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EHR-Embedded Decision Support to Prevent Stroke in Patients With AF
NCT04099485 · View on ClinicalTrials.gov ↗
Study Summary
Background and Significance - Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widespread underutilization of this therapy. To address this practice gap locally and improve stroke prevention for patients with AF in the UC Health system, the investigators have assembled an interprofessional team, the Cincinnati Atrial Fibrillation Initiative (CAFI). Objectives - The objective of this project, "EHR-Embedded Decision Support to Prevent Stroke in Patients with AF", is to improve thromboprophylaxis treatment decisions for patients with non-valvular AF and to increase awareness of the underutilization of appropriate thromboprophylaxis in the University of Cincinnati Health system, including vulnerable populations with health disparities. To achieve this objective, the investigators will implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST), embedded within the UC Health electronic health record (EHR) that will: (a) identify at the point of care, patients who might benefit substantially from a change in their current thromboprophylaxis; (b) provide patient-tailored guidance to support decision-making; and (c) provide an opportunity to refer the patient to a pharmacist-staffed AF Thromboprophylaxis Shared Decision-Making consultation service. Overview of Study Design - The overarching goal is to improve the rate of "appropriate thromboprophylaxis" by eliminating system barriers through provision of appropriate decision support in the right place and at the right time, that improves provider and patient knowledge about AF-related stroke risks, bleeding risks, practice gaps in prevention, and how to think about balancing risks and benefits of anticoagulation therapy, and by improving patient engagement in decision-making
Conditions Studied
Interventions
- OTHER Electronic Health Record Best Practice Advisory
Study Locations (1)
Ohio
- University of Cincinnati Health System — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2023-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04099485
The ClinicalTrials.gov registry entry for NCT04099485 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 179 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Electronic Health Record Best Practice Advisory is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04099485 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04099485 about?
NCT04099485 is a clinical study titled "EHR-Embedded Decision Support to Prevent Stroke in Patients With AF". Background and Significance - Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widesp...
What is the current status of trial NCT04099485?
This trial is currently completed. It is a NA study. The enrollment target is 608 participants. The study started on 2020-11-18. Estimated completion is 2023-02-28.
What conditions does trial NCT04099485 study?
This clinical trial studies the following conditions: Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04099485?
The interventions under investigation include: Electronic Health Record Best Practice Advisory (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04099485?
This trial is sponsored by University of Cincinnati, which has 179 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04099485 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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