RESPOND study (Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration)

SCIENTIFIC ABSTRACT "Failure to Rescue" defined as death after postoperative complications, is now recognised as a major problem in surgical care. Although elective units with high volumes have lower mortality rates, they still exhibit the same level of complications as those with poorer results. This tells us that these Units are more successful at saving patients when complications occur. Within Emergency General Surgery (EGS) this situation is further exacerbated as mortality rates are up to 10 times higher than for elective operations. Although this is partly due to worse pathology, it is also a reflection of under-resourced and fragmented systems of care for emergency patients compared to their elective counterparts. Analysis of failed attempts to rescue deteriorating patients highlights problems with communication, teamwork, hierarchy and inter-group conflicts, suggesting that a "Human Factors" (HF) approach to intervention is relevant. We propose to develop a Human Factors systems change intervention to reduce failure to rescue (FTR) in emergency surgery. Starting with an analysis of system strengths and weaknesses we will co-design a better system with staff and patients, and test it at a smaller scale before proceeding to a randomised trial. Informed by ethnographic observation of work and semi structured interviews, a FRAM model of the process for rescue of deteriorating patients in EGS will be developed, using information from 3 hospitals. (Work Package 1) Focus groups of frontline staff will use the FRAM analysis to co-design a revised process with HF scientists and patient representatives. The revised process will include a patient involvement element in the response. (Work Package 2) The revised rescue system will be trialled and refined in a Development study in a single EGS Unit, using Quality Improvement methodology and a standardised implementation strategy (Supported Champions). After 3 months this work will be extended to 2 further EGS Units in an Exploration study to determine whether the intervention can be delivered reliably to several Units simultaneously. Preliminary Health Economic analysis and qualitative process evaluation will be conducted at this stage. The success of this study will be judged by measures of process fidelity and velocity e.g. time from first alert to definitive intervention (Work Package 3) If process is substantially improved, the intervention will be evaluated in a cluster-randomised stepped-wedge trial involving the EGS Units of 24 hospitals (Work Package 4). Hospitals will adopt the intervention in 6 groups of 4. The study is powered for 90% probability of detecting a 20% reduction in FTR. The primary outcome will be Failure to Rescue defined as the ratio of mortality to significant complications (Dindo-Clavien 3+). Secondary outcomes will include mortality, hospital stay, ITU bed use and rates of specified re-interventions. A formal Health Economic analysis and qualitative process evaluation will be conducted as part of the proposed trial. Guidelines based on our findings will be developed for NHS use beyond the trial. These will be disseminated via the NIHR network to share learning on embedding effective changes, ensuring the maximum benefit to quality and safety at national level.