Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives (InPAct)
22. januar 2015 opdateret af: Hospices Civils de Lyon
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)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lyon, Frankrig, 69003
- Hospices Civils de Lyon
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Hypertensive patients on anti-hypertensive medication.
Patients of 85 general practitioners selected in Rhone-Alps/Auvergne and Paris region in France.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Patients with the InPAct intervention
The InPAct intervention will be presented to the last patients recruited by each general practitioner
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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.
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Patients without the InPAct intervention
The InPAct intervention will not be presented to the first patients recruited by each general practitioner
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: During the study : 19 months
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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.
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During the study : 19 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: During the study : 19 months
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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.
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During the study : 19 months
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The proportion of patients on antihypertensive drug presenting at least one situation of risk for ADE during the 90 days of patient follow up.
Tidsramme: During the study : 19 months
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During the study : 19 months
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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.
Tidsramme: During the study : 19 months
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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.
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During the study : 19 months
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The proportion of patients who developed at least one complication following an ADE detected during the 90 days of patient follow up.
Tidsramme: During the study : 19 months
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During the study : 19 months
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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.
Tidsramme: During the study : 19 months
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During the study : 19 months
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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.
Tidsramme: During the study : 19 months
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During the study : 19 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Cyrille COLIN, Hospices Civils de Lyon
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2012
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
30. maj 2012
Først indsendt, der opfyldte QC-kriterier
1. juni 2012
Først opslået (Skøn)
4. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- D50802
- PHRC National 2011 (Anden identifikator: government)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .