[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659867":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":47,"interventions":74,"overallOfficials":96,"centralContacts":100,"locations":110,"responsibleParty":228,"collaborators":230,"id":243,"slug":244,"hasResults":245,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":245,"sex":251,"minAge":252,"maxAge":37,"enrollmentInfo":253,"targetDuration":37,"studyType":256,"phases":257,"briefSummary":259,"conditions":260,"keywords":265,"overallStatus":271,"whyStopped":37,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":37},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Aim 1: Enrollment Opt-Out Rate","Proportion of eligible participants who opt-out of safety reporting participation by enrollment strategy","9 months",{"measure":14,"description":15,"timeFrame":12},"Aim 2: Safety Reporting Rate","Number of safety reports submitted per 100 patient-days by reporting strategy",{"measure":17,"description":18,"timeFrame":19},"Aim 3: Workflow Integration Success","Number of hospital units successfully integrating safety report reviews into existing safety workflows, with at least monthly review of FIQS safety reports in existing group safety meetings.","18 months",[21,24,27,31,34],{"measure":22,"description":23,"timeFrame":12},"Aim 1: Enrollment Opt-Out Rate by Demographics","Opt-out rates analyzed by participant race, ethnicity, and language preferences",{"measure":25,"description":26,"timeFrame":12},"Aim 2: Reporting Rate by Demographics","Safety reporting rates analyzed by participant race, ethnicity, and language preferences",{"measure":28,"description":29,"timeFrame":30},"All aims: Safety Report Content Categories","Distribution of safety report topics and categories by study arm","36 months",{"measure":32,"description":33,"timeFrame":19},"Aim 3: Safety Interventions Implemented","Number and types of system-level safety interventions undertaken and completed in response to safety reports",{"measure":35,"description":36,"timeFrame":19},"Aim 3: Implementation Barriers and Facilitators","Qualitative assessment of barriers and facilitators to successful integration of family safety reports into hospital safety efforts",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","SEQUENTIAL","This study uses a sequential parallel design across three aims conducted over different time periods. Aim 1 employs cluster randomization at the hospital unit level (units randomized to one of the two enrollment strategies) and takes place over 9 months. Aim 2 uses individual participant randomization (1:1 allocation to anonymous vs. identified reporting strategies) and takes place over the subsequent 9 months. Aim 3 is a single-arm implementation study where all participating units receive the toolkit intervention over the subsequent 18 month. Participants in Aims 1 and 2 are enrolled from sequential time periods, while Aim 3 participants may include both previous participants and new enrollees based on inpatient admissions during an 18-month implementation phase.","HEALTH_SERVICES_RESEARCH",{"masking":44,"maskingDescription":37,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR",[48,54,59,64,69],{"label":49,"type":50,"description":51,"interventionNames":52},"Aim 1: Text-Only Enrollment","ACTIVE_COMPARATOR","Family members of hospitalized children and adolescent patients (\\>12y.o.) receive automated text message invitations to participate in Family Input for Quality and Safety (FIQS) reporting when admitted to participating inpatient study units. The text message includes an opt-out option and a prompt to receive a link by text to an online brochure explaining the FIQS study. No in-person orientation or interaction with hospital staff is provided regarding study enrollment. Enrolled participants receive daily text messages prompting them to report safety observations through the mobile-responsive FIQS survey. This arm tests whether a streamlined, text-only enrollment approach can effectively engage families and adolescent patients in safety reporting without requiring hospital staff time for recruitment",[53],"Behavioral: Text-Only Enrollment Strategy",{"label":55,"type":50,"description":56,"interventionNames":57},"Aim 1: Text Plus In-Person Enrollment","Family members of hospitalized children and adolescent patients (\\>12 y.o) receive automated text message invitations to participate in Family Input for Quality and Safety (FIQS) reporting when admitted to participating study units, plus a brief in-person orientation from hospital staff (nurses or registration team members). The text message includes an opt-out option and a prompt to receive a link by text to an online brochure explaining the FIQS study. During the admission process, hospital staff provide a standardized verbal explanation of the FIQS study using a physical brochure. Enrolled participants receive daily text messages prompting them to report safety observations through the mobile-responsive FIQS survey. This arm tests whether adding brief in-person orientation by hospital staff (with a physical brochure) improves engagement in safety reporting compared to text-only enrollment.",[58],"Behavioral: Text Plus In-Person Enrollment Strategy",{"label":60,"type":50,"description":61,"interventionNames":62},"Aim 2: Default Anonymous Reporting with Website about Impact of Program","In a 1:1 randomized design, family members of hospitalized children and adolescent patients (\\>12 y.o.) participate in Family Input for Quality and Safety (FIQS) reporting, randomized to this arm, in which their reports are shared with participating hospital units without identifiers (unless they voluntarily provide contact information). For these participants, the FIQS survey tool will link to a website showing how FIQS reports have led to hospital safety improvements. Summary reports to unit leadership are anonymized unless participants choose to provide contact information for follow-up. If contact information is provided, reports are sent immediately to unit leaders for potential service recovery. This arm tests whether maintaining participant anonymity while providing information about program impact encourages ongoing engagement with safety reporting.",[63],"Behavioral: Anonymous Safety Reporting with Impact Website",{"label":65,"type":50,"description":66,"interventionNames":67},"Aim 2: Identified Reporting without Impact information","In a 1:1 randomized design, family members of hospitalized children and adolescent patients (\\>12 y.o) participate in safety reporting where all reports are automatically shared with participating hospital units with identifiers, allowing for direct follow-up and service recovery. Participants in this arm are not directed to receive information about the impact of the FIQS program through the website or as part of the FIQS survey. All reports are sent to site investigators and safety teams with medical record numbers for potential immediate response and service recovery. This arm tests whether making reports identifiable to hospital staff increases actionability and service recovery opportunities, and how reporting without an option to remain anonymous affects participant willingness to engage in reporting safety concerns.",[68],"Behavioral: Identified Safety Reporting",{"label":70,"type":6,"description":71,"interventionNames":72},"Aim 3: All site toolkit implementation","Participating hospital units receive a toolkit with lessons learned from earlier collaborative safety improvement efforts and participate in a one-hour coaching session to learn how to integrate Family Input for Quality and Safety (FIQS) reports into their existing quality improvement workflows. Units choose their preferred enrollment method (text-only or text plus in-person orientation) and reporting approach (anonymous or identified) based on findings from earlier study phases. Family members of hospitalized children and adolescent patients (\\>12 y.o.) use the FIQS mobile responsive safety reporting tool for 18 months while hospital teams implement toolkit recommendations to review FIQS reports, identify system-level problems, and develop safety interventions. This arm evaluates barriers and facilitators to successfully incorporating patient and family safety observations into hospital safety efforts without extensive, dedicated research infrastructure.",[73],"Other: Safety Reporting Integration Toolkit",[75,80,84,88,92],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":37},"BEHAVIORAL","Text-Only Enrollment Strategy","Automated text message invitation system for safety reporting participation with online educational materials but no in-person staff interaction during enrollment process.",[49],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":37},"Text Plus In-Person Enrollment Strategy","Automated text message invitation system combined with brief standardized verbal orientation provided by hospital staff during admission process using physical educational brochures.",[55],{"type":76,"name":85,"description":86,"armGroupLabels":87,"otherNames":37},"Anonymous Safety Reporting with Impact Website","Mobile safety reporting system where reports are shared without participant identifiers, combined with access to website showing safety improvement examples to encourage continued engagement.",[60],{"type":76,"name":89,"description":90,"armGroupLabels":91,"otherNames":37},"Identified Safety Reporting","Mobile safety reporting system where all reports are shared with hospital staff including participant identifiers to enable direct follow-up and service recovery.",[65],{"type":6,"name":93,"description":94,"armGroupLabels":95,"otherNames":37},"Safety Reporting Integration Toolkit","Implementation toolkit with lessons learned and one-hour coaching session to help hospital units integrate family safety reports into existing quality improvement workflows without research support.",[70],[97],{"name":98,"affiliation":5,"role":99},"Naomi Bardach, MD, MAS","PRINCIPAL_INVESTIGATOR",[101,106],{"name":102,"role":103,"phone":104,"phoneExt":37,"email":105},"Naomi S Bardach, MD, MAS","CONTACT","415-476-9188","Naomi.Bardach@ucsf.edu",{"name":107,"role":103,"phone":108,"phoneExt":37,"email":109},"Danea M Horn, PhD","916-247-6384","Danea.Horn@ucsf.edu",[111,129,138,152,168,186,198,213],{"facility":112,"status":37,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"UCLA Mattel Children's Hospital","Los Angeles","California","90095","United States","US",{"type":119,"coordinates":120},"Point",[121,122],-118.24368,34.05223,{"lat":122,"lon":121},[125],{"name":126,"role":103,"phone":127,"phoneExt":37,"email":128},"Audrey Kamzan, MD","310-825-9111","aKamzan@mednet.ucla.edu",{"facility":130,"status":37,"city":131,"state":114,"zip":132,"country":116,"countryCode":117,"cosmosGeoPoint":133,"geoPoint":137,"contacts":37},"UCSF Benioff Children's Hospital - Oakland","Oakland","94609",{"type":119,"coordinates":134},[135,136],-122.2708,37.80437,{"lat":136,"lon":135},{"facility":139,"status":37,"city":140,"state":114,"zip":141,"country":116,"countryCode":117,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"UC Davis Children's Hospital","Sacramento","95817",{"type":119,"coordinates":143},[144,145],-121.4944,38.58157,{"lat":145,"lon":144},[148],{"name":149,"role":103,"phone":150,"phoneExt":37,"email":151},"Jennifer Rosenthal, MD, MAS","916-734-2011","rosenthal@ucdsvis.edu",{"facility":153,"status":37,"city":154,"state":114,"zip":155,"country":116,"countryCode":117,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"UCSF Benioff Children's Hospital - San Francisco","San Francisco","94158",{"type":119,"coordinates":157},[158,159],-122.41942,37.77493,{"lat":159,"lon":158},[162,166],{"name":163,"role":103,"phone":164,"phoneExt":37,"email":165},"Glenn Rosenbluth, MD","415-476-9180","glenn.rosenbluth@ucsf.edu",{"name":167,"role":103,"phone":104,"phoneExt":37,"email":105},"Naomi Bardach, MD, MAS in Clinical Research",{"facility":169,"status":37,"city":170,"state":171,"zip":172,"country":116,"countryCode":117,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Texas Children's Hospital North Austin Campus","Austin","Texas","78717",{"type":119,"coordinates":174},[175,176],-97.74306,30.26715,{"lat":176,"lon":175},[179,183],{"name":180,"role":103,"phone":181,"phoneExt":37,"email":182},"Veena Ramgopal, MD","832-824-5447","vxramgop@texaschildrens.org",{"name":184,"role":103,"phone":181,"phoneExt":37,"email":185},"Joyee Vanchani, MD","jgvachan@bcm.edu",{"facility":187,"status":37,"city":188,"state":171,"zip":189,"country":116,"countryCode":117,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Texas Children's Hospital The Woodlands Inpatient and Emergency","The Woodlands","77384",{"type":119,"coordinates":191},[192,193],-95.48938,30.15799,{"lat":193,"lon":192},[196,197],{"name":180,"role":103,"phone":181,"phoneExt":37,"email":182},{"name":184,"role":103,"phone":181,"phoneExt":37,"email":185},{"facility":199,"status":37,"city":200,"state":201,"zip":202,"country":116,"countryCode":117,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Children's Hospital of Richmond at VCU","Richmond","Virginia","23219",{"type":119,"coordinates":204},[205,206],-77.46026,37.55376,{"lat":206,"lon":205},[209],{"name":210,"role":103,"phone":211,"phoneExt":37,"email":212},"Matthew Schefft, DO, MSHA","804-828-9602","matthew.schefft@vcuhealth.org",{"facility":214,"status":37,"city":215,"state":216,"zip":217,"country":116,"countryCode":117,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":119,"coordinates":219},[220,221],-122.33207,47.60621,{"lat":221,"lon":220},[224],{"name":225,"role":103,"phone":226,"phoneExt":37,"email":227},"Corrie McDaniel, DO","206-685-2775","Corrie.McDaniel@seattlechildrens.org",{"type":229,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[231,232,234,236,238,240],{"name":214,"class":6},{"name":233,"class":6},"Virginia Commonwealth University",{"name":235,"class":6},"University of California, Los Angeles",{"name":237,"class":6},"University of California, Davis",{"name":239,"class":6},"Baylor College of Medicine",{"name":241,"class":242},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100659867","fiqs-dissemination-and-implementation-100659867",false,"NCT07871136","FIQS Dissemination and Implementation","Family Input for Quality and Safety Dissemination and Implementation","FIQS DI","Inclusion Criteria:\n\n* Family members or caregivers of patients (aged 0 to 21 years) admitted to participating hospital units\n* Patients aged 13 years and older admitted to participating hospital units\n* English or Spanish speakers\n* Patient or parent\u002Fguardian owns a mobile phone\n* Patient or parent\u002Fguardian present during hospitalization\n\nExclusion Criteria:\n\n* Patients or parents\u002Fguardians who are non-English and non-Spanish speakers\n* Patients or parents\u002Fguardians who do not own a mobile phone\n* Patients admitted under sensitive services\n* Patients who are in the foster care system","ALL","13 Years",{"count":254,"type":255},21800,"ESTIMATED","INTERVENTIONAL",[258],"NA","This study is testing Family Input for Quality and Safety (FIQS), a mobile-based survey tool that allows hospitalized children's families and adolescent patients to report safety concerns in real-time by responding to a text message link on their mobile phone. The main questions it aims to answer are:\n\n1. Does the way families are invited to use the safety reporting survey (text-only invitation versus text plus brief in-person orientation) affect how many families participate and report safety concerns?\n2. Does sharing safety reports anonymously versus with patient identifiers (for example, the patient name or room number) affect how often families report concerns and how hospitals respond?\n3. What barriers and supports help hospitals successfully use the reports from the survey to make safety improvements without extensive\u002Fdedicated research infrastructure?\n\nResearchers will compare different enrollment approaches and anonymous versus identified reporting across multiple children's hospitals to see which methods work best for engagement with the FIQS tool. Participants will:\n\n* Receive automated text message invitations when their child is admitted to participating hospital units\n* Be randomly assigned to receive either text-only invitation or an additional brief in-person orientation\n* Use a mobile-responsive survey to report safety concerns during their hospital stay through daily text prompts\n* Be randomly assigned to have their reports shared either anonymously or with identification to help hospital staff follow up\n* Participate during hospitalization while hospitals learn to integrate family safety reports into their quality improvement efforts",[261,262,263,264],"Inpatient Experience Survey Administration","Inpatient Experience Survey Response","Inpatient Pediatric Care","Inpatient Pediatric Engagement and Shared Decision-Making",[266,267,268,269,270],"Family-centered safety surveillance","Pediatric hospital quality improvement","Patient engagement technology","Pediatric patient safety","Pediatric inpatient quality","NOT_YET_RECRUITING","2026-10-05",{"date":274,"type":275},"2026-10-13","ACTUAL",{"date":277,"type":255},"2026-10-19",{"date":279,"type":255},"2029-12-31",{"name":5,"class":6},8]