Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 5:07 AM
Study NCT ID:
NCT03986866
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Video-based, Patient-Focused Opioid Education in the Perioperative Period
Sponsor:
Organization:
Raw JSON
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Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients Who Discontinued Opioids by 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'id': 'OG001', 'title': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.\n\nVideo: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 months', 'description': 'Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Development of Chronic Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'id': 'OG001', 'title': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.\n\nVideo: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-150 days', 'description': 'Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Total Days to Opioid Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'id': 'OG001', 'title': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.\n\nVideo: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '17', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '20.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 months', 'description': 'Feasibility of collecting data on the number of days until opioid cessation', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Days until opioid cessation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'id': 'FG001', 'title': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.\n\nVideo: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'patient required admission so no longer fit study exclusion criteria of ambulatory surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'id': 'BG001', 'title': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.\n\nVideo: A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients who after randomization have an outpatient surgical encounter'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-04', 'size': 177996, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-23T12:19', 'hasProtocol': True}, {'date': '2018-12-18', 'size': 323732, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-22T11:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2019-06-05', 'resultsFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-03', 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of Post Operative Opioids', 'timeFrame': '7 days', 'description': 'Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge.'}, {'measure': 'Number of Patients Who Discontinued Opioids by 3 Months', 'timeFrame': 'Up to 3 months', 'description': 'Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark.'}], 'secondaryOutcomes': [{'measure': 'Development of Chronic Opioid Use', 'timeFrame': '90-150 days', 'description': 'Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively.'}, {'measure': 'Number of Total Days to Opioid Cessation', 'timeFrame': 'Up to 3 months', 'description': 'Feasibility of collecting data on the number of days until opioid cessation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Chronic Pain Post-Procedural']}, 'referencesModule': {'references': [{'pmid': '27025001', 'type': 'BACKGROUND', 'citation': 'Ayasrah SM, Ahmad MM. Educational Video Intervention Effects on Periprocedural Anxiety Levels Among Cardiac Catheterization Patients: A Randomized Clinical Trial. Res Theory Nurs Pract. 2016;30(1):70-84. doi: 10.1891/1541-6577.30.1.70.'}, {'pmid': '3319971', 'type': 'BACKGROUND', 'citation': 'Basch CE. Focus group interview: an underutilized research technique for improving theory and practice in health education. Health Educ Q. 1987 Winter;14(4):411-48. doi: 10.1177/109019818701400404.'}, {'pmid': '28403427', 'type': 'BACKGROUND', 'citation': 'Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.'}, {'pmid': '28873050', 'type': 'BACKGROUND', 'citation': 'Chakravarthy B, Somasundaram S, Mogi J, Burns R, Hoonpongsimanont W, Wiechmann W, Lotfipour S. Randomized pilot trial measuring knowledge acquisition of opioid education in emergency department patients using a novel media platform. Subst Abus. 2018 Jan 2;39(1):27-31. doi: 10.1080/08897077.2017.1375061. Epub 2017 Sep 29.'}, {'pmid': '27484682', 'type': 'BACKGROUND', 'citation': "Deyo RA, Hallvik SE, Hildebran C, Marino M, Dexter E, Irvine JM, O'Kane N, Van Otterloo J, Wright DA, Leichtling G, Millet LM. Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naive Patients: A Statewide Retrospective Cohort Study. J Gen Intern Med. 2017 Jan;32(1):21-27. doi: 10.1007/s11606-016-3810-3. Epub 2016 Aug 2."}, {'pmid': '19515102', 'type': 'BACKGROUND', 'citation': 'Hill AM, McPhail S, Hoffmann T, Hill K, Oliver D, Beer C, Brauer S, Haines TP. A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital. J Am Geriatr Soc. 2009 Aug;57(8):1458-63. doi: 10.1111/j.1532-5415.2009.02346.x. Epub 2009 Jun 8.'}, {'pmid': '29509867', 'type': 'BACKGROUND', 'citation': 'Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.'}, {'pmid': '26359332', 'type': 'BACKGROUND', 'citation': 'Meissner W, Coluzzi F, Fletcher D, Huygen F, Morlion B, Neugebauer E, Montes A, Pergolizzi J. Improving the management of post-operative acute pain: priorities for change. Curr Med Res Opin. 2015 Nov;31(11):2131-43. doi: 10.1185/03007995.2015.1092122. Epub 2015 Sep 30.'}, {'pmid': '29498951', 'type': 'BACKGROUND', 'citation': 'Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.'}, {'pmid': '11304773', 'type': 'BACKGROUND', 'citation': 'Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. J Clin Oncol. 2001 Apr 15;19(8):2206-12. doi: 10.1200/JCO.2001.19.8.2206.'}, {'pmid': '26654958', 'type': 'BACKGROUND', 'citation': 'Pereira L, Figueiredo-Braga M, Carvalho IP. Preoperative anxiety in ambulatory surgery: The impact of an empathic patient-centered approach on psychological and clinical outcomes. Patient Educ Couns. 2016 May;99(5):733-8. doi: 10.1016/j.pec.2015.11.016. Epub 2015 Nov 26.'}, {'pmid': '30095765', 'type': 'BACKGROUND', 'citation': 'Prabhu M, Dubois H, James K, Leffert LR, Riley LE, Bateman BT, Henderson M. Implementation of a Quality Improvement Initiative to Decrease Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2018 Sep;132(3):631-636. doi: 10.1097/AOG.0000000000002789.'}, {'pmid': '29406338', 'type': 'BACKGROUND', 'citation': 'Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.'}, {'pmid': '16100861', 'type': 'BACKGROUND', 'citation': 'Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.'}, {'pmid': '28301454', 'type': 'BACKGROUND', 'citation': 'Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use - United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 17;66(10):265-269. doi: 10.15585/mmwr.mm6610a1.'}, {'pmid': '16430605', 'type': 'BACKGROUND', 'citation': 'Sobo EJ, Seid M, Reyes Gelhard L. Parent-identified barriers to pediatric health care: a process-oriented model. Health Serv Res. 2006 Feb;41(1):148-72. doi: 10.1111/j.1475-6773.2005.00455.x.'}, {'pmid': '30149041', 'type': 'BACKGROUND', 'citation': 'Theisen KM, Myrga JM, Hale N, Cochran G, Sewall C, Macleod LC, Jacobs BL, Davies BJ. Excessive Opioid Prescribing After Major Urologic Procedures. Urology. 2019 Jan;123:101-107. doi: 10.1016/j.urology.2018.06.057. Epub 2018 Aug 24.'}, {'pmid': '29215369', 'type': 'BACKGROUND', 'citation': 'Thiels CA, Hanson KT, Cima RR, Habermann EB. From Data to Practice: Increasing Awareness of Opioid Prescribing Data Changes Practice. Ann Surg. 2018 Mar;267(3):e46-e47. doi: 10.1097/SLA.0000000000002623.'}, {'pmid': '25936786', 'type': 'BACKGROUND', 'citation': 'Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.'}, {'pmid': '11189670', 'type': 'BACKGROUND', 'citation': 'Watt-Watson J, Stevens B, Costello J, Katz J, Reid G. Impact of preoperative education on pain management outcomes after coronary artery bypass graft surgery: a pilot. Can J Nurs Res. 2000 Mar;31(4):41-56.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8403019/pdf/jpr-14-2583.pdf', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study designed to assess the feasibility of using a novel, video-based opioid education tool for opioid naïve ambulatory surgery patients in the perioperative period.', 'detailedDescription': 'Patients will be randomized to a video or no video prior to surgery then administered a phone questionnaire at post-op day 7, 30, and 90. The Arkansas Prescriptions Drug Monitoring Database will also be accessed for information on opioid prescription refills. The overall goal of the study is to evaluate the effect that video-based opioid education has on narcotic intake after outpatient surgery. The duration of the study will be approximately 3 months, plus a single 1-hour long focus group if desired by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 years or older\n* Not chronically receiving opioid analgesics\n* Patients who have not taken opioids 30 days pre-operatively\n* Undergoing surgical procedure not requiring overnight hospital stay\n\nExclusion Criteria:\n\n* Non-English speaking\n* Legally deaf or blind\n* On opiate contract\n* Has taken oral narcotic in the past 30 days\n* Unable to operate a telephone'}, 'identificationModule': {'nctId': 'NCT03986866', 'briefTitle': 'Video-based, Patient-Focused Opioid Education in the Perioperative Period', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Video-based, Patient-Focused Opioid Education in the Perioperative Period: A Feasibility Study', 'orgStudyIdInfo': {'id': '228789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Video', 'description': 'Patients are not shown the informational video on the safe usage of opioids.'}, {'type': 'EXPERIMENTAL', 'label': 'Video', 'description': 'Patients are shown an informational video on the safe usage of opioids.', 'interventionNames': ['Other: Video']}], 'interventions': [{'name': 'Video', 'type': 'OTHER', 'description': 'A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.', 'armGroupLabels': ['Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Johnathan H Goree, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'Lauren Byers, APRN', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}