Atrial FibrillationNCT02524977
Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation
A study testing Decision Support and Educational Intervention Only in people with Atrial Fibrillation and Atrial Flutter, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Decision Support and Educational Intervention Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2) or heart valve replacement (V42.3).
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Care Practices of UC Health
Cincinnati, Ohio, 45267
About this study
Official title: Impact of a Quality Improvement And Education Initiative on 'Appropriate' Use of Anticoagulant Therapy in Patients With Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Decision Support, Educational Intervention Only
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision SupportBehavioural
Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
Educational Intervention OnlyBehavioural
Educational conference series
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Only | Active comparator | 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. Receives: Behavioral: Educational Intervention Only |
| Educational Intervention plus Decision Support | Experimental | 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. Receives: Behavioral: Decision Support; Behavioral: Educational Intervention Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Pfizer, Bristol-Myers Squibb
- Responsible party
- Principal investigator, Mark Eckman, M.D., University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524977
- Sponsor's protocol ID
- 2013-0017
- Other IDs
- 1UL1TR001425-01
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2015
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eckman MH, Lip GY, Wise RE, Speer B, Sullivan M, Walker N, Kissela B, Flaherty ML, Kleindorfer D, Baker P, Ireton R, Hoskins D, Harnett BM, Aguilar C, Leonard AC, Arduser L, Steen D, Costea A, Kues J. Impact of an Atrial Fibrillation Decision Support Tool on thromboprophylaxis for atrial fibrillation. Am Heart J. 2016 Jun;176:17-27. doi: 10.1016/j.ahj.2016.02.009. Epub 2016 Feb 19.
PubMed 27264216