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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Patients on Anti-hypertensive Medication

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with the InPAct intervention

The InPAct intervention will be presented to the last patients recruited by each general practitioner

InPAct : Information for Participating Actively in cardiovascular treatment

Intervention Type OTHER

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.

Patients without the InPAct intervention

The InPAct intervention will not be presented to the first patients recruited by each general practitioner

No interventions assigned to this group

Interventions

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InPAct : Information for Participating Actively in cardiovascular treatment

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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No