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Social and Behavioral Influence (SBI) (SBI)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501006
First Posted: December 29, 2011
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ronald Epstein, University of Rochester
  Purpose
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).

Condition
Communication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social and Behavioral Influences on Clinical Care

Further study details as provided by Ronald Epstein, University of Rochester:

Primary Outcome Measures:
  • Physicians Communication Style [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures:
  • Physician Communication Moderators (Sex,Class) [ Time Frame: 2 years ]
    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.


Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient Roles
Physician communication styles will be evaluated with different patient roles.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and Female physicians of all races and ethnicities
Criteria

Inclusion Criteria:

  • Currently in clinical practice
  • Do not plan on moving during the next year

Exclusion Criteria:

  • Non-physicians
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501006


Locations
United States, New York
University Of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ronald Epstein, MD University of Rochester
  More Information

Responsible Party: Ronald Epstein, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01501006     History of Changes
Other Study ID Numbers: 33086
R01CA155376-01 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2011
First Posted: December 29, 2011
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Ronald Epstein, University of Rochester:
Physicians