[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659434":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":36,"interventions":49,"overallOfficials":57,"centralContacts":25,"locations":61,"responsibleParty":74,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":101,"overallStatus":106,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Seattle Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Eligible hospitalizations per site per month","Number of hospitalizations confirmed as initially eligible through study screening per month that a study site is open to recruitment.","During recruitment, anticipated to last approximately 2 years.",{"measure":14,"description":15,"timeFrame":16},"Clinician acceptance rate","Percentage of consented patients with known objection status for whom no clinician objected to randomization, including no reply after clinician notification and the response period.","During the initial hospitalization, before randomization or the end of recruitment for that patient (up to hospital day 30).",{"measure":18,"description":19,"timeFrame":20},"Family consent rate","Percentage of initially eligible families offered study participation who provide consent.","During recruitment in the initial hospitalization (up to hospital day 30).",{"measure":22,"description":23,"timeFrame":24},"Difference in seven-day primary care follow-up between study arms","Automatic minus as-needed difference in the percentage of patients with known follow-up status who have a clinical visit or call with their regular doctor or usual care team within seven days after discharge.","Within 7 days after hospital discharge.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Multicenter external pilot trial with individual 1:1 randomization, stratified by site, to automatic or as-needed postdischarge follow-up recommendations.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"SINGLE","Participants, caregivers and treating clinicians know the assigned recommendation. The coordinating-center will be blinded for adjudication of safety outcomes, including ICU readmission or death and relatedness to study participation.",[35],"OUTCOMES_ASSESSOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Automatic follow-up recommendation","ACTIVE_COMPARATOR","Families are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge.",[42],"Behavioral: Automatic follow-up recommendation",{"label":44,"type":45,"description":46,"interventionNames":47},"As-needed follow-up recommendation","EXPERIMENTAL","Families are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise.",[48],"Behavioral: As-needed follow-up recommendation",[50,54],{"type":51,"name":38,"description":52,"armGroupLabels":53,"otherNames":25},"BEHAVIORAL","Families are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge. This is the clinician or team the family usually contacts first for health concerns and may be a generalist, complex-care clinician or specialist. Other specialist care continues as usual.",[38],{"type":51,"name":44,"description":55,"armGroupLabels":56,"otherNames":25},"Families are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise. This recommendation concerns follow-up with the clinician or team the family usually contacts first for health concerns, which may be a generalist, complex-care clinician or specialist. Other specialist care continues as usual.",[44],[58],{"name":59,"affiliation":5,"role":60},"Nassr Nama, MD, MSc","PRINCIPAL_INVESTIGATOR",[62],{"facility":5,"status":25,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":25},"Seattle","Washington","98105","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-122.33207,47.60621,{"lat":72,"lon":71},{"type":60,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Nassr Nama","Assistant Professor","100659434","automatic-versus-as-needed-follow-up-after-hospitalization-for-children-with-medical-complexity-100659434",false,"NCT07864636","Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity","AFTERCARE: Automatic Versus Family-directed Transition Follow-up After Hospitalization: Evaluating Randomization, Caregiver Acceptability, and Recruitment fEasibility","AFTERCARE","Inclusion Criteria\n\n1. Children aged 1 to younger than 17 years at hospital admission.\n2. Chronic medical conditions affecting at least two body systems.\n3. Hospitalized on a general pediatric, complex care or equivalent service for a respiratory infection, urinary tract infection, skin or soft-tissue infection, or infectious gastroenteritis.\n4. Expected discharge home, with an adult parent or legal guardian available to provide consent and complete study activities.\n\nExclusion Criteria\n\n1. Enrollment after hospital day 30.\n2. Primary care follow-up already scheduled or recommended within seven days after discharge, or a strong family or clinician preference that makes randomization unacceptable.\n3. History of cancer or organ, bone marrow or stem-cell transplantation.\n4. A new type of medical equipment needed at home, or planned home intravenous nutrition or antibiotics.\n5. Selected complicated infections or infection-specific high-risk conditions.\n6. Foster care, hospice care or discharge to an institutional care setting.","ALL","1 Year","16 Years",{"count":89,"type":90},160,"ESTIMATED","INTERVENTIONAL",[93],"NA","Children with medical complexity often receive a recommendation to see an outpatient clinician soon after leaving the hospital. It is uncertain whether every child needs this routine visit or whether follow-up can be guided by the family's concerns and the child's recovery. AFTERCARE is a multicenter pilot randomized trial comparing these two follow-up recommendations for children hospitalized with an acute infection.\n\nFamilies will be assigned by chance to receive either a recommendation to arrange follow-up with their usual outpatient clinician within seven days or a recommendation to seek follow-up if the child is not improving as expected or new concerns arise. Families in both groups may seek medical care whenever needed. The study will assess recruitment, follow-up data collection, delivery of the recommendations and acceptability. Caregiver surveys and medical record review will also describe outpatient visits and hospital returns. This pilot will inform the design of a larger trial, and is not designed to establish that the strategies are equally safe or effective.",[96,97,98,99,100],"Children With Medical Complexity","Respiratory Tract Infections (RTI)","Urinary Tract Infection (UTI)","Acute Gastroenteritis","Skin and Soft Tissue Infection",[102,103,104,105],"Pediatric hospitalization","Postdischarge follow-up","Caregiver-directed care","Feasibility trial","NOT_YET_RECRUITING","2026-10-04",{"date":109,"type":110},"2026-10-08","ACTUAL",{"date":112,"type":90},"2026-10",{"date":114,"type":90},"2028-09",{"name":5,"class":6},1]