Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Official Title:||Clinical Trial to Increase t-PA Use in Stroke Treatment|
- Change in t-PA use with assessment of appropriateness of use and complications. [ Time Frame: January 2005 to January 2010 ] [ Designated as safety issue: No ]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).
- Changes in emergency physician knowledge and attitudes regarding thrombolytic use. [ Time Frame: 2007 to 2009 ] [ Designated as safety issue: No ]
- Intracerebral Hemorrhage [ Time Frame: 2007 to 2010 ] [ Designated as safety issue: Yes ]
- Systemic hemorrhage [ Time Frame: 2007 to 2010 ] [ Designated as safety issue: Yes ]
- tPA-use guideline deviations [ Time Frame: 2007 to 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Intervention||
Behavioral: Barrier assessment / interactive educational intervention
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.
|No Intervention: Control|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349479
|United States, Michigan|
|University of Michigan, Department of Emergency Medicine|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Phillip A. Scott, MD||University of Michigan|
|Principal Investigator:||Mary Haan, MPH, DrPhD||University of Michigan, Co-Investigator|
|Principal Investigator:||John M. Kalbfleisch, Math, PhD||University of Michigan, Co-Investigator|
|Principal Investigator:||Lewis Morgenstern, MD||University of Michigan, Co-Investigator|