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CompletedNCT02958943Updated Jul 8, 2022

Electronic Alerts for Stroke Prevention in Atrial Fibrillation

An interventional study of On-screen electronic alert in Atrial Fibrillation and Stroke, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
798
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Stroke

Keywords

  • atrial fibrillation
  • stroke
  • computerized decision support
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 798 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women
  • Age ≥ 18 years
  • Problem list entry of AF or atrial flutter
  • CHA2DS2VASc score ≥2

Exclusion criteria

Exclusion Criteria:

  • Active prescription for anticoagulant therapy
  • CHA2DS2VASc score \<2
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
798 participants (actual)

Study arms

  • Experimental
    Electronic Alert

    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.

    Behavioral: On-screen electronic alert

  • No intervention
    No Alert

    Each provider in the non-alert group will receive no such notification.

Interventions

  • BehavioralOn-screen electronic alert

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 3 months

Other outcomes

  1. frequency of stroke, TIA, systemic embolism

    frequency of stroke, TIA, systemic embolism

    Time frame: 3 months

  2. frequency of myocardial infarction

    frequency of myocardial infarction

    Time frame: 3 months

  3. frequency of all-cause mortality

    frequency of all-cause mortality

    Time frame: 3 months

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Piazza G, Hurwitz S, Campia U, Bikdeli B, Lou J, Khairani CD, Bejjani A, Snyder JE, Pfeferman M, Barns B, Rizzo S, Glezer A, Goldhaber SZ. Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2). Thromb Res. 2023 Jul;227:1-7. doi: 10.1016/j.thromres.2023.05.006. Epub 2023 May 11. PubMed 37182298 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Dec 2021, 42 months.

Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 42 months is close to that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2016
First posted
Nov 8, 2016
StartActual
Jun 1, 2018
Primary completionActual
Dec 31, 2021
CompletionActual
Jun 30, 2022
Last update
Jul 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02958943
Responsible party
Samuel Z.Goldhaber, MD (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Nov 8, 2016
Start date
Jun 1, 2018
Primary completion
Dec 31, 2021
Completion
Jun 30, 2022
Last update
Jul 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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