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Completed

NCT Number: NCT02223273

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brazil

São Paulo, 04004-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifaceted Strategy

Behavioral
  • 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

Primary outcomes

  1. Frequency of Evidence Based Strategies

    Time frame: 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

  2. Composite Adherence Score

    Time frame: 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

Secondary outcomes

  1. "All or None" Quality Measures

    Time frame: 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

  2. Additional Strategies

    Time frame: Discharge 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)

  3. Total Mortality

    Time frame: Discharge or 7 days after admission and 90 days

    In hospital and 90 days mortality

  4. Disability

    Time frame: 90 days

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

  5. Stroke Recurrence

    Time frame: 90 days

    Number of patients presenting a new stroke in 90 days

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: BRIDGEStroke

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2014
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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