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

Not Applicable
Completed
Conditions
Acute Ischemic Stroke
Interventions
Behavioral: Multifaceted Strategy
Registration Number
NCT02223273
Lead Sponsor
Hospital do Coracao
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1624
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Multifaceted StrategyMultifaceted StrategyMultifaceted Intervention 1. Simulation Based Team Training 2. Case Manager 3. Check lists 4. Reminders 5. Educational Materials
Primary Outcome Measures
NameTimeMethod
Frequency of Evidence Based StrategiesDischarge 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 ScoreDischarge 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

Secondary Outcome Measures
NameTimeMethod
"All or None" Quality MeasuresDischarge 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

Disability90 days

Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.

Stroke Recurrence90 days

Number of patients presenting a new stroke in 90 days

Additional StrategiesDischarge or 7 days after admission

Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time\< 45 min)

Total MortalityDischarge or 7 days after admission and 90 days

In hospital and 90 days mortality

Trial Locations

Locations (1)

Brazil

🇧🇷

São Paulo, Brazil

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