[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477961":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":41,"locations":50,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":25,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group: ISA-MI","EXPERIMENTAL","The ISA-MI study condition involves, in addition to the standard of care described for the SOC group, a clinician training activity related to using the ISA (Infant Sleep Assessment) tool. Clinicians assigned to the ISA-MI Group will view a 20-30-minute recorded video training session on infant safe sleep (including its epidemiology, risk factors and recommendations), use of the ISA tool, and use of motivational interviewing-inspired (MI) communication skills to respond to ISA parent responses. The ISA tool builds on the 2022 AAP infant sleep recommendations and will be implemented at the 2-month WBV.\n\nParents\u002Fpatients of physicians in the ISA-MI study condition will also be given several infant safe sleep related products that facilitate compliance with safe sleep recommendations, namely, a portable crib, a sleep sack and a pacifier.",[13],"Behavioral: ISA-MI",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group: Standard of Care (SOC)","The SOC study condition consists of WBVs that follow the usual practice of American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age- and developmentally based anticipatory guidance. As part of their training, pediatric residents receive formal teaching on core aspects of providing primary care to infants, including the AAP recommendations on safe sleep. This includes the recommended ABCS: babies should sleep Alone (no objects or people), on their Back (supine), in a Crib (or safe alternative including portable crib or bassinet), and in a Smoke-free environment.",[18],"Other: Standard of Care (SOC)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","ISA-MI","Parents seen by clinicians randomized to the intervention group will complete the Infant Sleep Assessment (ISA), either prior to their visit using MyChart (Epic patient portal) or on a tablet computer in the exam room while they wait for their clinician; 2) a Clinical Decision Support (CDS) smart form is created in the EMR based on the assessment results, with risks and MI-informed strategies highlighted; this information will be derived from a pre-programmed algorithm and theory-based, tailored communication strategies and messages; 3) the clinician uses the CDS smart form to guide counseling with the parent during the visit, applying their training in MI-informed counseling skills; and 4) Clinician gives the parent an After Visit Summary (AVS) from the EMR (or informs them that they can access the AVS in MyChart if the parent or other caregivers use the patient portal, MyChart), which summarizes and reinforces the safe sleep counseling.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of Care (SOC)","Parents seen by clinicians randomized to the control group will receive the usual practice that pediatric residents are taught which follows the American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age and developmentally based anticipatory guidance. As part of their training, residents receive formal teaching on core aspects of providing primary care to infants, including the AAP recommendations on safe sleep. This includes the recommended ABCS: babies should sleep Alone (no objects or people), on their Back (supine), in a Crib (or safe alternative including portable crib or bassinet), and in a Smoke-free environment.",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Barry Solomon, MD, MPH","Division of General Pediatrics","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Eileen M McDonald, MS","Johns Hopkins Bloomberg School of Public Health",{"name":39,"affiliation":33,"role":40},"Marisabel Cordon Villa de Leon, MPH","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Marisa Cordon Villa de Leon, MPH","CONTACT","443-564-0185","mcordon4@jh.edu",{"name":36,"role":44,"phone":48,"phoneExt":25,"email":49},"410-428-9063","emcdona1@jhu.edu",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Harriet Lane Clinic","RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-76.61219,39.29038,{"lat":63,"lon":62},[66,67],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},{"name":68,"role":44,"phone":25,"phoneExt":25,"email":69},"Barry Solomon, MD","bsolomon@jhmi.edu",{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[73],{"name":74,"class":75},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100477961","improving-pediatrician-counseling-about-infant-safe-sleep-using-the-electronic-medical-record-100477961",false,"NCT05503771","Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record","Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)","Inclusion Criteria:\n\n* English and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age)\n* Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate.\n\nExclusion Criteria:\n\n* Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)\n* Assigned resident is not enrolled in the study",true,"ALL","3 Days","75 Years",{"count":88,"type":89},350,"ESTIMATED","INTERVENTIONAL",[92],"NA","The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.",[95,96],"Sudden Infant Death","Sudden Unexplained Infant Death",[98,99,100,101,102],"Counseling","Motivational Interviewing","Medical Informatics","Clinical Decision Support","Electronic Medical Record","2025-12-08",{"date":105,"type":106},"2025-12-09","ACTUAL",{"date":108,"type":106},"2022-09-30",{"date":110,"type":89},"2027-02-28",{"name":5,"class":6},1]