Title: Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial. A stepped wedge randomised cluster trial of an intervention to improve quality of care for patients undergoing emergency laparotomy
Funder: Department of Health and Social Care

Abstract: Each year, more than one million adults undergo in-patient non-cardiac surgery in the NHS with an overall mortality between 1.6% and 3.6%. Deaths are most frequent amongst high-risk patients undergoing emergency surgery. The key factors associated with poor patient outcomes following emergency surgery are advancing age, co-existing medical disease and abdominal surgery. Around 35,000 patients present to NHS hospitals each year with precisely this pattern of risk and undergo a procedure termed ‘emergency laparotomy’ - major surgery to treat an acute life threatening problem within the abdomen. Both standards of patient care and mortality following this procedure vary widely between NHS hospitals indicating a need for quality improvement interventions to improve survival. A working group developed an integrated care pathway which may significantly improve quality of care for this patient group. Pathway interventions include consultant led treatment, timely surgery and planned admission to critical care. Some hospitals already meet some of these standards but there are few examples of systematic implementation of the entire care pathway. Many opinion leaders support the use of quality improvement projects to promote implementation but others question this approach which is not well supported by clinical evidence. This uncertainty affects the care of all high-risk surgical patients. We propose a randomised stepped wedge cluster trial of a quality improvement intervention to implement an integrated care pathway in patients scheduled for emergency laparotomy in 90 NHS hospitals to confirm the effect on survival at 90 days after surgery. This will provide a robust evidence base for quality improvement which will inform the treatment of 170,000 NHS high-risk surgical patients each year.

Lay abstract: More than one million patients undergo surgery each year in the NHS, following which 30,000 patients die without leaving hospital. However, most deaths occur amongst a sub-population of patients who we know are exposed to much greater risks. These patients require prolonged hospital care and suffer substantial reductions in functional independence and long-term survival. Advancing age, abdominal surgery and the need for emergency surgery are amongst the strongest factors associated with poor post-operative outcome. Around 35,000 patients present to NHS hospitals each year with precisely this pattern of risk and undergo a procedure termed emergency laparotomy (major surgery to treat a life threatening problem within the abdomen). Almost 9,000 emergency laparotomy patients will die within three months of surgery. Doctors recognise that these patients are particularly difficult to treat successfully. However, recent evidence shows that quite basic standards of patient care vary widely between hospitals. In particular, there are large differences in how often a senior surgeon is involved in planning and performing surgery, the presence of a senior anaesthetist during surgery and the use of planned admission to intensive care after surgery has been completed. These factors are likely to account in part for important differences between hospitals in the number of patients who die following emergency laparotomy, confirming the need for initiatives to improve quality of care and hence patient outcomes following this procedure. Doctors have developed guidelines which set out the important standards of care for emergency laparotomy patients. Three members of our group were involved in writing these guidelines which describe an ‘integrated care pathway’ pulling together everything which we believe will work best to optimise patient survival. Unfortunately, previous attempts to implement guidelines to improve patient care on a national basis have proved challenging. Some doctors see this kind of project as an implicit criticism of the standard of their work. Others question the benefits of these initiatives and point to the lack of clinical evidence that quality improvement initiatives improve patient outcomes. By studying the effects of introducing an integrated care pathway on survival for emergency laparotomy patients we would provide robust evidence for the benefits of quality improvement projects. This would help to ensure widespread clinician engagement benefiting not only this specific patient group but as many as 170,000 patients who undergo high-risk surgery each year in the NHS. We plan to perform a specially designed clinical trial allocating ninety hospitals in random order to a quality improvement intervention which will enable local staff to deliver the highest possible standard of care for emergency laparotomy patients. This 'stepped wedge cluster trial' design will avoid the need for individual patients to make a decision to take part. Instead, we will use existing healthcare data capture systems to provide anonymous data on individual patients. In this way we expect to make use of data describing 27,540 patients undergoing emergency laparotomy over an 85 week period. Our primary objective is to confirm whether fewer patients die within 90 days of surgery in hospitals where the quality improvement project is in place. We will also examine any effects on later deaths within 180 days following surgery, the number of days patients spend in hospital and the number of patients re-admitted to hospital. We will conduct a parallel ethnographic study (a study involving in depth observations and interviews with staff at sites) to find out how we can further improve uptake of the pathway. A health economics analysis will provide information on the cost effectiveness of the quality improvement project and, by working with the National Emergency Laparotomy Audit, we will also be able to evaluate the long-term effects of our intervention in the participating hospitals.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: ORAL AND GASTROINTESTINAL