Trial Outcomes & Findings for Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk. (NCT NCT02746107)
NCT ID: NCT02746107
Last Updated: 2016-10-31
Results Overview
after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
968 participants
Primary outcome timeframe
after seeing the decision aid (5 min)
Results posted on
2016-10-31
Participant Flow
Participant milestones
| Measure |
All Study Participants
all study participants were 968 (in all arms of this factorial RCT)
|
|---|---|
|
Overall Study
STARTED
|
968
|
|
Overall Study
2 Diagrams DA
|
482
|
|
Overall Study
1 Diagram DA
|
486
|
|
Overall Study
1year Risk Estimate
|
483
|
|
Overall Study
5year Risk Estimate
|
485
|
|
Overall Study
Target=Patient
|
486
|
|
Overall Study
Target=Physician
|
482
|
|
Overall Study
CHA2DS2-VASC Score = 1
|
195
|
|
Overall Study
CHA2DS2-VASC Score = 2
|
189
|
|
Overall Study
CHA2DS2-VASC Score = 3
|
195
|
|
Overall Study
CHA2DS2-VASC Score = 4
|
197
|
|
Overall Study
CHA2DS2-VASC Score = 5
|
192
|
|
Overall Study
COMPLETED
|
968
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk.
Baseline characteristics by cohort
| Measure |
All Participants
n=968 Participants
all participants in the study (968)
|
|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
704 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
264 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
968 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after seeing the decision aid (5 min)after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
Outcome measures
| Measure |
One Diagram
n=486 Participants
decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams
|
Two Diagrams
n=482 Participants
classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams
|
CHA2D2S-VASC Risk Score 3
|
CHA2D2S-VASC Risk Score 4
|
CHA2D2S-VASC Risk Score 5
|
|---|---|---|---|---|---|
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
|
400 participants
|
406 participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minutesthe proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years
Outcome measures
| Measure |
One Diagram
n=485 Participants
decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams
|
Two Diagrams
n=483 Participants
classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams
|
CHA2D2S-VASC Risk Score 3
|
CHA2D2S-VASC Risk Score 4
|
CHA2D2S-VASC Risk Score 5
|
|---|---|---|---|---|---|
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)
|
412 participants
|
394 participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minthe participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves
Outcome measures
| Measure |
One Diagram
n=486 Participants
decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams
|
Two Diagrams
n=482 Participants
classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams
|
CHA2D2S-VASC Risk Score 3
|
CHA2D2S-VASC Risk Score 4
|
CHA2D2S-VASC Risk Score 5
|
|---|---|---|---|---|---|
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)
|
442 participants
|
364 participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minThe 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.
Outcome measures
| Measure |
One Diagram
n=195 Participants
decision aid with one diagram (risk under treatment)
decision aid: decision aid with one/two diagrams
|
Two Diagrams
n=189 Participants
classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)
decision aid: decision aid with one/two diagrams
|
CHA2D2S-VASC Risk Score 3
n=195 Participants
|
CHA2D2S-VASC Risk Score 4
n=197 Participants
|
CHA2D2S-VASC Risk Score 5
n=192 Participants
|
|---|---|---|---|---|---|
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score
|
146 participants
|
159 participants
|
164 participants
|
172 participants
|
165 participants
|
Adverse Events
One Diagram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Two Diagrams
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Cristian Baicus
Carol Davila University of Medicine and Pharmacy Bucharest
Phone: +40788302355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place