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Intervention to Bridge the Evidence-based Gap in Stroke Care Quality (GoldenBridge)

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ClinicalTrials.gov Identifier: NCT02212912
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Yilong Wang, Ministry of Science and Technology of the People´s Republic of China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Behavioral: improvement intervention Behavioral: no intervention Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke
Actual Study Start Date : August 10, 2014
Actual Primary Completion Date : June 20, 2015
Actual Study Completion Date : July 30, 2016

Arm Intervention/treatment
Improvement intervention
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.
Behavioral: improvement intervention

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.


no intervention
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
Behavioral: no intervention
No intervention indicated that the physicians among control hospital provide routine




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.


Other Outcome Measures:
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Older than 18
  • Ischemic stroke within 7 days of the index event
  • Direct admission based on physician evaluation or arrival through the emergency department
  • Ability of patient or legally authorized representative to provide informed consent for 3, 6,and 12 months after initial symptom onset
  • Eligible events were confirmed by brain ct or mri within7 days after the onset of symptoms

Exclusion criteria:

  • Patients refuse to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212912


Locations
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China, Beijing
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Principal Investigator: Yilong Wang, M.D Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Principal Investigator: Yongjun Wang, M.D Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yilong Wang, Vice Director of Department of Science & Research Administration of Beijing Tiantan Hospital, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT02212912     History of Changes
Other Study ID Numbers: aic2014
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Yilong Wang, Ministry of Science and Technology of the People´s Republic of China:
acute ischemic stroke, performance measure, acute treatment
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes