Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02625402
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ksepucha@partners.org', 'phone': '6177243350', 'title': 'Karen Sepucha', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious and other (not including serious) adverse events were not collected/assessed.', 'description': 'Adverse events were not collected as part of this survey study.', 'eventGroups': [{'id': 'EG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hip and Knee Decision Quality Instruments Knowledge Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis'}, {'id': 'OG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis'}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '32.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '21.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Knowledge scores within 10% points'}], 'paramType': 'MEAN', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': '5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used the Decision Aid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis'}, {'id': 'OG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis'}], 'classes': [{'categories': [{'title': 'Reviewed most or all of the DA', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Reviewed none or some of the DA', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': '1 item asking patients how much they reviewed the program (none, some. most, all). The percentage who report viewing most or all will be calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We wanted to assess how much patients reviewed whichever decision aid they were randomized to before their visit. As such, we assessed how much they reviewed of the program (none, some, most, all) and will share the categorical results.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clear Treatment Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis'}, {'id': 'OG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis'}], 'classes': [{'categories': [{'title': 'Clear preference', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Not sure', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': "1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis'}, {'id': 'FG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Patient recruitment was conducted from December 2015 to March 2016. Patients were recruited at two hospitals. Consent for the study (or enrollment) was implied by completion of the survey, so the enrollment number is lower than the number that started the study and were assigned to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interactive Decision Aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise\n\nBrief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis'}, {'id': 'BG001', 'title': 'Video Decision Aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog\n\nLong video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender data was collected through chart review of enrolled patients.', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'The study participants between both groups were quite balanced. Mean age and gender did not have any significant differences based on group assignment.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2015-12-04', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2015-12-07', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-15', 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip and Knee Decision Quality Instruments Knowledge Subscale Scores', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': '5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Used the Decision Aid', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': '1 item asking patients how much they reviewed the program (none, some. most, all). The percentage who report viewing most or all will be calculated.'}, {'measure': 'Percentage of Participants With a Clear Treatment Preference', 'timeFrame': 'In clinic, immediately before the first visit with surgeon', 'description': "1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['decision making', 'decision aids', 'decision quality instruments', 'osteoarthritis', 'shared decision making'], 'conditions': ['Hip Osteoarthritis', 'Knee Osteoarthritis']}, 'referencesModule': {'availIpds': [{'url': 'https://mghdecisionsciences.org/tools-training/decision-quality-instruments/', 'type': 'Outcome measure', 'comment': 'Hip Osteoarthritis Decision Quality Instrument'}, {'url': 'https://mghdecisionsciences.org/tools-training/decision-quality-instruments/', 'type': 'Outcome measure', 'comment': 'Knee Osteoarthritis Decision Quality Instrument'}], 'references': [{'pmid': '23891070', 'type': 'BACKGROUND', 'citation': "Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25."}]}, 'descriptionModule': {'briefSummary': 'This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.', 'detailedDescription': 'This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. The vendors employ different design features (e.g. use of video for patient narratives, interactive values clarification exercise) and the study will examine the relative impact of the different features on decision quality. Eligible subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating provider. Immediately before the visit, participants will complete a short questionnaire about the decision aid. This pilot study will assist with determining the potential difference between these two decision aids on improving knowledge and use of decision aids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of either hip or knee osteoarthritis\n* Scheduled visit with participating orthopedic surgeon\n\nExclusion Criteria:\n\n* Prior partial or total knee or hip replacement surgery\n* Hip fracture or aseptic necrosis in the last 12 months\n* Rheumatoid arthritis or psoriatic arthritis\n* Unable to read or speak English'}, 'identificationModule': {'nctId': 'NCT02625402', 'briefTitle': 'Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '2013P001794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive decision aid', 'description': 'Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise', 'interventionNames': ['Behavioral: Brief interactive decision aid']}, {'type': 'EXPERIMENTAL', 'label': 'Video decision aid', 'description': 'Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog', 'interventionNames': ['Behavioral: Long video decision aid']}], 'interventions': [{'name': 'Brief interactive decision aid', 'type': 'BEHAVIORAL', 'description': 'The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis', 'armGroupLabels': ['Interactive decision aid']}, {'name': 'Long video decision aid', 'type': 'BEHAVIORAL', 'description': 'Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis', 'armGroupLabels': ['Video decision aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}], 'overallOfficials': [{'name': 'Karen R Sepucha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Newton-Wellesley Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karen Sepucha', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}