Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives
- Conditions
- Patients on Anti-hypertensive Medication
- Registration Number
- NCT01610817
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. During the study : 19 months 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.
- Secondary Outcome Measures
Name Time Method 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 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. During the study : 19 months 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.
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. During the study : 19 months 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.
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 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
Trial Locations
- Locations (1)
Hospices Civils de Lyon
🇫🇷Lyon, France