Increasing Stroke Treatment Through Interventional Change Tactics Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.

Detailed Description
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Stroke is a major public health problem. Only 1 to 3 percent of people with stroke patients in community settings are receiving tissue plasminogen activator (t-PA) therapy ten years after it was approved by the Food and Drug Administration (FDA). Data from academic stroke teams, stroke patient arrival times, and thrombolytic therapy (clot-dissolving) in myocardial infarction suggest substantially higher treatment rates are possible. The development and implementation of educational interventions to motivate physicians, other healthcare providers, and healthcare organizations, to learn the principles of acute stroke care is a high-priority. Limited prior work found a combination of community and professional education increased thrombolytic therapy for stroke from a pre-intervention rate of 2.2 percent to a post-intervention rate of 11.3 percent, with the data suggesting the professional education was the critical element for increasing use. The Increasing Stroke Treatment through Interventional behavioral Change Tactics (INSTINCT) trial is designed to evaluate a standardized, system-based barrier assessment and interactive educational intervention (BA-IEI) for increasing appropriate t-PA use in people with stroke. This multi-center, randomized, controlled study will be conducted at 24 hospital sites nationwide. The intervention, BA-IEI, targets emergency departments and is based on adult education and behavior change theory. BA-IEI is designed for replication in community health initiatives. It incorporates local stroke champion development, hospital-specific barrier evaluation, mixed CME targeting identified barriers, performance feedback, protocol development, and academic detailing. The primary endpoint will be the increase in appropriate use of t-PA for stroke with evaluations of change in emergency physician knowledge on t-PA use. The primary aims of this study are to determine if a BA-IEI is effective in increasing appropriate t-PA use in stroke, and if BA-IEI improves emergency physician knowledge, beliefs, and attitudes regarding the use of t-PA for acute stroke. Results from this study may lead to an effective method for increasing the use of t-PA for stroke.

Official Title
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Clinical Trial to Increase t-PA Use in Stroke Treatment

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Barrier assessment / interactive educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician staffed emergency department at all times 24/7 CT scanning availability Computerized pharmacy dispensing system for the emergency department or thrombolytic use log Agreement to participate and identified site investigator Exclusion Criteria: Primary children's, psychiatric, or long-term (convalescent) care hospital Established academic comprehensive stroke center (Detroit Receiving Hospital, Henry Ford Hospital, University of Michigan) Annual emergency department volume greater than 100,000 patients per year (only one hospital)
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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Behavioral: Barrier assessment / interactive educational intervention<br>* Intervention hospitals received a barrier assessment - interactive educational intervention (BA-IEI) which included: on-site barrier assessment, annual stroke champions meetings, stroke center telephone access, quarterly mock stroke codes, and ongoing feedback and education.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in t-PA use with assessment of appropriateness of use and complications. | The primary outcome was based on the change in the rate of tPA use between the pre-intervention period (Jan 2005 to Dec 2006) and the post-intervention period immediately following the conclusion of the first mock code stroke / CME intervention (Jan 2008 to Jan 2010). | January 2005 to January 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in emergency physician knowledge and attitudes regarding thrombolytic use. |  | 2007 to 2009 | 
| Intracerebral Hemorrhage |  | 2007 to 2010 | 
| Systemic hemorrhage |  | 2007 to 2010 | 
| tPA-use guideline deviations |  | 2007 to 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, tissue plasminogen activator, t-PA, barrier assessment and interactive educational intervention, BA-IEI