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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Evidence-based clinical pathway Standard operating procedures (SOP) of performance indicators A quality coordinator 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

Official Title
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Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Behavioral: improvement intervention
* Behavioral: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Improvement intervention<br>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<br>* 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.<br>|
| Other: no intervention<br>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<br>* No intervention indicated that the physicians among control hospital provide routine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications | 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. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| a composite measure score of performance measures | 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. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, performance measure, acute treatment