## Protocol Section
### Identification Module
**NCT ID:** NCT06416670

**Brief Title:** Skilled Nursing Facility Care at Home

**Official Title:** Skilled Nursing Facility Care at Home: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 2024P000266
#### Organization
**Class:** OTHER
**Full Name:** Brigham and Women's Hospital
### Status Module
#### Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Boston Medical Center

**Class:** OTHER

**Name:** Cambridge Health Alliance

#### Lead Sponsor

**Class:** OTHER

**Name:** Brigham and Women's Hospital

#### Responsible Party

**Investigator Affiliation:** Brigham and Women's Hospital

**Investigator Full Name:** David Levine

**Investigator Title:** Associate Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Skilled Nursing Facility

- Rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Control subjects will receive care at a skilled nursing facility as per usual.

**Label:** Usual skilled nursing facility care

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Intervention subjects will receive care in their home from a specialized care team.

**Intervention Names:**

- Other: Skilled nursing facility care at home

**Label:** Rehab at home

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rehab at home

**Description:** 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.

**Name:** Skilled nursing facility care at home

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab.

**Measure:** 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

#### Secondary Outcomes

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

**Measure:** Percent time supine per day

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

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

**Measure:** Total direct medical expenditure

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

**Description:** The Picker patient experience questionaire-15

**Measure:** Patient experience with care

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

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

**Measure:** 30-day readmission or 30-day mortality

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

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dmlevine@bwh.harvard.edu

**Name:** David M Levine, MD, MPH, MA

**Phone:** 617-732-7063

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
