Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration

Emergencies Clinical Trial

— RESPOND  

Official title:

RESPOND Study (Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919720
• Other study ID #: RESPOND NIHR200868
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2021
• Source: University of Oxford
• Contact: Peter McCulloch, MBChB, MD
• Phone: 07786267510
• Email: mcculloch.pa[@]nds.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9064
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies

Intervention

Behavioral:
• FRAM Model and Human Factors/Quality Improvement Intervention
The group will use semi-structured interviews and ethnographic observations to inform development of a Functional Resonance Analysis Method (FRAM) model of the process for rescue of deteriorating patients in EGS, using information from 3 hospitals. A focus group approach will be used in co-designing reform of the system for responding to post-operative deterioration, working with small groups of frontline clinical staff from relevant areas in the three Trusts involved.

Locations

Country	Name	City	State
United Kingdom	Professor Peter McCulloch	Oxford	Oxfordshire
United Kingdom	Buckinghamshire Healthcare NHS Trust	Stoke Mandeville

Sponsors (10)

Lead Sponsor	Collaborator
University of Oxford	Chelsea and Westminster NHS Foundation Trust, HUMAN FACTORS EVERYWHERE, Jonkoping University, LP Human Factors Ltd, Oxford University Hospitals NHS Trust, University of Birmingham, University of Leicester, University of Michigan, University of Southern California

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in response to deterioration	Reduction in ratio of mortality to complications	12 months
Primary	Improved Effectiveness of response to deterioration	Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,	12 months
Primary	Improved Effectiveness of response to deterioration	Average timings for initial response to MEWS triggers	12 months
Primary	Improved Effectiveness of response to deterioration	Average timings for the segments of the MEWS response process	12 months
Primary	Improved quality of response to deterioration	Qualitative interview data with senior surgeons showing comparison of response quality and success in cases where patient or carer alerts were present with those where they were not	12 months
Primary	Improved effectiveness of response to deterioration	Number of specialist interventions following emergency laparotomy	12 months
Secondary	Improvement in mortality of emergency laparotomy patients	reduction in mortality of emergency laparotomy patients	12 months
Secondary	Improvement in recovery of emergency laparotomy patients	Reduction in ITU stay and overall hospital stay	12 months