protocolSection identificationModule nctId: NCT06283953, orgStudyIdInfo id: 2023P001695, secondaryIdInfos id: IHS-2022C1-26100, type: OTHER_GRANT, domain: Patient Centered Outcomes Research Institute (PCORI), briefTitle: Boosting Resources for Tracheostomy Care at Home, acronym: BREATHE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Children's Hospital Medical Center, Cincinnati, collaborators name: Children's Hospital of Philadelphia, collaborators name: Children's Hospitals and Clinics of Minnesota, collaborators name: Children's National Research Institute, collaborators name: Rady Children's Hospital, San Diego, collaborators name: Patient-Centered Outcomes Research Institute, descriptionModule briefSummary: The goal of this trial is to advance our 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:* How can we 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 we 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., conditionsModule conditions: Tracheostomy, conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Trach@Home, interventions name: Trach Me Home, outcomesModule primaryOutcomes measure: Caregiver Burden, secondaryOutcomes measure: Medical Complications Associated with Tracheostomy, secondaryOutcomes measure: 6-month Readmission Rate, secondaryOutcomes measure: Frequency of pediatrician communication, secondaryOutcomes measure: Primary care pediatrician satisfaction, otherOutcomes measure: Medical Complications Associated with Tracheostomy, otherOutcomes measure: Caregiver Burden, otherOutcomes measure: Number of readmissions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of San Diego Rady Children's Hospital, city: La Jolla, state: California, zip: 92093, country: United States, contacts name: Matthew Brigger, MD, role: CONTACT, email: mbrigger@rchsd.org, contacts name: Matthew Brigger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Children's National Medical Center, Children's Research Institute, city: Silver Spring, state: Maryland, zip: 20910, country: United States, contacts name: Habib Zalzal, MD, role: CONTACT, email: hzalzal@cnmc.org, contacts name: Habib Zalzal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.99067, lon: -77.02609, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Karen Sepucha, PhD, role: CONTACT, email: ksepucha@mgh.harvard.edu, contacts name: Christopher Hartnick, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Children's Hospitals and Clinics of Minnesota, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, contacts name: Asitha Jayawardena, MD, role: CONTACT, email: asitha.jayawardena@childrensmn.org, contacts name: Asitha Jayawardena, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Matthew Smith, MD, role: CONTACT, email: matthew.smith@cchmc.org, contacts name: Matthew Smith, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19146, country: United States, contacts name: Luv Javia, MD, role: CONTACT, email: javia@chop.edu, contacts name: Luv Javia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False