RECRUITING

Skilled Nursing Facility Care At Home

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Skilled Nursing Facility Care At Home: a Randomized Controlled Trial

Quick Facts

Study Start:2024-06-03

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06416670

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

David M Levine, MD, MPH, MA

CONTACT

617-732-7063

dmlevine@bwh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02120

United States

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130

United States

Cambridge Health Alliance

Cambridge, Massachusetts, 02139

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-06-03

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Skilled Nursing Facility
Rehabilitation