Boosting Resources for Tracheostomy Care at Home (BREATHE)

Mass General Brigham

Status: Invitation-only

Conditions: Caregiver Burden; Tracheostomy

Treatments: Behavioral: Trach Plus; Behavioral: Trach Me Home

Study type: Interventional

Funder types: Other

Identifiers

NCT06283953

IHS-2022C1-26100 (Other Grant/Funding Number)

2023P001695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 4 patient groups

Active Comparator Caregivers

Active Comparator group

Description:

TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers

Treatment:

Behavioral: Trach Me Home

Intervention Caregivers

Experimental group

Description:

Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers.

Treatment:

Behavioral: Trach Me Home

Behavioral: Trach Plus

Active Comparator Physicians

Active Comparator group

Description:

Primary care physicians' of the enrolled participant's child receiving discharge communication

Treatment:

Behavioral: Trach Me Home

Intervention Physicians

Experimental group

Description:

Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge

Treatment:

Behavioral: Trach Me Home

Behavioral: Trach Plus