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Search / Trial NCT06283953

Boosting Resources for Tracheostomy Care at Home

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 21, 2024

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Shared Decision Making Patient Reported Outcomes Tracheostomy Ventilator Caregiver Discharge Program Pediatric

ClinConnect Summary

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 safe...

Gender

ALL

Eligibility criteria

  • 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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Cincinnati, Ohio, United States

Minneapolis, Minnesota, United States

Philadelphia, Pennsylvania, United States

La Jolla, California, United States

Silver Spring, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Christopher Hartnick, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported