilitative care at home upon discharge from the hospital, or when eligible for skilled-nursing facility care when requiring a step up in services at home. Home care will be delivered and overseen by a multidisciplinary clinical team, which will develop individualized care plans based on diagnosis, specific rehabilitation objectives, and broader goals of care.

Study Details

Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.

Key Dates

Start date
Aug 26, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Facility-based
    Facility based post acute care at a skilled nursing facility, as is the standard care model.
  • Active Comparator: Home-based
    Home-based Post-Acute Care

Primary Outcome Measure

30-Day Readmission and Mortality [ Time Frame: From time of enrollment to 30 days after enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baystate Medical CenterSpringfieldMassachusetts01199
Peter Lindenauer, MD
Peter Lindenauer, MD (PRINCIPAL_INVESTIGATOR)
UMass Memorial Medical CenterWorcesterMassachusetts02446
Apurv Soni, MD, PhD
Apurv Soni, MD, PhD (PRINCIPAL_INVESTIGATOR)

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