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NCT04099485 · ClinicalTrials.gov registry record · NA
EHR-Embedded Decision Support to Prevent Stroke in Patients With AF
A NA study of Atrial Fibrillation, sponsored by University of Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 608
- Enrollment target
- 1
- Study location
NCT04099485: Completed NA study of Atrial Fibrillation, sponsored by University of Cincinnati.
NCT04099485 is a NA study of Atrial Fibrillation that has completed, run by University of Cincinnati. The registered enrollment target is 608 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04099485, a NA study of Atrial Fibrillation, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 608 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
The primary outcome of interest for aim 1 is effectiveness, measured as the percent of patients with "appropriate thromboprophylaxis" based on the AFDST recommendation. If oral anticoagulant therapy is recommended, current treatment with any oral anticoagulant agent will be considered concordant with recommendations. We will assess post-intervention treatment at the completion of the study (up to 18 months) to determine the proportion of patients in each study arm receiving "appropriate thrombop
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 |
What the finished NCT04099485 record still lists
NCT04099485 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower).
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.
NCT04099485 reports a single indexed study location in Ohio.
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.
What interventions are being tested in trial NCT04099485?
The interventions under investigation include: Electronic Health Record Best Practice Advisory (OTHER).
Who is sponsoring clinical trial NCT04099485?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04099485's enrollment target sits among peer trials
608 51st of 202 higher than 152 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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