Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT04225468
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2020-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safe Options for ACL Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine milligram equivalents administered', 'timeFrame': 'Assessed at 30 days post surgery', 'description': 'Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts'}], 'secondaryOutcomes': [{'measure': 'Knowledge of safe opioid use', 'timeFrame': 'Assessed at baseline and 7-days post surgery', 'description': 'Change in pre and post test scores of a knowledge test of topics covered in the intervention including tolerance, weaning off opioids, safe disposal methods, and alternative pain management strategies.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention', 'opioid exposure', 'exposure reduction'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Opioid Use']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://uthsc.edu', 'label': 'UTHSC main website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.', 'detailedDescription': 'The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual \\[TAU\\] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics.\n\nThere will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a "booster" intervention session of the intervention 3 days after surgery.\n\nIn addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.\n* Be able to return to the clinic at least one time within the first 10 days post-op.\n\nExclusion Criteria:\n\n* Under 12 years of age\n* Contraindication to opioids\n* Unable to understand intervention material in English'}, 'identificationModule': {'nctId': 'NCT04225468', 'acronym': 'SOAR', 'briefTitle': 'Safe Options for ACL Recovery', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients', 'orgStudyIdInfo': {'id': '19-07075-XP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment As Usual (TAU)', 'description': 'No intervention will be administered.'}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Exposure Reduction Program 1 (OERP1)', 'description': 'Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.', 'interventionNames': ['Behavioral: ACL Opioid Exposure Reduction Program']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid Exposure Reduction Program 2 (OERP2)', 'description': 'Participants will engage in the same intervention as OERP1, but those in OERP2 will also receive a 5-minute "booster" intervention session 3 days after surgery.', 'interventionNames': ['Behavioral: ACL Opioid Exposure Reduction Program']}], 'interventions': [{'name': 'ACL Opioid Exposure Reduction Program', 'type': 'BEHAVIORAL', 'otherNames': ['ACL-OERP'], 'description': 'Subjects will engage in a brief, educational which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.', 'armGroupLabels': ['Opioid Exposure Reduction Program 1 (OERP1)', 'Opioid Exposure Reduction Program 2 (OERP2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2 years after data collection ends', 'ipdSharing': 'YES', 'description': 'It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karen Derefinko, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Memphis', 'class': 'OTHER'}, {'name': 'Campbell Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Karen Derefinko, PhD', 'investigatorAffiliation': 'University of Tennessee'}}}}