Trial Outcomes & Findings for Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation (NCT NCT02524977)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

One year

Results posted on

2018-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	738	846
Overall Study COMPLETED	692	801
Overall Study NOT COMPLETED	46	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Educational Intervention Only n=692 Participants 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	Educational Intervention Plus Decision Support n=801 Participants 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	Total n=1493 Participants Total of all reporting groups
Age, Continuous Mean Age	69.8 years STANDARD_DEVIATION 13.5 • n=5 Participants	70.2 years STANDARD_DEVIATION 13.3 • n=7 Participants	70 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	332 Participants n=5 Participants	352 Participants n=7 Participants	684 Participants n=5 Participants
Sex: Female, Male Male	360 Participants n=5 Participants	449 Participants n=7 Participants	809 Participants n=5 Participants
CHADSVASc	3.74 units on a scale STANDARD_DEVIATION 1.93 • n=5 Participants	3.60 units on a scale STANDARD_DEVIATION 1.86 • n=7 Participants	3.67 units on a scale STANDARD_DEVIATION 1.91 • n=5 Participants
HAS-BLED	2.18 units on a scale STANDARD_DEVIATION 1.20 • n=5 Participants	2.07 units on a scale STANDARD_DEVIATION 1.15 • n=7 Participants	2.12 units on a scale STANDARD_DEVIATION 1.19 • n=5 Participants
Proportion Receiving Oral Anticoagulant Therapy	346 participants n=5 Participants	400 participants n=7 Participants	746 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Educational Intervention Only n=692 Participants 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	Educational Intervention Plus Decision Support n=801 Participants 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
Changes in Discordant Antithrombotic Therapy Therapy Discordant from AFDST in 2014	291 participants	335 participants
Changes in Discordant Antithrombotic Therapy Therapy Discordant from AFDST in 2015	277 participants	329 participants

SECONDARY outcome

Timeframe: One year

Population: Number of patients for whom antithrombotic therapy was discordant from AFDST recommendation 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.

Outcome measures

Outcome measures
Measure	Educational Intervention Only n=240 Participants 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	Educational Intervention Plus Decision Support n=240 Participants 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
Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed	152 Participants	140 Participants

Adverse Events

Educational Intervention Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Intervention Plus Decision Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Research UC Health

University of Cincinnati Health

Phone: 513-558-6937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place