Impact of In-Hospital Quality of Care Improvement Initiative on Secondary Prevention of Acute Coronary Syndrome in Six Months After Patient Discharge: A Large Stepped Wedge- and Cluster-Randomized Controlled Trial

Abstract

Background: Patients discharged after acute coronary syndrome experience a high risk of major adverse cardiovascular events (MACE) within the first 6 months. We examined whether a quality of care improvement initiative implemented in hospitals affects clinical preventive management and outcomes after discharge.

Methods: We used data from the third phase of the CPACS-3 study (Clinical Pathways for Acute Coronary Syndromes in China), a large stepped wedge- and cluster-randomized trial conducted from 2011 to 2015, to evaluate the effectiveness of an in-hospital quality of care improvement program on the composite score of preventive medication use and the risk of MACE in 6 months after discharge among acute coronary syndrome survivors. The intervention included establishing a quality of care improvement team, training clinical staff, implementing acute coronary syndrome clinical pathways, performance assessment and feedback, online technical support, and patient education. A total of 101 hospitals were randomized into 4 wedges, and the intervention was initiated randomly by wedge and step. Participants recruited before (control) and after (intervention) the intervention initiation were compared with generalized estimating equations, adjusting for clustering and time trend.

Results: A total of 23 258 patients (11 224 in the intervention group and 12 034 in the control group), with a mean age of 63.6±11.6 years and 39% women, had available follow-up data on MACE and 14 826 patients (6813 in the intervention group and 8013 in the control group) had available data on preventive medication use at 6 months were analyzed. Compared with the control period, the mean preventive medication use score during the intervention period was higher at 6 months (65.8 versus 60.4 for intervention and control periods, adjusted mean difference, 3.7 [95% CI, 0.3-7.0]), but the 6-month incidence of MACE showed no difference (5.8% versus 6.6%, adjusted odds ratio, 1.04 [95% CI, 0.83-1.29]).

Conclusions: The in-hospital multifaceted quality of care improvement intervention in resource-constrained Chinese hospitals increased preventive medication use among acute coronary syndrome survivors in the 6 months after discharge, but this did not translate into a reduction in MACE.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01398228.

Keywords: acute coronary syndrome; clinical trial; quality improvement; secondary prevention.

Figure.

Study flowchart. *MACE indicates major adverse cardiovascular event.