Improving Patient Access to Stroke Therapy Study

Study Overview
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Brief Summary
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Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural hospitals, do not have the infrastructure or medical support to effectively treat AIS patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not receive proper treatment according to established guidelines. Thus, there remains an increasing need to assess and address the barriers that prevent patient access to proper AIS treatment. Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date, there have been no statewide studies initiated in Wisconsin to assess the regional barriers to the treatment of AIS patients with thrombolytic or endovascular therapy, and many hospitals do not routinely collect and analyze AIS patient data. The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage community hospitals statewide to identify the regional barriers to AIS therapy in WI.

Official Title
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Improving Patient Access to Stroke Therapy Study

Conditions
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Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Drug: Activase
* Device: Endovascular therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Clinical diagnosis of acute ischemic stroke or transient ischemic attack (TIA) ICD-9-CM code indicative of stroke or TIA Exclusion Criteria: Clinical diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage Stroke or TIA occurred while patient was hospitalized

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute ischemic stroke or TIA<br>Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy. | Drug: Activase<br>* Patients treated with Activase<br>* Other names: IV-tPA;Device: Endovascular therapy<br>* Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of regional pre-hospital, hospital, and community barriers to stroke therapy |  | At end of study (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of stroke patients treated with acute stroke therapy |  | At end of study (12 months) | 
| Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase® |  | At end of study (12 months) | 
| Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase® |  | At end of study (12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV-tPA, Activase, endovascular therapy