Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk.

• ClinicalTrials.gov Identifier: NCT02746107
• Recruitment Status: Completed
• First Posted: April 21, 2016
• Results First Posted: October 31, 2016
• Last Update Posted: October 31, 2016
• Sponsor: Cristian Baicus
• Information provided by (Responsible Party): Cristian Baicus, Carol Davila University of Medicine and Pharmacy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Stroke	Other: decision aid	Not Applicable

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.

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 968 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Official Title: 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.
• Study Start Date: March 2016
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: risk presented on 1 diagram; decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
Active Comparator: 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)	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
Active Comparator: 1year risk estimate; risk of stroke presented over a timeframe of 1 year	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
Experimental: 5year risk estimate; risk of stroke presented over a timeframe of 5 years	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
CHA2DS2-VASC risk score 1; CHA2DS2-VASC risk score =1	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
CHA2DS2-VASC risk score 2; CHA2DS2-VASC risk score =2	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
CHA2DS2-VASC risk score 3; CHA2DS2-VASC risk score =3	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
CHA2DS2-VASC risk score 4; CHA2DS2-VASC risk score =4	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
CHA2DS2-VASC risk score 5; CHA2DS2-VASC risk score =5	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
Active Comparator: prescription to virtual patient; prescription is done for a virtual patient	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
Experimental: prescription to physician himself; prescription is done to physician himself	Other: decision aid; decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself

Outcome Measures

Primary Outcome Measures :

1. 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

Other Outcome Measures:

1. Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years) [ Time Frame: 5 minutes ]
   the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years
2. Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself) [ Time Frame: 5 min ]
   the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves
3. Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score [ Time Frame: 5 min ]
   The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores. CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.

Eligibility Criteria

• Ages Eligible for Study: 24 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Romania

Colentina Clinica Hospital

Bucharest, Romania, 020125

Sponsors and Collaborators

Cristian Baicus

Investigators

• Study Chair: Cristian Baicus, PhD; Carol Davila University of Medicine and Pharmacy Bucharest - Colentina Hospital

More Information

• Responsible Party: Cristian Baicus, Professor of Internal Medicine, Carol Davila University of Medicine and Pharmacy
• ClinicalTrials.gov Identifier: NCT02746107
• Other Study ID Numbers: Studiul Cozia
• First Posted: April 21, 2016
• Results First Posted: October 31, 2016
• Last Update Posted: October 31, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: At the end, when published

Keywords provided by Cristian Baicus, Carol Davila University of Medicine and Pharmacy:

shared decision making; oral anticoagulant; atrial fibrillation; stroke; decision to treat

Additional relevant MeSH terms:

Stroke; Atrial Fibrillation; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes