Abstract 133: Protocol Deviations During and After IV Thrombolysis in Community Hospitals
Background and purpose Protocol deviations (PDs) before and immediately after IV thrombolysis for acute ischemic stroke are common. Patient and hospital factors associated with PDs are not well described. We aimed to determine which patient or hospital factors were associated with pre- and post-treatment PDs in a cohort of community treated thrombolysis patients.
Methods The INSTINCT (Increasing Stroke Treatment through Interventional Behavior Change Tactics) study was a multicenter, cluster-randomized controlled trial in 24 Michigan community hospitals evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use. PDs were defined based on 2007 AHA guidelines with the addition of the 3-4.5 hour treatment window, for which the ECASS III criteria were applied. PDs were categorized as pre-treatment (Pre-PDs), post-treatment (Post-PDs) or both. Multi-level logistic regression models were fitted to determine whether patient and hospital variables were associated with Pre-PDs or Post-PDs. The models included all variables specified a priori to be potentially clinically relevant; Pre-PD was included as a covariate in the model for Post-PD.
Results During the study, 557 patients (mean age 70; 52% male; median NIHSS 12) were treated with IV tPA. PDs occurred in 233 (42%) patients: 26% had only Post-PDs, 7% had only Pre-PDs, and 9% had both. The most common PDs included failure to treat post-treatment hypertension (131, 24%), antiplatelet agent within 24 hours of treatment (61, 11%), pre-treatment blood pressure over 185/110 (39, 7%), anticoagulant agent within 24 hours of treatment (31, 6%), and treatment outside the time window (29, 5%). Symptomatic intracranial hemorrhage (SICH) was observed in 7.3% of patients with PDs and 6.5% of patients without any PD. In-hospital case fatality was 12% with and 10% without a PD. The differences in SICH and case fatality were not statistically significant. In the fully adjusted model, older age was significantly associated with Pre-PDs (Table). When Post-PDs were evaluated with adjustment for Pre-PDs, age was not associated with PDs; however, Pre-PDs were associated with Post-PDs.
Conclusion Older age was associated with increased odds of Pre-PDs in Michigan community hospitals. Pre-PDs were associated with Post-PDs. SICH and in-hospital case fatality were not associated with PDs; however, the low number of such events limited our ability to detect a difference. Stroke severity and hospital factors were not associated with PDs.
- © 2012 by American Heart Association, Inc.