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ENROLLING BY INVITATION
NCT06283953
NA

Boosting Resources for Tracheostomy Care at Home

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-05-16

Completion Date

2027-10-01

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

BEHAVIORAL

Trach Plus

The Trach Plus program includes education, social support, and outreach to outpatient care team.

BEHAVIORAL

Trach Me Home

The Trach Me Home discharge program includes caregiver education, skills training and case management.

Locations (6)

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