Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives (InPAct)
22 de janeiro de 2015 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Observacional
Inscrição (Real)
1100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Lyon, França, 69003
- Hospices Civils de Lyon
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Hypertensive patients on anti-hypertensive medication.
Patients of 85 general practitioners selected in Rhone-Alps/Auvergne and Paris region in France.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: During the study : 19 months
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During the study : 19 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Cyrille COLIN, Hospices Civils de Lyon
Publicações e links úteis
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Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2012
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de junho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
30 de maio de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2012
Primeira postagem (Estimativa)
4 de junho de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de janeiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de janeiro de 2015
Última verificação
1 de janeiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D50802
- PHRC National 2011 (Outro identificador: government)
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