Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-03-06 @ 9:41 AM
Study NCT ID:
NCT03030469
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2017-01-22', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial prescription number of pills to dispense', 'timeFrame': 'Through study completion (18 months)', 'description': 'From the electronic health record'}], 'secondaryOutcomes': [{'measure': 'Initial prescription morphine milligram equivalents to dispense', 'timeFrame': 'Through study completion (18 months)', 'description': 'From the electronic health record'}, {'measure': 'Opioid analgesic reorder (y/n)', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'From the electronic health record'}, {'measure': 'Total opioid analgesic pills to dispense, including re-orders', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'From the electronic health record'}, {'measure': 'Total morphine milligram equivalents to dispense, including re-orders', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'From the electronic health record'}, {'measure': 'Outpatient visits', 'timeFrame': 'Within 30 days after the index prescription', 'description': 'From the electronic health record'}, {'measure': 'Emergency department visits', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'From the electronic health record'}, {'measure': 'Hospitalizations', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'From the electronic health record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '35792881', 'type': 'DERIVED', 'citation': 'Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Sugarman OK, Cunningham CO. Reducing Opioid Analgesic Prescribing in Dentistry Through Prescribing Defaults: A Cluster-Randomized Controlled Trial. Pain Med. 2023 Jan 4;24(1):1-10. doi: 10.1093/pm/pnac106.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult dentistry settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinical Site Inclusion Criteria:\n\n* Dentistry clinic within Montefiore Medical Center\n\nPatient Inclusion Criteria:\n\n* Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03030469', 'briefTitle': 'Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices', 'orgStudyIdInfo': {'id': '2016-7373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10-pill default', 'description': 'The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the "quantity dispensed" field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.', 'interventionNames': ['Other: Change in electronic health record default for new opioid analgesic prescriptions']}, {'type': 'EXPERIMENTAL', 'label': '5-pill default', 'description': 'New opioid analgesic prescriptions will automatically default to 5 pills.', 'interventionNames': ['Other: Change in electronic health record default for new opioid analgesic prescriptions']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.'}], 'interventions': [{'name': 'Change in electronic health record default for new opioid analgesic prescriptions', 'type': 'OTHER', 'armGroupLabels': ['10-pill default', '5-pill default']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marcus Bachhuber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marcus Bachhuber', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}