[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06722378":3,"trial-entities:NCT06722378":136,"trial-summary:NCT06722378":140},{"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":24,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":43,"secondary_outcomes":48,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":75,"locations":78,"central_contacts":120,"overall_officials":128,"references":130,"see_also_links":135},"NCT06722378","2024-1396","A Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children","Bedside Notes: A Multicenter Trial to Improve Family Clinical Note Access and Outcomes for Hospitalized Children","RECRUITING","2029-04","2025-12","2025-12-18","2025-04-01","University of Wisconsin, Madison","OTHER",false,"This study will test if giving parents access to their child's medical notes on a bedside tablet:\n\n* helps them get more involved in their care\n* helps identify safety concerns\n\nParents of hospitalized children will be randomly assigned to either use the Bedside Notes tool or follow usual care.\n\nTo see if this approach improves care and safety, researchers will measure:\n\n* note access\n* parent-reported safety concerns\n* overall experiences","Hospitalized children face alarming rates of harm due to medical errors, yet parents often lack access to the clinical information necessary to partner effectively in their child's care. Although clinicians are required to share inpatient clinical notes detailing diagnoses and treatment plans, \\\u003C10% of parents access these notes during hospitalization. To address this critical gap, we developed the Bedside Notes intervention, a multicomponent strategy to improve parent access to clinical notes during their child's hospitalization and engage them in safety efforts. The intervention includes: (1) real-time access to inpatient notes through their child's patient portal on a bedside tablet and (2) a notes orientation video. In a single-center study, this intervention was associated with a \\>10-fold increase in parent note access and enabled 20% of parents to identify potential safety concerns, with 60% of these concerns confirmed as safety issues.\n\nThis multisite randomized controlled trial (RCT) will evaluate the effectiveness of the Bedside Notes intervention in improving parent access to inpatient notes and enhancing safety reporting. Specific aims are to: (1) assess the impact of the intervention on parent note access, (2) evaluate its effect on parent-reported safety concerns and experiences, and (3) identify barriers and facilitators to implementation. Guided by the Systems Engineering Initiative for Patient Safety 2.0 framework, this hybrid type 1 RCT will enroll English- and Spanish-speaking parents of 600 children admitted to pediatric services at three hospitals. Parents will be randomized to either: (1) usual care (access to outpatient portals on personal devices) or (2) the Bedside Notes intervention (proxy access to patient portal on bedside tablets with accompanying orientation video). A subset of parents and healthcare staff will also be interviewed about their experience with the intervention. Data will be collected through surveys, interviews, and electronic health record audits.\n\nThis study is the first multisite RCT to evaluate the impact of inpatient note access on parent-reported outcomes. By leveraging bilingual recruitment, two EHR platforms, and input from a national advisory group, the study addresses barriers to equitable access and sustainability. Findings will advance understanding of how health information technology can engage parents as partners in improving inpatient safety for children and inform broader efforts to integrate families into safety initiatives.",[19,20,21,22,23],"Hospitalized Child","Pediatric Patient Safety","Medical Errors","Parental Engagement in Care","Inpatient Pediatric Care",[25,26,27,28,29],"Family-Centered Care","Electronic Health Records (EHR)","Safety Reporting","Parent Note Access","Quality Improvement","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[33],"NA",{"count":35,"type":36},630,"ESTIMATED",[38],{"type":14,"name":39,"description":40,"armGroupLabels":41},"Access to medical notes","Inpatient notes shared in real-time on a hospital-owned bedside tablet linked to their child's records.",[42],"Access to notes on a tablet",[44],{"measure":45,"description":46,"timeFrame":47},"Number of notes accessed","Researchers will abstract note access during hospitalization from the EHR and compare the frequency and proportion of available notes accessed between arms.","Duration of study participation, 2 to 7 days",[49,52,55,59],{"measure":50,"description":51,"timeFrame":47},"Safety concern reporting","Safety concern reporting will be measured using the OpenNotes safety concern reporting tool, a 9-item questionnaire adapted for parent-reported safety concerns during hospitalization. The tool will be translated into Spanish and piloted for this study. Parent-reported safety concerns will be reviewed by the PI and site PIs and categorized as definite safety issues, possible safety issues, or other. Definite and possible issues will be further categorized by type (e.g., medication, physical exam) and assessed via chart reviews for associated changes to the medical record or patient care (yes\u002Fno\u002Funcertain). Researchers will compare results across arms.",{"measure":53,"description":54,"timeFrame":47},"Hospital experience","Experience will be measured using the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, which evaluates parent perceptions of their hospital experience upon discharge. The survey includes closed-ended and Likert-style items rated on a 5-point scale, with \"strongly agree\" as the highest score. Key measures include overall hospital rating, willingness to recommend, and \"helping you report concerns.\" It is available in English and Spanish. It will be administered prior to hospital discharge and compared across arms.",{"measure":56,"description":57,"timeFrame":58},"Change in parent activation","Activation will be measured using the Parent-Patient Activation Measure (P-PAM), a 13-item Likert-style tool adapted from the Patient Activation Measure (PAM), assessing skills and confidence for managing a child's healthcare. Scores range from 0-100, with higher scores indicating greater activation. The P-PAM has demonstrated validity and reliability in both English and Spanish. It will be administered at baseline and prior to hospital discharge and compared across arms.","Baseline to discharge, 2 to 7 days",{"measure":60,"description":61,"timeFrame":58},"Change in Anxiety","Anxiety will be measured using the State-Trait Anxiety Inventory (STAI) Form Y, a 40-item Likert-style questionnaire assessing anxiety on a 4-point scale. Total scores range from 20-80, with higher scores indicating greater anxiety. The STAI is validated for sensitivity to health interventions over time and is available in English and Spanish. It will be administered at baseline and prior to hospital discharge and compared across arms.","ALL","18 Years",null,{"inclusion":66,"exclusion":69,"raw_text":74},[67,68],"English and Spanish-speaking parents or guardians of children under 12 years old who were hospitalized on a general pediatric service at one of the 3 centers","Age 18 and over",[70,71,72,73],"Parents of children 12 years of age and older","Parents unable to give written informed consent","Parents of children admitted for suspected abuse or neglect","Anticipated discharge within 24 hours","Inclusion Criteria:\n\n* English and Spanish-speaking parents or guardians of children under 12 years old who were hospitalized on a general pediatric service at one of the 3 centers\n* Age 18 and over\n\nExclusion Criteria:\n\n* Parents of children 12 years of age and older\n* Parents unable to give written informed consent\n* Parents of children admitted for suspected abuse or neglect\n* Anticipated discharge within 24 hours",[76,77],"ADULT","OLDER_ADULT",[79,92,104],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":89},"Children's Hospital of Los Angeles","Los Angeles","California","90027","United States",[86],{"name":87,"role":88},"Anna Egan, MD","SUB_INVESTIGATOR",{"lat":90,"lon":91},34.05223,-118.24368,{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":84,"contacts":98,"geoPoint":101},"Seattle Children's Hospital","NOT_YET_RECRUITING","Seattle","Washington","98105",[99],{"name":100,"role":88},"Arti Desai, MD",{"lat":102,"lon":103},47.60621,-122.33207,{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":84,"contacts":109,"geoPoint":117},"American Family Children's Hospital","Madison","Wisconsin","53792",[110,113,115],{"name":111,"role":112},"Michelle Kelly, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":114,"role":88},"Ryan Coller, MD, MPH",{"name":116,"role":88},"Catherine Arnott Smith, PhD",{"lat":118,"lon":119},43.07305,-89.40123,[121,125],{"name":111,"role":122,"phone":123,"email":124},"CONTACT","(608) 265-5545","michelle.kelly@wisc.edu",{"name":126,"role":122,"email":127},"Amanda Gatewood","akgatewood@pediatrics.wisc.edu",[129],{"name":111,"affiliation":13,"role":112},[131],{"pmid":132,"type":133,"citation":134},"40839550","BACKGROUND","O'Hare C, Gatewood AK, Baird J, Brown R, Coller RJ, Desai A, Egan A, Gerber D, McGuire T, Singh-Verdeflor KD, Smith CA, Verdelis GA, Warner G, Wong S, Kelly MM. A multicenter randomized trial to improve family clinical note access and outcomes for hospitalized children: The Bedside Notes study protocol. J Hosp Med. 2025 Nov;20(11):1256-1264. doi: 10.1002\u002Fjhm.70155. Epub 2025 Aug 21.",[],{"nct_id":4,"conditions":137,"biomarkers":139},[138,25,19,23,21,22,28,20,29,27],"Electronic Health Records",[],{"nct_id":4,"found":141,"summary":142,"prompt_version":152},true,{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This is an interventional study involving 630 participants. Parents will be randomly assigned to either use the Bedside Notes tool or receive usual care.","completed","Improving Family Access to Hospital Notes for Hospitalized Children","This study is testing if giving parents access to their child's medical notes on a bedside tablet, called \"Bedside Notes,\" can help them be more involved in their child's care and identify safety concerns. Parents of children under 12 who are hospitalized will either use the Bedside Notes tool or receive usual care. Researchers will measure how often parents access notes, any safety concerns they report, and their overall experiences. The goal is to see if this approach improves care and safety for hospitalized children. We are looking for 630 English or Spanish-speaking parents aged 18 or older whose children are under 12 and hospitalized on a general pediatric service.","Not specified.",110,"You would participate for the duration of your child's hospitalization, which is typically 2 to 7 days.","Not stated in the trial record.",[],"v2"]