Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-02 @ 12:04 PM
Study NCT ID:
NCT04498559
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Knowledge on Pain Management and Safe Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's knowledge about opioids based on a qualitative assessment", 'timeFrame': 'Prior to surgery', 'description': "Patient's answers to opioid-related questions will be summarized using grounded theory, and a comparative analytic strategy to categories. A PI-provided scoring manual will also be used to quantify the accuracy and level of patients' knowledge about opioids. Reference: Berkwits M, Inui TS. Making use of qualitative research techniques. J Gen Intern Med. 1998;13(3):195-199. doi:10.1046/j.1525-1497.1998.00054.x"}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Prior to surgery', 'description': "Is the age the of patient associated with patients' knowledge of opioids"}, {'measure': 'Sex', 'timeFrame': 'Prior to surgery', 'description': "Is the sex of the patient associated with patients' knowledge of opioids"}, {'measure': 'Race', 'timeFrame': 'Prior to surgery', 'description': "Is the race of the patient associated with patients' knowledge of opioids"}, {'measure': 'Ethnicity', 'timeFrame': 'Prior to surgery', 'description': "Is the ethnicity of the patient associated with patients' knowledge of opioids"}, {'measure': 'Previous surgeries', 'timeFrame': 'Prior to surgery', 'description': "Are previous surgeries of the patient associated with patients' knowledge of opioids"}, {'measure': 'Previous opioid usage', 'timeFrame': 'Prior to surgery', 'description': "Is the previous opioid usage of patient associated with patients' knowledge of opioids"}, {'measure': 'Education level', 'timeFrame': 'Prior to surgery', 'description': "Is the education level of the patient associated with patients' knowledge of opioids"}, {'measure': 'Occupation', 'timeFrame': 'Prior to surgery', 'description': "Is the occupation of the patient associated with patients' knowledge of opioids"}, {'measure': 'Alcohol and tobacco use', 'timeFrame': 'Prior to surgery', 'description': "Is the alcohol and tobacco use of the patient associated with patients' knowledge of opioids"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine what patients currently know about opioids, including their role in pain management, side effects, risks of abuse, and proper storage and disposal. It is critical for patients to be properly informed about opioid usage in treating postoperative pain, but current gaps in patient knowledge are not well understood.\n\nThis study will help identify knowledge deficiencies and guide future patient education. Additionally, this study will examine possible patient factors that may be associated with these gaps. Evaluation of patient knowledge will be assessed through interviews conducted before patients' day of surgery.", 'detailedDescription': 'Opioids are frequently prescribed to treat pain after surgery, and while these medications may be effective analgesics they are also susceptible to misuse and addiction. There are growing concerns that prescription opioids contribute to the existing opioid supply and become potential sources for abuse1,2. In fact, opioids are often abused by those using medications not prescribed to them but obtained from friends or relatives3,4.\n\nMany patients who undergo surgery are not given adequate information about opioids and strategies for postoperative pain management. Studies find that inadequate knowledge and inability to recall postoperative pain regimens result in poor compliance5. Many patients are also unaware of how to properly store and dispose of prescription opioids1,6 and this predisposes them to opioid misuse and improper saving and sharing of pills6.\n\nLittle is known, however, about the specific gaps in knowledge and what patient demographics may be associated with lack of understanding. As an initial step toward addressing these issues, this study seeks to identify deficiencies in patient understanding of opioids and pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing primary total hip replacement surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range between 18 and 80 years old\n* Undergoing primary total hip replacement surgery\n* English speaking\n\nExclusion Criteria:\n\n* Medical background (profession that involves the prescribing, dispensing, handling, or administering of opioids)\n* History of chronic opioid use (continuous opioid use for 3 or more months)\n* Opioid use within the past 3 months\n* Non-English speakers'}, 'identificationModule': {'nctId': 'NCT04498559', 'briefTitle': 'Patient Knowledge on Pain Management and Safe Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Evaluating Patient Knowledge of Pain Management and Safe Opioid Use Before Surgery', 'orgStudyIdInfo': {'id': '2019-2246'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing total hip replacement', 'description': 'Patients at HSS Main Campus undergoing primary total hip replacement surgery, age range between 18 and 80 years old, and English speaking'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bradley H Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 36 months after publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification', 'accessCriteria': 'Researchers who provide methodologically sound proposal\n\nTo achieve aims in the approved protocol\n\nProposals should be directed to leeb@hss.edu. Proposals may be submitted up to 36 months after article publication. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}