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Clinical Trials/NCT06416670
NCT06416670
Active, Not Recruiting
N/A

Skilled Nursing Facility Care at Home: A Randomized Controlled Trial

Brigham and Women's Hospital5 sites in 1 country300 target enrollmentJune 3, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Skilled Nursing Facility
Sponsor
Brigham and Women's Hospital
Enrollment
300
Locations
5
Primary Endpoint
Change in activities of daily living between admission to rehab and discharge from rehab
Status
Active, Not Recruiting
Last Updated
6 months ago

Overview

Brief Summary

We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting.

Registry
clinicaltrials.gov
Start Date
June 3, 2024
End Date
September 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Levine

Associate Physician

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • \>=18 years old
  • Requires SNF PAC care following hospitalization, as determined by the inpatient team (requires documented rehabilitative therapy recommendation)
  • Community-dwelling before hospitalization
  • Likely to return to community-dwelling status following short-term rehabilitation as determined by RAH liaison
  • Lives within 10 miles of any study site hospital (or per specified catchment)
  • Surgical trauma and elective patients (weight bearing as tolerated and transfer with no more than one-person assist)
  • Neurology patients - Stroke (needs acute rehabilitation, but insurance will not cover, so bound for SNF. Does not meet acute rehabilitation criteria and does not need long-term placement)

Exclusion Criteria

  • Environmental
  • Undomiciled
  • No working heat (October-April), no working air conditioning if forecast \> 80°F, or no running water
  • In police custody
  • Resides in a facility that does not allow advanced on-site care
  • Domestic violence screen positive
  • Weapons that cannot be appropriately secured
  • Difficulty accessing the bathroom (unless there is space for a bedside commode where the patient sleeps or if the patient is entirely dependent on toileting)
  • Home has insufficient accessible space to sleep, eat, and perform rehabilitative therapy
  • Home lacks sufficient kitchen facilities to either cook or heat meals

Outcomes

Primary Outcomes

Change in activities of daily living between admission to rehab and discharge from rehab

Time Frame: Admission to rehab until discharge from rehab, no more than 6 months

Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab.

Secondary Outcomes

  • Percent time supine per day(Admission to rehab until discharge from rehab, no more than 6 months)
  • Total direct medical expenditure(Admission to rehab until discharge from rehab, no more than 6 months)
  • Patient experience with care(Admission to rehab until discharge from rehab, no more than 6 months)
  • 30-day readmission or 30-day mortality(Discharge from rehab until 30-days later, no more than 30-days)

Study Sites (5)

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