nctId: NCT06355986 id: 39039039AFL4016 briefTitle: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation acronym: AF-ALERT3 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-30 date: 2026-07-30 date: 2024-04-10 date: 2024-04-10 name: Brigham and Women's Hospital class: OTHER name: Janssen, LP briefSummary: Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management. conditions: Atrial Fibrillation conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Assignment to a particular cluster (ALERT or NO ALERT) will be masked to the patient participant, investigator, and outcomes assessor. Since the intervention is a computer alert to the provider of record, he/she will be aware of whether or not a notification is provided. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Alert-based computerized decision support measure: Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment measure: Frequency of major bleeding at 6 months from enrollment. measure: Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group measure: Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Elizabeth Health city: Edgewood state: Kentucky zip: 41017 country: United States name: Benjamin Peterson, MD role: CONTACT phone: 617-987-1046 email: benjamin.peterson@stelizabeth.com lat: 39.01867 lon: -84.58189 facility: Mass General Brigham city: Boston state: Massachusetts zip: 02115 country: United States name: Gregory Piazza, MD, MS role: CONTACT phone: 781-956-5525 email: gregorypiazza@hotmail.com lat: 42.35843 lon: -71.05977 hasResults: False