NCT04190901

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,592

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

November 18, 2019

Last Update Submit

July 18, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Patient Confidence

    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.

    Approximately 10 minutes

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Warmth and Competence

    Approximately 10 minutes

  • Willingness to sue or complain

    Approximately 10 minutes

  • Fairness of the cost

    Approximately 10 minutes

Study Arms (4)

Simulated Black Male Physician

EXPERIMENTAL

Participants are randomized to view the clinical vignette with a simulated Black Male physician.

Behavioral: Simulated Black Male Physician

Simulated Black Female Physician

EXPERIMENTAL

Participants are randomized to view the clinical vignette with a simulated Black Female physician.

Behavioral: Simulated Black Female Physician

Simulated White Male Physician

EXPERIMENTAL

Participants are randomized to view the clinical vignette with a simulated White Male physician.

Behavioral: Simulated White Male Physician

Simulated White Female Physician

EXPERIMENTAL

Participants are randomized to view the clinical vignette with a simulated White Female physician.

Behavioral: Simulated White Female Physician

Interventions

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 Male 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 Black Female 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 Male 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.

Simulated White Female Physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Solnick RE, Peyton K, Kraft-Todd G, Safdar B. Effect of Physician Gender and Race on Simulated Patients' Ratings and Confidence in Their Physicians: A Randomized Trial. JAMA Netw Open. 2020 Feb 5;3(2):e1920511. doi: 10.1001/jamanetworkopen.2019.20511.

MeSH Terms

Conditions

RacismSexismPatient Satisfaction

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial DiscriminationTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 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".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

December 9, 2019

Study Start

March 9, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

We will make the data available upon individual request.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations