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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01152320
Trial of Spirometry Fundamentals™ in the Primary Care Setting
Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Misclassification of asthma severity has been reported when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment that may result in increased morbidity and increased healthcare utilization/cost. However, even when spirometry is utilized to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.
The goal of this study is to evaluate the effectiveness of the Spirometry Fundamentals™ tool in training primary care providers and their staff in producing high-quality flow-volume curves as compared to existing training modalities and to gather information in a 'real-world' setting that can be used to improve Spirometry Fundamentals™.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Currently few self-paced, distance learning programs exist that train staff to perform good quality spirometry tests. This study evaluates the effectiveness of a distance-learning tool for training primary care providers and their medical assistants in the use of spirometry to assist in managing obstructive lung disease (asthma and COPD). This tool is called "Spirometry Fundamentals™: A basic guide to lung function testing". It is a computer-based training program that teaches primary care providers and their staff what spirometry is, how it can be used, the techniques required to perform high-quality spirometry, and clinical interpretation of the spirometric data.
We evaluated the effectiveness of Spirometry Fundamentals in the primary care setting by conducting a randomized controlled trial (RCT). Study participants were primary care physicians (MDs or DOs) and their staff (medical assistants (MAs) or nurses (RNs)) and were recruited as study pairs. The role of the MDs was to utilize spirometry in clinical care by ordering spirometry tests based on their clinical judgment, and the role of the MAs was to perform the spirometry. The patients performed the spirometry as part of their usual care were not considered study subjects.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subjects must have internet access in order to transmit spirometry curve and survey data.
- Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
- Subjects must have access to a ndd Easyone spirometer.
Exclusion Criteria:
- Subjects who lack internet access which will be needed to transmit study data
- Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
- Subjects who lack access to a ndd Easyone spirometer.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Padrão de atendimento
|
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Experimental: Intervention
Spirometry Fundamentals™ CD training program
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MD-MA pairs randomized to the intervention arm of the study received 2 copies of the Spirometry Fundamentals™ CD.
Included with the CDs was a letter explaining that each member of the MD-MA pair should view the CD at their convenience within the following 3 weeks.
This letter included instructions on how to access the study website in order to complete an evaluation survey after viewing the CD.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Spirometry test quality
Prazo: Four months for controls; six months for intervention sites
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Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
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Four months for controls; six months for intervention sites
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Effect of frequency of spirometry use on primary outcome
Prazo: Four months for controls; six months for intervention sites
|
Examined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
|
Effect of practice location on primary outcome
Prazo: Four months for controls; six months for intervention sites
|
Examined whether practice location (private/community, hospital/university) related to the percent of passing testing sessions conducted by the office.
|
Four months for controls; six months for intervention sites
|
Effect of practice type on primary outcome
Prazo: Four months for controls; six months for intervention sites
|
Examined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of practice structure on primary outcome
Prazo: Four months for controls; six months for intervention sites
|
Examined whether practice structure related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Effect of months of spirometry use on primary outcome
Prazo: Four months for controls; six months for intervention sites
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Examined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.
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Four months for controls; six months for intervention sites
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rita Mangione-Smith, MD, MPH, University of Washington/Seattle Children's Hospital
- Investigador principal: James W Stout, MD, MPH, University of Washington
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
- 31552-E/A
- A26829 (Número de outro subsídio/financiamento: American Thoracic Society)
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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