Caregiver Burden, Tracheostomy
Conditions
Keywords
shared decision making, patient reported outcomes, tracheostomy, ventilator, caregiver, discharge program, pediatric
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALTrach Plus
The Trach Plus program includes education, social support, and outreach to outpatient care team.
BEHAVIORALTrach Me Home
The Trach Me Home discharge program includes caregiver education, skills training and case management.
Sponsors
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Children's Hospitals and Clinics of Minnesota
Children's National Research Institute
Rady Children's Hospital, San Diego
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study. The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden | 4 weeks post-discharge | Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Complications Associated with Tracheostomy | 6 months post-discharge | 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. |
| 6-month Readmission Rate | 6 months post-discharge | Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge. |
| Primary care pediatrician satisfaction | 6 months post-discharge | Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication. |
| Caregiver Burden | 6 months post-discharge | Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
| Frequency of pediatrician communication | 6 months post-discharge | Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of readmissions | 6 months post discharge | The total number of electronic health record documented emergency room visits and hospital admissions will be collected, with higher numbers being worse (indicating more readmissions). |
Countries
United States
Outcome results
None listed