Electronic Alerts for Stroke Prevention in Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-screen electronic alert
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, computerized decision support
Eligibility Criteria
Inclusion Criteria:
- Men and women
- Age ≥ 18 years
- Problem list entry of AF or atrial flutter
- CHA2DS2VASc score ≥2
Exclusion Criteria:
- Active prescription for anticoagulant therapy
- CHA2DS2VASc score <2
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Electronic Alert
No Alert
Arm Description
Each provider in the alert group will receive an on-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation.
Each provider in the non-alert group will receive no such notification.
Outcomes
Primary Outcome Measures
frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation
frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention before study randomization. The primary efficacy outcome will be determined by review of the EHR medication documentation for prescription of anticoagulation by 48 hours after randomization.
Secondary Outcome Measures
frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality
frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality at 3 months from randomization
frequency of major bleeding (as defined by the ISTH bleeding classification system)
major bleeding (as defined by the ISTH bleeding classification system) at 3 months from randomization
Full Information
NCT ID
NCT02958943
First Posted
November 5, 2016
Last Updated
July 5, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02958943
Brief Title
Electronic Alerts for Stroke Prevention in Atrial Fibrillation
Official Title
Electronic Alert-Based Computerized Decision Support to Increase Prescription of Anticoagulation in High-Risk Atrial Fibrillation Patients in the Outpatient Setting (AF-ALERT2)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, five options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. Data from this center (Brigham and Women's Hospital [BWH]) (1) demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to 2012 Focused Update of the European Society of Cardiology Guidelines for the Management of AF (2) receive anticoagulation.
Aim #1: To determine the impact of electronic alert-based computerized decision support (CDS) on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.
Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by 80% in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.
Aim #2: To determine the impact of electronic alert-based computerized decision support (CDS) on the frequency of stroke and systemic embolic events in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.
Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic embolism in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Data acquired through this study regarding the frequency of stroke and systemic embolism will be used to calculate sample size requirements for a future clinical end-point driven randomized controlled trial of electronic alerts to prevent stroke in high-risk AF patients.
Detailed Description
AF is associated with an increased risk of fatal and disabling ischemic stroke. Despite widely accessible evidence-based clinical practice guidelines, risk stratification tools (CHA2DS2-VASc and HAS-BLED) and five effective oral antithrombotic agents for stroke prevention (22), at least 40% of high-risk patients with AF worldwide remain unprotected because of failure to prescribe anticoagulation. The failure to prevent stroke in AF has become a critical international patient safety crisis. The root causes of underutilization include lack of provider and patient education about the importance of stroke prevention in AF, inadequate risk stratification, and concerns regarding the bleeding risk with anticoagulant therapy. The investigators were surprised to learn that even at BWH, underutilization of anticoagulation for stroke prevention in AF continues to be a concern (1).
The failure to prevent stroke in AF is similar to the crisis in VTE prevention among hospitalized patients from a decade ago. To address this critical patient safety problem, investigators evaluated the impact of alert-based CDS on VTE prevention (18). First, investigators designed software linked to our Electronic Health Record (EHR) and provider order entry program to identify hospitalized patients at risk for VTE using a weighted risk score and for whom prophylaxis was not ordered. Patients were randomized to the intervention group, in which the responsible physician received an electronic alert regarding the risk of VTE and recommendation regarding prophylaxis, or to the control group, in which no alert was issued. Compared with the control group, electronic alerts more than doubled the rate of thromboprophylaxis orders (from 14.5% to 33.5%; p<0.0001). The risk of symptomatic VTE was reduced by 41% (hazard ratio, 0.59; 95% confidence interval 0.43-0.81; p=0.001) among patients for whom an electronic alert was issued. Investigators have also shown that "human" (person-to-person) alert-based decision support for the prevention of VTE in at-risk hospitalized patients more than doubled the rate of VTE prophylaxis compared with controls during hospitalization (21) and after discharge (19).
The current study will determine the impact of electronic alert-based CDS on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Because this is a Quality Improvement initiative, investigators will not mandate a specific antithrombotic agent, regimen, or duration. Investigators will provide options for anticoagulation to prevent stroke in AF and allow the provider to make the best choice based on their clinical judgment. If there is a contraindication to anticoagulation or if the risks outweigh the benefits of antithrombotic therapy, the provider can elect to omit anticoagulation but will need to provide the rationale for doing so. The current study will also determine the impact of electronic alert-based CDS on the frequency of stroke and systemic embolic events in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Data acquired through this study regarding the frequency of stroke and systemic embolism will be used to calculate sample size requirements for a future clinical end-point driven randomized controlled trial of electronic alerts to prevent stroke in high-risk AF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
atrial fibrillation, stroke, computerized decision support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
798 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic Alert
Arm Type
Experimental
Arm Description
Each provider in the alert group will receive an on-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation.
Arm Title
No Alert
Arm Type
No Intervention
Arm Description
Each provider in the non-alert group will receive no such notification.
Intervention Type
Behavioral
Intervention Name(s)
On-screen electronic alert
Intervention Description
On-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation. Providers may then 1) access a template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence based clinical practice guidelines, or 3) proceed onto order entry after providing an explanation for why anticoagulation was not prescribed.
Primary Outcome Measure Information:
Title
frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation
Description
frequency of prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention before study randomization. The primary efficacy outcome will be determined by review of the EHR medication documentation for prescription of anticoagulation by 48 hours after randomization.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality
Description
frequency of stroke/TIA, systemic embolism, myocardial infarction and all-cause mortality at 3 months from randomization
Time Frame
3 months
Title
frequency of major bleeding (as defined by the ISTH bleeding classification system)
Description
major bleeding (as defined by the ISTH bleeding classification system) at 3 months from randomization
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
frequency of stroke, TIA, systemic embolism
Description
frequency of stroke, TIA, systemic embolism
Time Frame
3 months
Title
frequency of myocardial infarction
Description
frequency of myocardial infarction
Time Frame
3 months
Title
frequency of all-cause mortality
Description
frequency of all-cause mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women
Age ≥ 18 years
Problem list entry of AF or atrial flutter
CHA2DS2VASc score ≥2
Exclusion Criteria:
Active prescription for anticoagulant therapy
CHA2DS2VASc score <2
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
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Electronic Alerts for Stroke Prevention in Atrial Fibrillation
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