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Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool (AF SWCRT-CDS)

Primary Purpose

Atrial Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support (CDS) tool
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Patients):

  • A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 12/31/2025 within the patient's age >18 years.

Exclusion Criteria (Patients):

  • Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR
  • Recent brain, eye or spinal cord injury or surgery; OR
  • ED stroke, death or hospitalization at index visit; OR
  • Patient transferred from another hospital (to ensure availability of index ED visit data); OR
  • Left against medical advice; OR
  • Evidence of non-OAC naïve patient:

    • OAC prescribed in the prior 3mo to index ED visit; OR
    • Being managed by an anticoagulation clinic (ACC);

Inclusion/Exclusion Criteria (Clinicians): All ED clinicians (board certified or eligible) interfacing with patients.

Sites / Locations

  • Oregon Health & Science University (OHSU)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Link-Out

BPA + Link-out

BPA + FHIR

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of patients appropriately prescribed OACs after CDS tool implementation.
The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.

Secondary Outcome Measures

Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Secondary outcomes include the clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.

Full Information

First Posted
April 13, 2022
Last Updated
April 18, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05341986
Brief Title
Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool
Acronym
AF SWCRT-CDS
Official Title
Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool: A Stepped-Wedge Cluster Randomized Trial Design
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Although atrial fibrillation is commonly diagnosed and treated in the Emergency Department (ED), oral anticoagulation is significantly underprescribed. Underprescribing has been attributed to a lack of empowerment and deferral of prescribing to longitudinal care clinicians. Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of a clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
Detailed Description
OBJECTIVES: AIM 1: Compare the magnitude of change of appropriate OAC prescribing over time at each ED with EHR-Based CDS tool implementation. H1a. A CDS tool will increase the prescribing of OACs at ED discharge in patients with new AF. H1b. The highly-integrated EHR-based CDS tool with a trigger will have a greater impact on the volume of prescribing compared to a less integrated web-based portal. AIM 2: Evaluate clinician experiences with factors that influence the CDS tool implementation through a qualitative approach. H2a. Clinicians will have high acceptability of the tool and be open to additional CDS tools. H2b. Health system resources, such as the ability to refer patients to an anticoagulation clinic or primary care, will facilitate ED tool utilization. AIM 3 (Exploratory): Determine patient satisfaction and engagement with ED visits across the three steps of CDS tool implementation and explore patient-clinician stories as mini-case studies (dyads) related to the recall of their experiences. AIM 1 addresses whether a CDS tool can increase clinician prescribing-thereby improving long-term outcomes for patients. AIM 2 will address clinician facilitators and barriers to the CDS tool. AIM 3 (exploratory) will allow the exploration of a patient-centered approach for the future development of a scalable and generalizable strategy for large-scale dissemination. Through a convergent parallel quantitative-qualitative study, we will capitalize on a missed opportunity to change the trajectory of care and outcomes of newly ED-diagnosed AF patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of an electronic health record (EHR) clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke, in three ED settings with different practice patterns and culture, patient populations, and organizational readiness. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Link-Out
Arm Type
Other
Arm Description
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.
Arm Title
BPA + Link-out
Arm Type
Other
Arm Description
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.
Arm Title
BPA + FHIR
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Decision Support (CDS) tool
Intervention Description
Implementation of an EHR-based CDS tool for providers to use.
Primary Outcome Measure Information:
Title
Number of patients appropriately prescribed OACs after CDS tool implementation.
Description
The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.
Time Frame
through study completion, up to 4 years
Secondary Outcome Measure Information:
Title
Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Description
Secondary outcomes include the clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Time Frame
through study completion, up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Patients): A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 12/31/2025 within the patient's age >18 years. Exclusion Criteria (Patients): Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR Recent brain, eye or spinal cord injury or surgery; OR ED stroke, death or hospitalization at index visit; OR Patient transferred from another hospital (to ensure availability of index ED visit data); OR Left against medical advice; OR Evidence of non-OAC naïve patient: OAC prescribed in the prior 3mo to index ED visit; OR Being managed by an anticoagulation clinic (ACC); Inclusion/Exclusion Criteria (Clinicians): All ED clinicians (board certified or eligible) interfacing with patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bory Kea, MD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool

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