Increasing Stroke Treatment Through Interventional Change Tactics Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

Barrier assessment / interactive educational intervention

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No