- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02746107
Intention to Prescribe/Take OAC Depending on the Number of Risk Diagrams , and Period for the Estimation of the Risk.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objectives:
To answer the questions:
- 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)?
- 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?
- 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:
- Between the decision aid with 2 images (without treatment + with treatment) and the one with 1 image (risk only with treatment)
- Between the effect of the presentation of the stroke risk chart for 1 year and the stroke risk chart for 5 years.
- 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).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bucharest, Rumania, 020125
- Colentina Clinica Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: risk presented on 1 diagram
decision aid with risk of stroke presented on 1 diagram (risk under OAC treatment)
|
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
|
Comparador activo: 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)
|
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
|
Comparador activo: 1year risk estimate
risk of stroke presented over a timeframe of 1 year
|
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
|
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
|
Otro: CHA2DS2-VASC risk score 1
CHA2DS2-VASC risk score =1
|
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
|
Otro: CHA2DS2-VASC risk score 2
CHA2DS2-VASC risk score =2
|
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
|
Otro: CHA2DS2-VASC risk score 3
CHA2DS2-VASC risk score =3
|
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
|
Otro: CHA2DS2-VASC risk score 4
CHA2DS2-VASC risk score =4
|
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
|
Otro: CHA2DS2-VASC risk score 5
CHA2DS2-VASC risk score =5
|
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
|
Comparador activo: prescription to virtual patient
prescription is done for a virtual patient
|
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
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams
Periodo de tiempo: after seeing the decision aid (5 min)
|
after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment
|
after seeing the decision aid (5 min)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)
Periodo de tiempo: 5 minutes
|
the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years
|
5 minutes
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)
Periodo de tiempo: 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
|
5 min
|
Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score
Periodo de tiempo: 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.
|
5 min
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Cristian Baicus, PhD, Carol Davila University of Medicine and Pharmacy Bucharest - Colentina Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Studiul Cozia
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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