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NCT Number: NCT06355986

Computerized Decision Support to Prevent Stroke in Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Elizabeth Health, Edgewood, Kentucky, United States

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About this study

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 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%). Implementation science strategies, including computerized decision support (CDS), have been proposed as solutions to improve adherence to guideline recommendations. A previously conducted randomized controlled trial of alert-based CDS in 458 high-risk hospitalized patients with AF who were not being anticoagulated showed that the alert nearly tripled the proportion of hospitalized patients with AF and high-risk of stroke who were prescribed anticoagulation during the hospitalization, at discharge, and at 90 days compared with the control group. CDS in this trial was associated with an 88% reduction in the frequency of stroke or systemic embolic event and 87% reduction in the frequency of myocardial infarction (MI) at 90 days. A subsequent trial demonstrated that clinician-directed, alert-based CDS doubled prescription of antithrombotic therapy in high-risk ambulatory care patients with AF who were not prescribed anticoagulation at the time of randomization. A major lesson from the second trial was the importance that perceived bleeding risk played in the shared decision-making process between clinician and patient. These two trials demonstrated that bleeding risk is the predominant consideration when omitting anticoagulation or choosing to bypass a CDS alert. Clinicians often overestimate bleeding risk compared with objective bleeding risk scores (HAS-BLED).

Both prior trials were executed at a large tertiary-care center in Boston, Massachusetts. The feasibility and impact of an alert-based CDS strategy to improve stroke prevention in AF among ambulatory care patients in the community setting and outside of major tertiary-care centers remains to be determined. To address the feasibility and impact of a CDS strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, community-based, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female
  • Age ≥ 18 years
  • Problem list entry of atrial fibrillation or atrial flutter
  • CHA2DS2VASc score ≥ 2 for males
  • CHA2DS2VASc score ≥ 3 for females
  • No prescription for anticoagulant therapy

Exclusion criteria

  • Active prescription for anticoagulant therapy
  • CHA2DS2VASc score < 2 for males
  • CHA2DS2VASc score ≤ 2 for females

Treatment and study plan

Alert-based computerized decision support

Behavioral

An on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the provider that his or her patient is at risk for stroke due to AF, and that there is no order for anticoagulation. Clinicians who receive the computer alert will have three options: 1) access an order template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence-based clinical practice guidelines to learn more about stroke prevention in AF, or 3) continue with order entry after providing an explanation for why anticoagulation was not prescribed.

Primary outcomes

  1. 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

    Time frame: 90 days

    The primary efficacy outcome will be determined by review of the Electronic Health Record (EHR) medication documentation for prescription of anticoagulation by 90 days after enrollment. These data will be collected in the form of a BPA report and then confirmed by independent data abstractors.

  2. Frequency of major bleeding at 6 months from enrollment.

    Time frame: 6 months

    Defined by the ISTH bleeding classification system. These data will be confirmed by independent data abstractors and then independently adjudicated by a blinded 3-physician expert Clinical Events Committee.

Secondary outcomes

  1. 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

    Time frame: At 48 hours

    The frequency of this outcome will be compared with that from an earlier study as a historical cohort. This outcome will be determined by review of the EHR.

  2. 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

    Time frame: 6 months

    The secondary efficacy outcome will be determined by review of the EHR medication documentation. These data will be confirmed by independent data abstractors and then independently adjudicated by a blinded 3-physician expert Clinical Events Committee.

Other outcomes

  1. Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported

    Time frame: 6 months

    Determined by review of the EHR using standardized definition.

  2. Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months.

    Time frame: 6 months

    Defined by the ISTH bleeding classification system. These data will be confirmed by independent data abstractors and then independently adjudicated by a blinded 3-physician expert Clinical Events Committee.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Peterson, MD

CONTACT

[email protected]

6179871046

Gregory Piazza, MD, MS

CONTACT

[email protected]

7819565525

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

Community-Based, Cluster-Randomized Trial of Electronic Alert-Based Computerized Decision Support to Prevent Stroke in High-Risk Ambulatory Patients With Atrial Fibrillation (AF-ALERT3)

Acronym: AF-ALERT3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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