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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.
Full description
Objectives:
To answer the questions:
Study: 2x3 factorial randomized controlled trial (RCT) for comparison:
The comparison will be made for the spectrum of risks (scores CHA2DS2-VASC) from 1-5.
Sample size: was calculated a sample of 948 participants (474 + 474) for p = 0.05, power = 80% statistical difference between decisions of 5% (from 95% to 90%). The study does not have enough power neither to compare the 5 groups CHA2DS2-VASC (but we will make these comparisons with exploratory purpose), nor to test interactions.
Participants: physicians participating to the National Congress of Internal Medicine, physicians participating to courses, professional manifestations.
Randomization: randomization will be done on graph type (1 or 2 pictures), duration of risk estimate (1 year and 5 years) and the size of CHA2DS2-VASC risk score (1 to 5), and target prescription (patient or the doctor himself), a total of 40 possibilities. Randomization will be done in blocks of 40.
Participants will be asked to decide, depending on the risk chart, if the patient (or himself) will be treated, ignoring the risk of bleeding.
The chart will contain the pictogram according to the CHA2DS2-VASC risk score, without communicating the actual score, and the physician will have to make the decision to treat or not, depending on the perceived risk, and not on treatment guidelines.
No. questionnaire: first digit = number of risk diagrams (1 or 2); second digit = number of years for which the risk of stroke is calculated (1 or 5); third digit = CHA2DS2-VASC score (1-5). Ex: 253: 2 decision aid diagrams (with and without treatment), with an estimated risk of stroke for the next five years, in a patient with CHA2DS2-VASC score =3.
Effect (outcome): decision to treat / not to treat the patient / physician himself, with oral anticoagulants.
Statistical analysis: It will look for differences in bivariate analysis, and multivariate = logistic regression (dependent variable = treatment decision, the independent variables = number of charts, period for risk assessment (one or 5 years), prescription target (patient or the physician himself), CHA2DS2-VASC score, time from graduation, medical/teaching grade, working in hospital / ambulatory, the size of the city the physician works in, specialty, gender, age, if the physician has/had someone close with stroke (data from questionnaires).
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968 participants in 11 patient groups
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Data sourced from clinicaltrials.gov
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