Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Patients on Anti-hypertensive Medication

Intervention / Treatment
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* Other: InPAct : Information for Participating Actively in cardiovascular treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with the InPAct intervention<br>The InPAct intervention will be presented to the last patients recruited by each general practitioner | Other: InPAct : Information for Participating Actively in cardiovascular treatment<br>* 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.<br>|
| Patients without the InPAct intervention<br>The InPAct intervention will not be presented to the first patients recruited by each general practitioner | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | During the study : 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | During the study : 19 months | 
| The proportion of patients on antihypertensive drug presenting at least one situation of risk for ADE during the 90 days of patient follow up. |  | During the study : 19 months | 
| 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. | 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. | During the study : 19 months | 
| The proportion of patients who developed at least one complication following an ADE detected during the 90 days of patient follow up. |  | During the study : 19 months | 
| 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. |  | During the study : 19 months | 
| 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. |  | During the study : 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient information and active participation, Patient safety, Health education, Adverse drug event, Primary care, Antihypertensive drugs