Boosting Resources for Tracheostomy Care at Home

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.

Conditions

• Tracheostomy
• Caregiver Burden

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Karen Sepucha, PhD · Massachusetts General Hospital

• Christopher Hartnick, MD · Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-16

Primary Completion

2026-12-01

Completion

2027-10-01

Countries

• United States

Study Locations