- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02223273
Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) (BRIDGEStroke)
A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
Phase 1: An observational study ( registry) will be conducted with the objective of documenting the practice of stroke treatment in brazilian and latin american hospitals.
Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy to increase evidence based treatments usage for stroke patients. The hospitals will be randomized into two groups: the multifaceted strategy group and the usual care group.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Objective: The purpose of this study is to evaluate a multifaceted strategy to increase evidence based therapies for patients with acute ischemic stroke.
Study Population; Patients with suspected stroke or transient ischemic attack (TIA) with symptoms lasting up to 24h hours.
Quality Improvement Multifaceted Intervention: The strategy includes a simulation based team training, case manager, check lists, reminders and educational material.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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São Paulo, Brasil, 04004-050
- Brazil
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Patient Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years old, diagnosed with ischemic stroke (including transient ischemic attack) with symptoms lasting up to 24 hours.
Exclusion Criteria:
- Patients with signs of hemorrhagic stroke, expansive lesions, central nervous system infections, and those coming from institutions that did not provide institutional approval form signed by the patients' guardians.
Cluster Eligibility Criteria
Inclusion Criteria:
- Hospitals with a emergency department, with available tomography, neurologist and alteplase
Exclusion Criteria:
- Hospitals that don't provide Institutional Authorization Form
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Multifaceted Strategy
Multifaceted Intervention
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|
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Sem intervenção: Usual Care
Hospital Standard Treatment
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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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Frequency of Evidence Based Strategies
Prazo: Discharge or 7 days after admission
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For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
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Discharge or 7 days after admission
|
|
Composite Adherence Score
Prazo: Discharge or 7 days after admission
|
Composite Adherence Score: defined as the sum of usage of evidence based therapies in the first 48 hours and at discharge among the patients' total eligible opportunities.
For this purpose, patients with contraindications (which are specific for each endpoint) were excluded from the denominators.
Evidence based therapies in the first 48 hours include: antithrombotics within 48 hours of admission, use of recombinant Plasminogen Activator (Rt-PA)in patients who arrive at the hospital within 3.5 hours of symptom onset and who are treated within 4.5 hours of symptom onset, dysphagia screening, pre-deep venous thrombosis prophylaxis, door to needle time < 60 minutes, dysphagia screening).
Discharge Therapies include: antithrombotics, lipid lowering agents in patients with LDL 100 or not documented, anticoagulants for atrial fibrilation or flutter, assessment for rehabilitation and smoke cessation education
|
Discharge or 7 days after admission
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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"All or None" Quality Measures
Prazo: Discharge or 7 days after admission
|
Proportion of prescription of evidence-based strategies in the first 48 hours and at discharge "All or none" measures including the evidence based therapies in the first 48h: antithrombotics, use of recombinant Plasminogen Activator (Rt-PA)in patients who arrive at the hospital within 3.5 hours of symptom onset and who are treated within 4.5 hours of symptom onset, dysphagia screening, pre-deep venous thrombosis prophylaxis, door to needle time < 60 minutes, dysphagia screening).
Discharge Therapies include: antithrombotics, lipid lowering agents in patients with LDL 100 or not documented, anticoagulants for atrial fibrilation or flutter, assessment for rehabilitation and smoke cessation education
|
Discharge or 7 days after admission
|
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Additional Strategies
Prazo: Discharge or 7 days after admission
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Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min)
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Discharge or 7 days after admission
|
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Total Mortality
Prazo: Discharge or 7 days after admission and 90 days
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In hospital and 90 days mortality
|
Discharge or 7 days after admission and 90 days
|
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Disability
Prazo: 90 days
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Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.
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90 days
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Stroke Recurrence
Prazo: 90 days
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Number of patients presenting a new stroke in 90 days
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90 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: M. Julia Machline Carrion, MD, MHS, PhD, Hospital do Coracao
Publicações e links úteis
Publicações Gerais
- Machline-Carrion MJ, Santucci EV, Damiani LP, Bahit MC, Malaga G, Pontes-Neto OM, Martins SCO, Zetola VF, Normilio-Silva K, Rodrigues de Freitas G, Gorgulho A, De Salles A, Pacheco da Silva BG, Santos JY, de Andrade Jesuino I, Bueno PRT, Cavalcanti AB, Guimaraes HP, Xian Y, Bettger JP, Lopes RD, Peterson ED, Berwanger O; BRIDGE-Stroke Investigators. Effect of a Quality Improvement Intervention on Adherence to Therapies for Patients With Acute Ischemic Stroke and Transient Ischemic Attack: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Aug 1;76(8):932-941. doi: 10.1001/jamaneurol.2019.1012.
- Machline-Carrion MJ, Santucci EV, Damiani LP, Bahit C, Malaga G, Pontes-Neto OM, Martins SCO, Zetola VF, Normilio-Silva K, de Freitas GR, Gorgulho A, De Salles A, da Silva BGP, Santos JY, de Andrade Jesuino I, Bueno PRT, Cavalcanti AB, Guimaraes HP, Xian Y, Bettger JP, Lopes RD, Peterson ED, Berwanger O. An international cluster-randomized quality improvement trial to increase the adherence to evidence-based therapies for acute ischemic stroke and transient ischemic attack patients: Rationale and design of the BRIDGE STROKE Trial. Am Heart J. 2019 Jan;207:49-57. doi: 10.1016/j.ahj.2018.09.009. Epub 2018 Sep 30.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- BRIDGE-Stroke
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