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OpenTrials
Active, Not Recruiting

NCT Number: NCT06416670

Skilled Nursing Facility Care at Home

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Percent time supine per day

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

    The percentage of time a patient is supine per day, as measured by their wrist-worn accelerometer.

  2. Total direct medical expenditure

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

    The percent difference in direct cost of care to deliver rehab care.

  3. Patient experience with care

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

    The Picker patient experience questionaire-15

  4. 30-day readmission or 30-day mortality

    Time frame: Discharge from rehab until 30-days later, no more than 30-days

    The percentage of patients who are readmitted or deceased within 30-days of discharge from rehab.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Medical Center
  • Cambridge Health Alliance

Registry information

Official study title

Skilled Nursing Facility Care at Home: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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