title: Protocol Deviations before and after Treatment with Intravenous Tissue Plasminogen Activator in Community Hospitals.
abstract: BACKGROUND
  Protocol deviations before and after tissue plasminogen activator (tPA) treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict protocol deviations. We examined predictors of protocol deviations and the effects of protocol violations on symptomatic intracerebral hemorrhage (sICH).
  
  
  METHODS
  We used data from the Increasing Stroke Treatment through Interventional Behavior Change Tactics trial, a cluster-randomized, controlled trial evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use in 24 Michigan community hospitals, to review tPA treatments between 2007 and 2010. Protocol violations were defined as deviations from the standard tPA protocol, both before and after treatment. Multilevel logistic regression models were fitted to determine if patient and hospital variables were associated with pretreatment or post-treatment protocol deviations.
  
  
  RESULTS
  During the study, 557 patients (mean age 70, 52% male, median National Institutes of Health Stroke Scale score 12) were treated with tPA. Protocol deviations occurred in 233 (42%) patients: 16% had pretreatment deviations, 35% had post-treatment deviations, and 9% had both. The most common protocol deviations included elevated post-treatment blood pressure, antithrombotic agent use within 24 hours of treatment, and elevated pretreatment blood pressure. Protocol deviations were not associated with sICH, stroke severity, or hospital factors. Older age was associated with pretreatment protocol deviations (adjusted odds ratio [OR], .52; 95% confidence interval [CI], .30-.92). Pretreatment deviations were associated with post-treatment deviations (adjusted OR, 3.20; 95% CI, 1.91-5.35).
  
  
  CONCLUSIONS
  Protocol deviations were not associated with sICH. Aside from age, patient and hospital factors were not associated with protocol deviations.
authors.affiliation: Stroke Program, Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan. Electronic address: eriadelm@med.umich.edu.
authors.forename: Eric E
authors.initials: EE
authors.lastname: Adelman
authors.affiliation: Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.
authors.forename: Phillip A
authors.initials: PA
authors.lastname: Scott
authors.affiliation: Stroke Program, Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan.
authors.forename: Lesli E
authors.initials: LE
authors.lastname: Skolarus
authors.affiliation: Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.
authors.forename: Allison K
authors.initials: AK
authors.lastname: Fox
authors.affiliation: Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.
authors.forename: Shirley M
authors.initials: SM
authors.lastname: Frederiksen
authors.affiliation: Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan.
authors.forename: William J
authors.initials: WJ
authors.lastname: Meurer
mesh_terms: D000367:Age Factors; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy*; D002543:Cerebral Hemorrhage / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002985:Clinical Protocols; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019983:Guideline Adherence; D006282:Health Personnel / Q000193:education; D006764:Hospitals, Community / Q000706:statistics & numerical data*; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D007262:Infusions, Intravenous; D016015:Logistic Models; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; C067262:PLAT protein, human; D010959:Tissue Plasminogen Activator
keywords: Stroke; emergency department; tPA; thrombolysis