What is the EPOCH study?
High-risk patients undergoing emergency surgery account for 10% of all in-patient surgical procedures but 65% of deaths. Patients who develop complications but survive, require in-hospital care for prolonged periods, suffering substantial reductions in functional independence and long-term survival. Recent data show that abdominal surgery and the need for surgery on an emergency basis are amongst the strongest factors associated with poor post-operative outcome.Most opinion leaders agree there is an urgent need for a national project to improve survival for emergency laparotomy patients. However, there is uncertainty about how best to achieve such improvement. A report by the Royal College of Surgeons of England (RCS) described an integrated care pathway for patients undergoing emergency laparotomy which could improve the quality of care. However this is yet to be widely implemented in hospitals across the UK.
Quality improvement (QI) initiatives aim to improve patient experience and outcomes by taking a systematic approach that uses specific techniques to improve quality of care. However, doubts over the clinical effectiveness of quality improvement projects, particularly on patient outcome, continue to limit the success of these initiatives.
We propose to conduct a large pragmatic clinical trial of the effectiveness of a quality improvement project to implement a robust and evidence based integrated care pathway to improve patient outcomes following emergency laparotomy. Our aim is to provide the definitive evidence needed to inform practice in this area.
What data is the trial using?
The trial will combine data from the following sources:
The trial team is NOT collecting or processing any direct personal identifiers such as name, date of birth, NHS Number, address. However, the trial is collecting and processing data on health and health care usage, in some cases it is possible that this data could indirectly identify an individual.
Notification on information use for EPOCH participants
Queen Mary University London (QMUL) is the sponsor and data controller for this study based in the United Kingdom/England. Please see their website for more information, including privacy notices. You can also contact QMUL’s data protection officer: firstname.lastname@example.org
We will be using information about your care before during and after surgery the National Emergency Laparotomy Audit (NELA) and NHS Digital (see ‘What data is the trial using’ above) in order to undertake this study. This means that we are responsible for looking after your information and using it properly. We have support for processing this data from section 251 of the National Health Service Act 2006. For more information please read this document. The legal basis for processing this data is Article 6 (6.1.e) and 9 (2) part (i). For more information, please look at the ICO website.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
As a research organisation, we have a responsibility to share information with other researchers. In the future, reserachers may contact us and ask us for data from this study. We will assess each request on a case-by-case basis, using our Data Sharing Policies and Data Sharing Committee, for more information please see this page.
Queen Mary University London (QMUL) will keep identifiable information about you for 20 years after the study has finished. QMUL retains information in line with its published records retention schedule, for more information please look at the policy.
You can find out more about how we use your information, or make a complaint by contacting the trial Chief Investigator Dr Rupert Pearse, via the Trial Manager (Ann Thomson) at email@example.com alternatively you have the right to make a complaint to a supervisory authority. For example, the Information Commissioners Office (ICO): supervisory authority
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