Clinical trial NCT06416670: Skilled Nursing Facility Care At Home
Official title: Skilled Nursing Facility Care At Home: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skilled Nursing Facility
Rehabilitation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Cambridge Health Alliance
First posted: 2024-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in activities of daily living between admission to rehab and discharge from rehab
timeFrame: Admission to rehab until discharge from rehab, no more than 6 months
Secondary outcomes:
measure: Percent time supine per day
timeFrame: Admission to rehab until discharge from rehab, no more than 6 months
measure: Total direct medical expenditure
timeFrame: Admission to rehab until discharge from rehab, no more than 6 months
measure: Patient experience with care
timeFrame: Admission to rehab until discharge from rehab, no more than 6 months
measure: 30-day readmission or 30-day mortality
timeFrame: Discharge from rehab until 30-days later, no more than 30-days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
References: