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Clinical Trials/NCT02746107
NCT02746107CompletedNot Applicable

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.

Cristian Baicus1 site in 1 country968 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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:

  1. 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)?
  2. 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?
  3. 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:

  1. Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
  2. Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
  3. 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

Experimental

decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)

Intervention: decision aid (Other)

risk presented on 2 diagrams

Active Comparator

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

Active Comparator

risk of stroke presented over a timeframe of 1 year

Intervention: decision aid (Other)

5year risk estimate

Experimental

risk of stroke presented over a timeframe of 5 years

Intervention: decision aid (Other)

CHA2DS2-VASC risk score 1

Other

CHA2DS2-VASC risk score =1

Intervention: decision aid (Other)

CHA2DS2-VASC risk score 2

Other

CHA2DS2-VASC risk score =2

Intervention: decision aid (Other)

CHA2DS2-VASC risk score 3

Other

CHA2DS2-VASC risk score =3

Intervention: decision aid (Other)

CHA2DS2-VASC risk score 4

Other

CHA2DS2-VASC risk score =4

Intervention: decision aid (Other)

CHA2DS2-VASC risk score 5

Other

CHA2DS2-VASC risk score =5

Intervention: decision aid (Other)

prescription to virtual patient

Active Comparator

prescription is done for a virtual patient

Intervention: decision aid (Other)

prescription to physician himself

Experimental

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

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Cristian Baicus

Professor of Internal Medicine

Carol Davila University of Medicine and Pharmacy

Study Sites (1)

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