Clinical Trial Details

An International Cluster Randomized Quality-Improvement Trial to Increase the Adherence to Evidence-Based Therapies for Acute Ischemic Stroke and Transient Ischemic Attack Patients - The Bridge Stroke Trial

The purpose is to evaluate the effect of a multifaceted strategy compared to usual care on increasing the use of evidence-based treatments for 1624 acute ischemic stroke or transient ischemic attack patients in São Paulo, Brazil hospitals.

Multifaceted Strategy:

  • 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

Key Findings

The use of evidence-based therapies for Brazilian patients admitted with acute ischemic stroke and transient ischemic attack was significantly increased with use of multi-faceted quality improvement intervention.

Principal Investigator M. Julia Machline Carrion on BRIDGE Stroke

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M. Julia Machline Carrion, MD, MHS, PhD, summarizes the results of BRIDGE Stroke, which she presented during Scientific Sessions 2018.

BRIDGE Stroke - Commentary

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Don Lloyd-Jones, MD, ScM, vice chair of the program committee for Scientific Sessions 2018, comments on the results of the BRIDGE Stroke trial, which was presented at the meeting in Chicago this year.

Purpose: To evaluate the use of evidence-based therapies for a hospital-level multi-faceted quality improvement intervention in AIS or TIA patients in Brazil, Argentina, and Peru.

Trial Design: cluster-randomized trial 1624 patients patients in 32 hospitals in Brazil, Argentina, and Peru; quality improvement intervention (case management, reminders, educational materials, algorithms, and audit and feedback reports) vs routine practice.

Primary Endpoints: composite adherence score for first 48 hours from admission and at discharge for evidence-based quality performance measures.

Secondary Endpoint: 'all or none' composite score for first 48 hours and at discharge.

Results: The use of evidence-based therapies for patients admitted with acute ischemic stroke and transient ischemic attack did not significantly increase with the use of a multi-faceted quality improvement intervention.

BRIDGE Stroke Prevention Data
RoutinePop. Avg.
adds. ratio
Composite Score
Likely to get all eligible therapies – complete adherence

Detailed Results

Primary endpoint

  1. Composite Adherence Score for evidence-based performance in-hospital:
    Intervention 85.3%, Control 77.9%; population average OR=4.12; p=0.30

Secondary Endpoint

  1. Complete Adherence in-hospital (all-or-none):
    Intervention 49.2%, Control 25.2%; population average OR=2.59; p=0.01
  2. Rt-PA within therapeutic window: Intervention 55%, Control 39.3%; p=0.01
  3. Door-to-needle time < 60 minutes: Intervention 57.9%, Control 48.8%; p= 0.06
  4. Early antithrombotics: Intervention93.6%,Control 94.1%; p=0.22
  5. DVT prophylaxis: Intervention 72.4%, Control 50.2%; p=0.07
  6. Anticoagulants for AF or flutter: Intervention 76%, Control 79.4%; p=0.97
  7. Statins for LDL >100 or not documented: Intervention 90.8%, Control 90%; p=0.61
  8. Smoking cessation education: Intervention 72.1, Control 48.5%; p=0.04
  9. Rehabilitation assessment: Intervention 87.2%, Control 79.4%; p=0.28
  10. Dysphagia screening: Intervention 81.2%, Control 63.6%; p=0.14

Trial Design — cluster randomized trial where Brazilian hospitals were randomized to use the multifaceted strategy or usual care.
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.

Trial Population — 1624 patients with an ischemic stroke or TIA; mean age 70; 56.2% men.

Primary Endpoints:— within 48 hours of admission and at discharge:

  • Frequency of Evidence Based Strategies
  • Composite Adherence Score for evidence-based performance

Secondary Endpoints

  1. "All or None" Quality Measures (proportion of evidence-based strategies prescribed in the first 48 hours and at discharge) [antithrombotics, plasminogen activator, dysphagia screening, pre-deep venous thrombosis prophylaxis, door-to-needle time; discharge: antithrombotics, lipid lowering agents in patients with LDL 100 or not documented, anticoagulants for atrial fibrillation or flutter, assessment for rehabilitation, smoke cessation education]
  2. Proportion of use of additional strategies (recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min) at discharge or 7 days after admission
  3. Total Mortality at discharge or 7 days after admission and at 90 days
  4. Disability (measured by the Modified Rankin Scale) at discharge and in 90 days
  5. Stroke recurrence at 90 days

Sponsor— Hospital do Coracao


Key Words
Stroke, quality improvement, recombinant Plasminogen Activator (Rt-PA), anti-hypertensive medications, ischemic stroke, hemorrhagic stroke

Related Clinical Topics
Stroke rehabilitation, transient ischemic attack (TIA), primary and secondary stroke prevention, hypertension, atrial fibrillation