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Enrolling by Invitation

NCT Number: NCT06283953

Boosting Resources for Tracheostomy Care at Home

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.

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Key information

Conditions

Tracheostomy Behavior Behavioral Symptoms Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of San Diego Rady Children's Hospital, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trach Plus

Behavioral

The Trach Plus program includes education, social support, and outreach to outpatient care team.

Trach Me Home

Behavioral

The Trach Me Home discharge program includes caregiver education, skills training and case management.

Primary outcomes

  1. Caregiver Burden

    Time frame: 4 weeks post-discharge

    Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.

Secondary outcomes

  1. Medical Complications Associated with Tracheostomy

    Time frame: 6 months post-discharge

    4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.

  2. 6-month Readmission Rate

    Time frame: 6 months post-discharge

    Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge.

  3. Frequency of pediatrician communication

    Time frame: 6 months post-discharge

    Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report.

  4. Primary care pediatrician satisfaction

    Time frame: 6 months post-discharge

    Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.

  5. Medical Complications Associated with Tracheostomy

    Time frame: 4 weeks post-discharge

    4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.

  6. Caregiver Burden

    Time frame: 6 months post-discharge

    Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.

Other outcomes

  1. Number of readmissions

    Time frame: 6 months post discharge

    The total number of electronic health record documented emergency room visits and hospital admissions will be collected, with higher numbers being worse (indicating more readmissions).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
  • Children's Hospitals and Clinics of Minnesota
  • Children's National Research Institute
  • Patient-Centered Outcomes Research Institute
  • Rady Children's Hospital, San Diego

Registry information

Official study title

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

Acronym: BREATHE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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