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Skilled Nursing Facility at Home Trial

NCT06547645 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2026-03-11

No results posted yet for this study

Summary

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.

Conditions

  • Skilled Nursing Facility
  • Rehabilitation
  • Home Based Care

Interventions

OTHER

Sub-Acute Rehab at Home

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.

Sponsors & Collaborators

  • Baystate Health

    collaborator OTHER

  • UMass Memorial Health

    collaborator OTHER

  • Massachusetts Executive Office of Health and Human Services (EOHHS)

    collaborator UNKNOWN

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Principal Investigator · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547645 on ClinicalTrials.gov