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Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)
This study has been completed.

First Received on July 5, 2006.   Last Updated on November 16, 2011   History of Changes
Sponsor: University of Michigan
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party): Phillip A. Scott, University of Michigan
ClinicalTrials.gov Identifier: NCT00349479
  Purpose

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 Intervention
Stroke
Behavioral: Barrier assessment / interactive educational intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349479

Locations
United States, Michigan
University of Michigan, Department of Emergency Medicine
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
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
  More Information

Publications:
Scott PA, Xu Z, Meurer WJ, Frederiksen SM, Haan MN, Westfall MW, Kothari SU, Morgenstern LB, Kalbfleisch JD. Attitudes and beliefs of Michigan emergency physicians toward tissue plasminogen activator use in stroke: baseline survey results from the INcreasing Stroke Treatment through INteractive behavioral Change Tactic (INSTINCT) trial hospitals. Stroke. 2010 Sep;41(9):2026-32. Epub 2010 Aug 12.
Scott PA, Frederiksen SM, Kalbfleisch JD, Xu Z, Meurer WJ, Caveney AF, Sandretto A, Holden AB, Haan MN, Hoeffner EG, Ansari SA, Lambert DP, Jaggi M, Barsan WG, Silbergleit R. Safety of intravenous thrombolytic use in four emergency departments without acute stroke teams. Acad Emerg Med. 2010 Oct;17(10):1062-71.
Meurer WJ, Majersik JJ, Frederiksen SM, Kade AM, Sandretto AM, Scott PA. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med. 2011 May 6;11:5.
Meurer WJ, Caveney AF, Lo A, Zhang L, Frederiksen SM, Sandretto AM, Silbergleit R, Scott PA. Lack of association between pretreatment neurology consultation and subsequent protocol deviation in tissue plasminogen activator-treated patients with stroke. Stroke. 2010 Sep;41(9):2098-101. Epub 2010 Aug 5.
Caveney AF, Silbergleit R, Frederiksen S, Meurer WJ, Hickenbottom SL, Smith RW, Scott PA. Resource utilization and outcome at a university versus a community teaching hospital in tPA treated stroke patients: a retrospective cohort study. BMC Health Serv Res. 2010 Feb 19;10:44.
Meurer WJ, Scott PA, Caveney AF, Majersik JJ, Frederiksen SM, Sandretto A, Holden AB, Silbergleit R. Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator. Int J Stroke. 2010 Jun;5(3):163-6.
Scott PA. Enhancing community delivery of tissue plasminogen activator in stroke through community-academic collaborative clinical knowledge translation. Emerg Med Clin North Am. 2009 Feb;27(1):115-36, ix. Review.
Meurer WJ, Frederiksen SM, Majersik JJ, Zhang L, Sandretto A, Scott PA. Qualitative data collection and analysis methods: the INSTINCT trial. Acad Emerg Med. 2007 Nov;14(11):1064-71. Epub 2007 Jul 24.

Responsible Party: Phillip A. Scott, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00349479     History of Changes
Other Study ID Numbers: R01NS050372-02
Study First Received: July 5, 2006
Last Updated: November 16, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
stroke
tissue plasminogen activator
t-PA
barrier assessment and interactive educational intervention
BA-IEI

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012