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Completed

NCT Number: NCT00349479

Increasing Stroke Treatment Through Interventional Change Tactics Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Department of Emergency Medicine

Ann Arbor, Michigan, 48106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Barrier assessment / interactive educational intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Clinical Trial to Increase t-PA Use in Stroke Treatment

Acronym: INSTINCT

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2006
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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