Boosting Resources for Tracheostomy Care at Home

Caregiver Burden Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06283953
• Other study ID #: 2023P001695
• Secondary ID: IHS-2022C1-26100
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 480
• Est. completion date: October 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Tracheostomy

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of San Diego Rady Children's Hospital	La Jolla	California
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's National Medical Center, Children's Research Institute	Silver Spring	Maryland

Sponsors (7)

Lead Sponsor	Collaborator
Massachusetts General Hospital	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Medical Complications Associated with Tracheostomy	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 months post-discharge
Secondary	6-month Readmission Rate	Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge.	6 months post-discharge
Secondary	Frequency of pediatrician communication	Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report.	6 months post-discharge
Secondary	Primary care pediatrician satisfaction	Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.	6 months post-discharge
Secondary	Medical Complications Associated with Tracheostomy	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.	4 weeks post-discharge
Secondary	Caregiver Burden	Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.	6 months post-discharge