Clinical trial NCT01870492: Improving Patient Access to Stroke Therapy Study
Official title: Improving Patient Access to Stroke Therapy Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: IV-tPA
Activase
endovascular therapy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with an acute ischemic stroke (AIS) or transient ischemic attack (TIA) and meet all of the inclusion and none of the exclusion criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identification of regional pre-hospital, hospital, and community barriers to stroke therapy
timeFrame: At end of study (12 months)
Secondary outcomes:
measure: Total number of stroke patients treated with acute stroke therapy
timeFrame: At end of study (12 months)
measure: Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase®
timeFrame: At end of study (12 months)
measure: Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase®
timeFrame: At end of study (12 months)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College Wisconsin
name: Osama O Zaidat, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: