Failure to RescueRESPONDNCT04919720
Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration
A study testing FRAM Model and Human Factors/Quality Improvement Intervention in people with Failure to Rescue and Emergencies, run by University of Oxford at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Failure to Rescue, Emergencies
- What is being tested?
- FRAM Model and Human Factors/Quality Improvement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,064 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Mar 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Elena Villarreal contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Professor Peter McCulloch
Oxford, Oxfordshire, OX3 9DU
Peter McCulloch
Giles Bond-Smith
- Recruiting
Buckinghamshire Healthcare NHS Trust
Stoke Mandeville
Rame Sunthareswaran
Rame Sunthareswaran
About this study
Official title: 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.
Read the 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.
- Conditions
- Failure to Rescue, Emergencies
- Being tested
- FRAM Model and Human Factors/Quality Improvement Intervention
- Keywords
- Emergency General Surgery, Safety II, Human Factors and Ergonomics, Failure to Rescue, Laparotomy
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAM Model and Human Factors/Quality Improvement InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Human Factors Interventions | Other | A 'bundle' of human factors interventions designed to improve response to deteriorating patients. Receives: Behavioral: FRAM Model and Human Factors/Quality Improvement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in response to deterioration
Reduction in ratio of mortality to complications
Measured: 12 months
Improved Effectiveness of response to deterioration
Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,
Measured: 12 months
Improved Effectiveness of response to deterioration
Average timings for initial response to MEWS triggers
Measured: 12 months
Improved Effectiveness of response to deterioration
Average timings for the segments of the MEWS response process
Measured: 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
Measured: 12 months
Improved effectiveness of response to deterioration
Number of specialist interventions following emergency laparotomy
Measured: 12 months
Secondary outcomes (2)
Improvement in mortality of emergency laparotomy patients
reduction in mortality of emergency laparotomy patients
Measured: 12 months
Improvement in recovery of emergency laparotomy patients
Reduction in ITU stay and overall hospital stay
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start5 Mar 2021
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure to RescueStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Step-wedge, cluster-randomised trial
- Masking
- None (open label)
- Enrolment
- 9,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Peter McCulloch, MBChB, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919720
- Sponsor's protocol ID
- RESPOND NIHR200868
- Acronym
- RESPOND
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPOND Study (Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration)
- ClinicalTrials.gov ID
- NCT04919720
- Acronym / sponsor ID
- RESPOND / RESPOND NIHR200868
- Conditions
- Failure to Rescue, Emergencies
- Keywords
- Emergency General Surgery, Safety II, Human Factors and Ergonomics, Failure to Rescue, Laparotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,064 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- 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
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Step-wedge, cluster-randomised trial
| Arm | Type | Receives |
|---|---|---|
| Human Factors Interventions | Other | Behavioral: FRAM Model and Human Factors/Quality Improvement InterventionA 'bundle' of human factors interventions designed to improve response to deteriorating patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAM Model and Human Factors/Quality Improvement InterventionThe 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. | Behavioural | Human Factors Interventions |
Primary outcome
Improvement in response to deterioration
Time frame: 12 months
Reduction in ratio of mortality to complications
Improved Effectiveness of response to deterioration
Time frame: 12 months
Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,
Improved Effectiveness of response to deterioration
Time frame: 12 months
Average timings for initial response to MEWS triggers
Improved Effectiveness of response to deterioration
Time frame: 12 months
Average timings for the segments of the MEWS response process
Improved quality of response to deterioration
Time frame: 12 months
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
Time frame: 12 months
Number of specialist interventions following emergency laparotomy
2 secondary outcomes
Improvement in mortality of emergency laparotomy patients
Time frame: 12 months
Improvement in recovery of emergency laparotomy patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Failure to Rescue
RecruitingObservational study
'5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
Surgery, Failure to Rescue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Villarreal contact
Peter McCulloch, MBChB, MD principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAM Model and Human Factors/Quality Improvement Intervention in people with Failure to Rescue and Emergencies, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter McCulloch, MBChB, MD (07786267510, mcculloch.pa@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in response to deterioration (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.