Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)

University of Michigan

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Barrier assessment / interactive educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00349479

R01NS050372-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

24 participants in 2 patient groups

Intervention

Active Comparator group

Treatment:

Behavioral: Barrier assessment / interactive educational intervention

Control

No Intervention group