Recruiting

Home-based PAC

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06547645

Conditions

Skilled Nursing Facility

Rehabilitation

Home Based Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sub-Acute Rehab at Home

Study Details

Brief 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

Study ID

NCT06547645

Start date

Aug 26, 2024

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 or older
  • Admitted to an inpatient unit OR receiving home health and requiring an escalation to skilled-nursing facility care
  • Require post-acute care in a skilled nursing facility based on the clinical inpatient team's assessment (or, if the participant is coming from home, based on the home health team's assessment)
  • Pass the home readiness assessment
  • Reside within Greater Worcester or Greater Springfield

Exclusion Criteria:

  • Inability to return to a home residence where care can be provided
  • Inability for patient or their proxy to provide informed consent for the study
  • Requires long-term care
  • Requires palliative or hospice care
  • On active chemotherapy
  • Post-transplant surgery
  • Requires hemodialysis
  • Requires radiation therapy
  • Requires two-person assist or mechanical lift
  • Expresses unwillingness to be randomized to SNF OR SNF at Home care
  • Considered clinically inappropriate by SNF at Home clinical team

Study Design

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Principal Investigator:

Peter Lindenauer, MD

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 02446

Principal Investigator:

Apurv Soni, MD, PhD

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-03-11.