Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 12:09 AM
Study NCT ID:
NCT04116294
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2019-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Before after. During the before period, standard of care. During the after period, computer-assisted prescription for plain abdominal radiography (reminding the indication for this procedure).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-24', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication', 'timeFrame': 'Same ED consultation (or max 24 hours)', 'description': '4 indications are considered as appropriate : (1) foreign body suspicion, (2) checking after contrast injection, (3) catheter checking and (4) follow-up of urolithiasis. Order for PAR will be independantly reviewed by blinded assessors.'}], 'secondaryOutcomes': [{'measure': 'Incidence of additional radiological examination (CT, US, IRM) after the PAR', 'timeFrame': 'Same ED consultation (or max 24 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plain Abdominal Radiography']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 16 or more with a PAR.\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04116294', 'briefTitle': 'Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department', 'orgStudyIdInfo': {'id': '2018-02142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Before', 'description': 'Standard of care for informatic prescription.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'After', 'description': 'Computer-assisted prescription for radiological procedure', 'interventionNames': ['Other: Computer-assisted prescription']}], 'interventions': [{'name': 'Computer-assisted prescription', 'type': 'OTHER', 'description': 'The intervention is based on a computer-assisted prescription: when a PAR will be ordered, an alert will arise and explain the recognized indications for this examination and ask a confirmation for the prescription. This is a non-blocking system: physicians will be able to prescribe PAR even if the PAR is not appropriate.', 'armGroupLabels': ['After']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christophe A Fehlmann, MD', 'role': 'CONTACT', 'email': 'christophe.fehlmann@hcuge.ch', 'phone': '15149435717'}], 'facility': 'Hôpitaux Universitaires de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1217', 'city': 'Meyrin', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Omar Kherad, MD, MPH', 'role': 'CONTACT', 'email': 'omar.kherad@latour.ch'}], 'facility': 'Hôpital de La Tour', 'geoPoint': {'lat': 46.23424, 'lon': 6.08025}}], 'centralContacts': [{'name': 'Christophe Christophe, MD', 'role': 'CONTACT', 'email': 'Christophe.Fehlmann@hcuge.ch', 'phone': '+15149435717'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christophe Fehlmann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Junior attending, Principal Investigator', 'investigatorFullName': 'Christophe Fehlmann', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}