RESPOND WP4
Research type
Research Study
Full title
RESPOND study (Rescue for Emergency Surgery Patients Observed to uNdergo acute Deterioration) Work Package 4: A cluster-randomised stepped-wedge trial of a complex Human Factors intervention
IRAS ID
318646
Contact name
Peter McCulloch
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
This study is part of a 4 Work Package (WP) programme of research to improve how we respond when a patient deteriorates after emergency surgery on the abdomen. In work packages 1 & 2 we studied existing systems for responding to deteriorating patients and developed ideas for improvement by working with frontline doctors and nurses. In Work Package 3 these ideas were developed as clinical interventions and tested in the Emergency General Surgery units of three hospitals, using a Quality Improvement system for rapidly modifying the interventions to make them as effective as possible. In this Trial, part of WP4, the programme will test the final versions of all of the interventions in a randomised trial in Emergency General Surgery units at 24 hospitals.
The interventions include four parts or Strands: Patient Involvement Strand (Strand 1), Team Strengthening Strand (Strand 2), Systems Redesign Strand (Strand 3), Enhancing Shared Ownership Strand (Strand 4). We will analyse whether the interventions decrease the number of patients who die after developing a complication, and whether they reduce deaths from any cause. These are our primary aims, but we will also look for other important effects. We will study whether patients in the intervention group needed less time in intensive care, or fewer secondary operations. We will measure how quickly Quality of Life improves after getting home from hospital. We will estimate how much it costs to treat each patient before and after the introduction of the interventions, and how much the interventions cost to deliver. Finally, as in the pilot study (WP3), we will interview patients, carers and staff members as the study proceeds, to understand their feelings about the interventions, and to understand why things work or don’t work in different hospitals.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0382
Date of REC Opinion
17 Jan 2023
REC opinion
Further Information Favourable Opinion