Improving Patient Access to Stroke Therapy Study "IMPACT"

Suspended

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: Principle Investigator is relocating to a new institution

Conditions

Interventions

  • Activase Drug
    Other Names: IV-tPA
    Intervention Desc: Patients treated with Activase
    ARM 1: Kind: Experimental
    Label: Acute ischemic stroke or TIA
    Description: Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.
  • Endovascular therapy Device
    Intervention Desc: Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.
    ARM 1: Kind: Experimental
    Label: Acute ischemic stroke or TIA
    Description: Patients presenting with acute ischemic stroke or transient ischemic attack and underwent treatment using Activase and/or endovascular therapy.

Trial Design

  • Observation: Cohort
  • Perspective: Retrospective
  • Sampling: Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Identification of regional pre-hospital, hospital, and community barriers to stroke therapy At end of study (12 months) No
Secondary Total number of stroke patients treated with acute stroke therapy At end of study (12 months) No
Secondary Total number of stroke patients eligible to receive Activase® versus patients eligible but did not receive Activase® At end of study (12 months) No
Secondary Use of endovascular therapy in patients who received Activase® versus patients who did not receive Activase® At end of study (12 months) No

Sponsors