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CommunicationNCT03415308

REACH Implicit Bias Training Project

An observational study of Communication and Bias, Racial, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Focus Groups, Cognitive Interviews and Pilot Testing of Implicit Bias Training
How many people
114 participants
Where
1 siteUnited States
Study dates
18 Apr 2018to 1 Jun 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Aim 3:
  • Not a Duke Health system provider/affiliated provider
  • Does not provide clinical care at a Duke affiliated facility

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Development and Pilot Testing of an Implicit Bias Training Intervention for Providers to Advance Equity in Healthcare

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.

Read the detailed description

Despite substantial improvements in the overall health of our nation, racial and ethnic disparities in health and healthcare remain ubiquitous. Disparities are apparent after controlling for access to care, insurance, income, patient preferences, and clinical need, suggesting that providers and health systems are important contributors to racial disparities in healthcare. In its landmark report, "Unequal Treatment," the Institute of Medicine concluded that providers contribute to disparities through the effects of implicit bias. Implicit bias occurs when thoughts and feelings outside of conscious awareness and control affect judgment and/or behavior. It is closely related to stereotyping, but not necessarily associated with explicit bias (i.e., prejudice). It leads to involuntary "blind spots" in virtually all of us. Implicit racial bias in providers is associated with Blacks (compared to Whites) experiencing lower patient-centered communication, worse doctor-patient relationships, lower confidence in the doctor, and poorer health outcomes. Therefore, to address health disparities, there is an urgent need for interventions that address implicit bias in healthcare.

Across society, implicit bias training is increasingly used in public service, business and healthcare settings to raise self-awareness and provide self-management tools for avoiding actions based on implicit bias. While such interventions are well-conceived and intuitively attractive, they have not been rigorously tested. In order to make optimal use and insure sustained support for such training, its effectiveness must be rigorously demonstrated. The overall objective is to test the hypothesis that implicit bias training for healthcare providers will reduce racial/ethnic disparities in patient-centered care. Before investigators can definitively test this hypothesis, additional groundwork must be done.

This project will provide the preliminary evidence necessary to ultimately evaluate an implicit bias training intervention in a pragmatic, randomized clinical trial conducted at the health system level. To do so, investigators will achieve these specific aims:

Aim 1. Identify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. 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.

Aim 2. Refine an existing implicit bias intervention with input from providers, health system stakeholders and expert consultation. Investigators will conduct a series of semi-structured interviews 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.

Aim 3. In a pilot trial, determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes. Investigators will conduct a feasibility trial using the refined intervention emerging from Aim 2. These feasibility outcomes will prepare investigators for a future, fully-powered randomized trial of implicit bias training.

At the conclusion of this study, investigators will be prepared to test the impact of implicit bias training on racial/ethnic disparities in the clinical encounter, and thus move us toward delivery of equitable, evidence-based, patient- centered clinical care.

Being tested
Focus Groups, Cognitive Interviews, Pilot Testing of Implicit Bias Training
Keywords
Implicit Bias, Healthcare Equity
Medical subject headings
Communication, Racism, Bias, Implicit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focus GroupsOther

    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.

  • Cognitive InterviewsOther

    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

  • Pilot Testing of Implicit Bias TrainingOther

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

Study groups in NCT03415308
Study groupRoleWhat they receive
Patient Focus GroupsIdentify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. I
Receives: Other: Focus Groups
Stakeholders Cognitive InterviewsInvestigators will conduct a series of semi-structured interviews.
Receives: Other: Cognitive Interviews
Pilot Testing of Implicit Bias TrainingRefined intervention emerging from Aim 2. T
Receives: Other: Pilot Testing of Implicit Bias Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Training Measured by Participation

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

    Measured: 4 hours (post-training)

  2. 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.

    Measured: 4 hours (post-training)

Secondary outcomes (2)
  1. Variability in Any Trial Outcomes by Provider-related Characteristics

    Investigators will also gather provider data (age, sex, race, practice characteristics, time in practice, etc.) via self-report and assess and variability in outcomes by these characteristics.

    Measured: 4 hours (post-training)

  2. Change in IAT Outcomes From Baseline to Immediately Post-intervention

    Investigators will ask participants to complete an implicit association test (IAT) at baseline and immediately following training using the Brief IAT measure, which can be administered in under 5 minutes on a laptop computer. The Brief IAT provides comparable findings on implicit racial attitudes tests, when validated against the longer IAT measure.

    Measured: baseline, 4 hours (post-training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start18 Apr 2018
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415308
Sponsor's protocol ID
Pro00088354
Status last verified
Mar 2024
First submitted
23 Jan 2018
Last updated
18 Mar 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38903809

Questions about this trial

What is this clinical trial studying?

An observational study of Communication and Bias, Racial, run by Duke University 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 7 inclusion and 9 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 18 Mar 2024. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Training Measured by Participation (time frame: 4 hours (post-training)). 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?

On the ClinicalTrials.gov record for NCT03415308, which also lists 1 linked publication.

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 18 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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