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Intervention to Improve Prescribing in Elderly Patients

2 de janeiro de 2017 atualizado por: University Hospital, Basel, Switzerland

Intervention to Improve Appropriate Prescribing and Reduce Polypharmacy in Elderly Patients Admitted to an Internal Medicine Unit

This study tested the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy in elderly adults admitted to an internal medicine unit.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Background: Polypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.

Objective: To test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.

Design: single-center, interventional, quasi-experimental before-after study. Patients: Consecutive patients aged ≥65 years, hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).

Intervention: Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards.

Main Measures: The proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to Screening tool of older people's prescriptions (STOPP) criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria.

Tipo de estudo

Intervencional

Inscrição (Real)

450

Estágio

  • Não aplicável

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

65 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Consecutive patients aged ≥65 years,
  • patients hospitalized in the division of internal medicine of a Swiss secondary-level hospital from September to November 2012 (control group, N=450) and from September to November 2013 (intervention group, N=450).

Exclusion Criteria:

  • none

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

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: After introduction of the checklist
Review of medications of all consecutive admitted patients during the study period using a checklist
Outro: Checklist
Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards to review and adapt the medications of the patient.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in the proportion of patients prescribed potentially inappropriate medications (PIM) at discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
The proportion of patients prescribed PIMs at discharge, according to STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) criteria, before and after the introduction of the checklist.
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Change in the number of prescribed medications at discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Number of prescribed medications at discharge, before and after the introduction of the checklist.
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of prescribed drugs at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Prevalence of polypharmacy at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
concomitant use of more than 5 drugs
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Prevalence of hyperpolypharmacy at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
concomitant use of more than 10 drugs
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Prevalence of potentially inappropriate prescribing omissions (PPO) at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
according to START (Screening Tool of Alert doctors to the Right Treatment) criteria
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Number of patients prescribed NSAID at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Non-steroidal anti-inflammatory drugs (NSAID)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Rate (%) of inappropriate prescriptions of NSAID at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Non-steroidal anti-inflammatory drugs (NSAID)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Number of patients prescribed proton pump inhibitors at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
proton pump inhibitor (PPI)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Rate (%) of inappropriate prescriptions of proton pump inhibitors at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
proton pump inhibitor (PPI)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Number of patients prescribed systemic corticosteroids at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Rate (%) of inappropriate prescriptions of systemic corticosteroids at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Number of patients prescribed metamizole at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
Rate (%) of inappropriate prescriptions of metamizole at admission and discharge
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In-Hospital mortality rate
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
All-cause re-hospitalization rate
Prazo: In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)
re-hospitalization rate 30 days after discharge
In the 3 months after introduction of the checklist (Sept.-Nov. 2013, intervention group) and in 3 months (Sept.-Nov. 2012) one year before the introduction of the checklist (control group)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Basel, Switzerland

Investigadores

  • Investigador principal: Stefano Bassetti, MD, University Hospital, Basel, Switzerland

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 setembro de 2013

Conclusão Primária (Real)

1 de novembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

29 de fevereiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de março de 2016

Primeira postagem (Estimativa)

18 de março de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de janeiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de janeiro de 2017

Última verificação

1 de janeiro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 2013/039

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data are available.

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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