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

NCT02746107 | Completed Results DMC

• 1 other identifier: Studiul Cozia
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams

  after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment

  after seeing the decision aid (5 min)

Other Outcomes (3)

• Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)

  5 minutes

• Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)

  5 min

• Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score

  5 min

Study Arms (11)

risk presented on 1 diagram

EXPERIMENTAL

decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)

Other: decision aid

risk presented on 2 diagrams

ACTIVE COMPARATOR

decision aid with risk of stroke presented on 2 diagrams (one presenting risk without and one presenting risk with treatment)

Other: decision aid

1year risk estimate

ACTIVE COMPARATOR

risk of stroke presented over a timeframe of 1 year

Other: decision aid

5year risk estimate

EXPERIMENTAL

risk of stroke presented over a timeframe of 5 years

Other: decision aid

CHA2DS2-VASC risk score 1

OTHER

CHA2DS2-VASC risk score =1

Other: decision aid

CHA2DS2-VASC risk score 2

OTHER

CHA2DS2-VASC risk score =2

Other: decision aid

CHA2DS2-VASC risk score 3

OTHER

CHA2DS2-VASC risk score =3

Other: decision aid

CHA2DS2-VASC risk score 4

OTHER

CHA2DS2-VASC risk score =4

Other: decision aid

CHA2DS2-VASC risk score 5

OTHER

CHA2DS2-VASC risk score =5

Other: decision aid

prescription to virtual patient

ACTIVE COMPARATOR

prescription is done for a virtual patient

Other: decision aid

prescription to physician himself

EXPERIMENTAL

prescription is done to physician himself

Other: decision aid

Interventions

decision aid OTHER

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

1year risk estimate; 5year risk estimate; CHA2DS2-VASC risk score 1; CHA2DS2-VASC risk score 2; CHA2DS2-VASC risk score 3; CHA2DS2-VASC risk score 4; CHA2DS2-VASC risk score 5; prescription to physician himself; prescription to virtual patient; risk presented on 1 diagram; risk presented on 2 diagrams

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• physicians who never prescribe anticoagulant treatments, or do not deal with patients with stroke or bleeding because of anticoagulants

Sponsors & Collaborators

• Cristian Baicus: lead

Study Sites (1)

Colentina Clinica Hospital

Bucharest, 020125, Romania

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

* prescription was only simulated - not real patients, physicians had to imagine they had atrial fibrillation * results could be different on patients * participants had to decide prescription/not after seeing the risk diagram for only 5 minutes

Results Point of Contact

• Title: Professor Cristian Baicus
• Organization: Carol Davila University of Medicine and Pharmacy Bucharest

cbaicus@gmail.com

+40788302355

Study Officials

• Cristian Baicus, PhD

  Carol Davila University of Medicine and Pharmacy Bucharest - Colentina Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-09

Locations

RO (1)