Title: RESPOND study (Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration)
Funder: Department of Health and Social Care

Abstract: SCIENTIFIC ABSTRACT &ldquo;Failure to Rescue&rdquo; 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 &ldquo;Human Factors&rdquo; (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.

Lay abstract: Patient safety research studies problems in healthcare systems which harm patients. We want to study a healthcare situation where system problems are costing lives. In Emergency General Surgery (EGS), which deals mainly with patients with severe abdominal pain, the death rate after exploratory abdominal surgery to find out what s wrong (called laparotomy ) is 5 times higher than for similar routine surgery. Research on serious complications after major surgery shows that the patients chances of survival depend on how quickly and how well clinical teams react. We plan to analyse how surgical teams currently treat deteriorating patients, and help them develop and test better response systems. If we are successful, patients who develop complications will be treated faster and better, which will save lives and reduce time in hospital. Death rates after routine major surgery are lower in bigger hospitals than in smaller ones. We know this is not because larger units have less complications after surgery, but because they respond to them more effectively. Investigations of deaths after EGS frequently report that the teams involved did not respond rapidly and correctly to deterioration, and this is probably an important factor in the high laparotomy death rate. An effective response needs both early detection of problems and an efficient rescue system. Monitoring patients blood pressure, temperature, heart and breathing rates more reliably has not reduced death rates consistently, suggesting that it is more important to improve rescue systems. Research on why rescue systems sometimes don t work has highlighted communication and co-operation problems, and difficulties in getting specialist help quickly. Involving patients and families in the response may improve this process. Our plan involves: Using Human Factors science, which analyses how complex work systems succeed or fail, to analyse real life responses when EGS laparotomy patients deteriorate. Using Human Factors science, conduct small trials of improvements in systems for quickly arranging urgent re-operation or specialist referral. We will aim to learn from excellent practice as well as from analysis of failure. Select a bundle of 5 simple changes to rescue systems to make them faster and safer. One of these changes will be to develop reliable ways of involving patients and their families in raising the alarm. Test and modify the change bundle until we can show that it improves team performance during rescue. Once it appears stable and effective, test it in a multi-hospital trial. Hospitals will start using the new system at different dates (decided by chance), and we will compare their performance before and after they start. We will study the cost-effectiveness of the intervention and analyse what worked well and why, to make sure the lessons are learned effectively.

Research activity codes: 6.4 SURGERY
Health categories: GENERIC HEALTH RELEVANCE