Computerized Decision Support for Stroke Prevention in Atrial Fibrillation (AF-ALERT3 Trial)

N/A

Waitlist Available

Led By Gregory Piazza, MD, MS

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of a computerized decision support system in increasing the prescription of anticoagulation for stroke prevention in atrial fibrillation. The study will involve multiple medical centers and

Who is the study for?

This trial is for patients with atrial fibrillation, a heart condition that increases the risk of stroke. It aims to improve how often doctors prescribe blood thinners to prevent strokes in these patients. The study will take place in community medical centers.

What is being tested?

The trial is testing an alert-based computerized decision support system designed to help doctors follow guidelines on prescribing blood thinners more consistently. This system also assesses and manages bleeding risks associated with treatment.

What are the potential side effects?

Since this trial tests a decision support tool rather than a medication, there are no direct side effects from the intervention itself. However, increased prescription of anticoagulants may lead to higher bleeding risks which the tool aims to manage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of major bleeding at 6 months from enrollment.

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

Secondary study objectives

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

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

Other study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AlertExperimental Treatment1 Intervention

For Alert cluster sites, 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 United States (US) Food and Drug Administration (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.

Group II: No AlertActive Control1 Intervention

For No Alert cluster sites, no computerized alert notification will be issued to providers.

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