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Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00349479
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : February 25, 2013
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Phillip A. Scott, University of Michigan

Brief Summary:
The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Barrier assessment / interactive educational intervention Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Clinical Trial to Increase t-PA Use in Stroke Treatment
Study Start Date : May 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in t-PA use with assessment of appropriateness of use and complications. [ Time Frame: January 2005 to January 2010 ]
    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).

Secondary Outcome Measures :
  1. Changes in emergency physician knowledge and attitudes regarding thrombolytic use. [ Time Frame: 2007 to 2009 ]
  2. Intracerebral Hemorrhage [ Time Frame: 2007 to 2010 ]
  3. Systemic hemorrhage [ Time Frame: 2007 to 2010 ]
  4. tPA-use guideline deviations [ Time Frame: 2007 to 2010 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Physician staffed emergency department at all times
  • 24/7 CT scanning availability
  • Computerized pharmacy dispensing system for the emergency department or thrombolytic use log
  • Agreement to participate and identified site investigator

Exclusion Criteria:

  • Primary children's, psychiatric, or long-term (convalescent) care hospital
  • Established academic comprehensive stroke center (Detroit Receiving Hospital, Henry Ford Hospital, University of Michigan)
  • Annual emergency department volume greater than 100,000 patients per year (only one hospital)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00349479

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United States, Michigan
University of Michigan, Department of Emergency Medicine
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
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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
Publications of Results:
Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Phillip A. Scott, Associate Professor, University of Michigan Identifier: NCT00349479    
Other Study ID Numbers: R01NS050372-02 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by Phillip A. Scott, University of Michigan:
tissue plasminogen activator
barrier assessment and interactive educational intervention
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases