<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/NCT02212912</url>
  </required_header>
  <id_info>
    <org_study_id>aic2014</org_study_id>
    <nct_id>NCT02212912</nct_id>
  </id_info>
  <brief_title>Intervention to Bridge the Evidence-based Gap in Stroke Care Quality</brief_title>
  <acronym>GoldenBridge</acronym>
  <official_title>Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether a multifaceted quality improvement&#xD;
      intervention can improve the adherent rate of individual and composite of evidence-based&#xD;
      performance measures for patients with acute ischemic stroke within the first 7 days of&#xD;
      symptom onset and reduce the incidence of a new clinical vascular event, disability, and&#xD;
      all-cause mortality at discharge and long term clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study population:&#xD;
&#xD;
      patients with acute ischemic stroke who were admitted to the hospital within 7 days after the&#xD;
      initial symptom onset.&#xD;
&#xD;
      Program:&#xD;
&#xD;
      There are multifaceted quality improvement interventions including:&#xD;
&#xD;
        1. Evidence-based clinical pathway&#xD;
&#xD;
        2. Standard operating procedures (SOP) of performance indicators&#xD;
&#xD;
        3. A quality coordinator&#xD;
&#xD;
        4. Monitoring and feedback system of performance measures&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      Primary outcome:increase of adherence of evidence based treatment in clinical practice;&#xD;
      Secondary outcome: total mortality, disability, and major cerebrovascular events&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2014</start_date>
  <completion_date type="Actual">July 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 20, 2015</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>The primary end point was all-or-none measure of evidence-based performance measures in patients without contraindications, at the emergency department (Intravenous tissue-type plasminogen activator (tPA) in patients who arrive within 2 hours after initial symptom onset and treated within 3 hours), during 48 hours after admission (antithrombotic drugs; dysphagia screening; deep venous thrombosis prophylaxis including pneumatic compression devices, subcutaneous unfractionated heparin, low molecular weight heparin, or full-dose anticoagulation (e.g., with heparin or warfarin)) , and at discharge (antithrombotic therapy, discharge on anticoagulation for patients with atrial fibrillation, and discharged on statin, antihypertensive, and hypoglycemic medications). An all-or-none measure of care was used, which is defined as the proportion of patients who received all of the performance measure interventions for which they were eligible.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>a composite measure score of performance measures</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>The secondary primary end point was a new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality at discharge,3, 6, 12-months after initial symptom onset.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>a composite measure score of performance measures</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4800</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Improvement intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Improvement intervention is a multifaceted quality improvement method including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group indicated that the physicians will not be provided with the information of multifacet improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>improvement intervention</intervention_name>
    <description>Evidence-based clinical pathway: It contained general guideline-based recommendations about acute stroke management. Standard operating procedures (SOP) of performance indicators. A quality coordinator:The role of the quality coordinator includes interacting with physicians once gaps in the incorporation of evidence-based interventions are identified, ensuring that all components of the quality improvement intervention are being used for every acute ischemic stroke (AIS) patient.Monitoring and feedback system of performance measures.&#xD;
The system could view the level of implementation of prespecified performance measures at any time (per week recommended) , compare with the previous record of own study site and level of other clusters.</description>
    <arm_group_label>Improvement intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>No intervention indicated that the physicians among control hospital provide routine</description>
    <arm_group_label>no intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Older than 18&#xD;
&#xD;
          -  Ischemic stroke within 7 days of the index event&#xD;
&#xD;
          -  Direct admission based on physician evaluation or arrival through the emergency&#xD;
             department&#xD;
&#xD;
          -  Ability of patient or legally authorized representative to provide informed consent&#xD;
             for 3, 6,and 12 months after initial symptom onset&#xD;
&#xD;
          -  Eligible events were confirmed by brain ct or mri within7 days after the onset of&#xD;
             symptoms&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients refuse to participate in this study&#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>Yilong Wang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tian Tan Hospital, Capital Medical University, Beijing, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yongjun Wang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tian Tan Hospital, Capital Medical University, Beijing, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tian Tan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Yongjun Wang</investigator_full_name>
    <investigator_title>Executive Vice-President</investigator_title>
  </responsible_party>
  <keyword>acute ischemic stroke, performance measure, acute treatment</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>
    <mesh_term>Ischemia</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/NCT02212912
org study id: aic2014
nct id: NCT02212912
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate whether a multifaceted quality improvement
      intervention can improve the adherent rate of individual and composite of evidence-based
      performance measures for patients with acute ischemic stroke within the first 7 days of
      symptom onset and reduce the incidence of a new clinical vascular event, disability, and
      all-cause mortality at discharge and long term clinical outcome.
Study population:

      patients with acute ischemic stroke who were admitted to the hospital within 7 days after the
      initial symptom onset.

      Program:

      There are multifaceted quality improvement interventions including:

        1. Evidence-based clinical pathway

        2. Standard operating procedures (SOP) of performance indicators

        3. A quality coordinator

        4. Monitoring and feedback system of performance measures

      Endpoints:

      Primary outcome:increase of adherence of evidence based treatment in clinical practice;
      Secondary outcome: total mortality, disability, and major cerebrovascular events
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: The primary end point was all-or-none measure of evidence-based performance measures in patients without contraindications, at the emergency department (Intravenous tissue-type plasminogen activator (tPA) in patients who arrive within 2 hours after initial symptom onset and treated within 3 hours), during 48 hours after admission (antithrombotic drugs; dysphagia screening; deep venous thrombosis prophylaxis including pneumatic compression devices, subcutaneous unfractionated heparin, low molecular weight heparin, or full-dose anticoagulation (e.g., with heparin or warfarin)) , and at discharge (antithrombotic therapy, discharge on anticoagulation for patients with atrial fibrillation, and discharged on statin, antihypertensive, and hypoglycemic medications). An all-or-none measure of care was used, which is defined as the proportion of patients who received all of the performance measure interventions for which they were eligible.
measure: a composite measure score of performance measures
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.
measure: percentage of new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality
time frame: 3,6,12 months
description: The secondary primary end point was a new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality at discharge,3, 6, 12-months after initial symptom onset.
measure: a composite measure score of performance measures
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.
arm group label: Improvement intervention
arm group type: Other
description: Improvement intervention is a multifaceted quality improvement method including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.
arm group label: no intervention
arm group type: Other
description: The control group indicated that the physicians will not be provided with the information of multifacet improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care
intervention type: Behavioral
intervention name: improvement intervention
description: Evidence-based clinical pathway: It contained general guideline-based recommendations about acute stroke management. Standard operating procedures (SOP) of performance indicators. A quality coordinator:The role of the quality coordinator includes interacting with physicians once gaps in the incorporation of evidence-based interventions are identified, ensuring that all components of the quality improvement intervention are being used for every acute ischemic stroke (AIS) patient.Monitoring and feedback system of performance measures.
The system could view the level of implementation of prespecified performance measures at any time (per week recommended) , compare with the previous record of own study site and level of other clusters.
arm group label: Improvement intervention
intervention type: Behavioral
intervention name: no intervention
description: No intervention indicated that the physicians among control hospital provide routine
arm group label: no intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yilong Wang, M.D
role: Principal Investigator
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
last name: Yongjun Wang, M.D
role: Principal Investigator
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Yongjun Wang
investigator title: Executive Vice-President
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia