- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01979588
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice (WGA)
Previous work has shown that the epidemiological context of a patient's presentation can provide important information for clinicians to aid in diagnosis and treatment. With current electronic health records, it is increasingly possible to perform syndromic surveillance that is local and specific to a patient's characteristics.
The investigators have developed algorithms for syndromic surveillance for a number of conditions in which contextual information might be of use to treating clinicians. The syndromic surveillance algorithms already developed are for influenza-like-illness, whooping cough, asthma exacerbation, Group A Streptococcal pharyngitis, and gastroenteritis infection.
The investigators plan on studying these tools with a clustered randomized control cohort study evaluating how clinical decision making is affected by use of these tools by outpatient general practitioners. The goal is to incorporate these validated algorithms into a quality improvement tool which will provide point-of-care clinical decision support to clinicians
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The epidemiological context of a patient's presentation can provide important information for clinicians to aid in diagnosis and treatment. The investigators previously developed and validated a syndromic surveillance tool for detecting influenza-like illness (ILI) encounters. The investigators then evaluated 40,642 outpatient ILI episodes during 'flu seasons' over 6 years. The investigators found that even after controlling for patient presentation and physician factors, the context in which a patient presented was strongly associated with the likelihood that an antimicrobial agent would be prescribed. Specifically, patients were less likely to be prescribed an antibiotic if they presented with ILI during the pandemic influenza period (when awareness of 'flu season' was very high), or after their physician had personally seen many patients with ILI in the prior week.
Currently, most clinicians have only limited access to data regarding the 'context' in which a patient presents. Under such circumstances, physicians are often unaware of local epidemiological information that could help them make optimal treatment decisions. In centers with advanced use of electronic health records (EHRs), it is increasingly possible to perform syndromic surveillance that is local (e.g. specific to a neighborhood or school district), current (e.g. updated daily), and specific to a patient's characteristics (e.g. age, chief complaint).
To that end, the investigators have developed algorithms for syndromic surveillance for a number of syndromes including Asthma, ILI, Pertussis, Group A Streptococcus Pharyngitis, and Gastroenteritis. These algorithms may provide contextual information that might be of use to clinicians.
The purpose of this study is to determine the effect of how a point-of-care clinical decision tool in the form of syndromic surveillance algorithms affect clinical decision making amongst outpatient health care providers and also patient outcomes. We will be using a 2 year look back prior to tool roll out as a comparison.
Specific Aims:
To determine the effect this point-of-care clinical decision tool has on clinical decision making amongst primary care providers.
To determine the clinical outcomes of patients whose physicians had access to these tools
To understand how these point-of-care clinical decision tools are used among healthcare providers in day to day practice
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Northshore University Healthsystem
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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:
All patients seen in a Northshore University HealthSystem outpatient clinic (Family Medicine, Internal Medicine or Pediatric) between the Nov 1 2013 to Oct 31 2014
Exclusion Criteria:
None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Control
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
|
Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation
|
|
Comparador Ativo: What's Going Around Tool
Provider has access to What's Going Around Tool.
Provider also shown a video explaining how to use Tool
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Provider has access to the What's Going Around tool
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Prazo: 1 year
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Prazo: 1 year
|
1 year
|
|
Percent of primary care visits in which a patient received an antibiotic
Prazo: 1 year
|
1 year
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Percentage of visits for pediatric patients with asthma in which asthma counseling performed
Prazo: 1 year
|
1 year
|
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Percent of time a pertussis PCR was sent for patients with a complaint of cough during a period of high pertussis prevalence
Prazo: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of high prevalence of group A strep
Prazo: 1 year
|
1 year
|
|
Percent of time that a pertussis active antibiotic was prescribed in a patient with a complaint of a cough during a period of high pertussis prevalence
Prazo: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of low prevalence of group A strep
Prazo: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A strep appropriate antibiotic during a period of high prevalence of group A strep
Prazo: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep appropriate antibiotic during a period of low prevalence of group A strep
Prazo: 1 year
|
1 year
|
|
Percent of patients with asthma who have a hospital visit for asthma
Prazo: 1 year
|
1 year
|
|
Percentage of days that a physician used the What's Going Around tool of all days he/she worked in a year
Prazo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ari Robicsek, MD, Northshore University Healthsystem
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- What's Going Around
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