Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 1:42 PM
Study NCT ID:
NCT05875857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2023-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Utilization of Opioid Destruction Bags in the Post-op Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid destruction', 'timeFrame': 'Six to Eight weeks post discharge', 'description': 'Opioid destruction rates-total number of subjects reporting they destroyed their un-used opioids'}], 'secondaryOutcomes': [{'measure': 'Alternative opioid destruction methods', 'timeFrame': 'Six to Eight weeks post discharge', 'description': 'Utilization rate of alternate opioid destruction methods (take-back to pharmacy, mail back envelopes, flushing, etc.)-total number of subjects utilizing alternative opioid destruction methods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Opioid Use, Unspecified', 'Patient Empowerment', 'Total Knee Arthoplasty', 'Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This is a study on how patients use and store opioid pain medications at home after surgery and what happens to left over pills when patients are done taking them. Participants will be taught the proper storage and destruction of opioid pain medications, then contacted in 6-8 weeks about pain medication used, stored disposed of.', 'detailedDescription': 'This is a randomized single-center prospective survey study to describe the utilization of opioid destruction bags in the post-operative period. Participants who underwent surgery for Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) will be eligible for inclusion if discharging to home with an opioid prescription. Eligible participants will be randomized between two groups: 1) Control group will receive current standard of care 2) Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Participants will be phoned/emailed six to eight weeks post-surgery to complete a survey. Attempts will be made on three separate days to reach the participant via phone. If email is preferred, three reminders will be sent to complete the survey. If participant is unreachable, they will be considered lost to follow up. Survey questions will be comprised of various question styles, including: yes/no, multiple choice, and free text answers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n19 years of age or older Discharging to home and prescribed opioids at discharge post total knee arthroplasty or total hip arthroplasty\n\nExclusion Criteria:\n\nUnder 19 years of age Opioid medication use prior to surgery Not prescribed an opioid to take after discharge'}, 'identificationModule': {'nctId': 'NCT05875857', 'briefTitle': 'Patient Utilization of Opioid Destruction Bags in the Post-op Period', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Patient Utilization of Opioid Destruction Bags in the Post-op Period', 'orgStudyIdInfo': {'id': '0277-22-EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group will receive current standard of care education and surveys at 6-8 weeks post discharge.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Surveys will be sent to group at 6-8 weeks post discharge.', 'interventionNames': ['Behavioral: Opioid destruction education']}], 'interventions': [{'name': 'Opioid destruction education', 'type': 'BEHAVIORAL', 'description': 'Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Kristin R Daniel, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}