RacismNCT04180956
Addressing Microaggressions in Racially Charged Patient-provider Interactions: A Pilot Randomized Trial
A study testing Bias-reduction Intervention in people with Racism, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Racism
- What is being tested?
- Bias-reduction Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2016to 25 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical students or recent graduates of Bastyr University.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Seattle Clinic
Seattle, Washington, 98103
About this study
Official title: 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.
- Conditions
- Racism
- Being tested
- Bias-reduction Intervention
- Medical subject headings
- Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bias-reduction InterventionOther
A training for doctors
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Bias-reduction Intervention |
| Control | No intervention | The control condition was a waitlist condition. Doctors were given workshop materials after the study ended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Rapport Building from Pre- to Post-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.
Measured: 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
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.
Measured: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4ater after the intervention
Secondary outcomes (8)
Change in offensiveness from Pre- to Post-Intervention
Single-item question analyzed by responsiveness coders, asking "did the doctor say anything offensive?"
Measured: 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
Single-item question analyzed by responsiveness coders, asking "Was the doctor overtly biased against the patient?"
Measured: 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
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?"
Measured: 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
Single-item question analyzed by responsiveness coders, asking "Do you think the patient had a positive experience?"
Measured: 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
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
Measured: 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
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.
Measured: 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
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."
Measured: 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
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).
Measured: Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start24 May 2016
- Primary completion25 Sep 2016
- Study completion25 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RacismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial, wherein doctors are prospectively assigned to either an intervention or waitlist control condition.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bastyr University
- Responsible party
- Principal investigator, Jonathan Kanter, University of Washington
- Investigators
- Jonathan Kanter, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180956
- Sponsor's protocol ID
- Bastyr_16-1557
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared by request so as not to violate individual privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Racial Disparities in Healthcare: Developing Social Connections Through Behavioral Science
- ClinicalTrials.gov ID
- NCT04180956
- Acronym / sponsor ID
- Bastyr_16-1557
- Conditions
- Racism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bastyr University
- Study start
- 24 May 2016 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Sep 2016 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial, wherein doctors are prospectively assigned to either an intervention or waitlist control condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Bias-reduction InterventionThe 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. |
| Control | No intervention | –The control condition was a waitlist condition. Doctors were given workshop materials after the study ended. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students or recent graduates of Bastyr University.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bias-reduction InterventionA training for doctors | Other | Intervention |
Primary outcome
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.
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.
8 secondary outcomes
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
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
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
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
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No. IPD will be shared by request so as not to violate individual privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Kanter, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bias-reduction Intervention in people with Racism, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.