Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT03036969
Status:
UNKNOWN
Last Update Posted:
2018-07-18
First Post:
2017-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EPICS-8: Reasons for Emergency Department Utilization by Patients With Non-urgent Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with linkable records', 'timeFrame': '05/2016 - 05/2018', 'description': 'The Primary outcome will be the proportion of patients with successful record linkage.'}], 'secondaryOutcomes': [{'measure': 'Valid Questionnaire', 'timeFrame': '05/2016 - 05/2017', 'description': 'A patients questionnaire for the assessment of Emergency Department utilization by non-urgent patients will be developed. The outcome of this work package will be a valid patient questionnaire.'}, {'measure': 'Demographic characteristics of non-urgent ED patients', 'timeFrame': 'During the study period', 'description': 'Descriptive analysis of demographic characteristics of ED patients with non-urgent conditions'}, {'measure': 'Clinical characteristics of non-urgent ED patients', 'timeFrame': 'During the study period', 'description': 'Descriptive analysis of clinical characteristics of ED patients with non-urgent conditions'}, {'measure': 'Patient pathways for ED-Visits', 'timeFrame': '10/2017 - 05/2018', 'description': 'Explorative analysis of patient pathways for ED-visits with non-urgent conditions'}, {'measure': 'Influencing factors for ED-Visits', 'timeFrame': '10/2017 - 05/2018', 'description': 'Explorative analysis of influencing factors for ED-visits with non-urgent conditions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-urgent Emergencies']}, 'descriptionModule': {'briefSummary': 'EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:\n\nEmergency Departments (EDs) are an important interface between primary and secondary health care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be investigated in this project.', 'detailedDescription': 'EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:\n\nEmergency Departments (EDs) are an important interface between primary and the secondary health care system in Germany. The number of outpatient visits in the ED´s is still increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly unknown in Germany and will be explored in this project.\n\nEPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with data of the primary health care sector. Data linkage will be conducted for patients with the Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8 study is to develop a valid questionnaire for the assessment of reasons for ED utilization by non-urgent patients.\n\nPrimary objective:\n\nEstablishing of a research structure for the linkage of inhospital-data with data from the primary health care System. Records of 5,000 patients who attended one of the two EDs at the Charité University Medicine Berlin will be linked to Primary health care data.\n\nSecondary objectives:\n\n1. Development and testing of a questionaire for the identification of reasons for emergency department utilization by patients with non-urgent conditions (n=100)\n2. Characterization and quantification of non-urgent emergencies\n3. Explorative analysis of patient pathways and influencing factors for ED-visits with non-urgent conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '115 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult men and women who are discharged after emergency treatment (outpatients) with an initial Manchester Triage Category of blue, green or yellow.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility criteria for record linkage:\n\n* Age\\>= 18 years\n* Outpatients\n* MTS-Triage category blue, green or yellow\n* Treatment in one of the two participating EDs\n\nEligibility criteria for questionnaire pretest:\n\nInclusion Criteria:\n\n* Age\\>= 18 years\n* Outpatients\n* MTS-Triage category blue, green or yellow\n* Treatment in one of the two participating EDs\n* Eligibility to understand the study purposes and give written informed consent\n\nExclusion Criteria:\n\n* Dementia\n* no sufficient German language skills\n* patients with legal representatives'}, 'identificationModule': {'nctId': 'NCT03036969', 'acronym': 'EPICS-8', 'briefTitle': 'EPICS-8: Reasons for Emergency Department Utilization by Patients With Non-urgent Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Emergency Processes in Clinical Structures - EPICS-8: Gründe für Die Inanspruchnahme Der Notaufnahme Durch Patienten Mit Blauer, grüner Oder Gelber Triagekategorie Und Ambulantem Behandlungsbedarf', 'orgStudyIdInfo': {'id': 'EPICS-8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-urgent emergencies', 'description': 'Outpatients in the Emergency Department with the MTS-Triage category blue, green or yellow'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Möckel, MD', 'role': 'CONTACT', 'email': 'martin.moeckel@charite.de'}, {'name': 'Johann Frick, M A', 'role': 'CONTACT', 'email': 'johann.frick@charite.de', 'phone': '004930450553027'}], 'facility': 'Charité Universitätsmedizin - Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Martin Möckel, MD', 'role': 'CONTACT', 'email': 'martin.moeckel@charite.de'}, {'name': 'Johann Frick, M A', 'role': 'CONTACT', 'email': 'johann.frick@charite.de', 'phone': '004930450553027'}], 'overallOfficials': [{'name': 'Martin Möckel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zentralinstitut für die Kassenärztliche Versorgung in Deutschland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prov.', 'investigatorFullName': 'Martin Moeckel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}