Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 6:56 PM
Study NCT ID:
NCT06167759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient self-reported disposal of prescription opioids', 'timeFrame': '25-40 days after surgery', 'description': 'Patient self-reported disposal of prescription opioids'}], 'secondaryOutcomes': [{'measure': 'Opioid pills used', 'timeFrame': '25-40 days after surgery', 'description': 'Number of opioid pill used if opioid prescription was filled'}, {'measure': 'Opioid pills leftover', 'timeFrame': '25-40 days after surgery', 'description': 'Number of opioid pills left over if opioid prescription was filled'}, {'measure': 'Storage method', 'timeFrame': '25-40 days after surgery', 'description': 'If opioid prescription was filled, how the opioid pills were stored'}, {'measure': 'Disposal method', 'timeFrame': '25-40 days after surgery', 'description': 'If opioid prescription was filled, how the opioid pills were disposed'}, {'measure': 'Other pain management strategies', 'timeFrame': '25-40 days after surgery', 'description': 'Other pain management strategies that were used'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Inguinal Hernia', 'Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.\n\nThis study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire\n\nExclusion Criteria:\n\nPatients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment'}, 'identificationModule': {'nctId': 'NCT06167759', 'briefTitle': 'Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers', 'orgStudyIdInfo': {'id': 'HSC-MS-22-0807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid Use Agreement', 'description': 'Patients in this group will be administered a safe opioid use agreement by the research coordinator. This agreement is in addition to any routine education and counseling provided by the surgical team.', 'interventionNames': ['Other: Opioid Use Agreement']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patients in this group will receive standard care which includes safe opioid education from the surgical care team.'}], 'interventions': [{'name': 'Opioid Use Agreement', 'type': 'OTHER', 'description': 'This was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients).', 'armGroupLabels': ['Opioid Use Agreement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Physicians-MIST Bellaire Clinic', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77026', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Lyndon B. Johnson General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Physicians-MIST Sugar Land Clinic', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Jonah J Stulberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jonah Stulberg', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}