Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery: a stepped-wedge cluster randomised trial

Abstract

Background Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients.

Methods Stepped-wedge cluster randomised trial of patients aged ≥40 years undergoing emergency open major abdominal surgery. Hospitals were organised into 15 geographical clusters and commenced the QI programme in random order, based on a computer generated random sequence, over an 85-week period. The trial included an ethnographic study in six hospitals. The primary outcome measure was mortality within 90 days of surgery. Analyses were performed on an intention-to-treat basis. The primary outcome was analysed using a mixed-effects parametric survival model, adjusting for time-related effects.

Findings Of 15,873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. The primary outcome occurred in 1393 patients in the usual care group (16%) compared with 1210 patients in the QI group (16%) (HR QI vs usual care: 1.11 [0.96-1.28]). There were only modest overall improvements in processes of patient care following QI implementation. The ethnographic study revealed good QI engagement but limited time and resources to implement change, affecting which processes teams addressed, the rate of change and eventual success.

Interpretation There was no survival benefit from a QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. The success of the QI intervention may have been limited by the time and resources needed to improve patient care.