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Electronic Clinical Decision Support Tool for Atrial Fibrillation (AF SWCRT-CDS Trial)

N/A

Waitlist Available

Led By Bory Kea, MD, MCR

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

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

Must have

Patients must be over 18 years of age

Be older than 18 years old

Must not have

Valvular disease

ED stroke, death or hospitalization at index visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a clinical decision support tool can help doctors prescribe blood-thinners to AF patients who are at risk for stroke, and explore why doctors might not be prescribing them otherwise.

Who is the study for?

This trial is for adults over 18 with new-onset atrial fibrillation diagnosed in the emergency department, who haven't been prescribed oral anticoagulants recently. It's not for those with severe liver or kidney disease, recent major surgery, certain bleeding conditions, or if they're pregnant.

What is being tested?

The study tests a Clinical Decision Support tool designed to help doctors decide when to prescribe blood thinners to prevent strokes in patients with atrial fibrillation. The trial randomly assigns periods of time when different EDs will start using the tool.

What are the potential side effects?

Since this trial involves an electronic decision-making tool rather than medication, there are no direct side effects like you'd expect from drugs. However, indirect effects may include changes in how often blood thinners are prescribed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart valve problem.

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I was hospitalized or had a stroke or death event at my first visit.

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I have a low platelet count.

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I have not had recent surgery or injury to my brain, eye, or spinal cord.

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I have large veins in my esophagus.

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I have not had major surgery in the last 72 hours.

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I left the hospital against medical advice.

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I do not have severe liver or kidney disease.

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I have severe or hard-to-control bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients appropriately prescribed OACs after CDS tool implementation.

Secondary study objectives

Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Link-OutExperimental Treatment1 Intervention

Clinicians will be trained on the web-based portal of the CDS tool and shown where the Link to the tool will be available in the EHR.

Group II: BPA + Link-outExperimental Treatment1 Intervention

Clinicians will be trained on how a BPA is triggered when a patient is diagnosed with AF. The alert will pop up within the EHR with the Link-out to the web portal.

Group III: BPA + FHIRExperimental Treatment1 Intervention

Instead of a link to the web-based portal, the BPA will contain a link to the FHIR-integrated CDS tool portal. FHIR will automatically pull EHR data about the patient into the CDS tool portal. Data include demographic information, comorbidities in the active problem list, past medical and surgical history, and social history. Clinicians will also receive training before the implementation of this step.

0 / 10Eligibility criteria met