Addressing Microaggressions in Racially Charged Patient-provider Interactions: A Pilot Randomized Trial

November 30, 2019 updated by: Jonathan Kanter, University of Washington

Reducing Racial Disparities in Healthcare: Developing Social Connections Through Behavioral Science

Racial bias in medical care is a significant public health issue, with increased focus on microaggressions and the quality of patient-provider interactions. Innovations in training interventions are needed to decrease microaggressions and improve provider communication and rapport with patients of color during medical encounters. This paper presents a pilot randomized trial of an innovative clinical workshop that employed a theoretical model from social and contextual behavioral sciences. The intervention was largely informed by research on the importance of mindfulness and interracial contact involving reciprocal exchanges of vulnerability and responsiveness, to target processes centered on the providers' likelihood of expressing biases and negative stereotypes when interacting with patients of color in racially challenging moments. Twenty-five medical student and recent graduate participants were randomized to a workshop intervention or no intervention. Outcomes were measured via provider self-report and observed changes in targeted provider behaviors. Specifically, two independent, blind teams of coders assessed provider emotional rapport and responsiveness during simulated interracial patient encounters with standardized Black patients who presented specific racial challenges to participants. We observed greater improvements in observed emotional rapport and responsiveness (indexing fewer microaggressions), improved self-reported explicit attitudes toward minoritized groups, and improved self-reported working alliance and closeness with the Black standardized patients were observed and reported by intervention participants. Effects largely were driven by improvements by the White participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98103
        • Bastyr University Seattle Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical students or recent graduates of Bastyr University.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
The bias-reduction intervention opened with a didactic on health disparities, stereotypes, microaggressions, interracial provider-patient interactions and racism. Then, a guided, interracial eye-contact mindfulness exercise was performed to increase providers' awareness and acceptance of subtle bias that occurs in interracial interactions. Then, in small, mixed-race groups, participants practiced the above mindfulness skills while reciprocally sharing and responding with empathy to each other's personal life histories and personal narratives of loss and/or betrayal. The intervention ended with explicit practice component, involving practice and feedback.
Other: Bias-reduction Intervention
A training for doctors
No Intervention: Control
The control condition was a waitlist condition. Doctors were given workshop materials after the study ended.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Emotional Rapport Building from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4ater after the intervention
We used the Roter Interactional Analysis System (RIAS), a turn-by-turn coding system in which each provider and patient utterance is coded into one of 40 categories of speech, which can be combined to create various summary scores. RIAS codes have demonstrated validity with a variety of samples and medical contexts. For the current study, two trained RIAS coders provided ratings, and both coders coded a subset of tapes (10%) for reliability (r= 0.92). Because standardized patients in our study were following a protocol and not responding naturally, we analyzed only provider codes, specifically the Emotional Rapport Building summary score which is a composite of doctor codes including emotional statements, legitimizing statements, concern statements, partnership statements, self-disclosure statements, and reassurance statements.
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4ater after the intervention
Change in responsiveness to racial challenges from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4ater after the intervention
We modified observer-based responsiveness coding systems used in previous research that operationalized positive responsiveness in dyads as concrete instances of understanding, validation, and caring on a 0 to 3 scale. We expanded the previous 0 code, which originally combined both no responses (e.g., simply ignoring the challenge) and invalidating responses (e.g., defensive or microaggressive responses), into a negative responsiveness dimension and provided anchors and examples for each score, producing a Likert scale from - 3 to + 3, as shown in Table 3. Four coders were trained to high reliability.
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4ater after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in offensiveness from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Single-item question analyzed by responsiveness coders, asking "did the doctor say anything offensive?"
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in Bias from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Single-item question analyzed by responsiveness coders, asking "Was the doctor overtly biased against the patient?"
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in Recommendations from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Single-item question analyzed by responsiveness coders, asking "Would you recommend that a Black friend with the same problem as this patient see this doctor over any other doctor?"
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in Patient experience from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Single-item question analyzed by responsiveness coders, asking "Do you think the patient had a positive experience?"
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in Ethnocultural empathy from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Everyday Multicultural Competencies/Revised Scale of Ethnocultural Empathy (EMC/RSEE), which has strong evidence for factor structure, reliability and discriminant validity. There are multiple subscales; we were interested in empathic perspective-taking and acting as an ally
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in attitudes toward various ethnic/racial groups from Pre- to Post-Intervention
Time Frame: Pre-test occurred during screening, between 5 days and 4 months prior to Intervention; post-test occurred two days after intervention.
To assess explicit attitudes towards various ethnic and racial groups, participants provided feeling thermometer ratings for different groups of people, including African Americans and 13 other demographic categories, from 0 (extremely unfavorable) to 100 (extremely favorable). Low scores on feeling thermometers are interpreted as a simple indicator of explicit prejudice.
Pre-test occurred during screening, between 5 days and 4 months prior to Intervention; post-test occurred two days after intervention.
Change in Working alliance from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
After each standardized patient interaction, participants completed the 12-item Bond subscale of the Working Alliance Inventory (WAI), a widely used measure to assess the provider-patient alliance in therapeutic interactions. Bond subscale items ask about specific feelings toward the patient, including "I respect this patient."
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Change in Interaction closeness from Pre- to Post-Intervention
Time Frame: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
After each standardized patient interaction, participants answered three questions about their experience of the interaction. First, they completed the Inclusion of the Other in the Self (IOS) scale, a well-validated, single-item, pictorial measure of relational closeness which has been used to assess closeness in interracial contexts and between patients and providers. The other two closeness items were the following: 1) Relative to all your other relationships with patients (outside of this study), how would you characterize your relationship with this patient? and 2) Relative to what you know about other patient's relationships with their doctors, how would you characterize your relationship with this patient? Agreement with these items was assessed on a 7-point Likert scale ranging from 1 (less close) to 7 (more close).
Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bastyr University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Kanter, Ph.D., University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bastyr_16-1557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be shared by request so as not to violate individual privacy concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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