<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223273</url>
  </required_header>
  <id_info>
    <org_study_id>BRIDGE-Stroke</org_study_id>
    <nct_id>NCT02223273</nct_id>
  </id_info>
  <brief_title>Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)</brief_title>
  <acronym>BRIDGEStroke</acronym>
  <official_title>A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital do Coracao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital do Coracao</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 1: An observational study ( registry) will be conducted with the objective of&#xD;
      documenting the practice of stroke treatment in brazilian and latin american hospitals.&#xD;
&#xD;
      Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy&#xD;
      to increase evidence based treatments usage for stroke patients. The hospitals will be&#xD;
      randomized into two groups: the multifaceted strategy group and the usual care group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objective: The purpose of this study is to evaluate a multifaceted strategy to increase&#xD;
      evidence based therapies for patients with acute ischemic stroke.&#xD;
&#xD;
      Study Population; Patients with suspected stroke or transient ischemic attack (TIA) with&#xD;
      symptoms lasting up to 24h hours.&#xD;
&#xD;
      Quality Improvement Multifaceted Intervention: The strategy includes a simulation based team&#xD;
      training, case manager, check lists, reminders and educational material.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Evidence Based Strategies</measure>
    <time_frame>Discharge or 7 days after admission</time_frame>
    <description>For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Adherence Score</measure>
    <time_frame>Discharge or 7 days after admission</time_frame>
    <description>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 &lt; 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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>&quot;All or None&quot; Quality Measures</measure>
    <time_frame>Discharge or 7 days after admission</time_frame>
    <description>Proportion of prescription of evidence-based strategies in the first 48 hours and at discharge &quot;All or none&quot; 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 &lt; 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Strategies</measure>
    <time_frame>Discharge or 7 days after admission</time_frame>
    <description>Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time&lt; 45 min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Mortality</measure>
    <time_frame>Discharge or 7 days after admission and 90 days</time_frame>
    <description>In hospital and 90 days mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>90 days</time_frame>
    <description>Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Recurrence</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients presenting a new stroke in 90 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1624</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Multifaceted Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multifaceted Intervention&#xD;
Simulation Based Team Training&#xD;
Case Manager&#xD;
Check lists&#xD;
Reminders&#xD;
Educational Materials</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Hospital Standard Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multifaceted Strategy</intervention_name>
    <description>Simulation Based Team Training&#xD;
Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions&#xD;
Reminders -&#xD;
Check lists - decision support algorithm&#xD;
Distribution of educational materials: guidelines and recommendations for best practices</description>
    <arm_group_label>Multifaceted Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Eligibility Criteria&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old, diagnosed with ischemic stroke (including transient&#xD;
             ischemic attack) with symptoms lasting up to 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with signs of hemorrhagic stroke, expansive lesions, central nervous system&#xD;
             infections, and those coming from institutions that did not provide institutional&#xD;
             approval form signed by the patients' guardians.&#xD;
&#xD;
        Cluster Eligibility Criteria&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitals with a emergency department, with available tomography, neurologist and&#xD;
             alteplase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitals that don't provide Institutional Authorization Form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Otavio Berwanger, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital do Coração</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M. Julia Machline Carrion, MD, MHS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital do Coração</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brazil</name>
      <address>
        <city>São Paulo</city>
        <zip>04004-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke,</keyword>
  <keyword>quality improvement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223273
org study id: BRIDGE-Stroke
nct id: NCT02223273
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Frequency of Evidence Based Strategies
time frame: Discharge or 7 days after admission
description: For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
measure: Composite Adherence Score
time frame: Discharge or 7 days after admission
description: 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
measure: "All or None" Quality Measures
time frame: Discharge or 7 days after admission
description: 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
measure: Additional Strategies
time frame: Discharge or 7 days after admission
description: Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min)
measure: Total Mortality
time frame: Discharge or 7 days after admission and 90 days
description: In hospital and 90 days mortality
measure: Disability
time frame: 90 days
description: Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.
measure: Stroke Recurrence
time frame: 90 days
description: Number of patients presenting a new stroke in 90 days
arm group label: Multifaceted Strategy
arm group type: Experimental
description: Multifaceted Intervention
Simulation Based Team Training
Case Manager
Check lists
Reminders
Educational Materials
arm group label: Usual Care
arm group type: No Intervention
description: Hospital Standard Treatment
intervention type: Behavioral
intervention name: Multifaceted Strategy
description: 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
arm group label: Multifaceted Strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Otavio Berwanger, MD, PhD
role: Study Chair
affiliation: Hospital do Coração
last name: M. Julia Machline Carrion, MD, MHS, PhD
role: Principal Investigator
affiliation: Hospital do Coração
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke