Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives (InPAct)
22 gennaio 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1100
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Lyon, Francia, 69003
- Hospices Civils de Lyon
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Hypertensive patients on anti-hypertensive medication.
Patients of 85 general practitioners selected in Rhone-Alps/Auvergne and Paris region in France.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: During the study : 19 months
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During the study : 19 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Cyrille COLIN, Hospices Civils de Lyon
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2012
Completamento primario (Effettivo)
1 dicembre 2013
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
30 maggio 2012
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2012
Primo Inserito (Stima)
4 giugno 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
26 gennaio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 gennaio 2015
Ultimo verificato
1 gennaio 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- D50802
- PHRC National 2011 (Altro identificatore: government)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .