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 — OTHERPatients 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-basedFacility based post acute care at a skilled nursing facility, as is the standard care model.
- Active Comparator: Home-basedHome-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
- Study Team508-523-1284
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baystate Medical Center | Springfield | Massachusetts | 01199 | Peter Lindenauer, MD Peter Lindenauer, MD (PRINCIPAL_INVESTIGATOR) |
| UMass Memorial Medical Center | Worcester | Massachusetts | 02446 | Apurv Soni, MD, PhD Apurv Soni, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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