Boosting Resources for Tracheostomy Care at Home (BREATHE)

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

The goal of this trial is to advance our 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:

• How can we 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 we 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tracheostomy; Caregiver Burden
• Intervention / Treatment: Behavioral: Trach Me Home; Behavioral: Trach@Home

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 our 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:

• How can we 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 we 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. We 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.

We 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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Sepucha, PhD; Phone Number: 617-724-3350; Email: ksepucha@mgh.harvard.edu
• Study Contact Backup: Name: Lauren Leavitt, MA; Phone Number: 617-643-5320; Email: ljleavitt@mgh.harvard.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of San Diego Rady Children's Hospital
      • Contact: Matthew Brigger, MD; Email: mbrigger@rchsd.org
      • Principal Investigator: Matthew Brigger, MD
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Children's National Medical Center, Children's Research Institute
      • Contact: Habib Zalzal, MD; Email: hzalzal@cnmc.org
      • Principal Investigator: Habib Zalzal, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Karen Sepucha, PhD; Email: ksepucha@mgh.harvard.edu
      • Contact: Christopher Hartnick, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota
      • Contact: Asitha Jayawardena, MD; Email: asitha.jayawardena@childrensmn.org
      • Principal Investigator: Asitha Jayawardena, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
      • Principal Investigator: Matthew Smith, MD
      • Contact: Matthew Smith, MD; Email: matthew.smith@cchmc.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Children's Hospital of Philadelphia
      • Contact: Luv Javia, MD; Email: javia@chop.edu
      • Principal Investigator: Luv Javia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 planning to reside in the U.S. for at least 12 months after discharge

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator Caregivers; TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers	Behavioral: Trach Me Home; The Trach Me Home discharge program includes caregiver education, skills training and case management.
Experimental: Intervention Caregivers; Trach Me Home and Trach@Home with additional education, outpatient care team communication and social support for caregivers.	Behavioral: Trach Me Home; The Trach Me Home discharge program includes caregiver education, skills training and case management.; Behavioral: Trach@Home; The Trach@Home program includes education, social support, and outreach to outpatient care team.
Active Comparator: Active Comparator Physicians; Primary care physicians' of the enrolled participant's child receiving discharge communication	Behavioral: Trach Me Home; The Trach Me Home discharge program includes caregiver education, skills training and case management.
Experimental: Intervention Physicians; Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge	Behavioral: Trach Me Home; The Trach Me Home discharge program includes caregiver education, skills training and case management.; Behavioral: Trach@Home; The Trach@Home program includes education, social support, and outreach to outpatient care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden	Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, higher scores indicate higher burden	4 weeks post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Complications Associated with Tracheostomy	Adapted version of Medical Complications Associated with Tracheostomy scale that includes 4 caregiver reported items assessing urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Higher scores are worse.	6 months post-discharge
6-month Readmission Rate	Percentage with one or more electronic health record documented emergency room visits or hospital readmissions	6 months post-discharge
Frequency of pediatrician communication	Percentage of clinicians that reported communication with inpatient team prior to and/or shortly after discharge	6 months post-discharge
Primary care pediatrician satisfaction	Clinician reported satisfaction with discharge communication score, higher scores indicate higher satisfaction	6 months post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Complications Associated with Tracheostomy	Adapted version of Medical Complications Associated with Tracheostomy scale that includes 4 caregiver reported items assessing urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Higher scores are worse.	4 weeks post-discharge
Caregiver Burden	Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, higher scores indicate higher burden.	6 months post-discharge
Number of readmissions	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).	6 months post discharge

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia; Children's Hospital Medical Center, Cincinnati; Children's National Research Institute; Children's Hospitals and Clinics of Minnesota; Rady Children's Hospital, San Diego
• Investigators: Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital; Principal Investigator: Christopher Hartnick, MD, Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; shared decision making; caregiver; patient reported outcomes; tracheostomy; ventilator; discharge program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 2023P001695; IHS-2022C1-26100 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No