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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01610817
First received: May 30, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Patients on Anti-hypertensive Medication
Other: InPAct : Information for Participating Actively in cardiovascular treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: During the study : 19 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: During the study : 19 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: May 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with the InPAct intervention
The InPAct intervention will be presented to the last patients recruited by each general practitioner
Other: 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.
Patients without the InPAct intervention
The InPAct intervention will not be presented to the first patients recruited by each general practitioner

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610817

Locations
France
Hospices Civils de Lyon
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Cyrille COLIN Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01610817     History of Changes
Other Study ID Numbers: D50802, PHRC National 2011
Study First Received: May 30, 2012
Last Updated: October 9, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Hospices Civils de Lyon:
Patient information and active participation
Patient safety
Health education
Adverse drug event
Primary care
Antihypertensive drugs

Additional relevant MeSH terms:
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014