‘5 Rs to Rescue’: a study protocol of a multi-centre, stepped-wedged cluster trial in four African countries with a mixed methods process evaluation

Abstract Background Post-operative physiological deterioration that is not promptly treated, leading to a preventable death, is described as ‘failure to rescue’. In many resource-poor African hospitals, systems to prevent ‘failure to rescue’ are generally absent. This protocol outlines the methods for a stepped-wedge cluster trial that aims to determine the efficacy of a co-produced complex intervention, known as ‘5 Rs to Rescue’, in improving rescue capacity. Methods A multicentre stepped-wedged cluster trial will be conducted to evaluate the efficacy of ‘5 Rs to Rescue’ in four African countries. All consecutive elective and non-elective surgical patients aged ≥18 years admitted to participating hospital wards will be included. Five care processes will be implemented: risk assessment, recognition of deterioration, response to deterioration, reassessment, and reflection on the care provided. A three-month set-up phase will provide baseline data, followed by a six-month adaptation phase and a three-month sustainability phase. Comparison will be made between baseline and sustainability phases to determine whether the ‘5Rs to Rescue’ intervention increases surveillance for patients at risk of failure to rescue after surgery. A mixed-methods, theory-informed process evaluation will be conducted alongside the trial. This evaluation will combine small-group interviews, structured observations of care, and an end-of-study questionnaire. We will conduct deductive thematic analysis, mapped to the domains and constructs of the Consolidated Framework for Implementation Research. Discussion Given the unmet surgical need in Africa and projected increases in procedure volume, it is vitally important that interventional investigations continue for surgical patients. The outcomes of this study will inform the efficacy of the ‘5Rs to Rescue’ implementation. The intention is to then conduct a cluster randomised trial to demonstrate that the ‘5 Rs to Rescue’ intervention can decrease ‘failure to rescue’ and improve postoperative survival. Trial Registration: clinicaltrials.gov ID NCT06997328