Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF (SUPPORT-AF)
Primary Purpose
Atrial Fibrillation, Prescribing Practices, Anticoagulants
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anticoagulation (AC) Intervention--Academic Detailing
Anticoagulation (AC) Intervention--Prescribing Practices
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- University of Massachusetts providers caring for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
- cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic medical record (EHR).
Exclusion Criteria:
- University of Massachusetts providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
- cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anticoagulation (AC) Intervention
Control
Arm Description
Providers in this arm will receive supportive tools including Anticoagulation (AC) Intervention--Prescribing Practices and Anticoagulation (AC) Intervention--Academic Detailing to help them assess their Anticoagulant (AC) prescribing practices and will also meet with the study investigators for academic detailing.
Providers in this arm will not receive any intervention.
Outcomes
Primary Outcome Measures
Change to Provider prescription rates
The first primary outcome measure is to determine the impact of the intervention on provider prescribing rates (increase, decrease, same)
Change to Individual patient Anticoagulation (AC) status
The effect of the intervention on individual patient anti-coagulation status as demonstrated by random effects logistic regression models for post-intervention AC status (anticoagulated / not anticoagulated) as a function of pre-intervention AC status.
Secondary Outcome Measures
Change in provider confidence in applying evidence to balance stroke prevention with harm.
The change in provide confidence as assessed by confidence questions included in the provider survey distributed with the AC Provider Profile. More specifically, the change is calculated with an average score for each item in the confidence survey, using a four-point scale based on four response choices - not confident through very confident.
Full Information
NCT ID
NCT03583008
First Posted
June 26, 2018
Last Updated
March 19, 2019
Sponsor
University of Massachusetts, Worcester
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03583008
Brief Title
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF
Acronym
SUPPORT-AF
Official Title
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.
Detailed Description
Nearly 1 million patients with atrial fibrillation (AF) who meet guideline criteria for anticoagulation (AC) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. The objective of this project is to improve rates of adherence to AC guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing AC to patients with AF. The investigators will email providers individual auto-updating reports containing their AC prescription rate compared to their peers and compared to practice level AC prescription goal. This report will also contain a list of the provider's AF patients who are eligible to receive AC based on their CHA2DS2-VASc stroke risk score ≥ 2 and a list of eligible AF patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of AC. The investigators will also message providers through the EHR prior to an upcoming appointment with an eligible patient reminding them to discuss AC if they deem appropriate. In addition, the investigators will directly engage with providers through academic teledetailing to educate providers on AC and address misconceptions and barriers to initiating or resuming AC in AF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Prescribing Practices, Anticoagulants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anticoagulation (AC) Intervention
Arm Type
Experimental
Arm Description
Providers in this arm will receive supportive tools including Anticoagulation (AC) Intervention--Prescribing Practices and Anticoagulation (AC) Intervention--Academic Detailing to help them assess their Anticoagulant (AC) prescribing practices and will also meet with the study investigators for academic detailing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Providers in this arm will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Anticoagulation (AC) Intervention--Academic Detailing
Intervention Description
One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.
Intervention Type
Behavioral
Intervention Name(s)
Anticoagulation (AC) Intervention--Prescribing Practices
Intervention Description
Education and support related to anticoagulant prescribing practices.
Primary Outcome Measure Information:
Title
Change to Provider prescription rates
Description
The first primary outcome measure is to determine the impact of the intervention on provider prescribing rates (increase, decrease, same)
Time Frame
Intervention to three months post intervention.
Title
Change to Individual patient Anticoagulation (AC) status
Description
The effect of the intervention on individual patient anti-coagulation status as demonstrated by random effects logistic regression models for post-intervention AC status (anticoagulated / not anticoagulated) as a function of pre-intervention AC status.
Time Frame
Intervention to three months post intervention.
Secondary Outcome Measure Information:
Title
Change in provider confidence in applying evidence to balance stroke prevention with harm.
Description
The change in provide confidence as assessed by confidence questions included in the provider survey distributed with the AC Provider Profile. More specifically, the change is calculated with an average score for each item in the confidence survey, using a four-point scale based on four response choices - not confident through very confident.
Time Frame
Intervention to three months post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
University of Massachusetts providers caring for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic medical record (EHR).
Exclusion Criteria:
University of Massachusetts providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok Kapoor, MD, MSca
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01566
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32063041
Citation
Kapoor A, Amroze A, Vakil F, Crawford S, Der J, Mathew J, Alper E, Yogaratnam D, Javed S, Elhag R, Lin A, Narayanan S, Bartlett D, Nagy A, Shagoury BK, Fischer MA, Mazor KM, Saczynski JS, Ashburner JM, Lopes R, McManus DD. SUPPORT-AF II: Supporting Use of Anticoagulants Through Provider Profiling of Oral Anticoagulant Therapy for Atrial Fibrillation: A Cluster-Randomized Study of Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions About Anticoagulation in Patients With Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2020 Feb;13(2):e005871. doi: 10.1161/CIRCOUTCOMES.119.005871. Epub 2020 Feb 17.
Results Reference
derived
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Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF
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