Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip A. Scott, University of Michigan
ClinicalTrials.gov Identifier:
NCT00349479
First received: July 5, 2006
Last updated: February 22, 2013
Last verified: February 2013
  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

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
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, see Learn About Clinical Studies.

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:

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: February 22, 2013
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

ClinicalTrials.gov processed this record on October 19, 2014