Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:03 PM
Study NCT ID:
NCT01501006
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2011-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social and Behavioral Influence (SBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-26', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physicians Communication Style', 'timeFrame': '2 years', 'description': 'To examine the degree to which physicians communication style (ex inclusive, authoritative) and clinical decisions (ex. aggressive,passive) differ according to patient characteristics. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded.'}], 'secondaryOutcomes': [{'measure': 'Physician Communication Moderators (Sex,Class)', 'timeFrame': '2 years', 'description': 'To examine how patients participating in their care reduces these patient-specific differences in physician communication behaviors and decisions. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Physicians'], 'conditions': ['Communication']}, 'referencesModule': {'references': [{'pmid': '30632104', 'type': 'DERIVED', 'citation': 'Shields CG, Griggs JJ, Fiscella K, Elias CM, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The Influence of Patient Race and Activation on Pain Management in Advanced Lung Cancer: a Randomized Field Experiment. J Gen Intern Med. 2019 Mar;34(3):435-442. doi: 10.1007/s11606-018-4785-z. Epub 2019 Jan 10.'}, {'pmid': '28841847', 'type': 'DERIVED', 'citation': 'Elias CM, Shields CG, Griggs JJ, Fiscella K, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The social and behavioral influences (SBI) study: study design and rationale for studying the effects of race and activation on cancer pain management. BMC Cancer. 2017 Aug 25;17(1):575. doi: 10.1186/s12885-017-3564-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).', 'detailedDescription': 'This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and Female physicians of all races and ethnicities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently in clinical practice\n* Do not plan on moving during the next year\n\nExclusion Criteria:\n\n* Non-physicians'}, 'identificationModule': {'nctId': 'NCT01501006', 'acronym': 'SBI', 'briefTitle': 'Social and Behavioral Influence (SBI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Social and Behavioral Influences on Clinical Care', 'orgStudyIdInfo': {'id': '33086'}, 'secondaryIdInfos': [{'id': 'R01CA155376-01', 'link': 'https://reporter.nih.gov/quickSearch/R01CA155376-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient Roles', 'description': 'Physician communication styles will be evaluated with different patient roles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University Of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Ronald Epstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ronald Epstein', 'investigatorAffiliation': 'University of Rochester'}}}}