Boosting Resources for Tracheostomy Care at Home

Official title

Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial

Overview

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.

Interventions

• Behavioral Trach Plus
  The Trach Plus program includes education, social support, and outreach to outpatient care team.
• Behavioral Trach Me Home
  The Trach Me Home discharge program includes caregiver education, skills training and case management.

Primary outcome measures

• Caregiver Burden [Time frame: 4 weeks post-discharge]

Secondary outcome measures (6)

• Medical Complications Associated with Tracheostomy [Time frame: 6 months post-discharge]
• 6-month Readmission Rate [Time frame: 6 months post-discharge]
• Frequency of pediatrician communication [Time frame: 6 months post-discharge]
• Primary care pediatrician satisfaction [Time frame: 6 months post-discharge]
• Medical Complications Associated with Tracheostomy [Time frame: 4 weeks post-discharge]
• Caregiver Burden [Time frame: 6 months post-discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 6 centers

• University of San Diego Rady Children's Hospital — La Jolla
• Children's National Medical Center, Children's Research Institute — Silver Spring
• Massachusetts General Hospital — Boston
• Children's Hospitals and Clinics of Minnesota — Minneapolis
• Cincinnati Children's Hospital Medical Center — Cincinnati
• Children's Hospital of Philadelphia — Philadelphia

Publications

• Sepucha K, Callans K, Leavitt L, Chang Y, Vo H, Brigger M, Broughton S, Cahill J, Chinnadurai S, Germann J, Giordano T, Greenlick-Michals H, Javia L, Jayawardena ADL, Osthimer J, Patel RC, Redmann A, Roumiantsev S, Simmons L, Smith M, Tate M, Warren M, Whalen K, Yager P, Zalzal H, Hartnick C. Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol PMID 39468582

Identifiers

NCT: NCT06283953 · 2023P001695 · IHS-2022C1-26100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗