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

Primary Purpose

Failure to Rescue, Emergencies

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FRAM Model and Human Factors/Quality Improvement Intervention
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failure to Rescue focused on measuring Emergency General Surgery, Safety II, Human Factors and Ergonomics, Failure to Rescue, Laparotomy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Professor Peter McCullochRecruiting
  • Buckinghamshire Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Human Factors Interventions

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in mortality of emergency laparotomy patients
reduction in mortality of emergency laparotomy patients
Improvement in recovery of emergency laparotomy patients
Reduction in ITU stay and overall hospital stay

Full Information

First Posted
March 22, 2021
Last Updated
June 8, 2021
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, University of Michigan, University of Southern California, University of Leicester, University of Birmingham, Jonkoping University, LP Human Factors Ltd, Chelsea and Westminster NHS Foundation Trust, HUMAN FACTORS EVERYWHERE
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1. Study Identification

Unique Protocol Identification Number
NCT04919720
Brief Title
Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration
Acronym
RESPOND
Official Title
RESPOND Study (Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust, University of Michigan, University of Southern California, University of Leicester, University of Birmingham, Jonkoping University, LP Human Factors Ltd, Chelsea and Westminster NHS Foundation Trust, HUMAN FACTORS EVERYWHERE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Rescue, Emergencies
Keywords
Emergency General Surgery, Safety II, Human Factors and Ergonomics, Failure to Rescue, Laparotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Step-wedge, cluster-randomised trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
9064 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Human Factors Interventions
Arm Type
Other
Arm Description
A 'bundle' of human factors interventions designed to improve response to deteriorating patients.
Intervention Type
Behavioral
Intervention Name(s)
FRAM Model and Human Factors/Quality Improvement Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in response to deterioration
Description
Reduction in ratio of mortality to complications
Time Frame
12 months
Title
Improved Effectiveness of response to deterioration
Description
Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,
Time Frame
12 months
Title
Improved Effectiveness of response to deterioration
Description
Average timings for initial response to MEWS triggers
Time Frame
12 months
Title
Improved Effectiveness of response to deterioration
Description
Average timings for the segments of the MEWS response process
Time Frame
12 months
Title
Improved quality of response to deterioration
Description
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
Time Frame
12 months
Title
Improved effectiveness of response to deterioration
Description
Number of specialist interventions following emergency laparotomy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement in mortality of emergency laparotomy patients
Description
reduction in mortality of emergency laparotomy patients
Time Frame
12 months
Title
Improvement in recovery of emergency laparotomy patients
Description
Reduction in ITU stay and overall hospital stay
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter McCulloch, MBChB, MD
Phone
07786267510
Email
mcculloch.pa@nds.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Villarreal
Email
elena.villarreal@nds.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McCulloch, MBChB, MD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Peter McCulloch
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter McCulloch
First Name & Middle Initial & Last Name & Degree
Giles Bond-Smith
Facility Name
Buckinghamshire Healthcare NHS Trust
City
Stoke Mandeville
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rame Sunthareswaran
First Name & Middle Initial & Last Name & Degree
Rame Sunthareswaran

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration

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