Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT04198961
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Intervention to Chronic Opioid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of patients who receives naloxone prescription', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'Change in the number of patients who receives naloxone prescription'}, {'measure': 'change of number of documentation about safety discussions', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'change of number of documentation about safety discussions'}, {'measure': 'change of number of order for urine toxicology screening', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'change of number of order for urine toxicology screening'}, {'measure': 'change of number of documentation of prescription drug monitoring program (CURES) results', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'change of number of documentation of prescription drug monitoring program (CURES) results'}, {'measure': 'change of number of signed opioid informed consent forms', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'change of number of signed opioid informed consent forms'}], 'secondaryOutcomes': [{'measure': 'Change in number of patients on long-term high risk doses of opioid pain medications', 'timeFrame': 'baseline, 1, 3- and 6-months and 12 months', 'description': 'decreases in daily dose of opioids and number of patients on opioids ≥ 90mg MEDD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Opioid Therapy']}, 'descriptionModule': {'briefSummary': 'This pilot study will attempt to apply an electronic chart intervention to improve safety for patients on chronic opioid medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients prescribed long-term opioid therapy of doses greater than 90 morphine equivalent daily dose (MEDD)\n\nExclusion Criteria:\n\n* Patients prescribed short-term opioid medications for acute pain (less than a 90-day supply over the past 120 days), sublingual buprenorphine, methadone maintenance for opioid use disorder or with oncology or palliative care diagnoses will be excluded.'}, 'identificationModule': {'nctId': 'NCT04198961', 'briefTitle': 'Electronic Intervention to Chronic Opioid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'An Electronic Chart Intervention to Improve Safety for Patients on Chronic Opioid Therapy', 'orgStudyIdInfo': {'id': 'IRB-54148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic Intervention', 'description': 'Individualized opioid taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.', 'interventionNames': ['Other: opioid prescribing']}], 'interventions': [{'name': 'opioid prescribing', 'type': 'OTHER', 'description': 'Individualized taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.', 'armGroupLabels': ['Electronic Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Huiqiong Deng, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Huiqiong Deng', 'investigatorAffiliation': 'Stanford University'}}}}