Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-02-20 @ 9:41 AM
Study NCT ID:
NCT03003832
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings
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': 15000}}, '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': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-22', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial prescription <= 10 pills (y/n)', 'timeFrame': 'Through study completion (18 months)', 'description': 'Extracted from the electronic medical record'}], 'secondaryOutcomes': [{'measure': 'Initial prescription number of pills', 'timeFrame': 'Through study completion (18 months)', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Initial prescription morphine milligram equivalents', 'timeFrame': 'Through study completion (18 months)', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Opioid analgesic re-order (y/n)', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Total opioid analgesic pills prescribed, including re-orders', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Total morphine milligram equivalents prescribed, including re-orders', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Outpatient visits', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Emergency department visits', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}, {'measure': 'Hospitalizations', 'timeFrame': 'Within 30 days after the initial prescription', 'description': 'Extracted from the electronic medical record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '33885773', 'type': 'DERIVED', 'citation': 'Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Thakral M, Cunningham CO. Effect of Changing Electronic Health Record Opioid Analgesic Dispense Quantity Defaults on the Quantity Prescribed: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e217481. doi: 10.1001/jamanetworkopen.2021.7481.'}, {'pmid': '29678969', 'type': 'DERIVED', 'citation': 'Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Cunningham CO. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019559. doi: 10.1136/bmjopen-2017-019559.'}]}, '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 primary care and emergency department 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 matched pairs of Montefiore Medical Center clinical sites, stratified by specialty and teaching status, 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* Primary care clinic (internal medicine, family medicine, or urgent care) or emergency department 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\nPatient Exclusion Criteria:\n\n* Cancer diagnosis code within the past 1 year'}, 'identificationModule': {'nctId': 'NCT03003832', 'briefTitle': 'Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings', '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 Primary Care and Emergency Department Settings', 'orgStudyIdInfo': {'id': '2016-6036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', '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': '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': ['Intervention']}]}, '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'}}}}