Overview

This trial is active, not recruiting.

Condition patients on anti-hypertensive medication
Treatment inpact : information for participating actively in cardiovascular treatment
Sponsor Hospices Civils de Lyon
Start date May 2012
End date December 2013
Trial size 1100 participants
Trial identifier NCT01610817, D50802, PHRC National 2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
The InPAct intervention will be presented to the last patients recruited by each general practitioner
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.
The InPAct intervention will not be presented to the first patients recruited by each general practitioner

Primary Outcomes

Measure
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.
time frame: During the study : 19 months

Secondary Outcomes

Measure
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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: During the study : 19 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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)
Principal investigator Cyrille COLIN
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.