Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-09 @ 2:15 AM
Study NCT ID:
NCT02204605
Status:
WITHDRAWN
Last Update Posted:
2016-12-22
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The principal investigator left the institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Likert Scale for Satisfaction', 'timeFrame': 'At enrollment'}, {'measure': 'Likert Scale for Satisfaction', 'timeFrame': '4-6 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient Self-Efficacy Questionnaire (PSEQ-2)', 'timeFrame': 'At enrollment'}, {'measure': 'Patient Self-Efficacy Questionnaire (PSEQ-2)', 'timeFrame': '4-6 weeks'}, {'measure': 'Patient Health Questionnaire (PHQ-2)', 'timeFrame': 'at enrollment'}, {'measure': 'Patient Health Questionnaire (PHQ-2)', 'timeFrame': '4-6 weeks'}, {'measure': 'QuickDASH (Disabilities of the Arm, Shoulder, and Hand)', 'timeFrame': 'At enrollment'}, {'measure': 'QuickDASH (Disabilities of the Arm, Shoulder, and Hand)', 'timeFrame': '4-6 weeks'}, {'measure': 'Numerical Rating Scale for Pain', 'timeFrame': 'at enrollment'}, {'measure': 'Numerical Rating Scale for Pain', 'timeFrame': '4-6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patients', 'puzzling', 'conditions'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The investigators would like to determine if there is a difference in patient satisfaction among patients who have puzzling pain conditions and receive one evaluation from their treating physician, and those that receive an evaluation from their treating physician and from a group of consulting physicians by video. The investigators expect to enroll 128 patients at Massachusetts General Hospital.', 'detailedDescription': "Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.\n\nPrimary study question:\n\n1. Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.\n\n Secondary study questions:\n2. Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.\n3. There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients (\\>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).\n* English fluency and literacy\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant Women'}, 'identificationModule': {'nctId': 'NCT02204605', 'briefTitle': 'Video-based Consensus Opinion for Hand and Upper Extremity Problems', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'orgStudyIdInfo': {'id': '2014P000132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Visits are not videotaped'}, {'type': 'EXPERIMENTAL', 'label': 'Videoed Patients', 'description': 'Patients will have their visit videotaped.', 'interventionNames': ['Behavioral: Video-based Consensus Opinion']}], 'interventions': [{'name': 'Video-based Consensus Opinion', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Videoed Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David Ring, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David C. Ring, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}