Boosting Resources for Tracheostomy Care at Home
BREATHE
Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial
2 other identifiers
interventional
480
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
May 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
October 14, 2025
October 1, 2025
2.5 years
February 21, 2024
October 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver Burden
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
4 weeks post-discharge
Secondary Outcomes (6)
Medical Complications Associated with Tracheostomy
6 months post-discharge
6-month Readmission Rate
6 months post-discharge
Frequency of pediatrician communication
6 months post-discharge
Primary care pediatrician satisfaction
6 months post-discharge
Medical Complications Associated with Tracheostomy
4 weeks post-discharge
- +1 more secondary outcomes
Other Outcomes (1)
Number of readmissions
6 months post discharge
Study Arms (4)
Active Comparator Caregivers
ACTIVE COMPARATORTrachMeHome program delivered in the hospital including education, skills training and case management for caregivers
Intervention Caregivers
EXPERIMENTALTrach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.
Active Comparator Physicians
ACTIVE COMPARATORPrimary care physicians' of the enrolled participant's child receiving discharge communication
Intervention Physicians
EXPERIMENTALPrimary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge
Interventions
The Trach Plus program includes education, social support, and outreach to outpatient care team.
The Trach Me Home discharge program includes caregiver education, skills training and case management.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Children's Hospital Medical Center, Cincinnaticollaborator
- Children's Hospital of Philadelphiacollaborator
- Children's Hospitals and Clinics of Minnesotacollaborator
- Children's National Research Institutecollaborator
- Rady Children's Hospital, San Diegocollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (6)
University of San Diego Rady Children's Hospital
La Jolla, California, 92093, United States
Children's National Medical Center, Children's Research Institute
Silver Spring, Maryland, 20910, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
Related Publications (1)
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 for a stratified randomization trial. Trials. 2024 Oct 28;25(1):722. doi: 10.1186/s13063-024-08522-x.
PMID: 39468582DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Sepucha, PhD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Christopher Hartnick, MD
Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study. The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 28, 2024
Study Start
May 16, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After study results have been published, about 1 year after the end of the funded grant period, the study materials and de-identified data will be placed on an open access service such as ICPSR where they will be available indefinitely.
- Access Criteria
- Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.