Clinical trial NCT01610817: Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients on Anti-hypertensive Medication
Keywords: Patient information and active participation
Patient safety
Health education
Adverse drug event
Primary care
Antihypertensive drugs
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients on anti-hypertensive medication. Patients of 85 general practitioners selected in Rhone-Alps/Auvergne and Paris region in France.

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.

Eligibility criteria: 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.

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.
timeFrame: 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.
timeFrame: During the study : 19 months
measure: The proportion of patients on antihypertensive drug presenting at least one situation of risk for ADE during the 90 days of patient follow up.
timeFrame: During the study : 19 months
measure: 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.
timeFrame: During the study : 19 months
measure: The proportion of patients who developed at least one complication following an ADE detected during the 90 days of patient follow up.
timeFrame: During the study : 19 months
measure: 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.
timeFrame: During the study : 19 months
measure: 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.
timeFrame: During the study : 19 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Cyrille COLIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchet-Poyau K, Occelli P, Touzet S, Langlois-Jacques C, Figon S, Dubois JP, Duclos A, Chaneliere M, Colin C, Rabilloud M, Keriel-Gascou M. Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. BMC Fam Pract. 2021 Aug 7;22(1):165. doi: 10.1186/s12875-021-01478-w.
citation: Keriel-Gascou M, Buchet-Poyau K, Duclos A, Rabilloud M, Figon S, Dubois JP, Brami J, Vial T, Colin C. Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial. Implement Sci. 2013 Jun 19;8:69. doi: 10.1186/1748-5908-8-69.