Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT03892551
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2019-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': 'within 30 days of the day of presentation to the ED', 'description': '30-day mortality is defined as death within 30 days of the day of presentation to the ED'}], 'secondaryOutcomes': [{'measure': 'Number of hospitalizations', 'timeFrame': 'day of presentation to the ED', 'description': 'Hospitalization is defined as the direct admission from the ED to any hospital in-patient department with a stay of over 24 hours'}, {'measure': 'Number of ICU-admissions', 'timeFrame': 'day of presentation to the ED', 'description': 'ICU-admission is defined as any direct admission to the ICU of the University Hospital of Basel'}, {'measure': 'Death rate (In-hospital mortality)', 'timeFrame': 'from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)', 'description': 'In-hospital mortality is defined as death occurring during presentation to the ED and hospital discharge'}, {'measure': 'Number of institutionalisations', 'timeFrame': 'within 365 days of the day of presentation to the ED', 'description': 'Institutionalisation is defined as no time spent at home during 365 days following presentation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['risk prediction', 'Electronic triage systems (ETS)', 'undertriage', 'overtriage'], 'conditions': ['Triage Risk Stratification']}, 'referencesModule': {'references': [{'pmid': '35138670', 'type': 'DERIVED', 'citation': 'Rueegg M, Nissen SK, Brabrand M, Kaeppeli T, Dreher T, Carpenter CR, Bingisser R, Nickel CH. The clinical frailty scale predicts 1-year mortality in emergency department patients aged 65 years and older. Acad Emerg Med. 2022 May;29(5):572-580. doi: 10.1111/acem.14460. Epub 2022 Apr 23.'}, {'pmid': '32336486', 'type': 'DERIVED', 'citation': 'Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.'}]}, 'descriptionModule': {'briefSummary': "This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.", 'detailedDescription': "Most Emergency Departments (EDs) perform an initial risk stratification of patients, called Triage. Establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. The earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. New ways to improve diagnosis accuracy early on in patients' ED visits are needed. Although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints.\n\nThis study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.\n\nAccording to acuity patients undergo triage or directly proceed to the treatment unit. Patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. Afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. Patients in need of immediate therapy will receive therapy before start of the interview. Following the interview, patients undergo routine triage.The physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). Treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the ED of the University Hospital Basel over a time-course of 9 weeks from 25.03.2019 to 27.05.2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting to the ED of the University Hospital Basel and awaiting triage\n\nExclusion Criteria:\n\n* unwillingness to participate\n* insufficient ability to communicate with the study personnel.'}, 'identificationModule': {'nctId': 'NCT03892551', 'acronym': 'EMERGE IV', 'briefTitle': 'Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE IV)', 'orgStudyIdInfo': {'id': 'PB_2019_00008; me19Bingisser'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients admitted to emergency ward', 'description': 'all patients admitted to the emergency ward and awaiting triage are observed', 'interventionNames': ['Other: Assessment of symptoms patients presenting when admitted to ED', 'Other: Reason for patient presentation at ED', 'Other: physicians rating of severity of illness', 'Diagnostic Test: Assessment of vital signs', 'Other: Clinical Frailty Scale', 'Other: Impaired mobility on presentation (IMOP)', 'Other: Assessment of suspected diagnosis and differential diagnoses']}], 'interventions': [{'name': 'Assessment of symptoms patients presenting when admitted to ED', 'type': 'OTHER', 'description': 'Questionnaire with a predefined list of 35 symptoms', 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'Reason for patient presentation at ED', 'type': 'OTHER', 'description': 'Exploratory interview assessing reason for patient presentation at ED', 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'physicians rating of severity of illness', 'type': 'OTHER', 'description': 'numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)', 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'Assessment of vital signs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)', 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'Clinical Frailty Scale', 'type': 'OTHER', 'description': "Assessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill", 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'Impaired mobility on presentation (IMOP)', 'type': 'OTHER', 'description': 'Assessment of IMOP: defined as being unable to stand unaided or walk without help', 'armGroupLabels': ['patients admitted to emergency ward']}, {'name': 'Assessment of suspected diagnosis and differential diagnoses', 'type': 'OTHER', 'description': "Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.", 'armGroupLabels': ['patients admitted to emergency ward']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Emergency Medicine, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Roland Bingisser, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency Medicine, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}