NCT04180956

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

October 30, 2018

Last Update Submit

November 30, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    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

    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

    Pre-test occurred on Day 1, the Intervention occurred Day 2, and then post-test occurred Day 4

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: Bias-reduction Intervention

Control

NO INTERVENTION

The control condition was a waitlist condition. Doctors were given workshop materials after the study ended.

Interventions

A training for doctors

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical students or recent graduates of Bastyr University.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr University Seattle Clinic

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

Racism

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Jonathan Kanter, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The participants, who are the care providers, are blind to condition in that they are simply told when to show up for patient exams and the workshop (intervention condition). The outcomes assessors who rated microaggressions was blind to condition.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial, wherein doctors are prospectively assigned to either an intervention or waitlist control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 29, 2019

Study Start

May 24, 2016

Primary Completion

September 25, 2016

Study Completion

September 25, 2016

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

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

Locations