Improving Patient Access to Stroke Therapy Study

Terminated

• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Interventions: Drug: Activase; Device: Endovascular therapy

• Registration Number: NCT01870492
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Study Start: 2014-01
• Primary Completion: 2015-09-29
• Study Completion: 2015-09-29
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke or TIA	Endovascular therapy	Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.
Acute ischemic stroke or TIA	Activase	Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.

Primary Outcome Measures

Name	Time	Method
Identification of regional pre-hospital, hospital, and community barriers to stroke therapy	At end of study (12 months)

Secondary Outcome Measures

Name	Time	Method
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)
Total number of stroke patients treated with acute stroke therapy	At end of study (12 months)

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States