Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives (InPAct)
22 de enero de 2015 actualizado por: Hospices Civils de Lyon
Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives : InPAct Study (Information for Participating Actively in Cardiovascular Treatment)
Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France.
50% of these ADEs could be preventable.
Cardiovascular drugs are frequently involved in ADEs.
A common underlying factor of such events is inadequate communication between patients and medical personnel.
General practitioners (GP) often initiate the treatment of hypertension, being generally the first prescribers of these medications.
12.6% of the patients present an ADE with hypertensive drug after 3 months.
The InPAct procedure is a tool to facilitate communication in order to improve patient safety in primary care.
In the context of the primary care prescription of an antihypertensive drug, the GP informs the patient about hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs, which helps the patient to detect and declare situations involving a heightened risk of antihypertensive-related ADEs.
The aim of the InPAct study is to evaluate the efficiency of the InPAct intervention in primary care.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A stepped wedge cluster randomized study, with 8 clusters and 5 periods of 3 months each.
Each cluster is composed of about ten general practitioners.
The InPAct intervention will not be presented to the first patients recruited by each general practitioner, whereas it will be presented to all their last patients.
The period of intervention introduction by each general practitioner will be randomized amongst the 5 periods.
Tipo de estudio
De observación
Inscripción (Actual)
1100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lyon, Francia, 69003
- Hospices Civils de Lyon
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Hypertensive patients on anti-hypertensive medication.
Patients of 85 general practitioners selected in Rhone-Alps/Auvergne and Paris region in France.
Descripción
Inclusion Criteria:
- Patient monitored for essential hypertension requiring a first prescription, a renewal or a change of antihypertensive drug treatment
- Patient with the ability to understand and express themselves in French
- Patient accepting to communicate his phone number and accepting a telephone survey within the fourth month following its inclusion in the study.
Exclusion Criteria :
- Patient with a psychiatric disorder or a progressive dementia.
- Patient with hypertension in pregnancy or secondary hypertension.
- Patient with an acute hypertensive crisis.
- Patient under guardianship.
- Patient who is likely to move or may have an irregular follow up within 6 months following its inclusion in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients with the InPAct intervention
The InPAct intervention will be presented to the last patients recruited by each general practitioner
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Educational guide presented by general practitioners to the patients.
A first part of the guide contains some information on cardiovascular risk and on the benefits and risks of antihypertensive drugs.
A second part of the guide consists of encouraging the patient to take an active part in monitoring of its treatment.
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Patients without the InPAct intervention
The InPAct intervention will not be presented to the first patients recruited by each general practitioner
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The proportion of patients on antihypertensive drug reporting themselves at least one Adverse Drug Event (ADE) to their general practitioner during their 90 days of follow up.
Periodo de tiempo: During the study : 19 months
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Symptoms could have begun before patient inclusion in the study, but symptoms have to be related to an ADE and reported during the 90 days of patient follow up.
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During the study : 19 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The proportion of patients on antihypertensive drug with at least an ADE detected (reported by the patient himself, or not) during their 90 days of follow up.
Periodo de tiempo: During the study : 19 months
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Symptoms could have begun before patient inclusion in the study, but symptoms have to be related to an ADE during the 90 days of patient follow up.
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During the study : 19 months
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The proportion of patients on antihypertensive drug presenting at least one situation of risk for ADE during the 90 days of patient follow up.
Periodo de tiempo: During the study : 19 months
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During the study : 19 months
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The proportion of patients on antihypertensive drug for whom a physician has changed or modified at least one prescription during the 90 days of patient follow up.
Periodo de tiempo: During the study : 19 months
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This modification had to be made following an ADE or a situation of risk for ADE associated with taking an anti-hypertensive drug or a drug associated with antihypertensive treatment.
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During the study : 19 months
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The proportion of patients who developed at least one complication following an ADE detected during the 90 days of patient follow up.
Periodo de tiempo: During the study : 19 months
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During the study : 19 months
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A mean score of patient satisfaction regarding the communication and information on drug prescription and management of hypertension by the general practitioner, during the 90 days of patient follow up.
Periodo de tiempo: During the study : 19 months
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During the study : 19 months
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A mean score of patient skill in health after 90 days of follow-up, including a score of patient knowledge on cardiovascular risk and on the benefits and risks of antihypertensive drugs, and a score of patient skill in situation of ADE.
Periodo de tiempo: During the study : 19 months
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During the study : 19 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Cyrille COLIN, Hospices Civils de Lyon
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Buchet-Poyau K, Occelli P, Touzet S, Langlois-Jacques C, Figon S, Dubois JP, Duclos A, Chaneliere M, Colin C, Rabilloud M, Keriel-Gascou M. Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. BMC Fam Pract. 2021 Aug 7;22(1):165. doi: 10.1186/s12875-021-01478-w.
- Keriel-Gascou M, Buchet-Poyau K, Duclos A, Rabilloud M, Figon S, Dubois JP, Brami J, Vial T, Colin C. Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial. Implement Sci. 2013 Jun 19;8:69. doi: 10.1186/1748-5908-8-69.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2012
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2012
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2012
Publicado por primera vez (Estimar)
4 de junio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de enero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de enero de 2015
Última verificación
1 de enero de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- D50802
- PHRC National 2011 (Otro identificador: government)
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. .