Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter
AF-ALERT
Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)
1 other identifier
interventional
458
1 country
1
Brief Summary
Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 15, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedOctober 31, 2018
October 1, 2018
1.8 years
January 6, 2015
October 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Defined as prescription of therapeutic dose anticoagulation
90 days
Secondary Outcomes (6)
Frequency of composite of major adverse cardiovascular events at 90 days
90 days
Frequency of stroke or transient ischemic attack (TIA) at 90 days
90 days
Frequency of acute myocardial infarction at 90 days
90 days
Frequency of all cause mortality at 90 days
90 days
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
90 days
- +1 more secondary outcomes
Study Arms (2)
Alert Group
EXPERIMENTALIf the patient is randomized to the alert group, their ordering provider will receive a computer electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy.
Control Group
NO INTERVENTIONIf the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.
Interventions
A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.
Eligibility Criteria
You may qualify if:
- High-risk patients ≥ 21 years old with paroxysmal, persistent, or permanent nonvalvular AF or atrial flutter (CHA2DS2VASc score ≥ 1) who are not prescribed anticoagulant therapy for stroke prevention and are hospitalized at BWH will be eligible for randomization.
You may not qualify if:
- \<21 years old
- no diagnosis of AF or atrial flutter
- not hospitalized at BWH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Daiichi Sankyocollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (2)
Piazza G, Hurwitz S, Carroll B, Goldhaber SZ. Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy : Piazza: outcomes of high-bleeding risk AF patients. J Thromb Thrombolysis. 2021 Jul;52(1):281-290. doi: 10.1007/s11239-020-02296-0. Epub 2020 Sep 30.
PMID: 33000390DERIVEDPiazza G, Hurwitz S, Galvin CE, Harrigan L, Baklla S, Hohlfelder B, Carroll B, Landman AB, Emani S, Goldhaber SZ. Alert-based computerized decision support for high-risk hospitalized patients with atrial fibrillation not prescribed anticoagulation: a randomized, controlled trial (AF-ALERT). Eur Heart J. 2020 Mar 7;41(10):1086-1096. doi: 10.1093/eurheartj/ehz385.
PMID: 31228189DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Z Goldhaber, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Thrombosis Research Group
Study Record Dates
First Submitted
January 6, 2015
First Posted
January 15, 2015
Study Start
May 1, 2016
Primary Completion
February 1, 2018
Study Completion
September 1, 2018
Last Updated
October 31, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share