Increasing Stroke Treatment Through Interactive Behavioral Change Tactics (INSTINCT) Study
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke
Intervention: barrier assessment and interactive educational intervention, BA-IEI (Behavioral)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Phillip A. Scott, MD, Principal Investigator, Affiliation: University of Michigan
Mary Haan, MPH, DrPhD, Affiliation: University of Michigan, Co-Investigator
John M. Kalbfleisch, Math, PhD, Affiliation: University of Michigan, Co-Investigator
Lewis Morgenstern, MD, Affiliation: University of Michigan, Co-Investigator
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.
Clinical Details
Official title: Clinical Trial to Increase t-PA Use in Stroke Treatment
Study design: Other, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Primary outcome: Change in t-PA use with assessment of appropriateness of use and complications.
Secondary outcome: Changes in emergency physician knowledge and attitudes regarding thrombolytic use.
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 Interactive 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
University of Michigan, Department of Emergency Medicine, Ann Arbor, Michigan 48106, United States
Additional Information
Starting date: May 2005
Ending date: April 2010
Last updated: December 11, 2007
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