Boosting Resources for Tracheostomy Care at Home

Not Applicable

• Conditions: Caregiver Burden; Tracheostomy
• Interventions: Behavioral: Trach Plus; Behavioral: Trach Me Home

• Registration Number: NCT06283953
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Status Verified: 2024-05
• Study Start: 2024-05-16
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20
• Primary Completion: 2026-12-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 480

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Physicians	Trach Plus	Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge
Active Comparator Caregivers	Trach Me Home	TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers
Active Comparator Physicians	Trach Me Home	Primary care physicians' of the enrolled participant's child receiving discharge communication
Intervention Caregivers	Trach Plus	Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.
Intervention Caregivers	Trach Me Home	Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.
Intervention Physicians	Trach Me Home	Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge

Primary Outcome Measures

Name	Time	Method
Caregiver Burden	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 Outcome Measures

Name	Time	Method
6-month Readmission Rate	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.
Frequency of pediatrician communication	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.
Primary care pediatrician satisfaction	6 months post-discharge	Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.
Caregiver Burden	6 months post-discharge	Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
Medical Complications Associated with Tracheostomy	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.

Trial Locations

Locations (6)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

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

Children's National Medical Center, Children's Research Institute; 🇺🇸 Silver Spring, Maryland, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States