Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Behavioral: Multifaceted Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifaceted Strategy<br>Multifaceted Intervention Simulation Based Team Training Case Manager Check lists Reminders Educational Materials | Behavioral: Multifaceted Strategy<br>* Simulation Based Team Training Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions Reminders - Check lists - decision support algorithm Distribution of educational materials: guidelines and recommendations for best practices<br>|
| No Intervention: Usual Care<br>Hospital Standard Treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Evidence Based Strategies | For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge | Discharge or 7 days after admission | 
| Composite Adherence Score | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All or None Quality Measures | 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 | 
| Additional Strategies | Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min) | Discharge or 7 days after admission | 
| Total Mortality | In hospital and 90 days mortality | Discharge or 7 days after admission and 90 days | 
| Disability | Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days. | 90 days | 
| Stroke Recurrence | Number of patients presenting a new stroke in 90 days | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke,, quality improvement