Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 7:21 PM
Study NCT ID:
NCT03856060
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' perception of physicians' compassion after they watch the first video", 'timeFrame': '1 year" or "up to 24 weeks", "through study completion', 'description': "Quantified by the total score of ratings from a comprehensive 5-item tool which assesses dimensions such as warm/cold, pleasant/unpleasant, compassionate/distant, sensitive/insensitive, and caring/uncaring (ranging from 0 to 10 for each item, and from 0 to 50 for the total score). Physicians' compassion, communication skills and professionalism will be compared between standard electronic health record (EHR) and integrated EHR groups at the end of each video using a two-sample t-test or Wilcoxon rank-sum test when appropriate. The mixed model will be applied to further explore the patterns of physicians' compassion, communication skills and professionalism from both videos. Patients' preference of physician and perception of EHR will be compared between standard EHR and integrated EHR groups using Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will also be employed."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Neoplasm', 'Locally Advanced Malignant Neoplasm', 'Malignant Neoplasm', 'Metastatic Malignant Neoplasm', 'Recurrent Malignant Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "This trial assesses patient perception of physician's compassion, communication skills, and professionalism during clinic visits through the use of videos and questionnaires.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To compare patients' perception of physicians' compassion after they watch the first scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.\n\nSECONDARY OBJECTIVES:\n\nI. To compare patients' perception of physicians' compassion after they watch the second scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.\n\nII. To compare patients' perception of physicians' communication skills after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.\n\nIII. To compare patients' perception of physicians' professionalism after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.\n\nIV. To compare patients' perception of physicians' compassion, communication skills and professionalism after they watch two scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.\n\nV. To compare patients' preference after they watch two scripted-video vignettes of physicians sequentially: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.\n\nVI. To examine patients' perception of EHR in healthcare delivery. VII. To establish demographic and clinical factors of patients preference for the physician.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients complete questionnaires and watch a video portraying a physician using a standard electronic health record (EHR) and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.\n\nGROUP II: Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of cancer either early disease or advanced cancer defined as locally advanced, recurrent or metastatic disease.\n* Outpatients (either new referrals or follow-ups) seen in the Supportive Care Clinic.\n* English speaking.\n* Patients with normal cognitive status (Memorial Delirium Assessment Scale \\[MDAS\\] =\\< 6/30) who can understand the nature and purpose of the study and have the ability to complete the consent process.\n\nExclusion Criteria:\n\n* Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be measured by the Edmonton Symptom Assessment Scale (ESAS) and Memorial Delirium Assessment Scale (MDAS), and will be determined by the principal investigator and/or attending physician who is caring for the patient during that visit.'}, 'identificationModule': {'nctId': 'NCT03856060', 'briefTitle': "Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits", 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': "Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits: a Randomized Controlled Trial (EHR Study #2)", 'orgStudyIdInfo': {'id': '2018-1016'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00508', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-1016', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (questionnaires, videos)', 'description': 'Patients complete questionnaires and watch a video portraying a physician using a standard EHR and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.', 'interventionNames': ['Other: Questionnaire Administration', 'Other: Video']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (video, questionnaire)', 'description': 'Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.', 'interventionNames': ['Other: Questionnaire Administration', 'Other: Video']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Group I (questionnaires, videos)', 'Group II (video, questionnaire)']}, {'name': 'Video', 'type': 'OTHER', 'description': 'Watch videos of doctor and patient interaction in different settings', 'armGroupLabels': ['Group I (questionnaires, videos)', 'Group II (video, questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ali Haider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}