|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Michigan |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | 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 and interactive educational intervention, BA-IEI |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Clinical Trial to Increase t-PA Use in Stroke Treatment |
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Behavioral: barrier assessment and interactive educational intervention, BA-IEI
The study consists of 3 phases with 12 intervention sites and 12 control sites Pre-intervention phase: 12 months baseline acute stroke tPA use data. ED physician knowledge/attitudes regarding tPA use in stroke using a web based survey. Random assignment to "intervention" or "control" arms. Intervention phase (intervention sites only): "local stroke champions" support; 1-day study meeting in Ann Arbor. On-site assessments of barriers to tPA use in stroke in the ED. Two 1-day educational interventions (at 3-month intervals) with on-site CME sessions and a mock stroke code. Access to tPA stroke expertise (24/7) via the University of Michigan Brain Injury Group; electronic messaging on tPA use; debriefing for known tPA-use complications. Post-intervention phase, (all sites): Monthly tPA use. Quarterly ICD-9 reports. Review of all ED tPA treated stroke cases by retrospective chart/imaging review. Physician reassessment with survey at 6, 18 and 30 months. |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan, Department of Emergency Medicine | |
| Ann Arbor, Michigan, United States, 48106 | |
| 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
| Responsible Party: | University of Michigan Department of Emergency Medicine ( Phillip A. Scott, MD, Principal Investigator ) |
| Study ID Numbers: | R01NS050372-02 |
| Study First Received: | July 5, 2006 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00349479 History of Changes |
| Health Authority: | United States: Federal Government |
|
stroke tissue plasminogen activator t-PA barrier assessment and interactive educational intervention BA-IEI |
|
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents |
Cardiovascular Agents Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction |
