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| ID | Type | Description | Link |
|---|---|---|---|
| IHS-2022C1-26100 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Children's Hospitals and Clinics of Minnesota | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator Caregivers | Active Comparator | TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers |
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| Intervention Caregivers | Experimental | Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers. |
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| Active Comparator Physicians | Active Comparator | Primary care physicians' of the enrolled participant's child receiving discharge communication |
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| Intervention Physicians | Experimental | Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trach Plus | Behavioral | The Trach Plus program includes education, social support, and outreach to outpatient care team. |
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| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden | Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. | 4 weeks post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of readmissions | 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). | 6 months post discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Christopher Hartnick, MD | Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of San Diego Rady Children's Hospital | La Jolla | California | 92093 | United States | ||
| Children's National Medical Center, Children's Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39468582 | Derived | Sepucha K, Callans K, Leavitt L, Chang Y, Vo H, Brigger M, Broughton S, Cahill J, Chinnadurai S, Germann J, Giordano T, Greenlick-Michals H, Javia L, Jayawardena ADL, Osthimer J, Patel RC, Redmann A, Roumiantsev S, Simmons L, Smith M, Tate M, Warren M, Whalen K, Yager P, Zalzal H, Hartnick C. Boosting REsources And caregiver empowerment for Tracheostomy care at HomE (BREATHE) Study: study protocol for a stratified randomization trial. Trials. 2024 Oct 28;25(1):722. doi: 10.1186/s13063-024-08522-x. |
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To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers.
The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
After study results have been published, about 1 year after the end of the funded grant period, the study materials and de-identified data will be placed on an open access service such as ICPSR where they will be available indefinitely.
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Children's National Research Institute |
| OTHER |
| Rady Children's Hospital, San Diego | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
| Trach Me Home | Behavioral | The Trach Me Home discharge program includes caregiver education, skills training and case management. |
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| 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. | 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. | 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. | 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. | 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. | 6 months post-discharge |
| Silver Spring |
| Maryland |
| 20910 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | United States |