Skip to main content
OpenTrials
Completed

NCT Number: NCT01610817

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patients on Anti-hypertensive Medication Adherence Interventions Behavior Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

InPAct : Information for Participating Actively in cardiovascular treatment

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.

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

  3. 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

    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.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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)

Acronym: InPAct

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 4, 2012
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.