Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter (AF-ALERT)
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Electronic Alert
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- <21 years old
- no diagnosis of AF or atrial flutter
- not hospitalized at BWH
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Alert Group
Control Group
Arm Description
If 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.
If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.
Outcomes
Primary Outcome Measures
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Defined as prescription of therapeutic dose anticoagulation
Secondary Outcome Measures
Frequency of composite of major adverse cardiovascular events at 90 days
Defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment
Frequency of stroke or transient ischemic attack (TIA) at 90 days
An acute stroke was defined as a new, focal neurologic deficit of sudden onset, lasting at least 24 hours, not due to a readily identifiable nonvascular cause (e.g., brain tumor, trauma), as confirmed by a neurologist. All strokes required confirmation by imaging or autopsy. TIA was defined as a transient episode of neurologic dysfunction caused by suspected focal cerebral, spinal cord, or retinal ischemia without evidence of acute infarction and confirmed by a neurologist.
Frequency of acute myocardial infarction at 90 days
Acute MI was defined as the detection of a rise and/or fall of cardiac biomarkers (cardiac troponin T), with at least one value being elevated above the 99th percentile upper reference limit and with at least one of the following: 1) symptoms of myocardial ischemia; 2) new (or presumably new) significant ST-segment/T-wave changes or left bundle branch block; 3) development of pathological Q waves on ECG; 4) new loss of viable myocardium or regional wall motion abnormality by imaging; or 5) identification of intracoronary thrombus by angiography or autopsy.
Frequency of all cause mortality at 90 days
All-cause mortality was determined by review of the EHR. Causes of death were classified as stroke, myocardial infarction, pulmonary embolism, other cardiovascular cause, bleeding, cancer, or non-cardiovascular and non-cancer.
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
Defined by the International Society on Thrombosis and Haemostasis [ISTH] bleeding classification system) at 90 days from enrollment.14 Using the ISTH classification, bleeding was defined as major if it was overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, required the transfusion of 2 or more units of blood, occurred into a critical site, or contributed to death. Clinically relevant non-major bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.
Frequency of systemic embolism at 90 days
Systemic embolism was defined as sudden loss of perfusion of a limb or extracranial organ
Full Information
NCT ID
NCT02339493
First Posted
January 6, 2015
Last Updated
October 29, 2018
Sponsor
Brigham and Women's Hospital
Collaborators
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02339493
Brief Title
Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter
Acronym
AF-ALERT
Official Title
Alert-Based Computerized Decision Support for Stroke Prevention in High-Risk Hospitalized Patients With Atrial Fibrillation: A Randomized, Controlled Trial (AF-ALERT)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. The investigators have the following specific aims:
Aim #1 (Primary Efficacy Endpoint)- To assess whether an alert-based computerized decision support strategy increases prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Hypothesis #1- An alert-based computer decision support (CDS) strategy will increase prescription of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Aim #2 (Secondary Efficacy Endpoint)- To determine the potential impact of an alert-based computerized decision support strategy on the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
Hypothesis #2- This study will provide proof-of-concept data, including event rates, from which to design a larger randomized control trial to assess whether an alert-based CDS strategy will reduce the frequency of a composite of major adverse cardiovascular events at 90 days, defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
458 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert Group
Arm Type
Experimental
Arm Description
If 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
If the patient is randomized to the control group, the computer program will not issue an on-screen electronic alert.
Intervention Type
Other
Intervention Name(s)
Computer Electronic Alert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of prescription of anticoagulation during hospitalization, at discharge, and at 90 days from enrollment.
Description
Defined as prescription of therapeutic dose anticoagulation
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Frequency of composite of major adverse cardiovascular events at 90 days
Description
Defined as cerebrovascular accident, systemic embolism, myocardial infarction (MI), and all-cause mortality at 90 days from enrollment
Time Frame
90 days
Title
Frequency of stroke or transient ischemic attack (TIA) at 90 days
Description
An acute stroke was defined as a new, focal neurologic deficit of sudden onset, lasting at least 24 hours, not due to a readily identifiable nonvascular cause (e.g., brain tumor, trauma), as confirmed by a neurologist. All strokes required confirmation by imaging or autopsy. TIA was defined as a transient episode of neurologic dysfunction caused by suspected focal cerebral, spinal cord, or retinal ischemia without evidence of acute infarction and confirmed by a neurologist.
Time Frame
90 days
Title
Frequency of acute myocardial infarction at 90 days
Description
Acute MI was defined as the detection of a rise and/or fall of cardiac biomarkers (cardiac troponin T), with at least one value being elevated above the 99th percentile upper reference limit and with at least one of the following: 1) symptoms of myocardial ischemia; 2) new (or presumably new) significant ST-segment/T-wave changes or left bundle branch block; 3) development of pathological Q waves on ECG; 4) new loss of viable myocardium or regional wall motion abnormality by imaging; or 5) identification of intracoronary thrombus by angiography or autopsy.
Time Frame
90 days
Title
Frequency of all cause mortality at 90 days
Description
All-cause mortality was determined by review of the EHR. Causes of death were classified as stroke, myocardial infarction, pulmonary embolism, other cardiovascular cause, bleeding, cancer, or non-cardiovascular and non-cancer.
Time Frame
90 days
Title
Frequency of major bleeding or clinically relevant non-major bleeding at 90 days
Description
Defined by the International Society on Thrombosis and Haemostasis [ISTH] bleeding classification system) at 90 days from enrollment.14 Using the ISTH classification, bleeding was defined as major if it was overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, required the transfusion of 2 or more units of blood, occurred into a critical site, or contributed to death. Clinically relevant non-major bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.
Time Frame
90 days
Title
Frequency of systemic embolism at 90 days
Description
Systemic embolism was defined as sudden loss of perfusion of a limb or extracranial organ
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
<21 years old
no diagnosis of AF or atrial flutter
not hospitalized at BWH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Z Goldhaber, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33000390
Citation
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.
Results Reference
derived
PubMed Identifier
31228189
Citation
Piazza 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.
Results Reference
derived
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Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter
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