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Electronic Alerts for Stroke Prevention in Atrial Fibrillation

NCT02958943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2022-07-08

No results posted yet for this study

Summary

Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, five options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. Data from this center (Brigham and Women's Hospital \[BWH\]) (1) demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to 2012 Focused Update of the European Society of Cardiology Guidelines for the Management of AF (2) receive anticoagulation.

Aim #1: To determine the impact of electronic alert-based computerized decision support (CDS) on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by 80% in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Aim #2: To determine the impact of electronic alert-based computerized decision support (CDS) on the frequency of stroke and systemic embolic events in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention.

Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic embolism in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention. Data acquired through this study regarding the frequency of stroke and systemic embolism will be used to calculate sample size requirements for a future clinical end-point driven randomized controlled trial of electronic alerts to prevent stroke in high-risk AF patients.

Conditions

Interventions

BEHAVIORAL

On-screen electronic alert

On-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation. Providers may then 1) access a template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence based clinical practice guidelines, or 3) proceed onto order entry after providing an explanation for why anticoagulation was not prescribed.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958943 on ClinicalTrials.gov