Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 9:47 AM
Study NCT ID:
NCT04970069
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Education
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'turana@ccf.org', 'phone': '2162172312', 'title': 'Dr. Alparslan Turan', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '72 hours after surgery or until discharge, whichever was earlier.', 'eventGroups': [{'id': 'EG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.', 'otherNumAtRisk': 483, 'deathsNumAtRisk': 483, 'otherNumAffected': 181, 'seriousNumAtRisk': 483, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.', 'otherNumAtRisk': 474, 'deathsNumAtRisk': 474, 'otherNumAffected': 176, 'seriousNumAtRisk': 474, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary catheterization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anti-emetic use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 155}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.'}, {'id': 'OG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '42'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '45'}]}]}], 'analyses': [{'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.18', 'estimateComment': 'The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.', 'groupDescription': 'Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours after surgery', 'description': 'Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.', 'unitOfMeasure': 'Morphine milligrams equivalent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat analysis population'}, {'type': 'SECONDARY', 'title': 'Time-weighted Average Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.'}, {'id': 'OG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours after surgery, or until discharge, whichever was earlier', 'description': 'Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention to treat population'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Post Operative Pain Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.'}, {'id': 'OG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '3 days after surgery', 'description': 'Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.'}, {'id': 'FG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '530'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '474'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Analgesic Education', 'description': 'Video on analgesic education: A four minute video informing the patient about opioids.'}, {'id': 'BG001', 'title': 'General Perioperative Education', 'description': 'Video on general perioperative education: A four minute video informing the patient about general perioperative process.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '15', 'groupId': 'BG000'}, {'value': '60', 'spread': '15', 'groupId': 'BG001'}, {'value': '60', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '566', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '781', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of chronic pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.'}, {'title': 'Type of surgery', 'classes': [{'title': 'Laparoscopic colorectal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Orthopedic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Laparoscopic abdominal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '408', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '798', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-04', 'size': 555444, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-07T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1057}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2021-07-16', 'resultsFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-09', 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': '72 hours after surgery', 'description': 'Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Time-weighted Average Pain Scores', 'timeFrame': '72 hours after surgery, or until discharge, whichever was earlier', 'description': 'Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward.'}, {'measure': 'Satisfaction With Post Operative Pain Management', 'timeFrame': '3 days after surgery', 'description': 'Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the effect of preoperative education on postoperative opioid.', 'detailedDescription': 'The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Modified informed consent\n* Adults ≥18 years\n* American Society of Anaesthesiologists physical status 1-4\n* Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery\n* Personal visit the PACE clinic\n* Anticipated overnight postoperative hospitalization\n* Reasonable English fluency\n\nExclusion Criteria:\n\n* Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent\n* Regional block or epidural analgesia'}, 'identificationModule': {'nctId': 'NCT04970069', 'briefTitle': 'Preoperative Education', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Effect of Preoperative Education on Postoperative Opioid Consumption', 'orgStudyIdInfo': {'id': '21-626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Analgesic education', 'interventionNames': ['Other: Video on analgesic education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'General perioperative education', 'interventionNames': ['Other: Video on general perioperative education']}], 'interventions': [{'name': 'Video on analgesic education', 'type': 'OTHER', 'description': 'A four minute video informing the patient about opioids.', 'armGroupLabels': ['Analgesic education']}, {'name': 'Video on general perioperative education', 'type': 'OTHER', 'description': 'A four minute video informing the patient about general perioperative process.', 'armGroupLabels': ['General perioperative education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Alparslan Turan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}