Home care for patients needing skilled nursing facility services

Skilled Nursing Facility Care At Home: a Randomized Controlled Trial

This study tests if providing skilled nursing care at home, with the help of technology, can help patients recover better than staying in a traditional nursing facility.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT06416670 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of providing skilled nursing facility care at home for patients who would typically be admitted to a skilled nursing facility after hospitalization. Participants will be randomly assigned to receive care either in their own homes, supported by a technology-enabled team, or in a traditional skilled nursing facility. The study aims to assess the outcomes of home-based care compared to conventional facility care, focusing on rehabilitation and recovery. By leveraging technology, the trial seeks to enhance patient comfort and potentially improve rehabilitation outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require skilled nursing facility care following hospitalization and are likely to return to community living.

Not a fit: Patients who are undomiciled, lack essential utilities, or reside in facilities that do not permit advanced on-site care may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow patients to receive necessary rehabilitation services in the comfort of their own homes, potentially improving recovery and satisfaction.

How similar studies have performed: Other studies have shown promising results for home-based rehabilitation approaches, indicating potential for success in this novel intervention.

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

Where this trial is running

Boston, Massachusetts and 4 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• Boston Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
• Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States (RECRUITING)
• Cambridge Health Alliance — Cambridge, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: David M Levine, MD, MPH, MA

Conditions: Skilled Nursing Facility, Rehabilitation