Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-11 @ 5:00 AM
Study NCT ID:
NCT03821103
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2019-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2019-01-25', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Retained knowledge of buprenorphine-naloxone treatment Questionaire', 'timeFrame': 'Three months', 'description': 'Compare retention of knowledge and assessment from before and after the training in the two arms.The scale is not a validated tool. It is a construct of questions to measure retained knowledge about buprenorphine-naloxone initiation.\n\nThe scale is a percentage of questions answered correctly. Minimum score is 0% and maximum score is 100%.\n\nHigher values signify more favorable outcomes.'}], 'primaryOutcomes': [{'measure': 'Change in Emergency Department initiated buprenorphine-naloxone treatment', 'timeFrame': 'One year', 'description': 'Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone'}], 'secondaryOutcomes': [{'measure': 'Training Attendance', 'timeFrame': 'First week', 'description': 'Measure the number of clinicians who attend the training with the incentive.'}, {'measure': 'Change in attitude about buprenorphine-naloxone Questionaire', 'timeFrame': 'Three months', 'description': 'The scale is not a validated tool. It is a construct to measure attitudes about buprenorphine-naloxone.\n\nIt is a Likert scale 1-5, 1 being strongly disagree and 5 being strongly agree. Higher values signify more favorable outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use']}, 'referencesModule': {'references': [{'pmid': '35415804', 'type': 'DERIVED', 'citation': "Khatri UG, Lee K, Lin T, D'Orazio JL, Patel MS, Shofer FS, Perrone J. A Brief Educational Intervention to Increase ED Initiation of Buprenorphine for Opioid Use Disorder (OUD). J Med Toxicol. 2022 Jul;18(3):205-213. doi: 10.1007/s13181-022-00890-7. Epub 2022 Apr 12."}]}, 'descriptionModule': {'briefSummary': 'This study seeks to test standard and behavioral economic-enhanced training strategies to bolster first-time Emergency Department-initiated buprenorphine-naloxone administration among Emergency Department providers.', 'detailedDescription': 'Philadelphia is experiencing a significant opioid crisis. Through this novel pilot study, critical training about opioid use disorder and medication-assisted treatment with buprenorphine-naloxone will be provided to emergency providers and changes in clinical practice will be incentivized in order to optimize treatment engagement for patients with opioid use disorder in the Emergency Department.\n\nParticipants will be invited to participate in a brief in-person training session, will receive a pre- and post-session knowledge and attitude assessment, and will be invited to self-report first-time buprenorphine-naloxone Emergency Department administration within the 3 month study period.\n\nParticipants will be randomized to one of two arms: standard training arm and behavioral economic enhanced arm. The standard training arm will receive the aforementioned intervention. The behavioral economic enhanced arm will additionally receive an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders.\n\nEndpoints of interest include retained knowledge and change in provider attitudes regarding Emergency department buprenorphine-naloxone administration and treatment following training and again at 3 months, and first-time Emergency department administration of buprenorphine-naloxone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents and Advanced Practice Providers and attending clinicians working in emergency departments in Pennsylvania.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03821103', 'briefTitle': 'Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments', 'orgStudyIdInfo': {'id': '832359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard training arm', 'description': 'The standard training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period.', 'interventionNames': ['Behavioral: Training']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral economic enhanced arm', 'description': 'The behavioral economic enhanced training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period in addition to an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders', 'interventionNames': ['Behavioral: Training', 'Behavioral: Behavioral economic enhanced arm']}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'description': 'The training includes of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department (ED) administration within 3 month study period', 'armGroupLabels': ['Behavioral economic enhanced arm', 'Standard training arm']}, {'name': 'Behavioral economic enhanced arm', 'type': 'BEHAVIORAL', 'description': 'Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders', 'armGroupLabels': ['Behavioral economic enhanced arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jeanmarie Perrone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Medical Toxicology', 'class': 'OTHER'}, {'name': 'Blue Cross Blue Shield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}