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Clinical Trials/NCT06547645
NCT06547645
Recruiting
N/A

Skilled Nursing Facility at Home Trial

University of Massachusetts, Worcester4 sites in 1 country650 target enrollmentAugust 26, 2024

Overview

Phase
N/A
Intervention
Facility-based
Conditions
Skilled Nursing Facility
Sponsor
University of Massachusetts, Worcester
Enrollment
650
Locations
4
Primary Endpoint
30-Day Readmission and Mortality
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2024
End Date
May 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Apurv Soni

Assistant Professor

University of Massachusetts, Worcester

Eligibility Criteria

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

Arms & Interventions

Facility-based

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

Home-based

Home-based Post-Acute Care

Intervention: Sub-Acute Rehab at Home

Outcomes

Primary Outcomes

30-Day Readmission and Mortality

Time Frame: 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 Outcomes

  • 90- and 180- day Readmission and Mortality(From time of enrollment, up to 6 months post-enrollment)
  • Mortality rate(From time of enrollment 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)
  • Length of stay(From time of enrollment, up to 6 months post-enrollment)

Study Sites (4)

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