Boosting Resources for Tracheostomy Care at Home

Enrolling by invitation · Not applicable

Conditions studied: Tracheostomy, Caregiver Burden

In brief

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.

Key facts

Study ID

NCT06283953

Run by

Massachusetts General Hospital

People needed

480

Starts

2024-05-16

Expected to finish

2027-10-01

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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