Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO

Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement

The goal of this study is to determine the effectiveness of a direct-to-provider virtual education program ("AF and EKG Interpretation Project ECHO") for primary care providers who manage patients with atrial fibrillation (AF). The main questions this study aims to answer are:

  1. Will participants have improvement in knowledge and confidence in managing patients with atrial fibrillation after program completion?
  2. Will quality and performance metrics improve at the patient level for program participants?

Participants will be asked to:

  • Participate in 12 hours of virtual education sessions over twelve weeks via Zoom.
  • Complete a knowledge and confidence assessment online before the program starts and after its completion.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary care provider (Physician, Nurse Practitioner, Physician Assistant) with primary practice in the state of North Carolina
  • Care for adult population

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AF and EKG Interpretation Project ECHO
All recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.
The AF and EKG Interpretation Project ECHO program is delivered via Zoom videoconferencing technology and includes 12, 1-hour long sessions that involve education on best practice management of AF for primary care providers. Each session includes an EKG challenge, case presentation by a participant, didactic presentation, and time for open Q&A. Supplementary materials are made available to all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Patients Prescribed Appropriate Anticoagulation
Time Frame: 1-year prior to intervention session 1 and 1-year post intervention session 12
This outcome measures the number of patients prescribed appropriate anticoagulation medication based on risk factors for stroke including congestive heart failure (C), hypertension (H), Age >74 (A2), Diabetes (D), prior stroke or transient ischemic attack (TIA) (S2), vascular disease (V), age 65-74 (A), female sex (Sc), commonly referred to as CHA2DS2-VASc stroke risk score for patients with atrial fibrillation. CHA2DS2-VASc score includes 7 indicators of stroke risk (age (<65=0, 65-74=1, 75+= 2), sex (male=0, female=1), heart failure (no=0, yes=1), hypertension (no=0, yes=1), prior stroke/TIA (no=0, yes=2), history of vascular disease (no=0, yes=1), and diabetes (no=0, yes=1). Anticoagulation is indicated for a female with a score 3 or higher and males with a score of 2 or higher. This information will be collected from electronic health records of patients cared for by providers who participated in the program.
1-year prior to intervention session 1 and 1-year post intervention session 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Score on Provider Knowledge Assessment
Time Frame: Baseline and 12 weeks post intervention session 12
This outcome measures the change in provider knowledge in Afib management using an internally developed knowledge test. The test includes 25 multiple choice questions based on clinical case scenarios. The number of questions answered correctly prior to the start of the program will be compared with the number of questions answered correctly after program completion.
Baseline and 12 weeks post intervention session 12
Change in Provider Confidence Level
Time Frame: Baseline and 12 weeks post intervention session 12
This outcome measures the change in provider confidence in managing patients with Afib. Confidence is measured using an internally developed confidence scale on 9 key areas of management related to Afib. Each of the 9 questions is measured on a 5 point likert scale from 1 (not at all confident) to 5 (extremely confident) for a total score ranging from 9 to 45 with the higher the score related to higher confidence in managing patients with Afib.
Baseline and 12 weeks post intervention session 12
Change in Number of Patients Prescribed Appropriate Antiplatelet Therapy
Time Frame: 1-year prior to intervention session 1 and 1-year post intervention session 12
This outcome measures the number of Afib patients prescribed appropriate antiplatelet therapy. Antiplatelet therapy is considered appropriate if the patient has a history of vascular disease. Antiplatelet therapy will be considered not appropriate if the patient has a history of Afib and no history of vascular disease. This information will be collected from electronic health records of patients cared for by providers who participated in the program.
1-year prior to intervention session 1 and 1-year post intervention session 12
Change in Number of Patients with Blood Pressure at Goal
Time Frame: 1-year prior to intervention session 1 and 1-year post intervention session 12
This outcome measures the number of patients who achieve blood pressure at goal at outpatient primary care visits. Blood pressure at goal is determined by guidelines set forth by the American College of Cardiology (ACC) and American Heart Association (AHA) which is less than 130 mmHg systolic and less than 80 mmHg diastolic. This information will be collected from electronic health records of patients cared for by providers who participated in the program.
1-year prior to intervention session 1 and 1-year post intervention session 12
Change in Number of Patients with Heart Rate at Target
Time Frame: 1-year prior to intervention session 1 and 1-year post intervention session 12
This outcome measures the number of patients who achieve heart rate at goal at outpatient primary care visits. Heart rate at goal is determined by guidelines set forth by the American Heart Association (AHA) and American College of Cardiology (ACC) which recommends a heart rate of less than 110 beats per minute. This information will be collected from electronic health records of patients cared for by providers who participated in the program.
1-year prior to intervention session 1 and 1-year post intervention session 12
Change in Number of Emergency Department Visits or Hospitalizations for AF or Stroke
Time Frame: 1-year prior to intervention session 1 and 1-year post intervention session 12
This outcome measures the number of patient visits to the emergency department and number of hospitalizations for a primary diagnosis of Afib or stroke. The number of visits 1 year prior to the intervention will be compared to the number of visits during the 1 year following intervention session 12. This information will be collected from electronic health records of patients cared for by providers who participated in the program.
1-year prior to intervention session 1 and 1-year post intervention session 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anil Gehi, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2022

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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