NCT05890274

Brief 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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

May 17, 2023

Last Update Submit

April 23, 2026

Conditions

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

  • Change Score on Provider Knowledge Assessment

    Baseline and 12 weeks post intervention session 12

  • Change in Provider Confidence Level

    Baseline and 12 weeks post intervention session 12

  • Change in Number of Patients Prescribed Appropriate Antiplatelet Therapy

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

  • Change in Number of Patients with Blood Pressure at Goal

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

  • Change in Number of Patients with Heart Rate at Target

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

  • +1 more secondary outcomes

Study Arms (1)

AF and EKG Interpretation Project ECHO

EXPERIMENTAL

All recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.

Other: AF and EKG Interpretation Project ECHO

Interventions

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.

AF and EKG Interpretation Project ECHO

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (3)

  • 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.

    PMID: 30686041BACKGROUND
  • 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.

    PMID: 33793326BACKGROUND
  • 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.

    PMID: 24685669BACKGROUND

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anil Gehi, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 6, 2023

Study Start

September 4, 2022

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.
Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations