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NIHR Signal National quality improvement programmes need time and resources to have an impact

Published on 9 July 2019

doi: 10.3310/signal-000789

A large trial assessing the effectiveness of a UK-wide quality improvement programme did not show any difference in patient outcomes. However, the likely reasons for this were carefully investigated and provide some useful insights on implementation.

Several (37) quality improvement components were included in the ambitious package designed to reduce variation in care and improve outcomes for adults undergoing emergency abdominal surgery. There was no difference in survival at 30 days, length of hospital stay or rates of re-admission between the usual care and intervention groups.

This NIHR-funded study included a process evaluation showing that the intervention wasn’t fully implemented in all the 93 participating hospitals. There was good engagement from clinical staff with the programme, but busy staff had limited time and resources to implement change.

To be successful, more attention needs to be paid to the practicalities and time required to implement such programmes.

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Why was this study needed?

Emergency abdominal surgery is a high-risk procedure, with a much greater risk of death than other types of surgery. More than 1.53 million adults have inpatient surgery each year in the NHS, with a 30-day mortality of 1.5%. About 30,000 patients have emergency abdominal surgery each year, with 30-day mortality greater than 10%. There is evidence of wide variation in care for this patient group in NHS hospitals.

In 2011, the Royal College of Surgeons proposed a set of standards for the care of these patients, which they suggest should be a driver for improvement. There were 37 individual components to their recommended care pathway. This included steps to improve outcomes like automatic admission to intensive care for these patients.

Small studies have shown that QI programmes are associated with improved survival after emergency abdominal surgery. But it isn’t clear how effective a national scale implementation of a “bundle” of improvement interventions could be. This study aimed to answer that question.

What did this study do?

The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was a stepped-wedge cluster-randomised trial. It included 15,873 patients aged 40 years or over who were undergoing emergency open major abdominal surgery. Ninety-three NHS hospitals took part in the trial. These were organised into 15 geographical clusters.

All hospitals started the trial with their usual care procedures. Each cluster was then randomly allocated to start the quality improvement (QI) programme at five-week intervals, for 18 months. So the length of the intervention varied from five to eighty weeks, and each hospital had a period as a control group. QI leads in each hospital were given support and materials to implement the hospital-wide improvement programme. The design of this study took account of the gradual introduction of these changes across the country, enabling sites to compare outcomes before and after changes as well as with other sites who had not yet introduced improvements.

Patients were not aware of which study group they were in, but it wasn’t possible to mask hospital staff and investigators.

What did it find?

  • There was no difference between the usual care and intervention groups in number of deaths from any cause within 90 days of surgery, which occurred in 16% (1,393/8,482) of the usual care group, and 16% (1,210/7,374) of the QI group.
  • Length of hospital stay was the same in each group: 8 days (interquartile range 13 to 23) in the usual care group and to 8 days (interquartile range 13 to 24) in the QI group.
  • Hospital re-admission rates within 180 days were also similar: 20% (1,618/7,969) of the usual care group compared with 18% (1,242/6,723) of the QI group (HR 0.87, 95% CI 0.73 to 1.04).
  • There was no evidence that the QI intervention became more effective the longer it had been implemented.
  • A process evaluation found that staff had no additional time in their working days to accommodate the changes involved with the QI intervention. Most hospitals didn’t have the time or resources to implement all 37 improvement processes, so selected elements of the intervention. Some of the QI leads found challenges in getting support for change within their organisations.

What does current guidance say on this issue?

The Royal College of Surgeons published a commissioning guide in 2014 for emergency general surgery (acute abdominal pain). The guidance outlines what the best care looks like, and what procedures the best units will have in place. It says that commissioners can play a role in encouraging service improvement, and defines levers for implementation and improvement within the emergency general surgery pathways.

Quality measures include the presence of a consultant surgeon and a consultant anaesthetist, the proportion of patients admitted to critical care immediately after surgery, and availability of interventional radiology.

What are the implications?

This well-designed trial did not show any difference in patient outcomes between the usual care and the QI intervention groups in real-world settings. The process evaluation suggests that this could be due to the way the intervention was implemented, rather than because the intervention wasn’t effective.

Researchers suggest that for such complex change in practice to be successful, QI programmes need to allow for differences between organisations in terms of culture and willingness to change. More attention also needs to be given to the resources and time required to implement interventions and detect improvements in patient care. This is where long-term national data sets can be useful.

Citation and Funding

Peden CJ, Stephens T, Martin G et al. Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial. Lancet. 2019;393:2213-21.


This project was funded by the NIHR Health Services and Delivery Research Programme (project number 12/5005/10).

Bibliography

Martin GP, Kocman D, Stephens T et al. Pathways to professionalism? Quality improvement, care pathways, and the interplay of standardisation and clinical autonomy. Sociol Health Illn. 2017;39:1314-29.

NHS Improvement. General surgery: Getting it Right First Time Programme national specialty report. London: NHS Improvement; 2017.

Royal College of Surgeons. Commissioning guide: emergency general surgery (acute abdominal pain). London: Royal College of Surgeons; 2014.

Royal College of Surgeons. The high-risk general surgical patient: raising the standard. London: Royal College of Surgeons; 2018.

Stephens TJ, Peden CJ, Pearse RM et al. Improving care at scale: process evaluation of a multi-component quality improvement intervention to reduce mortality after emergency abdominal surgery (EPOCH trial). Implementation Science. 2018;13(142).

Why was this study needed?

Emergency abdominal surgery is a high-risk procedure, with a much greater risk of death than other types of surgery. More than 1.53 million adults have inpatient surgery each year in the NHS, with a 30-day mortality of 1.5%. About 30,000 patients have emergency abdominal surgery each year, with 30-day mortality greater than 10%. There is evidence of wide variation in care for this patient group in NHS hospitals.

In 2011, the Royal College of Surgeons proposed a set of standards for the care of these patients, which they suggest should be a driver for improvement. There were 37 individual components to their recommended care pathway. This included steps to improve outcomes like automatic admission to intensive care for these patients.

Small studies have shown that QI programmes are associated with improved survival after emergency abdominal surgery. But it isn’t clear how effective a national scale implementation of a “bundle” of improvement interventions could be. This study aimed to answer that question.

What did this study do?

The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was a stepped-wedge cluster-randomised trial. It included 15,873 patients aged 40 years or over who were undergoing emergency open major abdominal surgery. Ninety-three NHS hospitals took part in the trial. These were organised into 15 geographical clusters.

All hospitals started the trial with their usual care procedures. Each cluster was then randomly allocated to start the quality improvement (QI) programme at five-week intervals, for 18 months. So the length of the intervention varied from five to eighty weeks, and each hospital had a period as a control group. QI leads in each hospital were given support and materials to implement the hospital-wide improvement programme. The design of this study took account of the gradual introduction of these changes across the country, enabling sites to compare outcomes before and after changes as well as with other sites who had not yet introduced improvements.

Patients were not aware of which study group they were in, but it wasn’t possible to mask hospital staff and investigators.

What did it find?

  • There was no difference between the usual care and intervention groups in number of deaths from any cause within 90 days of surgery, which occurred in 16% (1,393/8,482) of the usual care group, and 16% (1,210/7,374) of the QI group.
  • Length of hospital stay was the same in each group: 8 days (interquartile range 13 to 23) in the usual care group and to 8 days (interquartile range 13 to 24) in the QI group.
  • Hospital re-admission rates within 180 days were also similar: 20% (1,618/7,969) of the usual care group compared with 18% (1,242/6,723) of the QI group (HR 0.87, 95% CI 0.73 to 1.04).
  • There was no evidence that the QI intervention became more effective the longer it had been implemented.
  • A process evaluation found that staff had no additional time in their working days to accommodate the changes involved with the QI intervention. Most hospitals didn’t have the time or resources to implement all 37 improvement processes, so selected elements of the intervention. Some of the QI leads found challenges in getting support for change within their organisations.

What does current guidance say on this issue?

The Royal College of Surgeons published a commissioning guide in 2014 for emergency general surgery (acute abdominal pain). The guidance outlines what the best care looks like, and what procedures the best units will have in place. It says that commissioners can play a role in encouraging service improvement, and defines levers for implementation and improvement within the emergency general surgery pathways.

Quality measures include the presence of a consultant surgeon and a consultant anaesthetist, the proportion of patients admitted to critical care immediately after surgery, and availability of interventional radiology.

What are the implications?

This well-designed trial did not show any difference in patient outcomes between the usual care and the QI intervention groups in real-world settings. The process evaluation suggests that this could be due to the way the intervention was implemented, rather than because the intervention wasn’t effective.

Researchers suggest that for such complex change in practice to be successful, QI programmes need to allow for differences between organisations in terms of culture and willingness to change. More attention also needs to be given to the resources and time required to implement interventions and detect improvements in patient care. This is where long-term national data sets can be useful.

Citation and Funding

Peden CJ, Stephens T, Martin G et al. Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial. Lancet. 2019;393:2213-21.


This project was funded by the NIHR Health Services and Delivery Research Programme (project number 12/5005/10).

Bibliography

Martin GP, Kocman D, Stephens T et al. Pathways to professionalism? Quality improvement, care pathways, and the interplay of standardisation and clinical autonomy. Sociol Health Illn. 2017;39:1314-29.

NHS Improvement. General surgery: Getting it Right First Time Programme national specialty report. London: NHS Improvement; 2017.

Royal College of Surgeons. Commissioning guide: emergency general surgery (acute abdominal pain). London: Royal College of Surgeons; 2014.

Royal College of Surgeons. The high-risk general surgical patient: raising the standard. London: Royal College of Surgeons; 2018.

Stephens TJ, Peden CJ, Pearse RM et al. Improving care at scale: process evaluation of a multi-component quality improvement intervention to reduce mortality after emergency abdominal surgery (EPOCH trial). Implementation Science. 2018;13(142).

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

Published on 30 April 2019

Peden, C. J.,Stephens, T.,Martin, G.,Kahan, B. C.,Thomson, A.,Rivett, K.,Wells, D.,Richardson, G.,Kerry, S.,Bion, J.,Pearse, R. M.

Lancet , 2019

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1.11, 0.96-1.28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.

Expert commentary

The evidence for QI in surgical care has traditionally been limited by small (underpowered) trials. The EPOCH study addressed this issue through the NELA (National Emergency Laparotomy Audit) and a trial on almost 16,000 patients throughout the whole NHS linking results from Hospital Episode Statistics (HES).

While the study results did not reveal any significant QI benefits, it did resolve much of the controversy in the field of surgical QI.

This work reinforces the strengths of successfully deriving clinical information from a widely adopted national audit. The future in this field, therefore, lies with a continued emphasis on generating real-world evidence through the linkage of large-scale national RCTs with corresponding administrative data sets.

Professor the Lord Darzi of Denham, the Paul Hamlyn Chair of Surgery at Imperial College London, Director of the Institute of Global Health Innovation at Imperial College London; Honorary Consultant Surgeon at Imperial College Hospital NHS Trust and the Royal Marsden Hospital    

The commentator declares no conflicting interests

Expert commentary

What did the EPOCH trial test? A need to improve emergency surgical care or that QI methodology can deliver change at scale – neither. EPOCH fundamentally investigated the feasibility of whether structure may translate the good intentions of clinical “champions” into rapid culture change, in a workforce often struggling to deliver usual care.

The complexities of promoting multiple components of perioperative care, in limited time, with limited education and in a newly developed program, were unlikely to move outcomes.

Clinician empowerment remains the backbone for quality improvement but small, appropriately-resourced steps rather than one giant leap, may be more realistic.

Chris Snowden, Consultant Anaesthetist, The Newcastle upon Tyne Hospitals NHS Foundation Trust; Honorary Clinical Senior Lecturer, Newcastle University

The commentator declares no conflicting interests