Atrial Fibrillation, Atrial Flutter
Conditions
Brief summary
Study objective was to improve decision-making and thromboprophylaxis for patients with Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool for individual patient-level decision-making about oral anticoagulant therapy. To accomplish these goals, the investigators studied the incremental impact of adding a quality-improvement (QI) intervention to an educational package (for practice staff and clinicians) using a computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual patient-level decision-making about oral anticoagulant therapy in patients with non-valvular AF. The decision support tool incorporates individual patients' risk factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment based upon the projected quality-adjusted life expectancy gained or lost with the addition of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.
Detailed description
Setting - Cluster randomized trial. Setting - Primary care practices of an integrated healthcare system. Participants - 1,493 adults with non-valvular AF seen between April 2014 and March 2015. Intervention - Treatment recommendations were made by an Atrial Fibrillation Decision Support Tool (AFDST) based on projections for quality-adjusted life expectancy calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage.
Interventions
BEHAVIORALDecision Support
Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
BEHAVIORALEducational Intervention Only
Educational conference series
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Pfizer
Bristol-Myers Squibb
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Study subjects were physicians in our primary care network. * Patients included in the study were identified through our health system's clinical data store with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32)
Exclusion criteria
Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2) or heart valve replacement (V42.3).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Discordant Antithrombotic Therapy | One year | Changes in the proportion of patients with current therapy that was discordant from the decision support tool recommendation between the start and finish date of the study (one year period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed | One year | Change in discordance between decision support tool recommendation and actual treatment among patients whose physicians reviewed the decision support tool report. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Intervention Only Educational Intervention Only - Educational package was delivered as 2 didactic noon-conferences on atrial fibrillation with a review of up-to-date anticoagulation guidelines for stroke prevention, and distribution of educational materials. Physicians delivering the noon conference series at all of the general internal medicine and primary care practice sites included 3 stroke neurologists, 2 cardiologists, and a general internist (PI) who were co-investigators in this study. Internists who were faculty at the University of Cincinnati and Internal Medicine residents also had an opportunity to participate in the first of the noon conferences in a special Department of Medicine Grand Rounds delivered by the PI.
All practices (intervention and control groups) received the educational package focused on physicians, and clinical and non-clinical staff who would be involved in this QI process.
Educational Intervention Only: Educational conference series | 692 |
| Educational Intervention Plus Decision Support Educational Intervention plus Decision Support - Physicians in the intervention arm received a practice-level and physician-level summary report via a secure web site designed for patients with treatment recommendations that were discordant with current therapy, along with an explanation for the recommendation, the gain or loss in QALYs predicted by the decision model and the current 2014 ACC/AHA/HRS guidelines. Providers were also reminded of upcoming visits for patients being seen within the next week so they could review their reports and use them in discussions with their patients.
Decision Support: Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
Educational Intervention Only: Educational conference series | 801 |
| Total | 1,493 |
Baseline characteristics
| Characteristic | Educational Intervention Only | Educational Intervention Plus Decision Support | Total |
|---|---|---|---|
| Age, Continuous Mean Age | 69.8 years STANDARD_DEVIATION 13.5 | 70.2 years STANDARD_DEVIATION 13.3 | 70 years STANDARD_DEVIATION 13 |
| CHADSVASc | 3.74 units on a scale STANDARD_DEVIATION 1.93 | 3.60 units on a scale STANDARD_DEVIATION 1.86 | 3.67 units on a scale STANDARD_DEVIATION 1.91 |
| HAS-BLED | 2.18 units on a scale STANDARD_DEVIATION 1.2 | 2.07 units on a scale STANDARD_DEVIATION 1.15 | 2.12 units on a scale STANDARD_DEVIATION 1.19 |
| Proportion Receiving Oral Anticoagulant Therapy | 346 participants | 400 participants | 746 participants |
| Sex: Female, Male Female | 332 Participants | 352 Participants | 684 Participants |
| Sex: Female, Male Male | 360 Participants | 449 Participants | 809 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 692 | 0 / 801 |
| serious Total, serious adverse events | 0 / 692 | 0 / 801 |
Outcome results
Primary
Changes in Discordant Antithrombotic Therapy
Changes in the proportion of patients with current therapy that was discordant from the decision support tool recommendation between the start and finish date of the study (one year period).
Time frame: One year
Population: Patients with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis of AF (427.31) or atrial flutter (427.32) who did not have diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2), or heart valve replacement (V42.3) in their active problem list.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational Intervention Only | Changes in Discordant Antithrombotic Therapy | Therapy Discordant from AFDST in 2014 | 291 participants |
| Educational Intervention Only | Changes in Discordant Antithrombotic Therapy | Therapy Discordant from AFDST in 2015 | 277 participants |
| Educational Intervention Plus Decision Support | Changes in Discordant Antithrombotic Therapy | Therapy Discordant from AFDST in 2014 | 335 participants |
| Educational Intervention Plus Decision Support | Changes in Discordant Antithrombotic Therapy | Therapy Discordant from AFDST in 2015 | 329 participants |
p-value: 0.02Chi-squared
Secondary
Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed
Change in discordance between decision support tool recommendation and actual treatment among patients whose physicians reviewed the decision support tool report.
Time frame: One year
Population: Number of patients for whom antithrombotic therapy was discordant from AFDST recommendation among patients for whom AFDST report was reviewed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Only | Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed | 152 Participants |
| Educational Intervention Plus Decision Support | Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed | 140 Participants |