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Skilled Nursing Facility At Home Trial

U

University of Massachusetts, Worcester

Status

Enrolling

Conditions

Rehabilitation
Home Based Care
Skilled Nursing Facility

Treatments

Other: Sub-Acute Rehab at Home

Study type

Interventional

Funder types

Other

Identifiers

NCT06547645
STUDY00001862

Details and patient eligibility

About

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.

Enrollment

650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

650 participants in 2 patient groups

Facility-based
No Intervention group
Description:
Facility based post acute care at a skilled nursing facility, as is the standard care model.
Home-based
Active Comparator group
Description:
Home-based Post-Acute Care
Treatment:
Other: Sub-Acute Rehab at Home

Trial contacts and locations

2

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Central trial contact

Study Team

Data sourced from clinicaltrials.gov

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