Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04919720
Status:
RECRUITING
Last Update Posted:
2021-06-09
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Step-wedge, cluster-randomised trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9064}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in response to deterioration', 'timeFrame': '12 months', 'description': 'Reduction in ratio of mortality to complications'}, {'measure': 'Improved Effectiveness of response to deterioration', 'timeFrame': '12 months', 'description': 'Number, severity and duration of Modified Early Warning Score (MEWS) system alerts,'}, {'measure': 'Improved Effectiveness of response to deterioration', 'timeFrame': '12 months', 'description': 'Average timings for initial response to MEWS triggers'}, {'measure': 'Improved Effectiveness of response to deterioration', 'timeFrame': '12 months', 'description': 'Average timings for the segments of the MEWS response process'}, {'measure': 'Improved quality of response to deterioration', 'timeFrame': '12 months', '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'}, {'measure': 'Improved effectiveness of response to deterioration', 'timeFrame': '12 months', 'description': 'Number of specialist interventions following emergency laparotomy'}], 'secondaryOutcomes': [{'measure': 'Improvement in mortality of emergency laparotomy patients', 'timeFrame': '12 months', 'description': 'reduction in mortality of emergency laparotomy patients'}, {'measure': 'Improvement in recovery of emergency laparotomy patients', 'timeFrame': '12 months', 'description': 'Reduction in ITU stay and overall hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency General Surgery', 'Safety II', 'Human Factors and Ergonomics', 'Failure to Rescue', 'Laparotomy'], 'conditions': ['Failure to Rescue', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'This is a Five Year programme designed to identify and evaluate human factors interventions to improve the response to patients deteriorating following emergency surgery.\n\nThe programme comprises four work packages:\n\nWork 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.', 'detailedDescription': '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.\n\nThe investigators will study the cost-effectiveness of the intervention and analyse what worked well and why, to make sure the lessons are learned effectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senior Medical staff in EGS and in other departments and disciplines with important roles in rescue (Anaesthetics, Gastroenterology, Interventional Radiology, Intensive Treatment Unit)\n* Junior medical staff in EGS (First Year 1 and 2, Core trainee and Surgical Trainee 3 + grades)\n* Senior nursing staff in EGS and other relevant departments (Theatres, Intensive Treatment Unit/outreach)\n* Recovered patients or their carers\n\nExclusion Criteria:\n\n* Patients lacking mental capacity\n* Patients who cannot communicate in English AND for whom translation facilities cannot be secured\n* Patients with documented PTSD (Post Traumatic Stress Disorder) related to their experience of complications after laparotomy'}, 'identificationModule': {'nctId': 'NCT04919720', 'acronym': 'RESPOND', 'briefTitle': 'Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'RESPOND Study (Rescue for Emergency Surgery Patients Observed to uNdergo Acute Deterioration)', 'orgStudyIdInfo': {'id': 'RESPOND NIHR200868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Human Factors Interventions', 'description': "A 'bundle' of human factors interventions designed to improve response to deteriorating patients.", 'interventionNames': ['Behavioral: FRAM Model and Human Factors/Quality Improvement Intervention']}], 'interventions': [{'name': 'FRAM Model and Human Factors/Quality Improvement Intervention', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Human Factors Interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Peter McCulloch', 'role': 'CONTACT'}, {'name': 'Giles Bond-Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Professor Peter McCulloch', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Stoke Mandeville', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rame Sunthareswaran', 'role': 'CONTACT'}, {'name': 'Rame Sunthareswaran', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Buckinghamshire Healthcare NHS Trust', 'geoPoint': {'lat': 51.78606, 'lon': -0.79157}}], 'centralContacts': [{'name': 'Peter McCulloch, MBChB, MD', 'role': 'CONTACT', 'email': 'mcculloch.pa@nds.ox.ac.uk', 'phone': '07786267510'}, {'name': 'Elena Villarreal', 'role': 'CONTACT', 'email': 'elena.villarreal@nds.ox.ac.uk'}], 'overallOfficials': [{'name': 'Peter McCulloch, MBChB, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'University of Leicester', 'class': 'OTHER'}, {'name': 'University of Birmingham', 'class': 'OTHER'}, {'name': 'Jonkoping University', 'class': 'OTHER'}, {'name': 'LP Human Factors Ltd', 'class': 'UNKNOWN'}, {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'HUMAN FACTORS EVERYWHERE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}