Clinical trial NCT04919720: Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration
Official title: RESPOND Study (Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Failure to Rescue
Emergencies
Keywords: Emergency General Surgery
Safety II
Human Factors and Ergonomics
Failure to Rescue
Laparotomy
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: University of Michigan
name: University of Southern California
name: University of Leicester
name: University of Birmingham
name: Jonkoping University
name: LP Human Factors Ltd
name: Chelsea and Westminster NHS Foundation Trust
name: HUMAN FACTORS EVERYWHERE
First posted: 2021-06-09
Enrollment: 9064
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Step-wedge, cluster-randomised trial
Primary purpose: TREATMENT

Brief summary: This is a Five Year programme designed to identify and evaluate human factors interventions to improve the response to patients deteriorating following emergency surgery.

The programme comprises four work packages:

Work Package 1: Qualitative interviews and observations to analyse current rescue systems; Work Package 2: Identify and co-design interventions to improve rescue systems,involving both staff and patients and carers; Work Package 3: Mixed-methods feasibility trial across 3 sites in England, Work Package 4: Step-wedge randomised control trial based across 24 hospital sites in England, evaluating efficacy of interventions in improving response to deteriorating patients.

Detailed description: Patient safety researchers study problems in healthcare systems which harm patients. The investigators wish to study a healthcare situation where system problems are costing lives. In Emergency General Surgery (EGS), dealing mainly with patients with severe abdominal pain, the death rate after abdominal surgery to find out what's wrong (called 'laparotomy') is 5 times higher than for similar routine surgery. Studies of serious complications after major operations show that when patients deteriorate after surgery, their chances of survival depend on how quickly and how well clinical teams react. The investigators plan to analyse how EGS teams currently treat deteriorating patients, and help them develop and test better response systems. Up to 3000 deaths per year could be avoided if these systems were improved . Human Factors science analyses how complex work systems succeed or fail, and how to improve them. The investigators will conduct a Human Factors analysis of real life responses to deterioration in EGS laparotomy patients, examining how staff actually deal with deteriorating patients (referred to as "work as done"), and how this differs from official guidelines (referred to as "work as imagined"). A modern approach to Human Factors called "Safety II" studies both strengths and weaknesses of systems to design solutions. The investigators will use this method to analyse current EGS rescue systems, and develop a new system for managing deterioration, including ways of involving patients or carers effectively. The investigators will test and modify this system until it can be shown that it improves team performance during rescue. Once it appears stable and effective, the investigators will test it in a multi-hospital trial. Hospitals will start using the new system at different dates (decided by chance), and the investigators will compare their performance before and after they start.

The investigators will study the cost-effectiveness of the intervention and analyse what worked well and why, to make sure the lessons are learned effectively.

Eligibility criteria: Inclusion Criteria:

* Senior Medical staff in EGS and in other departments and disciplines with important roles in rescue (Anaesthetics, Gastroenterology, Interventional Radiology, Intensive Treatment Unit)
* Junior medical staff in EGS (First Year 1 and 2, Core trainee and Surgical Trainee 3 + grades)
* Senior nursing staff in EGS and other relevant departments (Theatres, Intensive Treatment Unit/outreach)
* Recovered patients or their carers

Exclusion Criteria:

* Patients lacking mental capacity
* Patients who cannot communicate in English AND for whom translation facilities cannot be secured
* Patients with documented PTSD (Post Traumatic Stress Disorder) related to their experience of complications after laparotomy

Primary outcomes:
measure: Improvement in response to deterioration
timeFrame: 12 months
measure: Improved Effectiveness of response to deterioration
timeFrame: 12 months
measure: Improved Effectiveness of response to deterioration
timeFrame: 12 months
measure: Improved Effectiveness of response to deterioration
timeFrame: 12 months
measure: Improved quality of response to deterioration
timeFrame: 12 months
measure: Improved effectiveness of response to deterioration
timeFrame: 12 months
Secondary outcomes:
measure: Improvement in mortality of emergency laparotomy patients
timeFrame: 12 months
measure: Improvement in recovery of emergency laparotomy patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Professor Peter McCulloch
state: Oxfordshire
city: Stoke Mandeville
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
Study officials:
affiliation: University of Oxford
name: Peter McCulloch, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References: