Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT01768494
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2013-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Triage and Hospitalisation In Adult General Medical Emergency Patients: the TRIAGE Study
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Left over blood samples of routinely collect blood tubes on admission will be asserved and aliquoted for later batch analysis of blood biomarkers (bio-bank)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2013-01-09', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial triage priority', 'timeFrame': 'within 30 days', 'description': 'Initial triage priority adjudicated by the attending ED physician. Attending ED physicians will classify all patients at ED discharge as either high triage priority or low triage priority in respect to the time patients need to be seen by a physician based on all available information at ED discharge'}, {'measure': 'Adverse 30 day outcome (death or intensive care unit admission) within 30 days following ED admission', 'timeFrame': 'Within 30 days of ED admission', 'description': 'Adverse 30 day outcome (death or intensive care unit admission) within the hospital stay and within 30 days following ED admission'}, {'measure': 'Care needs after hospital discharge', 'timeFrame': 'Within 30 days', 'description': 'Care needs after hospital discharge will be defined as transfer of patients to a post-acute care institution (i.e. transition to a nursing home and others).'}], 'secondaryOutcomes': [{'measure': 'Time to first physician contact', 'timeFrame': 'Within 30 days', 'description': 'Time to first physician contact as assessed in the nursing chart; we will investigate this endpoint stratified by patient risk, i.e. we will compare time to first physician contact in high-triage-priority and low-triage-priority patients and stratified by different diagnoses.'}, {'measure': 'Time to initiation of adequate medical therapy', 'timeFrame': 'Wihtin 30 days', 'description': 'Time to initiation of adequate medical therapy in predefined subgroups (e.g., antibiotic therapy for infections, door to needle time for myocardial infarction; early goal directed therapy in sepsis patients, pain relief medication in patients presenting with pain, blood pressure control in patients with a hypertensive crisis); we will further assess time to discharge from the ED to the ward.'}, {'measure': 'Satisfaction with care', 'timeFrame': 'Within 30 days', 'description': 'Satisfaction with care as assessed with a systematic questionnaire in the day 30 telephone interview'}, {'measure': 'Hospital costs', 'timeFrame': 'Within 30 days', 'description': 'Overall hospital costs as assessed by the electronic medical records'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Emergencies']}, 'referencesModule': {'references': [{'pmid': '33554514', 'type': 'DERIVED', 'citation': 'Haag E, Gregoriano C, Molitor A, Kloter M, Kutz A, Mueller B, Schuetz P. Does mid-regional pro-adrenomedullin (MR-proADM) improve the sequential organ failure assessment-score (SOFA score) for mortality-prediction in patients with acute infections? Results of a prospective observational study. Clin Chem Lab Med. 2021 Jan 14;59(6):1165-1176. doi: 10.1515/cclm-2020-1566. Print 2021 May 26.'}, {'pmid': '30782737', 'type': 'DERIVED', 'citation': 'Eckart A, Hauser SI, Kutz A, Haubitz S, Hausfater P, Amin D, Amin A, Huber A, Mueller B, Schuetz P. Combination of the National Early Warning Score (NEWS) and inflammatory biomarkers for early risk stratification in emergency department patients: results of a multinational, observational study. BMJ Open. 2019 Jan 17;9(1):e024636. doi: 10.1136/bmjopen-2018-024636.'}, {'pmid': '30647051', 'type': 'DERIVED', 'citation': 'Eckart A, Hauser SI, Haubitz S, Struja T, Kutz A, Koch D, Neeser O, Meier MA, Mueller B, Schuetz P. Validation of the hospital frailty risk score in a tertiary care hospital in Switzerland: results of a prospective, observational study. BMJ Open. 2019 Jan 15;9(1):e026923. doi: 10.1136/bmjopen-2018-026923.'}, {'pmid': '28164367', 'type': 'DERIVED', 'citation': 'Kutz A, Struja T, Hausfater P, Amin D, Amin A, Haubitz S, Bernard M, Huber A, Mueller B, Schuetz P; TRIAGE study group. The association of admission hyperglycaemia and adverse clinical outcome in medical emergencies: the multinational, prospective, observational TRIAGE study. Diabet Med. 2017 Jul;34(7):973-982. doi: 10.1111/dme.13325. Epub 2017 Feb 28.'}, {'pmid': '27557531', 'type': 'DERIVED', 'citation': 'Faessler L, Kutz A, Haubitz S, Mueller B, Perrig-Chiello P, Schuetz P. Psychological distress in medical patients 30 days following an emergency department admission: results from a prospective, observational study. BMC Emerg Med. 2016 Aug 24;16(1):33. doi: 10.1186/s12873-016-0097-y.'}, {'pmid': '26656373', 'type': 'DERIVED', 'citation': 'Laukemann S, Kasper N, Kulkarni P, Steiner D, Rast AC, Kutz A, Felder S, Haubitz S, Faessler L, Huber A, Fux CA, Mueller B, Schuetz P. Can We Reduce Negative Blood Cultures With Clinical Scores and Blood Markers? Results From an Observational Cohort Study. Medicine (Baltimore). 2015 Dec;94(49):e2264. doi: 10.1097/MD.0000000000002264.'}, {'pmid': '26511878', 'type': 'DERIVED', 'citation': 'Schuetz P, Hausfater P, Amin D, Amin A, Haubitz S, Faessler L, Kutz A, Conca A, Reutlinger B, Canavaggio P, Sauvin G, Bernard M, Huber A, Mueller B; TRIAGE Study group. Biomarkers from distinct biological pathways improve early risk stratification in medical emergency patients: the multinational, prospective, observational TRIAGE study. Crit Care. 2015 Oct 29;19:377. doi: 10.1186/s13054-015-1098-z.'}, {'pmid': '26458788', 'type': 'DERIVED', 'citation': 'Steiner D, Renetseder F, Kutz A, Haubitz S, Faessler L, Anderson JB, Laukemann S, Rast AC, Felder S, Conca A, Reutlinger B, Batschwaroff M, Tobias P, Buergi U, Mueller B, Schuetz P. Performance of the Manchester Triage System in Adult Medical Emergency Patients: A Prospective Cohort Study. J Emerg Med. 2016 Apr;50(4):678-89. doi: 10.1016/j.jemermed.2015.09.008. Epub 2015 Oct 14.'}, {'pmid': '23822525', 'type': 'DERIVED', 'citation': 'Schuetz P, Hausfater P, Amin D, Haubitz S, Fassler L, Grolimund E, Kutz A, Schild U, Caldara Z, Regez K, Zhydkov A, Kahles T, Nedeltchev K, von Felten S, De Geest S, Conca A, Schafer-Keller P, Huber A, Bargetzi M, Buergi U, Sauvin G, Perrig-Chiello P, Reutlinger B, Mueller B. Optimizing triage and hospitalization in adult general medical emergency patients: the triage project. BMC Emerg Med. 2013 Jul 4;13:12. doi: 10.1186/1471-227X-13-12.'}]}, 'descriptionModule': {'briefSummary': 'Patients presenting to the emergency department (ED) currently face inacceptable delays in initial treatment, and long and costly hospital stays due to suboptimal initial triage. Accurate ED triage should focus not only on initial treatment priority, but also on prediction of medical risk and nursing needs to improve site of care decision and to simplify early discharge management. Herein, we propose a large prospective cohort study to optimize initial patient triage for (a) better determination of initial treatment priority, (b) overall risk and need for inhospital treatment and (c) early assessment of post-acute nursing needs.', 'detailedDescription': "Background: Patients presenting to the emergency department (ED) currently face inacceptable delays in initial treatment, and long and costly hospital stays due to suboptimal initial triage. Accurate ED triage should focus not only on initial treatment priority, but also on prediction of medical risk and nursing needs to improve site of care decision and to simplify early discharge management. Different triage scores have been proposed, such as the Manchester Triage Score (MTS). Yet, these scores focus only on treatment priority, have suboptimal performance and lack validation in the Swiss Health care system. Because the MTS will be introduced into clinical routine of the Kantonsspital Aarau, we propose a large prospective cohort study to optimize initial patient triage. Specifically, the aim of this trial is to derive a three part triage algorithm to better predict (a) treatment priority; (b) medical risk and thus need for inhospital treatment; (c) post-acute care needs of patient's at the most proximal time point of ED admission.\n\nMethods / Design: Prospective, observational, cohort study. We will include all consecutive medical patients seeking ED care into this observational registry. There will be no exclusions except for non-adult and non-medical patients. Vital signs will be recorded and left over blood samples will be stored for later batch analysis of blood markers. Upon ED discharge, the post-acute care score will be recorded. Attending ED physicians will adjudicate triage priority based on all available results at the time of discharge. Patients will be reassessed daily during the hospital course for medical and nursing stability. To assess outcomes, data from electronic medical records will be used and all patient will be contacted 30 days after hospital admission to assess vital status, rehospitalisation and quality of life measures.\n\nWe aim to include between 5000 and 7000 patients over one year of recruitment to derive the three part triage algorithm. The respective main endpoints were defined as (a) initial triage priority (high vs. low priority) adjudicated by the attending ED physician at ED discharge, (b) adverse 30 day outcome (death or intensive care unit admission) within 30 days following ED admission to assess patients risk and thus need for inhospital treatment and (c) care needs after hospital discharge, defined as transfer of patients to a post-acute care institution, for early recognition and planning of post-acute care needs. Other outcomes are time to first physician contact, time to initiation of adequate medical therapy, length of hospital stay, patient's satisfaction with care and overall hospital costs.\n\nDiscussion: Using a reliable initial triage system for estimating initial treatment priority, need for inhospital treatment and post-acute care needs is an innovative and persuasive approach for a more targeted management of medical patients in the ED. Our group has proven feasibility with a track record of several completed and ongoing trials. The proposed interdisciplinary project has unprecedented potential to improve initial triage decisions and optimize resource allocation to the sickest patients from admission to discharge. The algorithms derived in this study will be compared in a later randomized controlled trial against a usual care control group in terms of resource use, length of hospital stay, overall costs and patient's outcomes in terms of mortality, rehospitalisation, quality of life and satisfaction with care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive medical patients seeking ED care will be included. There will be no exclusions except for non-adult and non-medical patients. We expect to include 5000 - 8000 patients over one year of recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive medical patients seeking ED care\n\nExclusion Criteria:\n\n* age below 18 years'}, 'identificationModule': {'nctId': 'NCT01768494', 'acronym': 'TRIAGE', 'briefTitle': 'Optimizing Triage and Hospitalisation In Adult General Medical Emergency Patients: the TRIAGE Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Optimizing Triage and Hospitalisation In Adult General Medical Emergency Patients: the TRIAGE Study', 'orgStudyIdInfo': {'id': 'TRIAGE-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Aarau', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'University Clinic, Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}], 'overallOfficials': [{'name': 'Philipp Schütz, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Clinic, Kantonsspital Aarau, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr.med.', 'investigatorFullName': 'Philipp Schuetz', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}