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Cluster-Randomized Trial of Thrombolysis Implementation Support in Metropolitan and Regional Australian Stroke Centers: Lessons for Individual and Systems Behavior Change.
- Source :
-
Journal of the American Heart Association [J Am Heart Assoc] 2020 Feb 04; Vol. 9 (3), pp. e012732. Date of Electronic Publication: 2020 Jan 24. - Publication Year :
- 2020
-
Abstract
- Background Intravenous thrombolytic therapy (IVT) with tissue plasminogen activator for acute ischemic stroke is underutilized in many parts of the world. Randomized trials to test the effectiveness of thrombolysis implementation strategies are limited. Methods and Results This study aimed to test the effectiveness of a multicomponent, multidisciplinary tissue plasminogen activator implementation package in increasing the proportion of thrombolyzed cases while maintaining accepted benchmarks for low rates of intracranial hemorrhage and high rates of functional outcomes at 3 months. A cluster randomized controlled trial of 20 hospitals in the early stages of thrombolysis implementation across 3 Australian states was undertaken. Monitoring of IVT rates during the baseline period allowed hospitals (the unit of randomization) to be grouped into 3 baseline IVT strata-very low rates (0% to ≤4.0%); low rates (>4.0% to ≤10.0%); and moderate rates (>10.0%). Hospitals were randomized to an implementation package (experimental group) or usual care (control group) using a 1:1 ratio. The 16-month intervention was based on behavioral theory and analysis of the steps, roles, and barriers to rapid assessment for thrombolysis eligibility and involved comprehensive strategies addressing individual and system-level change. The primary outcome was the difference in tissue plasminogen activator proportions between the 2 groups postintervention. The absolute difference in postintervention IVT rates between intervention and control hospitals adjusted for baseline IVT rate and stratum was not significant (primary outcome rate difference=1.1% (95% CI -1.5% to 3.7%; P =0.38). Rates of intracranial hemorrhage remained below international benchmarks. Conclusions The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior. Clinical Trial Registration URL: www.anzctr.org.au Unique identifiers: ACTRN12613000939796 and U1111-1145-6762.
- Subjects :
- Aged
Aged, 80 and over
Australia
Benchmarking trends
Brain Ischemia diagnosis
Female
Fibrinolytic Agents adverse effects
Humans
Infusions, Intravenous
Male
Middle Aged
Quality Improvement trends
Quality Indicators, Health Care trends
Stroke diagnosis
Thrombolytic Therapy adverse effects
Time Factors
Tissue Plasminogen Activator adverse effects
Treatment Outcome
Brain Ischemia drug therapy
Fibrinolytic Agents administration & dosage
Practice Patterns, Physicians' trends
Stroke drug therapy
Thrombolytic Therapy trends
Tissue Plasminogen Activator administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2047-9980
- Volume :
- 9
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of the American Heart Association
- Publication Type :
- Academic Journal
- Accession number :
- 31973599
- Full Text :
- https://doi.org/10.1161/JAHA.119.012732