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Skilled Nursing Facility Care at Home

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Mass General Brigham

Status

Active, not recruiting

Conditions

Rehabilitation
Skilled Nursing Facility

Treatments

Other: Skilled nursing facility care at home

Study type

Interventional

Funder types

Other

Identifiers

NCT06416670
2024P000266

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

Usual skilled nursing facility care
No Intervention group
Description:
Control subjects will receive care at a skilled nursing facility as per usual.
Rehab at home
Active Comparator group
Description:
Intervention subjects will receive care in their home from a specialized care team.
Treatment:
Other: Skilled nursing facility care at home

Trial contacts and locations

5

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Central trial contact

David M Levine, MD, MPH, MA

Data sourced from clinicaltrials.gov

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