protocolSection identificationModule nctId: NCT06355986, orgStudyIdInfo id: 39039039AFL4016, briefTitle: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation, acronym: AF-ALERT3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2026-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Janssen, LP, descriptionModule 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., conditionsModule conditions: Atrial Fibrillation, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Alert-based computerized decision support, outcomesModule primaryOutcomes 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, primaryOutcomes measure: Frequency of major bleeding at 6 months from enrollment., secondaryOutcomes 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, secondaryOutcomes 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, otherOutcomes measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported, otherOutcomes measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Elizabeth Health, city: Edgewood, state: Kentucky, zip: 41017, country: United States, contacts name: Benjamin Peterson, MD, role: CONTACT, phone: 617-987-1046, email: benjamin.peterson@stelizabeth.com, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Mass General Brigham, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Gregory Piazza, MD, MS, role: CONTACT, phone: 781-956-5525, email: gregorypiazza@hotmail.com, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False