Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration

NCT04919720 | Recruiting

• 1 other identifier: RESPOND NIHR200868
• Study Type: interventional
• Target: 9,064
• Locations: 1 country
• Sites: 2

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.

Conditions

Failure to Rescue; Emergencies

Keywords

Emergency General Surgery; Safety II; Human Factors and Ergonomics; Failure to Rescue; Laparotomy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Improvement in mortality of emergency laparotomy patients

  12 months

• Improvement in recovery of emergency laparotomy patients

  12 months

Study Arms (1)

Human Factors Interventions

OTHER

A 'bundle' of human factors interventions designed to improve response to deteriorating patients.

Behavioral: FRAM Model and Human Factors/Quality Improvement Intervention

Interventions

FRAM Model and Human Factors/Quality Improvement Intervention BEHAVIORAL

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.

Human Factors Interventions

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator
• University of Michigan: collaborator
• University of Southern California: collaborator
• University of Leicester: collaborator
• University of Birmingham: collaborator
• Jonkoping University: collaborator
• LP Human Factors Ltd: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• HUMAN FACTORS EVERYWHERE: collaborator

Study Sites (2)

Professor Peter McCulloch

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Buckinghamshire Healthcare NHS Trust

Stoke Mandeville, United Kingdom

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter McCulloch, MBChB, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter McCulloch, MBChB, MD

CONTACT

07786267510; mcculloch.pa@nds.ox.ac.uk

Elena Villarreal

CONTACT

elena.villarreal@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step-wedge, cluster-randomised trial

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: June 9, 2021
• Study Start: March 5, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)