Skilled Nursing Facility at Home Trial

NCT06547645 | Recruiting DMC

• 1 other identifier: STUDY00001862
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 30-Day Readmission and Mortality

  Hospital readmission rates and mortality rates between the intervention and control groups in the first 30 days after enrollment

  From time of enrollment to 30 days after enrollment

Secondary Outcomes (6)

• 90- and 180- day Readmission and Mortality

  From time of enrollment, up to 6 months post-enrollment

• Days Alive

  From time of enrollment, up to 6 months post-enrollment

• Activities of Daily Living

  From time of enrollment, up to 6 months post-enrollment

• Healthcare Costs

  From time of enrollment, up to 6 months post-enrollment

• Mortality rate

  From time of enrollment to 6 months post-enrollment

Study Arms (2)

Facility-based

NO INTERVENTION

Facility based post acute care at a skilled nursing facility, as is the standard care model.

Home-based

ACTIVE COMPARATOR

Home-based Post-Acute Care

Other: Sub-Acute Rehab at Home

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.

Also known as: SNF at Home

Home-based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Baystate Health: collaborator
• UMass Memorial Health: collaborator
• Massachusetts Executive Office of Health and Human Services (EOHHS): collaborator

Study Sites (2)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 02446, United States

RECRUITING

Study Officials

• Principal Investigator

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

508-523-1284; homerehab@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)