Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 9:14 PM
Study NCT ID:
NCT06835335
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Prescribing in the Emergency Department for Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063505', 'term': 'Racism'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D011287', 'term': 'Prejudice'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D063508', 'term': 'Social Discrimination'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1063}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine prescription', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The proportion of patient for which physician would have prescribed morphine'}], 'secondaryOutcomes': [{'measure': 'Analgesic prescription between groups', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To compare analgesic prescription between groups'}, {'measure': 'factors associated with differences in management between groups', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'identify factors associated with differences in management (urgency level, morphine prescription and computed tomography scan ordering)'}, {'measure': 'Differences according to patient and practitioner gender', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'analyze the difference in morphine treatment prescribed according to patient and practitioner gender'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Discrimination, Racial', 'Pain Management', 'Emergency Medicine', 'Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'This study consists of a clinical vignette presented to emergency physicians asking them what they would prescribe to a patient with acute abdominal pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population will consist in emergency medicine resident and physician, speaking French or English, in European countries.\n\nThe population will be recruited with the use of professional networks and social medias', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a emergency physician\n\nExclusion Criteria:\n\n* Working outside of Europe.'}, 'identificationModule': {'nctId': 'NCT06835335', 'acronym': 'DOPED-SCD', 'briefTitle': 'Opioid Prescribing in the Emergency Department for Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Differential Opioid Prescribing in the Emergency Department for Patients With Sickle Cell Disease: a Vignette-based International Randomised Trial.', 'orgStudyIdInfo': {'id': '25.02.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-black man', 'description': 'the case will present a non black man', 'interventionNames': ['Behavioral: opioid prescription']}, {'label': 'Black man', 'description': 'the case will present a non black man', 'interventionNames': ['Behavioral: opioid prescription']}, {'label': 'non-black woman', 'description': 'the case will present a non black woman', 'interventionNames': ['Behavioral: opioid prescription']}, {'label': 'black woman', 'description': 'the case will present a black woman', 'interventionNames': ['Behavioral: opioid prescription']}], 'interventions': [{'name': 'opioid prescription', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of a randomized questionnaire presenting a clinical case of a patient suffering from severe abdominal pain. The control case was "As an emergency physician in an adult emergency department, you are presented with the following patient: The patient is a 39-year-old non-smoking male/female with a history of Meniere\'s disease and an allergy to Bactrim. He/she presents with abdominal pain that began abruptly 2 hours ago and has persisted despite taking NEFOPAM 45 minutes ago. This is his first episode. His/her vital signs are blood pressure 140/66, heart rate 91, pulse ox 97%, temperature 36.8°C. He/she rates his/her pain as 8/10 without any analgesic position. On clinical examination he/she presents with localized epigastric tenderness. The rest of the abdomen is soft, painless and depressed. There are hydro-aeriform noises. No diarrhea or vomiting. The rest of the clinical examination showed no abnormalities.". In the intervention case, patient had history of S', 'armGroupLabels': ['Black man', 'Non-black man', 'black woman', 'non-black woman']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30900', 'city': 'Nîmes', 'state': 'Occitanie', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': 'M139WL', 'city': 'Manchester', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS FT', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}