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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04190901
Other study ID # 2000022317
Secondary ID 129169068
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2018
Est. completion date July 31, 2018

Study information

Verified date July 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 3592
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
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.
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.
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.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Confidence "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)]*
"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.
Approximately 10 minutes
Primary Believed Symptom Checker over Doctor "Which diagnosis do you think is more likely to be correct?" [the doctor's diagnosis (0); online symptom checker (1)] Approximately 10 minutes
Primary Likelihood of Requesting more Tests "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)] Approximately 10 minutes
Primary Patient Satisfaction: scale "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.
Approximately 10 minutes
Primary Likelihood to Recommend "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)] Approximately 10 minutes
Secondary Warmth and Competence 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.
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).
Approximately 10 minutes
Secondary Willingness to sue or complain "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"*
"Would you file a complaint against this doctor?" [5 = "Definitely"; 4 = "Probably"; 3 = "Might or might not"; 2 = "Probably not"; 1 = "Definitely not"]
"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.
Approximately 10 minutes
Secondary Fairness of the cost "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.
Approximately 10 minutes
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