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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
480
The Trach Plus program includes education, social support, and outreach to outpatient care team.
The Trach Me Home discharge program includes caregiver education, skills training and case management.
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
Caregiver Burden
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
Time frame: 4 weeks post-discharge
Medical Complications Associated with Tracheostomy
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.
Time frame: 6 months post-discharge
6-month Readmission Rate
Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge.
Time frame: 6 months post-discharge
Frequency of pediatrician communication
Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report.
Time frame: 6 months post-discharge
Primary care pediatrician satisfaction
Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.
Time frame: 6 months post-discharge
Medical Complications Associated with Tracheostomy
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse.
Time frame: 4 weeks post-discharge
Caregiver Burden
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.
Time frame: 6 months post-discharge
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