Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-09 @ 8:18 AM
Study NCT ID:
NCT03058393
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2017-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analyzing Challenging Clinical Discussions in Orthopaedics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064871', 'term': 'Teach-Back Communication'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Extenuating circumstances', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Provider's uninterrupted utterances", 'timeFrame': 'End of discussion with patient, 20 minutes', 'description': 'We will assess this outcome directly from audio-recorded conversations. A coding scheme will then be developed that captures the average length of provider utterance without asking a question or an interruption from a patient'}, {'measure': 'Patient/provider talking ratio', 'timeFrame': 'End of discussion with patient, 20 minutes', 'description': 'This outcome will also be assessed from audio-recorded conversations. The transcript will be coded and the coding scheme will compare how often and how long patients talk compared to provider talking.'}], 'secondaryOutcomes': [{'measure': 'Providers perceptions about teach-back', 'timeFrame': 'End of semi-structured interview, one hour', 'description': 'This outcome will be assessed via semi-structured interviews.'}, {'measure': 'Providers belief of future use of teach-back', 'timeFrame': 'End of semi-structured interview, one hour', 'description': 'This outcome will be assessed via the semi-structured interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Teach-Back Communication', 'Arthritis', 'Knee Osteoarthritis', 'Knee Arthropathy']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to analyze patient:provider communication surrounding the discussion of difficult clinical conversations such as knee replacement options. This study will also examine how using the teach-back communication technique can improve communication between patients and providers. Orthopedic residents, fellows, physician assistants, and attendings that agree to participate will be consented. Patients, who are likely to engage in a difficult clinical conversation, such as those who have a clinical indication for a Total Knee Replacement or a Partial Knee Replacement, will be recruited from participating providers clinical schedules. Patient:provider interactions will be recorded and then the providers will attend a 1 hour education lecture about how to use teach-back. After attending the lecture, additional patient:provider interactions will be recorded and analyzed via a qualitative approach. Additionally, providers will participate in a semi-structured interview to capture their perceptions of teach-back and what challenges and benefits they may derive from using it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Patient Participants):\n\n* Age 18 years and older\n* Clinical indication for multiple treatment options\n\nExclusion Criteria (Patient Participants):\n\n* Non-English speaking\n* Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit\n\nInclusion Criteria (Provider Participants)\n\n* Age 18 years and older\n* A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery\n\nExclusion criterion (Provider Participants):\n\n• Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03058393', 'briefTitle': 'Analyzing Challenging Clinical Discussions in Orthopaedics', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effectiveness of Teach-back in Orthopedic Treatment Decision Discussions', 'orgStudyIdInfo': {'id': 'Pro00079809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teach-Back Group', 'description': 'A teach-back lesson will be provided to physician participants (Teach-Back Group), who are participating in challenging clinical discussions with patients', 'interventionNames': ['Other: Teach-Back Lesson']}], 'interventions': [{'name': 'Teach-Back Lesson', 'type': 'OTHER', 'description': 'A teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients', 'armGroupLabels': ['Teach-Back Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Richard C Mather III, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}