A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,624
- 试验地点
- 1
- 主要终点
- Frequency of Evidence Based Strategies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Multifaceted Strategy
Multifaceted Intervention
- Simulation Based Team Training
- Case Manager
- Check lists
- Reminders
- Educational Materials
干预措施: Multifaceted Strategy (Behavioral)
Usual Care
Hospital Standard Treatment
结局指标
主要结局
Frequency of Evidence Based Strategies
时间窗: Discharge or 7 days after admission
For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
Composite Adherence Score
时间窗: 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
次要结局
- Total Mortality(Discharge or 7 days after admission and 90 days)
- "All or None" Quality Measures(Discharge or 7 days after admission)
- Disability(90 days)
- Stroke Recurrence(90 days)
- Additional Strategies(Discharge or 7 days after admission)