NCT03415308

Brief Summary

The overall goal and theme of the Duke Center for Research to Advance Equity in Healthcare is to reduce racial and ethnic disparities in health through interventions that affect the clinical encounter. To achieve this goal, there is an urgent need for interventions that address implicit bias in healthcare. Implicit bias training is widely used to raise self-awareness and provide self-management tools. The overall objective is to test the hypothesis that implicit bias training for healthcare providers will reduce racial and ethnic disparities in patient- centered care. The proposed project will lay the groundwork for testing that hypothesis by using patient focus groups to garner a deeper understanding of perceptions of implicit bias in the clinical encounter; provider and health system stakeholder semi-structured interviews to inform refinement of the existing implicit bias training at Duke; and perform a pilot study of implicit bias training for providers. At the conclusion of this study, the investigators will have the necessary preliminary data to propose a definitive trial to determine the impact of an implicit bias training intervention for providers on racial and ethnic disparities in patient-centered care. This research will ultimately lead to the delivery of equitable, evidence-based, patient-centered care for all.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

4.1 years

First QC Date

January 23, 2018

Results QC Date

May 17, 2023

Last Update Submit

March 14, 2024

Conditions

Keywords

Implicit BiasHealthcare Equity

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Training Measured by Participation

    Investigators will judge the trial as feasible if at least 50% of eligible providers agree to participate.

    4 hours (post-training)

  • Acceptability

    At least 80% of those enrolled complete the trial (attend both sessions); and achieve at least 75% adherence to all intervention activities and exercises.

    4 hours (post-training)

Secondary Outcomes (2)

  • Variability in Any Trial Outcomes by Provider-related Characteristics

    4 hours (post-training)

  • Change in IAT Outcomes From Baseline to Immediately Post-intervention

    baseline, 4 hours (post-training)

Study Arms (3)

Patient Focus Groups

Identify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. I

Other: Focus Groups

Stakeholders Cognitive Interviews

Investigators will conduct a series of semi-structured interviews.

Other: Cognitive Interviews

Pilot Testing of Implicit Bias Training

Refined intervention emerging from Aim 2. T

Other: Pilot Testing of Implicit Bias Training

Interventions

Investigators will use qualitative methods to gather data on the elements associated with the patient perception of implicit bias (e.g. communication, respect, patient-centeredness) to ensure that our selected outcomes reflect the breadth of patients' concerns.

Patient Focus Groups

To gather insights from stakeholders regarding how to best refine the design of our existing implicit bias intervention to ensure that we have addressed potential facilitators and barriers to uptake, use, and sustainability

Stakeholders Cognitive Interviews

Determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training.

Pilot Testing of Implicit Bias Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For Aim 1, investigators will use the community population. Aims 2 and 3 focus specifically on providers and stakeholders at Duke medical center.

You may qualify if:

  • Aim 1:
  • Had at least 2 non-urgent ambulatory care visits any Healthcare facility in the past year (via self-report)
  • Proficient in English
  • Aim 2:
  • Providers from Durham-based ambulatory clinics in the Duke Health System or Stakeholder
  • Aim 3:
  • Providers from the Duke Health System providing care to a continuity patient panel.

You may not qualify if:

  • Aim 1:
  • Less than 2 non-urgent visits
  • Patient not identifying as black, white or Hispanic
  • Non-English speaking
  • Aim 2:
  • Not a Duke provider or stakeholder
  • Aim 3:
  • Not a Duke Health system provider/affiliated provider
  • Does not provide clinical care at a Duke affiliated facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Svetkey LP, Bennett GG, Reese B, Corsino L, Pinheiro SO, Fischer JE, Seidenstein J, Olsen MK, Brown T, Ezem N, Liu E, Majors A, Steinhauser KE, Sullivan BH, van Ryn M, Wilson SM, Yang H, Johnson KS. Design and pilot test of an implicit bias mitigation curriculum for clinicians. Front Med (Lausanne). 2024 Jun 6;11:1316475. doi: 10.3389/fmed.2024.1316475. eCollection 2024.

MeSH Terms

Conditions

CommunicationRacismBias, Implicit

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

BehaviorPrejudiceSocial BehaviorSocial Discrimination

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Alesha Majors
Organization
Duke Center for Research to Advance Healthcare Equity

Study Officials

  • Gary G Bennett, Ph.D

    Duke University

    PRINCIPAL INVESTIGATOR
  • Kimberly S Johnson, MD

    Duke University

    STUDY DIRECTOR
  • Laura P Svetkey, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

April 18, 2018

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 18, 2024

Results First Posted

March 18, 2024

Record last verified: 2024-03

Locations