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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Failure to Rescue
• Intervention / Treatment: Behavioral: FRAM Model and Human Factors/Quality Improvement Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 9064
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter McCulloch, MBChB, MD; Phone Number: 07786267510; Email: mcculloch.pa@nds.ox.ac.uk
• Study Contact Backup: Name: Elena Villarreal; Email: elena.villarreal@nds.ox.ac.uk

Study Locations

• United Kingdom
  • Stoke Mandeville, United Kingdom
    • Recruiting
    • Buckinghamshire Healthcare NHS Trust
    • Contact: Rame Sunthareswaran
    • Principal Investigator: Rame Sunthareswaran
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • Professor Peter McCulloch
      • Contact: Peter McCulloch
      • Principal Investigator: Giles Bond-Smith

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Human Factors Interventions; A 'bundle' of human factors interventions designed to improve response to deteriorating patients.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in response to deterioration	Reduction in ratio of mortality to complications	12 months
Improved Effectiveness of response to deterioration	Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,	12 months
Improved Effectiveness of response to deterioration	Average timings for initial response to MEWS triggers	12 months
Improved Effectiveness of response to deterioration	Average timings for the segments of the MEWS response process	12 months
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
Improved effectiveness of response to deterioration	Number of specialist interventions following emergency laparotomy	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in mortality of emergency laparotomy patients	reduction in mortality of emergency laparotomy patients	12 months
Improvement in recovery of emergency laparotomy patients	Reduction in ITU stay and overall hospital stay	12 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: University of Michigan; University of Southern California; Chelsea and Westminster NHS Foundation Trust; University of Birmingham; University of Leicester; Oxford University Hospitals NHS Trust; Jonkoping University; LP Human Factors Ltd; HUMAN FACTORS EVERYWHERE
• Investigators: Principal Investigator: Peter McCulloch, MBChB, MD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Anticipated): February 28, 2026
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Laparotomy; Emergency General Surgery; Safety II; Human Factors and Ergonomics; Failure to Rescue
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: RESPOND NIHR200868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No