Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-29 @ 10:31 AM
Study NCT ID:
NCT03836235
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mouthwash samples will be used to test for the presence of single-nucleotide polymorphisms (CYP2D6, OPRM1, COMT, ABCB1, OCT1) in the genes that mediate opioid metabolism.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, as measured by number of subjects with at least one fall adverse event', 'timeFrame': 'Up to 30 days', 'description': 'The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults', 'quality of life', 'adverse events'], 'conditions': ['Opioid Use']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this project is to promote responsible opioid prescribing, immediately improving patient safety and ultimately decreasing healthcare costs by reducing older adult morbidity and mortality due to opioid-related injury. The objective of this pilot project is to gather data to inform the development of the STOP Injury tool and evaluate additional predictive factors and important outcomes relevant to prescription opioids.', 'detailedDescription': "The experience from this project will lay the groundwork on prospective validation of STOP Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow inclusion of candidate variables in the STOP Injury tool to include those that are most feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life outcomes that should be considered when assessing opioid medication adverse events.\n\nAim 1. Evaluate the association between prescription opioid adverse events in older adults and candidate risk prediction variables proposed for STOP Injury prediction score The study team will conduct a pilot prospective observational study of 200 patients 50 years or older who are initiated on opioids from the emergency department (ED). The investigators will analyze the association between candidate risk factors and opioid adverse events (falls and OD).\n\nAim 2. Evaluate the association between prescription opioid adverse events and genetic factors.\n\nIn the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide polymorphisms related to opioid metabolism, transport, and effect.\n\nAim 3. Measure the impact of opioid medications on quality of life measures in older adults The investigators will implement a series of quality of life measures on a subset of patients as a pilot study to determine which measures capture the impact prescription opioids have on older adults' quality of life"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will seek to enroll 200 subjects. All patients 50 years or older presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.) will be screened for eligibility using the inclusion and exclusion criteria listed below. To accomplish Aim 3, the investigators will enroll a convenience subset of patients by approaching every third subject enrolled with the option to consent for Aim 3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.)\n* Patient has not used opioids 15 days or more within the last 30 days\n* Patient does not have opioid medications at home\n* Discharge to home with an opioid prescription\n\nExclusion Criteria:\n\n* Bed-bound or uses wheelchair\n* Living in skilled nursing facility or assisted living facility\n* Non-English speaking\n* Unable to provide consent\n* Incarcerated\n* Lack of reliable telephone access\n* Use of opioids on most days for \\>3 months'}, 'identificationModule': {'nctId': 'NCT03836235', 'acronym': 'STOP Injury', 'briefTitle': 'Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department', 'orgStudyIdInfo': {'id': 'IRB201802137- N'}, 'secondaryIdInfos': [{'id': 'R33AG056540', 'link': 'https://reporter.nih.gov/quickSearch/R33AG056540', 'type': 'NIH'}, {'id': 'JAX ASCENT Junior Scholar', 'type': 'OTHER_GRANT', 'domain': 'US Department of Health and Human Services'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Sophia Sheikh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UF College of Medicine--Jacksonville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Department of Health and Human Services', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}