Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
Primary Purpose
Atrial Fibrillation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AF and EKG Interpretation Project ECHO
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- University of North Carolina, Chapel Hill
- Duke University
- Wake Forest University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AF and EKG Interpretation Project ECHO
Arm Description
All recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05890274
First Posted
May 17, 2023
Last Updated
May 25, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, Wake Forest University, Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05890274
Brief Title
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
Official Title
Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 4, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University, Wake Forest University, Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AF and EKG Interpretation Project ECHO
Arm Type
Experimental
Arm Description
All recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.
Intervention Type
Other
Intervention Name(s)
AF and EKG Interpretation Project ECHO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Number of Patients Prescribed Appropriate Anticoagulation
Description
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.
Time Frame
1-year prior to intervention session 1 and 1-year post intervention session 12
Secondary Outcome Measure Information:
Title
Change Score on Provider Knowledge Assessment
Description
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.
Time Frame
Baseline and 12 weeks post intervention session 12
Title
Change in Provider Confidence Level
Description
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.
Time Frame
Baseline and 12 weeks post intervention session 12
Title
Change in Number of Patients Prescribed Appropriate Antiplatelet Therapy
Description
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.
Time Frame
1-year prior to intervention session 1 and 1-year post intervention session 12
Title
Change in Number of Patients with Blood Pressure at Goal
Description
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.
Time Frame
1-year prior to intervention session 1 and 1-year post intervention session 12
Title
Change in Number of Patients with Heart Rate at Target
Description
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.
Time Frame
1-year prior to intervention session 1 and 1-year post intervention session 12
Title
Change in Number of Emergency Department Visits or Hospitalizations for AF or Stroke
Description
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.
Time Frame
1-year prior to intervention session 1 and 1-year post intervention session 12
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Gehi, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30686041
Citation
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. Erratum In: Circulation. 2019 Aug 6;140(6):e285.
Results Reference
background
PubMed Identifier
33793326
Citation
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.
Results Reference
background
PubMed Identifier
24685669
Citation
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. Erratum In: J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7.
Results Reference
background
Links:
URL
https://hsc.unm.edu/echo/
Description
University of New Mexico Project ECHO Website
Learn more about this trial
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
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