Trial record 1 of 1 for:
Cozia
Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk.
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| ClinicalTrials.gov Identifier: NCT02746107 |
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Recruitment Status :
Completed
First Posted : April 21, 2016
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
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Sponsor:
Cristian Baicus
Information provided by (Responsible Party):
Cristian Baicus, Carol Davila University of Medicine and Pharmacy
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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 |
Show Detailed Description
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Experimental: risk presented on 1 diagram
decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)
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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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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)
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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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Active Comparator: 1year risk estimate
risk of stroke presented over a timeframe of 1 year
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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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Experimental: 5year risk estimate
risk of stroke presented over a timeframe of 5 years
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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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CHA2DS2-VASC risk score 1
CHA2DS2-VASC risk score =1
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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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CHA2DS2-VASC risk score 2
CHA2DS2-VASC risk score =2
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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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CHA2DS2-VASC risk score 3
CHA2DS2-VASC risk score =3
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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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CHA2DS2-VASC risk score 4
CHA2DS2-VASC risk score =4
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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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CHA2DS2-VASC risk score 5
CHA2DS2-VASC risk score =5
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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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Active Comparator: prescription to virtual patient
prescription is done for a virtual patient
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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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Experimental: prescription to physician himself
prescription is done to physician himself
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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 |
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.
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| 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
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 |
| 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 Posted: | April 21, 2016 Key Record Dates |
| 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:
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shared decision making oral anticoagulant atrial fibrillation stroke decision to treat |
Additional relevant MeSH terms:
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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 |