Increasing Stroke Treatment Through Interventional Change Tactics Study (INSTINCT)
Clinical Trial to Increase t-PA Use in Stroke Treatment
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106
- University of Michigan, Department of Emergency Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Řízení
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Aktivní komparátor: Zásah
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in t-PA use with assessment of appropriateness of use and complications.
Časové okno: January 2005 to January 2010
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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).
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January 2005 to January 2010
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Changes in emergency physician knowledge and attitudes regarding thrombolytic use.
Časové okno: 2007 to 2009
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2007 to 2009
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Intracerebral Hemorrhage
Časové okno: 2007 to 2010
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2007 to 2010
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Systemic hemorrhage
Časové okno: 2007 to 2010
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2007 to 2010
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tPA-use guideline deviations
Časové okno: 2007 to 2010
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2007 to 2010
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Phillip A. Scott, MD, University of Michigan
- Vrchní vyšetřovatel: Mary Haan, MPH, DrPhD, University of Michigan, Co-Investigator
- Vrchní vyšetřovatel: John M. Kalbfleisch, Math, PhD, University of Michigan, Co-Investigator
- Vrchní vyšetřovatel: Lewis Morgenstern, MD, University of Michigan, Co-Investigator
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R01NS050372-02 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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