Skilled Nursing Facility Care at Home

NCT06416670 | Active Not Recruiting DMC

• 1 other identifier: 2024P000266
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Skilled Nursing Facility; Rehabilitation

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (4)

• 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 Arms (2)

Usual skilled nursing facility care

NO INTERVENTION

Control subjects will receive care at a skilled nursing facility as per usual.

Rehab at home

ACTIVE COMPARATOR

Intervention subjects will receive care in their home from a specialized care team.

Other: Skilled nursing facility care at home

Interventions

Skilled nursing facility care at home OTHER

Skilled nursing facility care at home delivers a range of advanced rehabilitation services in patients' homes, enabling care at home despite requiring intensive rehabilitative care. Our approach blends personalized, high-level professional care with innovative technology applications to ensure adequate rehabilitation.

Rehab at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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)

You may not qualify if:

• 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
• Patient, or patient's family caregiver, unable to communicate via telephone
• Patient, or patient's family caregiver, lacks consistent access to a telephone
• Clinical
• Requires more than one assist (unless the family can provide additional 24/7 assistance)
• Requires care of new ostomy or teaching ostomy care

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boston Medical Center: collaborator
• Cambridge Health Alliance: collaborator

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)