Title: Improving Outcomes in Post-Operative Emergency Laparotomy Care - The EMERALD Project
Funder: Department of Health and Social Care

Abstract: BackgroundEach year 27,000 patients undergo an emergency laparotomy (EmLap). EmLap is associated with significant burden to patients and costs the NHS 650 million annually. Outcomes require improvement and post-operative care is key. Currently, evidence-based standard post-operative care pathways are lacking. Development of a high quality, cost-effective intervention for post-operative EmLap care is needed. ObjectivesMy overall aim is to improve post-operative care and outcomes in EmLap. To understand current peri-operative processes and their impact on recovery, clinical, patient-reported and health economic outcomes. To identify core clinical and patient-reported outcomes of importance and to reach consensus on measurable outputs. To co-develop a complex intervention (EMERALD). To assess the feasibility of implementation of EMERALD. To identify the optimal trial design for a future evaluation.Methods Preparatory work for this fellowship includes a preliminary logic model of the EMERALD intervention, which will be iteratively refined. The hypothesised EMERALD intervention will consist of several components which may include medical, nursing, physiotherapy, nutritional and psychological.Work Package 1: Describing current standards of peri-operative care in EmLapI will undertake a cohort study utilising routine patient data in EmLap to identify interventions currently delivered in the peri-operative setting. Clinical, patient-reported and health economic outcomes will be collected. Sites with an established peri-operative pathway will be invited to participate in multidisciplinary team focus groups to identify facilitators of and barriers to implementation. Patients at these sites will be recruited to understand their perceptions and needs.Work Package 2: Design and development of EMERALD Identified interventions, with their associated outcomes (WP1), will be incorporated into a Delphi study and will be prioritised by an expert panel for inclusion into the overarching EMERALD intervention. Prioritised interventions will be co-developed into a post-operative care pathway jointly by patients and healthcare professionals using the principles of Experience-based Co-Design. An upfront EMERALD implementation strategy will be devised based on my findings using the principles of Normalisation Process Theory.Work Package 3: Feasibility evaluation of EMERALD I have designed a feasibility-implementation study; a sequential cohort study consisting of fixed and variable time periods with integrated process evaluation to assess the feasibility of EMERALD intervention implementation, the need for further optimisation and optimal future trial design. The study consists of five phases rolled out sequentially across five hospital sites.Work Package 4: Outcome assessment in EmLapI will supervise a PhD student (funded by Leeds University) to identify outcomes of important to clinicians and patients and develop these into a core outcome set and patient-reported outcome measure for EmLap.ImpactI will have developed a high-quality, multidisciplinary, patient-centred, complex intervention and will have identified the optimal trial design for a future phase III evaluation. Results will be discussed with NHS leaders and key organisations to influence future health policy. Methodologically, this project will generate new data in EmLap including the integration of two routinely collected datasets, use of co-design and upfront implementation in EmLap complex intervention development, innovative feasibility study design and the development of EmLap specific COS and PROM.

Lay abstract: AimsThe aim of this fellowship is to improve post-operative care in emergency laparotomy (EmLap) by designing a dedicated post-operative intervention. The specific aims of the EMERALD project are: To understand the current standards in post-operative care and their impact on patient outcomes. To identify clinical and patient outcomes of importance and how to measure these appropriately. To develop, refine and test a new intervention aimed to improve post-operative patient outcomes.BackgroundEmLap is a major operation that involves opening the abdomen and repairing any emergency problem.Approximately 27,000 patients undergo EmLap per year within the NHS.Despite a series of national projects to improve care,poor patient outcomes following EmLap remain common.Improving patient outcomes and standardising care in EmLap has been identified as a clinical priority. However,the guidance for post-operative care processes and interventions is limited and consists of low-quality evidence.This fellowship aims to design a high quality, evidence-based intervention for EmLap,which will include training and guidelines on best medical care to help hospitals implement good quality patient care.It is hypothesised the EMERALD intervention will consist of several standardised components including medical,nursing, physiotherapy,nutritional and psychological. EMERALD uses a mixed-methods,multidisciplinary research approach,which will improve patient outcomes and will lead to better research design in acute care.DesignEMERALD is designed as a series of work packages (WP) involving patients, healthcare professionals and researchers. WP1 will identify post-operative interventions delivered in routine clinical practice and their impact on patient outcomes,and their costs using existing datasets.It will also identify clinician and patient perceptions of post-operative EmLap care, identify barriers to implementing care pathways and how to overcome this,and will identify outcomes of importance when assessing post-operative care. WP2 will take the information identified from WPI to help design the EMERALD intervention.The first step will involve expert healthcare professionals and patients prioritising individual interventions identified in WP1 for inclusion into the overarching EMERALD intervention using a Delphi study.The prioritised interventions will be included in the EMERALD intervention, which will be designed by patients and healthcare professionals equally, using the principles of experience-based co-design. An upfront strategy will also be designed to aid future implementation of the EMERALD intervention. WP3 will undertaking preliminary testing of the EMERALD intervention using a new study design.This will assess whether it is possible to implement the EMERALD intervention and how this is done, it will also assess whether further refinements are required. Results from this fellowship will inform the design of a future trial to definitively assess the impact of EMERALD. WP4 will standardise research by developing a core outcome set and a patient-reported outcome measure specifically for use in EmLap. Patient and public involvement This project has been informed by a dedicated EMERALD Patient and Public group, who have made several recommendations and changes to project design and delivery to improve patient experience and ease participation. An EMERALD Patient Oversight Group will be convened and will meet at quarterly intervals throughout the fellowship to inform key aspects, including developing patient facing documents, advise on minimising the additional burden on participants, and advising on the format and content of the dissemination of the project findings. Patient representatives will be included on the project oversight committees. Dissemination Key policy makers, including NHS trusts, health boards and national organisations involved in EmLap care will be informed of the outputs.The findings will be presented at national and international conferences and published in peer reviewed journals. Results will be disseminated to patients by participating sites via a newsletter and by presentations at relevant patient groups.The results of this fellowship will inform the design of a phase III trial to definitively assess the impact of EMERALD.

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