RCT Concerning the Intention to Prescribe/Take Oral Anticoagulants for Atrial Fibrillation Depending on the Number of Risk Diagrams (w Treatment +/- w/Out Treatment), and Number of Years (1 or 5) for the Estimation of the Risk of Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cristian Baicus
- Enrollment
- 968
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
Study Overview
Brief Summary
Randomized study concerning the effect of the number of risk diagrams (with treatment +/- without treatment), the period of stroke risk estimation (one year or five years) and the target of prescription (the patient with atrial fibrillation or the physician himself, imagining she/he has atrial fibrillation) on the intention to prescribe or not oral anticoagulation.
Detailed Description
Objectives:
To answer the questions:
- Concerning the decision to prescribe (take) treatment on the basis of a decision aid, are there necessary both diagrams (that with risk without treatment, and that with risk under treatment), or it is enough only the second (risk under treatment, which normally gives all the needed information)?
- Concerning the decision to prescribe (take) treatment, is it a difference between the effects of the presentation on decision aid of the risk of stroke for the next 1 year, and the presentation of the estimated risk of stroke for the next 5 years?
- Is the decision different if physicians prescribe the anticoagulant treatment to patients, over if they should take it themselves?
Study: 2x3 factorial randomized controlled trial (RCT) for comparison:
- Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
- Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
- The decision to prescribe to patients over the decision to take the treatment themselves.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- None
Eligibility Criteria
- Ages
- 24 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •physicians who prescribe anticoagulant treatment for atrial fibrillation (cardiology, internal medicine, family medicine, hematology) or who deal with patients with stroke (neurology, pathology) or bleeding (gastroenterology)
Exclusion Criteria
- •physicians who never prescribe anticoagulant treatments, or do not deal with patients with stroke or bleeding because of anticoagulants
Arms & Interventions
risk presented on 1 diagram
decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)
Intervention: decision aid (Other)
risk presented on 2 diagrams
decision aid with risk of stroke presented on 2 diagrams (one presenting risk without and one presenting risk with treatment)
Intervention: decision aid (Other)
1year risk estimate
risk of stroke presented over a timeframe of 1 year
Intervention: decision aid (Other)
5year risk estimate
risk of stroke presented over a timeframe of 5 years
Intervention: decision aid (Other)
CHA2DS2-VASC risk score 1
CHA2DS2-VASC risk score =1
Intervention: decision aid (Other)
CHA2DS2-VASC risk score 2
CHA2DS2-VASC risk score =2
Intervention: decision aid (Other)
CHA2DS2-VASC risk score 3
CHA2DS2-VASC risk score =3
Intervention: decision aid (Other)
CHA2DS2-VASC risk score 4
CHA2DS2-VASC risk score =4
Intervention: decision aid (Other)
CHA2DS2-VASC risk score 5
CHA2DS2-VASC risk score =5
Intervention: decision aid (Other)
prescription to virtual patient
prescription is done for a virtual patient
Intervention: decision aid (Other)
prescription to physician himself
prescription is done to physician himself
Intervention: decision aid (Other)
Outcomes
Primary Outcomes
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
Time Frame: after seeing the decision aid (5 min)
after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Cristian Baicus
Professor of Internal Medicine
Carol Davila University of Medicine and Pharmacy
