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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05890274
Collaborator
Duke University (Other), Wake Forest University (Other), Bristol-Myers Squibb (Industry)
120
3
1
30.9
40
1.3

Study Details

Study Description

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Other: AF and EKG Interpretation Project ECHO
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement
Actual Study Start Date :
Sep 4, 2022
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AF and EKG Interpretation Project ECHO

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

Other: AF and EKG Interpretation Project ECHO
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Number of Patients Prescribed Appropriate Anticoagulation [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.

Secondary Outcome Measures

  1. Change Score on Provider Knowledge Assessment [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.

  2. Change in Provider Confidence Level [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.

  3. Change in Number of Patients Prescribed Appropriate Antiplatelet Therapy [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.

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina, Chapel Hill Chapel Hill North Carolina United States 27599
2 Duke University Durham North Carolina United States 27710
3 Wake Forest University Winston-Salem North Carolina United States 27109

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • Duke University
  • Wake Forest University
  • Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT05890274
Other Study ID Numbers:
  • 22-1350a
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2023