Skilled Nursing Facility Care at Home

NCT ID: NCT06416670

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Usual skilled nursing facility care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Rehab at home

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

Group Type: ACTIVE_COMPARATOR

Skilled nursing facility care at home

Intervention Type: 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.

Interventions

Skilled nursing facility care at home

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.

Intervention Type: OTHER

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
• 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
• Requires frequent suctioning, tracheostomy, and ventilator needs
• Requires total parenteral nutrition
• Requires nasogastric tube feeds
• Requires durable medical equipment not already in place at home and excluded below
• Requires daily subcutaneous injection unless patient or family caregiver is teachable and able to administer daily
• Acute delirium noted by RAH liaison requiring more than one caregiver
• Active psychiatric diagnosis without an adequate treatment plan
• On methadone requiring daily pickup of medication
• Requires administration of intravenous controlled substances
• Requires administration of specialty medications not already in place at home
• Requires transfusion of blood products
• Requires three times weekly or more transfers back and forth to obtain specialty medical care
• Requires hemodialysis
• Orthopedic trauma and elective patients
• Traumatic brain injury
• Wound or appliance care that requires daily nursing care
• For spine trauma: neurologic deficits requiring more than one assist
• Neurology patients

• PRESS score (for ischemic stroke; use PRESS app): no return to pre-stroke diet > 50%
• FUNC score (for primary intracerebral hemorrhage only): <75% probability of functional independence at 90 days
• ASTRAL score (for ischemic stroke only and patients with pre-stroke independence [Modified Rankin Scale 0-2]): <75% probability of a 90-day poor functional outcome (Modified Rankin Scale result of 3-6)
• RAH census is full

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Cambridge Health Alliance

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Levine

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

2024P000266

Identifier Type: -

Identifier Source: org_study_id