Skilled Nursing Facility at Home Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Skilled Nursing Facility; Home Based Care
• Intervention / Treatment: Other: Sub-Acute Rehab at Home

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: 508-523-1284; Email: homerehab@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: Peter Lindenauer, MD
      • Principal Investigator: Peter Lindenauer, MD
    • Worcester, Massachusetts, United States, 02446
      • Recruiting
      • UMass Memorial Medical Center
      • Contact: Apurv Soni, MD, PhD
      • Principal Investigator: Apurv Soni, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: SNF at Home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days Alive	Starting with the day of randomization, the total number of days alive outside of the hospital during the study period.	From time of enrollment, up to 6 months post-enrollment
Activities of Daily Living	Compare the improvement in ability to perform activities of daily living between the intervention and control groups from time of enrollment to 30, 90 and 180-days after enrollment.	From time of enrollment, up to 6 months post-enrollment
Healthcare Costs	Compare healthcare cost incurred and healthcare utilization between the intervention and control group during the PAC episode as well as from time of enrollment to the end of the PAC episode.	From time of enrollment, up to 6 months post-enrollment
Mortality rate	Compare mortality rates during the study period between the intervention and control groups.	From time of enrollment to 6 months post-enrollment
Length of stay	Compare length-of-stay (number of days) that study participants receive post-acute, SNF-level care during the index PAC episode between the intervention and control groups	From time of enrollment, up to 6 months post-enrollment
90- and 180- day Readmission and Mortality	Hospital readmission rates and mortality rates between the intervention and control groups in the 90- and 180- days after enrollment	From time of enrollment, up to 6 months post-enrollment

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Baystate Health; UMass Memorial Health; Massachusetts Executive Office of Health and Human Services (EOHHS)
• Investigators: Principal Investigator: Principal Investigator, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00001862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No