Increasing Stroke Treatment Through Interventional Change Tactics Study

NCT00349479 | Completed DMC

• 1 other identifier: R01NS050372-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; tissue plasminogen activator; t-PA; barrier assessment and interactive educational intervention; BA-IEI

Outcome Measures

Primary Outcomes (1)

• Change in t-PA use with assessment of appropriateness of use and complications.

  The primary outcome was based on the change in the rate of tPA use between the "pre-intervention" period (Jan 2005 to Dec 2006) and the "post-intervention" period immediately following the conclusion of the first mock "code stroke / CME intervention (Jan 2008 to Jan 2010).

  January 2005 to January 2010

Secondary Outcomes (4)

• Changes in emergency physician knowledge and attitudes regarding thrombolytic use.

  2007 to 2009

• Intracerebral Hemorrhage

  2007 to 2010

• Systemic hemorrhage

  2007 to 2010

• tPA-use guideline deviations

  2007 to 2010

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Behavioral: Barrier assessment / interactive educational intervention

Control

NO INTERVENTION

Interventions

Barrier assessment / interactive educational intervention 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician staffed emergency department at all times
• /7 CT scanning availability
• Computerized pharmacy dispensing system for the emergency department or thrombolytic use log
• Agreement to participate and identified site investigator

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan, Department of Emergency Medicine

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (10)

• Scott PA, Frederiksen SM, Kalbfleisch JD, Xu Z, Meurer WJ, Caveney AF, Sandretto A, Holden AB, Haan MN, Hoeffner EG, Ansari SA, Lambert DP, Jaggi M, Barsan WG, Silbergleit R. Safety of intravenous thrombolytic use in four emergency departments without acute stroke teams. Acad Emerg Med. 2010 Oct;17(10):1062-71. doi: 10.1111/j.1553-2712.2010.00868.x.

  PMID: 21040107 BACKGROUND

• Meurer WJ, Majersik JJ, Frederiksen SM, Kade AM, Sandretto AM, Scott PA. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med. 2011 May 6;11:5. doi: 10.1186/1471-227X-11-5.

  PMID: 21548943 BACKGROUND

• Meurer WJ, Caveney AF, Lo A, Zhang L, Frederiksen SM, Sandretto AM, Silbergleit R, Scott PA. Lack of association between pretreatment neurology consultation and subsequent protocol deviation in tissue plasminogen activator-treated patients with stroke. Stroke. 2010 Sep;41(9):2098-101. doi: 10.1161/STROKEAHA.110.588491. Epub 2010 Aug 5.

  PMID: 20689081 BACKGROUND

• Caveney AF, Silbergleit R, Frederiksen S, Meurer WJ, Hickenbottom SL, Smith RW, Scott PA. Resource utilization and outcome at a university versus a community teaching hospital in tPA treated stroke patients: a retrospective cohort study. BMC Health Serv Res. 2010 Feb 19;10:44. doi: 10.1186/1472-6963-10-44.

  PMID: 20170487 BACKGROUND

• Meurer WJ, Scott PA, Caveney AF, Majersik JJ, Frederiksen SM, Sandretto A, Holden AB, Silbergleit R. Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator. Int J Stroke. 2010 Jun;5(3):163-6. doi: 10.1111/j.1747-4949.2010.00425.x.

  PMID: 20536612 BACKGROUND

• Scott PA. Enhancing community delivery of tissue plasminogen activator in stroke through community-academic collaborative clinical knowledge translation. Emerg Med Clin North Am. 2009 Feb;27(1):115-36, ix. doi: 10.1016/j.emc.2008.07.001.

  PMID: 19218023 BACKGROUND

• Meurer WJ, Frederiksen SM, Majersik JJ, Zhang L, Sandretto A, Scott PA. Qualitative data collection and analysis methods: the INSTINCT trial. Acad Emerg Med. 2007 Nov;14(11):1064-71. doi: 10.1197/j.aem.2007.05.005. Epub 2007 Jul 24.

  PMID: 17652268 BACKGROUND

• Scott PA, Xu Z, Meurer WJ, Frederiksen SM, Haan MN, Westfall MW, Kothari SU, Morgenstern LB, Kalbfleisch JD. Attitudes and beliefs of Michigan emergency physicians toward tissue plasminogen activator use in stroke: baseline survey results from the INcreasing Stroke Treatment through INteractive behavioral Change Tactic (INSTINCT) trial hospitals. Stroke. 2010 Sep;41(9):2026-32. doi: 10.1161/STROKEAHA.110.581942. Epub 2010 Aug 12.

  PMID: 20705931 RESULT

• Skolarus LE, Scott PA, Burke JF, Adelman EE, Frederiksen SM, Kade AM, Kalbfleisch JD, Ford AL, Meurer WJ. Antihypertensive treatment prolongs tissue plasminogen activator door-to-treatment time: secondary analysis of the INSTINCT trial. Stroke. 2012 Dec;43(12):3392-4. doi: 10.1161/STROKEAHA.112.662684. Epub 2012 Oct 2.

  PMID: 23033348 RESULT

• Scott PA, Meurer WJ, Frederiksen SM, Kalbfleisch JD, Xu Z, Haan MN, Silbergleit R, Morgenstern LB; INSTINCT Investigators. A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial. Lancet Neurol. 2013 Feb;12(2):139-48. doi: 10.1016/S1474-4422(12)70311-3. Epub 2012 Dec 21.

  PMID: 23260188 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 7, 2006
• Study Start: May 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

US (1)