[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05746247":3,"trial-entities:NCT05746247":84,"trial-summary:NCT05746247":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":14,"eligibility_criteria":56,"std_ages":67,"locations":70,"central_contacts":80,"overall_officials":81,"references":82,"see_also_links":83},"NCT05746247","849516","Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics","ENROLLING_BY_INVITATION","2026-06-30","2026-03","2026-03-05","2022-03-01","University of Pennsylvania","OTHER",false,"The goal of this study is to identify individuals at high risk of FH, and to encourage the appropriate diagnosis and treatment of individuals at high risk of FH through the use of implementation science and behavioral economics principles.\n\nPhase 1: Applying the FIND FH tool to the health system EHR and gathering data for pilot development; Phase 2: Pilot development and implementation; Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2","Phase 1:\n\nAim 1: Adjusting and refining the application of the FIND FH tool to the UPHS EHR database Aim 2: Identifying the barriers and facilitators to making a diagnosis of FH and initiating or intensifying therapy for individuals with FH through qualitative interviews with clinicians and patients and creating a behavioral roadmap to inform the implementation approaches to test in the pilots\n\nPhase 2:\n\nAim 1: Co-design implementation strategies using behavioral economics in partnership with the Family Heart Foundation Aim 2: Pilot implementation strategies with an enrollment goal of 80 patients total (40 per pilot) who have been flagged by the FIND FH tool as having probable FH to ascertain feasibility, acceptability, and appropriateness\n\nPhase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2",[18],"Familial Hypercholesterolemia",[20,21],"machine learning","FIND FH","INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},750,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Testing centralized referral mechanism for PCPs","For patients with a Penn PCP, we are testing a centralized referral mechanism to increase the number of referrals to preventive cardiology (default\u002Fopt out referrals)\n\nFor default\u002Fopt out: PCPs will receive a pended order for a referral for their patient to see a lipid specialist for a formal FH evaluation. Not interacting with the pended order or accepting the pended order will indicate that the referral to a lipid specialist should be placed.",[35],"Patients with a primary care physician within the UPHS health system",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation","All eligible patients will be informed that they have been identified by the FIND FH tool as potentially having familial hypercholesterolemia. All patients will be invited to schedule a telehealth appointment with a lipid specialist for a formal evaluation for FH.",[35,40],"Patients without a primary care physician within the UPHS health system",[42],{"measure":43,"description":44,"timeFrame":45},"Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention","Patients will be evaluated for familial hypercholesterolemia (FH), an underdiagnosed genetic type of high cholesterol. An FH diagnosis will be defined using the Dutch Lipid Clinic Network Diagnostic (DLCN) Criteria for FH (Unlikely, Possible, Probable, Definite). The clinician will also make a clinical assessment of FH informed by the DLCN score and clinical expertise from the appointment.","Day 1 - post intervention study visit",[47,50],{"measure":48,"description":49,"timeFrame":45},"Proportion of patients that have a change to their lipid management because of the intervention","Defined as the proportion of patients that start (or are prescribed) statins, ezetimibe, PCSK9 inhibitors, or have any intensification of any lipid lowering medications as a result of the visit with the lipid specialist for patients that qualify at the time of the appointment with the lipid specialist.",{"measure":51,"description":52,"timeFrame":45},"Proportion of patients that have a change to their lipid management among patients that were candidates for a change to their lipid management because of the intervention","Defined as the proportion of patients that start (or are prescribed) statins, ezetimibe, PCSK9 inhibitors, or have any intensification of any lipid lowering medications as a result of the visit with the lipid specialist for patients that qualified and were not already optimally treated at the time of the appointment.","ALL","18 Years",null,{"inclusion":57,"exclusion":62,"raw_text":66},[58,59,60,61],"Must be a patient at Penn Medicine","Must have been flagged by the FIND FH tool as having a high probability of FH","First language is English","Resides in PA or NJ",[63,64,65],"Already have been clinically diagnosed with FH using the proper ICD-10 code","Currently see a lipid specialist at Penn Medicine","Pass study clinician's Study Validity Check","Inclusion Criteria:\n\n* Must be a patient at Penn Medicine\n* Must have been flagged by the FIND FH tool as having a high probability of FH\n* First language is English\n* Resides in PA or NJ\n\nExclusion Criteria:\n\n* Already have been clinically diagnosed with FH using the proper ICD-10 code\n* Currently see a lipid specialist at Penn Medicine\n* Pass study clinician's Study Validity Check",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"University of Pennsylvania Health System","Philadelphia","Pennsylvania","19146","United States",{"lat":78,"lon":79},39.95238,-75.16362,[],[],[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Hyperlipoproteinemia, Type IIa",[],{"nct_id":4,"found":14,"summary":55,"prompt_version":55}]