A cluster-randomized trial to improve stroke care in hospitals

Abstract

Objective: We evaluated the effect of performance feedback on acute ischemic stroke care quality in Minnesota hospitals.

Methods: A cluster-randomized controlled trial design with hospital as the unit of randomization was used. Care quality was defined as adherence to 10 performance measures grouped into acute, in-hospital, and discharge care. Following preintervention data collection, all hospitals received a report on baseline care quality. Additionally, in experimental hospitals, clinical opinion leaders delivered customized feedback to care providers and study personnel worked with hospital administrators to implement changes targeting identified barriers to stroke care. Multilevel models examined experimental vs control, preintervention and postintervention performance changes and secular trends in performance.

Results: Nineteen hospitals were randomized with a total of 1,211 acute ischemic stroke cases preintervention and 1,094 cases postintervention. Secular trends were significant with improvement in both experimental and control hospitals for acute (odds ratio = 2.7, p = 0.007) and in-hospital (odds ratio = 1.5, p < 0.0001) care but not discharge care. There was no significant intervention effect for acute, in-hospital, or discharge care.

Conclusion: There was no definite intervention effect: both experimental and control hospitals showed significant secular trends with performance improvement. Our results illustrate the potential fallacy of using historical controls for evaluating quality improvement interventions.

Classification of evidence: This study provides Class II evidence that informing hospital leaders of compliance with ischemic stroke quality indicators followed by a structured quality improvement intervention did not significantly improve compliance more than informing hospital leaders of compliance with stroke quality indicators without a quality improvement intervention.

Figure 1 Project for the Improvement of Stroke Care Management in Minnesota (PRISMM) study design Reason for hospital attrition after randomization: 19 hospitals took part in the preintervention data collection. All hospitals had Institutional Review Board (IRB) approval at the start of PRISMM. The advent of Health Insurance Portability and Accountability Act in Minnesota in 2002 while the study was underway led to all hospitals reapplying for IRB approval. Two hospitals, unable to obtain IRB reapproval for the second phase of data collection, dropped out.

Figure 2 Change in acute (A), in-hospital (B), and discharge care (C) bundles preintervention and postintervention in experimental vs control hospitals Calculation of bundle performance was by combining a weighted average of performance on each measure comprising the bundle (table 1). This illustrates secular trends in both acute and in-hospital care and the lack of interaction of these trends with experimental vs control conditions (i.e., no intervention effect). Discharge care did not show any secular trend or intervention effect.