Electronic Clinical Decision Support Tool for Atrial Fibrillation

(AF SWCRT-CDS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Oral anticoagulants

Disqualifiers: Valvular disease, Pregnancy, Severe bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic tool, the Clinical Decision Support (CDS) tool, to assist doctors in deciding when to prescribe blood thinners for patients with atrial fibrillation. This condition causes irregular heartbeats and increases stroke risk. The tool aims to improve the prescription rates of oral anticoagulants in emergency departments. It will compare different methods of integrating this tool into doctors' workflows to determine the most effective approach. Eligible participants have been diagnosed with new atrial fibrillation during an emergency room visit and have never been prescribed blood thinners. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance patient care in emergency settings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on patients who have not been prescribed oral anticoagulants in the last 3 months, so if you are currently on such medication, you may not be eligible.

What prior data suggests that this clinical decision support tool is safe for use in atrial fibrillation management?

Research has shown that clinical decision support (CDS) tools are generally safe in healthcare. These tools assist doctors in making decisions using patient information. Studies have found that CDS tools can enhance how doctors prescribe treatments like blood thinners for patients with atrial fibrillation (AF), helping them adhere to guidelines more effectively.

CDS tools do not directly affect the body, so they lack side effects that a new drug might have. Instead, they operate in the background, providing doctors with useful information. Previous studies have identified no major safety concerns with using CDS tools for managing AF. Their main goal is to ensure doctors have the right information to help reduce the risk of strokes in AF patients.

Thus, participating in a trial with a CDS tool focuses on improving healthcare quality without introducing new physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage atrial fibrillation (AF) using an Electronic Clinical Decision Support (CDS) tool integrated with electronic health records (EHR). Unlike traditional methods that rely on manual data entry and clinician memory, this tool offers a more streamlined process by using FHIR technology to automatically pull comprehensive patient data like demographics and medical history into the CDS system. This approach aims to enhance decision-making efficiency and accuracy, potentially improving patient outcomes by offering tailored, timely treatment recommendations.

What evidence suggests that this clinical decision support tool is effective for atrial fibrillation?

Research has shown that tools designed to assist doctors in decision-making can enhance the use of blood-thinning treatments for patients with atrial fibrillation (AF). In this trial, clinicians will use different versions of a Clinical Decision Support (CDS) tool. One study found that such a tool increased the number of AF patients receiving the appropriate blood-thinning treatment. This aligns with other findings that these tools help doctors adhere to treatment guidelines more effectively. Another study discovered that a computerized decision tool improved the frequency of correct blood-thinning treatment in primary care. By simplifying treatment decisions, these tools could reduce the risk of stroke in AF patients by ensuring they receive the correct medications. ^{2 3 5 6 7}

Who Is on the Research Team?

Bory Kea, MD, MCR

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed with atrial or paroxysmal fibrillation between 1/11/2022 and 12/31/2025.

I am over 18 years old.

Exclusion Criteria

I have a heart valve problem.

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

I have been prescribed blood thinners in the last 3 months or am managed by a blood thinner clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the clinical decision support (CDS) tool in the Emergency Department for patients with new-onset atrial fibrillation

Stepped-wedge design over 4 years

Ongoing visits as per ED protocol

Evaluation

Evaluation of clinician experiences and patient satisfaction with the CDS tool

Concurrent with implementation phase

Follow-up

Participants are monitored for safety and effectiveness after CDS tool implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Decision Support (CDS) tool

Trial Overview

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.

How Is the Trial Designed?

Group I: Link-Out Experimental Treatment 1 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-out Experimental Treatment 1 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 + FHIR Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

Clinical decision support (CDS) tools integrated into electronic health records can significantly enhance patient care outcomes by providing real-time data analysis for clinicians during critical decision-making processes.

The implementation of CDS tools in a community hospital setting has shown positive outcome data, indicating their effectiveness in improving healthcare organization performance, especially as financial reimbursement models shift towards patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support. How CDS tools impact patient care outcomes. Anton, BB., Schafer, JJ., Micenko, A., et al.[2019]

A clinical decision support system (CDSS) helps healthcare providers by detecting potential drug interactions and errors, which can lead to improved patient safety and reduced clinical errors.

The implementation of a CDSS can save time and money while also decreasing morbidity and mortality rates, highlighting its effectiveness in enhancing patient care and supporting nursing informatics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support in critical care nursing. Lyons, A., Richardson, S.[2019]

The study involving 60 registered nurses demonstrated that clinical decision support (CDS) tools significantly improved the adoption of best practices and reduced care planning time compared to a control group, indicating their effectiveness in enhancing evidence-based decision-making.

While all CDS formats (text, text + graph, and text + table) showed similar adoption rates, the study found that RNs with higher numeracy and graph literacy performed better in terms of care planning time, suggesting that the effectiveness of CDS tools may vary based on individual skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Meaningful Care Plan Clinical Decision Support: Feasibility and Effects of a Simulated Pilot Study. Keenan, GM., Lopez, KD., Yao, Y., et al.[2022]

Clinical decision support (CDS) tools significantly improve the prescription of appropriate medications and dosages, with a pooled risk ratio of 1.48 based on 6 studies, indicating they are effective at the point of medication ordering or dispensing.

CDS tools also enhance laboratory monitoring and treatment responses to abnormal test results, showing a pooled risk ratio of 1.40, but evidence for their effectiveness in reducing adverse drug events remains inconsistent, suggesting further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Laboratory Test-Based Clinical Decision Support Tools on Medication Errors and Adverse Drug Events: A Laboratory Medicine Best Practices Systematic Review. Whitehead, NS., Williams, L., Meleth, S., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12450513/

Cost-effectiveness of a clinical decision support system for ...

Clinical decision support for stroke prevention in atrial fibrillation (CDS-AF): rationale and design of a cluster randomized trial in the primary care setting.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002870324001030

Computerized clinical decision support to improve stroke ...

We assessed whether computerized clinical decision support (CDS) would enable guideline-based antithrombotic therapy for AF patients in primary care.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02635685

Clinical Decision Support for Stroke Prevention in Atrial ...

The effectiveness measure is percentage of all patients with atrial fibrillation getting anticoagulation therapy in the clinical decision support tool group ...

4.

bmcprimcare.biomedcentral.com

bmcprimcare.biomedcentral.com/articles/10.1186/s12875-025-02905-y

Effect of a clinical decision support system for non-valvular ...

The utilization of GP-CDSS-2.0 in primary care had the potential to raise the proportion of appropriate anticoagulation among patients with AF.

5.

journals.plos.org

journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002528

A clinical decision support tool for improving adherence to ...

The present study demonstrates that a CDS can increase guideline adherence for anticoagulant therapy in patients with AF.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11134712/

a systematic review and meta-analysis of randomized ...

We report no significant difference with the use of CDSS compared to routine care in anticoagulant or antiplatelet prescription in eligible patients with AF.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5726779/

Atrial Fibrillation Decision Support Tool: Population ...

The tool generates patient–specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding, using quality-adjusted ...