[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06283953":3,"trial-entities:NCT06283953":147,"trial-summary:NCT06283953":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":50,"secondary_outcomes":54,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":81,"locations":84,"central_contacts":133,"overall_officials":134,"references":141,"see_also_links":146},"NCT06283953","2023P001695","Boosting Resources for Tracheostomy Care at Home","Boosting Resources and Caregiver Empowerment for Trach Care at Home: A Pragmatic Randomized Trial","ENROLLING_BY_INVITATION","2027-10-01","2025-10","2025-10-14","2024-05-16","Massachusetts General Hospital","OTHER",false,"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:\n\n* 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?\n* 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?\n\nCaregiver 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:\n\n* 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?\n* 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?\n\nCaregiver 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.\n\nThe 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.",[19,20],"Tracheostomy","Caregiver Burden",[22,23,24,25,26,27,28],"shared decision making","patient reported outcomes","tracheostomy","ventilator","caregiver","discharge program","pediatric","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[32],"NA",{"count":34,"type":35},480,"ESTIMATED",[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Trach Plus","The Trach Plus program includes education, social support, and outreach to outpatient care team.",[42,43],"Intervention Caregivers","Intervention Physicians",{"type":38,"name":45,"description":46,"armGroupLabels":47},"Trach Me Home","The Trach Me Home discharge program includes caregiver education, skills training and case management.",[48,49,42,43],"Active Comparator Caregivers","Active Comparator Physicians",[51],{"measure":20,"description":52,"timeFrame":53},"Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden.","4 weeks post-discharge",[55,59,62,65,68,69],{"measure":56,"description":57,"timeFrame":58},"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":60,"description":61,"timeFrame":58},"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.",{"measure":63,"description":64,"timeFrame":58},"Frequency of pediatrician communication","Percentage of pediatrician-specific communication with inpatient team prior to and\u002For shortly after discharge documented in electronic medical record or by pediatrician report.",{"measure":66,"description":67,"timeFrame":58},"Primary care pediatrician satisfaction","Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication.",{"measure":56,"description":57,"timeFrame":53},{"measure":20,"description":52,"timeFrame":58},"ALL","18 Years",null,{"inclusion":74,"exclusion":76,"raw_text":80},[75],"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",[77,78,79],"Patients transferred to other hospital or facility (and\u002For 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","Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Patients transferred to other hospital or facility (and\u002For not discharged to home during study period)\n* Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic\n* Not residing in the U.S. for at least 12 months after discharge",[82,83],"ADULT","OLDER_ADULT",[85,94,102,109,117,125],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"University of San Diego Rady Children's Hospital","La Jolla","California","92093","United States",{"lat":92,"lon":93},32.84727,-117.2742,{"facility":95,"city":96,"state":97,"zip":98,"country":90,"geoPoint":99},"Children's National Medical Center, Children's Research Institute","Silver Spring","Maryland","20910",{"lat":100,"lon":101},38.99067,-77.02609,{"facility":13,"city":103,"state":104,"zip":105,"country":90,"geoPoint":106},"Boston","Massachusetts","02114",{"lat":107,"lon":108},42.35843,-71.05977,{"facility":110,"city":111,"state":112,"zip":113,"country":90,"geoPoint":114},"Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"lat":115,"lon":116},44.97997,-93.26384,{"facility":118,"city":119,"state":120,"zip":121,"country":90,"geoPoint":122},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":123,"lon":124},39.12711,-84.51439,{"facility":126,"city":127,"state":128,"zip":129,"country":90,"geoPoint":130},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19146",{"lat":131,"lon":132},39.95238,-75.16362,[],[135,138],{"name":136,"affiliation":13,"role":137},"Karen Sepucha, PhD","PRINCIPAL_INVESTIGATOR",{"name":139,"affiliation":140,"role":137},"Christopher Hartnick, MD","Massachusetts Eye and Ear Infirmary \u002F Massachusetts General Hospital",[142],{"pmid":143,"type":144,"citation":145},"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\u002Fs13063-024-08522-x.",[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Tracheotomy",[],{"nct_id":4,"found":15,"summary":72,"prompt_version":72}]