Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration

NCT04919720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9064

Last updated 2021-06-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • University of Southern California

    collaborator OTHER
  • University of Leicester

    collaborator OTHER
  • University of Birmingham

    collaborator OTHER
  • Jonkoping University

    collaborator OTHER
  • LP Human Factors Ltd

    collaborator UNKNOWN
  • Chelsea and Westminster NHS Foundation Trust

    collaborator OTHER
  • HUMAN FACTORS EVERYWHERE

    collaborator UNKNOWN
  • University of Oxford

    lead OTHER

Principal Investigators

  • Peter McCulloch, MBChB, MD · University of Oxford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919720 on ClinicalTrials.gov