[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470535":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":64,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":12,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":12,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","This arm is the usual care arm of parents and providers who are randomized to proceed with usual care and are not given the family safety reporting intervention.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental: Intervention arm","EXPERIMENTAL","This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.",[18],"Behavioral: Family safety reporting intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Family safety reporting intervention","Family safety reporting intervention for patients\u002Ffamilies",[14],[26],{"name":27,"affiliation":28,"role":29},"Alisa Khan, MD, MPH","Boston Children's Hospital\u002FHarvard Medical School","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","6173552565","alisa.khan@childrens.harvard.edu",{"name":36,"role":32,"phone":37,"phoneExt":12,"email":38},"Monica Soni, BA","8572183233","monica.soni@childrens.harvard.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54,56,57,60,62],{"name":27,"role":32,"phone":55,"phoneExt":12,"email":34},"617-355-2565",{"name":27,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":58,"role":59,"phone":12,"phoneExt":12,"email":12},"Jennifer Baird, PhD, MPH, RN","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":12,"phoneExt":12,"email":12},"Hsiang \"Shonna\" Yin, MD, MS",{"name":63,"role":59,"phone":12,"phoneExt":12,"email":12},"Michelle Kelly, MD, MPH",{"type":29,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Alisa Khan","Pediatric Hospitalist\u002FAssistant Professor of Pediatrics",[68,71],{"name":69,"class":70},"Agency for Healthcare Research and Quality (AHRQ)","FED",{"name":72,"class":73},"Pediatric Research in Inpatient Settings (PRIS)","UNKNOWN","100470535","patients-and-families-improving-safety-in-hospitals-by-actively-reporting-experiences-100470535",false,"NCT05407129","Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences","Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)","I-SHARE","Inclusion Criteria:\n\n* Patient\u002FFamily\u002FCaregiver who has been hospitalized on the study unit during the study period (within the past 24 hours) or hospital employee who works at the study sites\n* Participants speaking all languages are eligible\n\nExclusion Criteria:\n\n* Admitted awaiting inpatient psychiatric placement\n* In state custody\n* Admitted for greater than 24 hours\n* Same day discharge\n* Covid positive\n* Previously enrolled in I-SHARE\n* Airborne illness precautions",true,"ALL",{"count":85,"type":86},656,"ESTIMATED","INTERVENTIONAL",[89],"NA","Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family\u002Fstaff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.",[92,93,94,95,96,97],"Family Reported Errors and Adverse Events","Health Disparities","Family Safety Reporting","Patient Safety","Voluntary Incident Reporting","Quality Improvement","2026-03-22",{"date":100,"type":101},"2026-03-24","ACTUAL",{"date":103,"type":101},"2023-04-13",{"date":105,"type":86},"2028-10-28",{"name":5,"class":6},1]