- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02408952
Triagem para o uso de álcool e drogas por jovens: um estudo dos profissionais de cuidados primários
14 de julho de 2023 atualizado por: Kaiser Permanente
Este estudo avalia a implementação e eficácia de duas modalidades de Triagem, Intervenção Breve e Encaminhamento para Tratamento (SBIRT) para reduzir o uso de álcool e outras drogas (AOD) por adolescentes em uma clínica pediátrica de grande porte.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Os sistemas de saúde não implementaram Triagem, Intervenção Breve e Encaminhamento para Tratamento (SBIRT) para adolescentes, apesar de pesquisas demonstrarem sua eficácia.
Com base em pesquisas anteriores que identificaram barreiras à triagem de AOD para adolescentes na Atenção Primária pediátrica (CP) e um estudo piloto que concluiu que o SBIRT era viável, bem recebido e promovia encaminhamentos e início de tratamento especializado, o aplicativo de pesquisa atual propõe randomizar 45 Médicos de Atenção Primária (PCPs) na clínica pediátrica de um centro médico dentro de um grande sistema de saúde gerenciado, Kaiser Permanente Northern California, para três braços - 1) Cuidados Usuais; 2) SBIRT entregue pelos PCPs; e 3) SBIRT ministrado por Especialistas em Medicina Comportamental (BMS).
O objetivo do estudo é comparar a implementação, eficácia e custo-efetividade do SBIRT para adolescentes em CP nos três braços do estudo.
Os pacientes completarão triagem baseada em evidências e medidas de avaliação de AOD que foram incorporadas ao registro médico eletrônico (EMR) do plano de saúde.
Um modelo misto será usado para comparar os resultados da implementação (taxas de triagem e identificação, intervenção breve, encaminhamento para tratamento de Dependência Química e início do tratamento) e eficácia (resultados do paciente quanto ao uso e abstinência de AOD) em 12 meses.
O modelo considera as correlações intraclasse entre os pacientes dentro dos provedores.
O custo-efetividade relativo à implementação e os resultados do paciente serão examinados.
Barreiras e facilitadores de implementação e viabilidade por meio de entrevistas qualitativas com médicos e administradores também serão examinados.
O estudo é significativo na medida em que examina questões que devem ser abordadas para estimular a adaptação generalizada do SBIRT.
As intervenções propostas são altamente viáveis no atual ambiente de reforma da saúde devido ao aumento de recursos e treinamento para Centros de Saúde Qualificados Federalmente e planos de saúde privados.
É inovador ao usar o EMR para mudar a prática clínica e integrar sistematicamente o AOD no PC e como uma plataforma para coletar dados de pesquisa.
Tipo de estudo
Intervencional
Inscrição (Real)
9084
Estágio
- Não aplicável
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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California
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Oakland, California, Estados Unidos, 94612
- Stacy A Sterling
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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
12 anos a 80 anos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Descrição
Existem duas populações de estudo, conforme descrito abaixo, portanto, a grande faixa de limite de idade.
Critério de inclusão:
- Todos os prestadores de cuidados primários de adolescentes na clínica de cuidados primários pediátricos serão incluídos.
- Todos os prontuários eletrônicos de pacientes adolescentes, com idades entre 12 e 18 anos, na atenção primária pediátrica serão examinados.
Critério de exclusão:
- Quaisquer prestadores de cuidados primários de adolescentes que não trabalhem no local de pesquisa da clínica de cuidados primários pediátricos serão excluídos.
- Serão excluídos os prontuários eletrônicos dos adolescentes que não fizerem parte da clínica pediátrica do local da pesquisa.
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: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Médico de cuidados primários
Se o adolescente for identificado em risco de uso de substâncias, a triagem e o encaminhamento de intervenção breve para o tratamento administrado são feitos pelo médico da atenção primária
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A triagem, a intervenção breve e o encaminhamento para o tratamento são realizados pelo médico da atenção primária
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Experimental: Especialista em Medicina Comportamental
Se o adolescente for identificado em risco de uso de substâncias, a triagem e a intervenção breve serão encaminhadas para tratamento pelo especialista em medicina comportamental
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A triagem, intervenção breve e encaminhamento para tratamento é feita pelo Especialista em Medicina Comportamental.
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Sem intervenção: Cuidados usuais
Os cuidados são administrados normalmente
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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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Taxa de triagem
Prazo: Taxa de triagem inicial - no índice de visita ao poço
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A proporção de pacientes que são rastreados com o uso de AOD do questionário Teen Well Check ou perguntas sobre sintomas de humor, entre todos os pacientes com consultas de puericultura Teen.
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Taxa de triagem inicial - no índice de visita ao poço
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Taxa de identificação de problemas
Prazo: Taxa inicial de identificação de problemas - no índice de visita ao poço, após a triagem
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A proporção de pacientes rastreados que respondem "sim" ao uso de AOD ou sintomas de humor nos últimos 12 meses e "sim" a pelo menos uma pergunta CRAFFT não relacionada ao carro.
(Estar em um carro com alguém que usa AOD pode não estar relacionado ao problema da criança, mas a ter um dos pais/outro adulto que dirigiu bebendo/usando).
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Taxa inicial de identificação de problemas - no índice de visita ao poço, após a triagem
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Taxa de avaliação
Prazo: Dentro de 2 semanas após a data de visita do poço índice
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Proporção de pacientes com triagem positiva para álcool ou outras drogas, ou risco de saúde mental, que são avaliados posteriormente usando a ferramenta CRAFFT.
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Dentro de 2 semanas após a data de visita do poço índice
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Taxa de Intervenção Breve
Prazo: Dentro de 14 dias após a avaliação na visita do poço índice
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A proporção de pacientes que recebem uma intervenção em 14 dias, entre aqueles identificados com risco de DOA (com base no escore CRAFFT).
Documentado no EHR por médicos, usando um código V Administrativo ICD-9 para aconselhamento sobre uso de substâncias ou aconselhamento comportamental.
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Dentro de 14 dias após a avaliação na visita do poço índice
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Taxa de encaminhamento para tratamento especializado
Prazo: Dentro de 6 meses após a visita do índice ao poço
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A proporção de pacientes que recebem encaminhamentos para tratamento especializado em saúde comportamental, entre aqueles identificados pelo CRAFFT como necessitando de tal tratamento.
Documentado no EHR.
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Dentro de 6 meses após a visita do índice ao poço
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Especialidade de Iniciação de Tratamento de Saúde Comportamental
Prazo: Dentro de 2 anos pós-intervenção
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Definido como a porcentagem encaminhada, que tem pelo menos uma visita especializada em saúde comportamental entre aqueles identificados com um problema de saúde comportamental.
Documentado no EHR.
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Dentro de 2 anos pós-intervenção
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Uso de álcool e outras drogas
Prazo: Uso nos últimos 6 meses, 1 e 2 anos pós-intervenção
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Uso de álcool e drogas: Os itens do EHR medem o uso de álcool, maconha e outras drogas e tabaco nos últimos 30 dias e 6 meses, incluindo dias de uso, quantidade consumida (qualquer, 3+ e 5+ bebidas) e dias de consumo excessivo de álcool (3+ e 5+).
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Uso nos últimos 6 meses, 1 e 2 anos pós-intervenção
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Resultados relacionados ao uso de substâncias
Prazo: nos últimos 6 meses, 1 e 2 anos pós-intervenção
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Problemas legais, escolares e familiares relacionados a AOD: As perguntas do EHR também incluem medidas do Inventário Abrangente de Gravidade do Adolescente (CASI),148 um questionário semiestruturado que mede a saúde e o funcionamento do adolescente nos domínios educacional, legal e de relações familiares.
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nos últimos 6 meses, 1 e 2 anos pós-intervenção
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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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 (Real)
1 de outubro de 2011
Conclusão Primária (Real)
1 de outubro de 2013
Conclusão do estudo (Estimado)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
20 de março de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de março de 2015
Primeira postagem (Estimado)
6 de abril de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de julho de 2023
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2023
Última verificação
1 de julho de 2023
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 11-07796
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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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