Skilled Nursing Facility At Home Trial

Not Applicable

Recruiting

• Conditions: Rehabilitation; Skilled Nursing Facility; Home Based Care
• Interventions: Other: Sub-Acute Rehab at Home

• Registration Number: NCT06547645
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Study Start: 2024-08-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-01-26
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based	Sub-Acute Rehab at Home	Home-based Post-Acute Care

Primary Outcome Measures

Name	Time	Method
30-Day Readmission and Mortality	From time of enrollment to 30 days after enrollment	Hospital readmission rates and mortality rates between the intervention and control groups in the first 30 days after enrollment

Secondary Outcome Measures

Name	Time	Method
60- and 180- day Readmission and Mortality	From time of enrollment, up to 6 months post-enrollment	Hospital readmission rates and mortality rates between the intervention and control groups in the 60- and 180- days after enrollment
Days Alive	From time of enrollment, up to 6 months post-enrollment	Starting with the day of randomization, the total number of days alive outside of the hospital during the study period.
Activities of Daily Living	From time of enrollment, up to 6 months post-enrollment	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.
Healthcare Costs	From time of enrollment, up to 6 months post-enrollment	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.
Mortality rate	From time of enrollment to 6 months post-enrollment	Compare mortality rates during the study period between the intervention and control groups.
Length of stay	From time of enrollment, up to 6 months post-enrollment	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

Trial Locations

Locations (2)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States