Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Physician Race and Gender on Simulated Patients' Ratings

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.
 
ClinicalTrials.gov Identifier: NCT04190901
Recruitment Status : Completed
First Posted : December 9, 2019
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

The purpose of the study was to determine whether the race and gender of a simulated doctor affected analog patients' reported confidence and satisfaction in the simulated doctor's diagnosis and treatment plan. The study used two randomized patient analog experiments.

This study is complete and pre-analysis plans (PAPs) for each experiment were published prior to data collection. The PAPs are available at: http://aspredicted.org/blind.php?x=43xj25 (Study 1) and https://aspredicted.org/blind.php?x=369st7 (Study 2).


Condition or disease Intervention/treatment Phase
Bias, Racial Bias, Sex Patient Satisfaction Physician-Patient Relations Behavioral: Simulated Black Male Physician Behavioral: Simulated Black Female Physician Behavioral: Simulated White Male Physician Behavioral: Simulated White Female Physician Not Applicable

Detailed Description:

Prior literature is unclear on whether patients display bias in their evaluations of physicians based on their race or gender. The investigators estimated the effects of physician race and gender using an online clinical vignette. Participants played the role of analog patients reporting to the Emergency Department (ED) with symptoms consistent with gastroenteritis. Participants were provided with a diagnosis of gastroenteritis by a simulated ED physician. The race (black or white) and gender (male or female) of the simulated physician was randomly assigned in a 2x2 factorial experiment. Simulated physicians provided a diagnosis of gastroenteritis and contradicted by an Online Symptom Checker. Following the physician's diagnosis and contradiction by the Online Symptom Checker, participants rated the simulated physician on survey measures of satisfaction and confidence in both the treatment plan and diagnosis. The main (null) hypothesis tested was that there were no differences across the four treatment arms (Black Female, Black Male, White Female, White Male). Participants for the first experiment (Study 1) were recruited from Amazon Mechanical Turk (MTurk) and participants for the second experiment (Study 2) were recruited from Lucid.

Primary Aim: To determine whether the race and gender of a simulated physician had a causal effect on participants' confidence and satisfaction in the physician's diagnosis and treatment plan in an ED setting.

Exploratory Aims: To determine whether the race and gender of a simulated physician had a casual effect on participants' perceptions of the warmth and competence of the physician, their willingness to sue or complain about the physician for an incorrect diagnosis, and their perceived fairness of the charge for the visit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3592 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a 2x2 experimental design. Subjects were randomly assigned to one of four possible conditions: Black Female, Black Male, White Female, White Male. Within each condition, subjects were randomly assigned 1 of 10 possible putative doctors from a total of 40 putative doctors, 10 for each condition. For example, 10 Black Female doctors, etc. The images of putative physicians were selected from actors in the Chicago Face Database and altered to wear a white coat. Given that the vast majority of Emergency Physicians in the United States are white men, the White Males condition served as the "control".
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Physician Race and Gender on Simulated Patients' Ratings and Confidence in Their Physicians: A Randomized Trial
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: Simulated Black Male Physician
Participants are randomized to view the clinical vignette with a simulated Black Male physician.
Behavioral: Simulated Black Male Physician
Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated Black Male physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.

Experimental: Simulated Black Female Physician
Participants are randomized to view the clinical vignette with a simulated Black Female physician.
Behavioral: Simulated Black Female Physician
Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated Black Female physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.

Experimental: Simulated White Male Physician
Participants are randomized to view the clinical vignette with a simulated White Male physician.
Behavioral: Simulated White Male Physician
Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated White Male physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.

Experimental: Simulated White Female Physician
Participants are randomized to view the clinical vignette with a simulated White Female physician.
Behavioral: Simulated White Female Physician
Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated White Female physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.




Primary Outcome Measures :
  1. Patient Confidence [ Time Frame: Approximately 10 minutes ]
    1. "How confident are you that this doctor made the correct diagnosis?" Study 1: [not at all confident (0) to completely confident (100)] Study 2: [not at all confident (1) to completely confident (5)]*
    2. "How confident are you that this doctor made the correct treatment plan?" Study 1: [not at all confident (0) to completely confident (100)] Study 2: [not at all confident (1) to completely confident (5)]*

      • The Patient Confidence outcome for each study participant was the unweighted average of their ratings on questions a and b. In Study 1, this item was measured using 0-100 point scales. In Study 2, this outcome was measured using 5 point scales. For all analyses, these Patient Confidence outcomes from a and b were rescaled to match the 1-5 point range from Study 2.

  2. Believed Symptom Checker over Doctor [ Time Frame: Approximately 10 minutes ]
    "Which diagnosis do you think is more likely to be correct?" [the doctor's diagnosis (0); online symptom checker (1)]

  3. Likelihood of Requesting more Tests [ Time Frame: Approximately 10 minutes ]
    "Would you ask the doctor to perform additional diagnostic tests? (Such as the CT scan recommended by the Symptom Checker)." [definitely not (1); probably not (2); might or might not (3); probably (4); definitely (5)]

  4. Patient Satisfaction: scale [ Time Frame: Approximately 10 minutes ]

    "What number would you use to rate your care during this emergency room visit?" Study 1: [0 (worse possible care) to 100 (best possible care)] Study 2: [0 (worse possible care) to 10 (best possible care)]*

    *In Study 1, the Patient Satisfaction was measured using a 0-100 point scale. In Study 2, this was measured using a 10 point scale. For all analyses, this Patient Satisfaction outcome from Study 1 was rescaled to match the 0-10 point range in Study 2.


  5. Likelihood to Recommend [ Time Frame: Approximately 10 minutes ]
    "Would you recommend this doctor to your friends and family?" [definitely not (1); probably not (2); might or might not (3); probably (4); definitely (5)]


Secondary Outcome Measures :
  1. Warmth and Competence [ Time Frame: Approximately 10 minutes ]
    1. Study 1: "How do you imagine this doctor would be in a real interaction?". 7-item scale: Tolerant, Warm, Sincere, Good-natured, Intelligent, Competent, Confident.
    2. Study 2: "Based on the doctor's diagnosis, to what extent do you find [him/her]". 6-item scale: Kind, Qualified, Intelligent, Competent, Open-minded, Trustworthy.

      • Warmth and Competence were measured in Study 1 (7-item scale) and Study 2 (6-item scale).

  2. Willingness to sue or complain [ Time Frame: Approximately 10 minutes ]

    "You take the doctor's advice and go home. Over the next few days, the pain in your abdomen got worse and you returned to the hospital where you were diagnosed with appendicitis. Your appendix had burst and you developed a serious infection. This required emergency surgery and an extended stay in the hospital's intensive Care Unit"*

    1. "Would you file a complaint against this doctor?" [5 = "Definitely"; 4 = "Probably"; 3 = "Might or might not"; 2 = "Probably not"; 1 = "Definitely not"]
    2. "Would you consider suing this doctors?" [5 = "Definitely"; 4 = "Probably"; 3 = "Might or might not"; 2 = "Probably not"; 1 = "Definitely not"]

      • Willingness to sue or complain was only measured in Study 2.

  3. Fairness of the cost [ Time Frame: Approximately 10 minutes ]

    "You would be charged about $350 for this emergency department visit. How fair do you think this charge is?" [0 = "Completely unfair" to 100 = "Completely Fair"]*

    *Fairness of the cost was only measured in Study 1.




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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults over 18 years old

Exclusion Criteria:

  • Participants who reported current pregnancy
  • Participants who reported a current or prior diagnosis of cancer
  • Participants who reported a history of abdominal surgery

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): NCT04190901


Locations
Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Statistical Analysis Plan  [PDF] July 25, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04190901    
Other Study ID Numbers: 2000022317
12916 ( Other Identifier: AsPredicted.org )
9068 ( Other Identifier: AsPredicted.org )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make the data available upon individual request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: All data and replication code will be posted on an open-source website after the manuscript is accepted.
Access Criteria: We have no restrictions on access. All data and replication code will be posted on an open-source website after the manuscript is accepted.
URL: https://dataverse.harvard.edu/dataverse/kpeyton

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No