- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05890274
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
April 23, 2026 updated by: University of North Carolina, Chapel Hill
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:
- Will participants have improvement in knowledge and confidence in managing patients with atrial fibrillation after program completion?
- 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
Intervention / Treatment
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
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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.
General Publications
- Carey RM, Wright JT Jr, Taler SJ, Whelton PK. Guideline-Driven Management of Hypertension: An Evidence-Based Update. Circ Res. 2021 Apr 2;128(7):827-846. doi: 10.1161/CIRCRESAHA.121.318083. Epub 2021 Apr 1.
- January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1350a
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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