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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT02746107

First Posted: April 21, 2016

Last Update Posted: October 31, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Cristian Baicus, Carol Davila University of Medicine and Pharmacy

Purpose

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	Intervention
Atrial Fibrillation Stroke	Other: decision aid


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

U.S. FDA Resources

Further study details as provided by Cristian Baicus, Carol Davila University of Medicine and Pharmacy:

Primary Outcome Measures:

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:

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
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
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.


Enrollment:	968
Study Start Date:	March 2016
Study Completion Date:	June 2016
Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	24 Years and older (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746107

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 History of Changes
Other Study ID Numbers:	Studiul Cozia
First Submitted:	April 18, 2016
First Posted:	April 21, 2016
Results First Submitted:	June 9, 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 Anticoagulants

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