Skilled Nursing Facility Care at Home

Skilled Nursing Facility Care at Home: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Skilled Nursing Facility
• Intervention / Treatment: Other: Skilled nursing facility care at home

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David M Levine, MD, MPH, MA; Phone Number: 617-732-7063; Email: dmlevine@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual skilled nursing facility care; Control subjects will receive care at a skilled nursing facility as per usual.
Active Comparator: Rehab at home; Intervention subjects will receive care in their home from a specialized care team.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activities of daily living between admission to rehab and discharge from rehab	Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab.	Admission to rehab until discharge from rehab, no more than 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent time supine per day	The percentage of time a patient is supine per day, as measured by their wrist-worn accelerometer.	Admission to rehab until discharge from rehab, no more than 6 months
Total direct medical expenditure	The percent difference in direct cost of care to deliver rehab care.	Admission to rehab until discharge from rehab, no more than 6 months
Patient experience with care	The Picker patient experience questionaire-15	Admission to rehab until discharge from rehab, no more than 6 months
30-day readmission or 30-day mortality	The percentage of patients who are readmitted or deceased within 30-days of discharge from rehab.	Discharge from rehab until 30-days later, no more than 30-days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Boston Medical Center; Cambridge Health Alliance

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024P000266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No