- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01396044
Daily Checklists and Outcome in the Intensive Care Unit
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.
The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Admission to a medical intensive care unit (MICU) team during the study timeframe
Exclusion Criteria:
- Transfer from MICU team to a separate ICU team within 12 hours of admission
- Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Electronic checklist
|
Electronic checklist for process of care issues implemented in our institution.
Training on a regular basis of the electronic checklist arm to use the electronic checklist.
Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
|
|
Experimental: Verbal prompting
Verbal prompting with written checklist
|
Prompting by study investigators of physicians on the verbal prompting arm.
Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Empiric Antibiotic Duration
Prazo: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
|
During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
|
|
|
Proportion of Empiric Antibiotics
Prazo: ICU admission
|
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
|
ICU admission
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hospital Mortality
Prazo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
|
Length of Stay
Prazo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
|
Ventilator-free Days
Prazo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
Proportion of Successful Prompts
Prazo: During ICU admission, an average of 5 days (although individual patients may vary)
|
Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed |
During ICU admission, an average of 5 days (although individual patients may vary)
|
|
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Prazo: ICU admission
|
Proportion of patients-days on which empirical antibiotics were used
|
ICU admission
|
|
Standardized Mortality Ratio
Prazo: Hospital admission
|
Hospital admission
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Curtis H Weiss, MD, Northwestern University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NUIRBSTU00013313
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