Increasing Stroke Treatment Through Interventional Change Tactics Study "INSTINCT"

Completed

Phase N/A Results

Trial Description

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 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

Interventions

  • Alteplase Drug
    Intervention Desc: IV
  • Barrier assessment and interactive educational intervention, BA-IEI Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Intervention
  • Barrier assessment / interactive educational intervention Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Intervention

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

All hospitals were geographically isolated to prevent cross-contamination, and are also matched pairs where one member within each pair will be randomized to treatment or control. The intervention consists of developing local “stroke champions”; The educational intervention includes site barrier assessments to thrombolytic use, continuing education tailored to identified barriers, 24/7 telephone access to acute stroke treatment specialists, ongoing targeted messaging and performance feedback. The educational intervention targets the entire system of acute stroke care. Additionally, the following mechanisms will be provided to enhance behavior change in the intervention group: providing physicians access to thrombolytic stroke expertise as needed (24/7); providing electronic messaging feedback on hospital thrombolytic use; and providing critical incident debriefing for tPA complications (ICH).

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in tPA use, with assessment of appropriateness of use and complications.
Secondary Changes in emergency physician knowledge and attitudes regarding thrombolytic use at 12 months following the first IEI.
Primary Change in t-PA use with assessment of appropriateness of use and complications. 36 months from January 2007 to Dec. 2009 No
Secondary Changes in emergency physician knowledge and attitudes regarding thrombolytic use. 36 months from January 2007 to Dec. 2009 No
Secondary Intracerebral Hemorrhage 2007 to 2010 Yes
Secondary Systemic hemorrhage 2007 to 2010 Yes
Secondary tPA-use guideline deviations 2007 to 2010 Yes

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