Clinical trial NCT06283953: Boosting Resources for Tracheostomy Care at Home
Official title: Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tracheostomy
Caregiver Burden
Keywords: shared decision making
patient reported outcomes
tracheostomy
ventilator
caregiver
discharge program
pediatric
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Children's Hospital of Philadelphia
name: Children's Hospitals and Clinics of Minnesota
name: Children's National Research Institute
name: Rady Children's Hospital, San Diego
name: Patient-Centered Outcomes Research Institute
First posted: 2024-02-28
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:

* What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
* How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?

Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

Detailed description: The study is focused on a rare and medically complex population of children with tracheostomies. The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites. The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main question\[s\] it aims to answer are:

* What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
* How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?

Caregiver participants will randomly assigned to the Comparator arm (gold standard discharge program) or to the Intervention arm (gold standard program with other components). Caregiver participants will complete three surveys over the course of 6 months. The investigators will test two main hypotheses: the Intervention arm will have (1) significantly lower caregiver burden at 4 weeks post discharge (primary outcome) and (2) significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm.

The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm.

Eligibility criteria: Inclusion Criteria:

* Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator

Exclusion Criteria:

* Patients transferred to other hospital or facility (and/or not discharged to home during study period)
* Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic
* Not residing in the U.S. for at least 12 months after discharge

Primary outcomes:
measure: Caregiver Burden
timeFrame: 4 weeks post-discharge
Secondary outcomes:
measure: Medical Complications Associated with Tracheostomy
timeFrame: 6 months post-discharge
measure: 6-month Readmission Rate
timeFrame: 6 months post-discharge
measure: Frequency of pediatrician communication
timeFrame: 6 months post-discharge
measure: Primary care pediatrician satisfaction
timeFrame: 6 months post-discharge
measure: Medical Complications Associated with Tracheostomy
timeFrame: 4 weeks post-discharge
measure: Caregiver Burden
timeFrame: 6 months post-discharge
Other outcomes:
measure: Number of readmissions
timeFrame: 6 months post discharge
Locations:
city: La Jolla
country: United States
facility: University of San Diego Rady Children's Hospital
state: California
city: Silver Spring
country: United States
facility: Children's National Medical Center, Children's Research Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
name: Christopher Hartnick, MD
role: PRINCIPAL_INVESTIGATOR
References: