Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349479
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2006-07-05
Brief Title:
Increasing Stroke Treatment Through Interventional Change Tactics Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Clinical Trial to Increase t-PA Use in Stroke Treatment
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSTINCT
Brief 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
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 22 percent to a post-intervention rate of 113 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
Limited prior work found a combination of community and professional education increased thrombolytic therapy for stroke from a pre-intervention rate of 22 percent to a post-intervention rate of 113 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None