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Atrial FibrillationNCT05890274

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

A study testing AF and EKG Interpretation Project ECHO in people with Atrial Fibrillation, run by University of North Carolina, Chapel Hill at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
AF and EKG Interpretation Project ECHO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesUnited States
Study dates
4 Sep 2022to 25 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Duke University

    Durham, North Carolina, 27710

  • Wake Forest University

    Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: 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?
Read more

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.
Being tested
AF and EKG Interpretation Project ECHO
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AF and EKG Interpretation Project ECHOOther

    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.

Study groups in NCT05890274
Study groupRoleWhat they receive
AF and EKG Interpretation Project ECHOExperimentalAll recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.
Receives: Other: AF and EKG Interpretation Project ECHO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of Patients Prescribed Appropriate Anticoagulation

    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.

    Measured: 1-year prior to intervention session 1 and 1-year post intervention session 12

Secondary outcomes (6)

  1. Change Score on Provider Knowledge Assessment

    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.

    Measured: Baseline and 12 weeks post intervention session 12

  2. Change in Provider Confidence Level

    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.

    Measured: Baseline and 12 weeks post intervention session 12

  3. Change in Number of Patients Prescribed Appropriate Antiplatelet Therapy

    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.

    Measured: 1-year prior to intervention session 1 and 1-year post intervention session 12

  4. Change in Number of Patients with Blood Pressure at Goal

    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.

    Measured: 1-year prior to intervention session 1 and 1-year post intervention session 12

  5. Change in Number of Patients with Heart Rate at Target

    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.

    Measured: 1-year prior to intervention session 1 and 1-year post intervention session 12

  6. Change in Number of Emergency Department Visits or Hospitalizations for AF or Stroke

    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.

    Measured: 1-year prior to intervention session 1 and 1-year post intervention session 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start4 Sep 2022
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890274
Sponsor's protocol ID
22-1350a
Status last verified
Apr 2026
First submitted
17 May 2023
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30686041

  • 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.

    PubMed 33793326

  • 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.

    PubMed 24685669

Questions about this trial

What is this clinical trial studying?

A study testing AF and EKG Interpretation Project ECHO in people with Atrial Fibrillation, run by University of North Carolina, Chapel Hill at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Patients Prescribed Appropriate Anticoagulation (time frame: 1-year prior to intervention session 1 and 1-year post intervention session 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890274, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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Clinical Trial NCT05890274 | AzTrials