Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT04425668
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single blinded- dentists to be blinded; Analyses will be done by blinded analyst'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-06', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the amount of opioid prescribed measured in the total oral morphine equivalents', 'timeFrame': 'baseline, up to 3 months', 'description': 'Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used. These periods yield 63 working weekdays in each period.'}], 'secondaryOutcomes': [{'measure': 'Change in the number of opioid prescriptions', 'timeFrame': 'baseline, up to 3 months', 'description': 'Number of opioid prescription details through PDMP data pulled from MAPS.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentist'], 'conditions': ['Opioid Prescribing', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.\n\nExclusion Criteria:\n\n* All oral Surgeons in Michigan. Michigan dentists who have a significant (\\>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.'}, 'identificationModule': {'nctId': 'NCT04425668', 'briefTitle': 'Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort', 'orgStudyIdInfo': {'id': 'HUM00175142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Continuing educational']}, {'type': 'EXPERIMENTAL', 'label': 'Academic detailing intervention', 'interventionNames': ['Behavioral: Academic detailing (AD)']}], 'interventions': [{'name': 'Academic detailing (AD)', 'type': 'BEHAVIORAL', 'description': 'In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist.', 'armGroupLabels': ['Academic detailing intervention']}, {'name': 'Continuing educational', 'type': 'OTHER', 'description': 'Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah.\n\nIn this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Chad Brummett', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Chad Brummett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Michigan Department of Health and Human Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology Research, Senior Associate Chair for Research', 'investigatorFullName': 'Chad Brummett', 'investigatorAffiliation': 'University of Michigan'}}}}