CommunicationNCT03415308
REACH Implicit Bias Training Project
An observational study of Communication and Bias, Racial, run by Duke University at 1 site in United States.
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
- Conditions the study is for
- Communication, Bias, Racial, Relation, Doctor Patient
- 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.
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.
- Conditions
- Communication, Bias, Racial, Relation, Doctor Patient
- 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 group | Role | What they receive |
|---|---|---|
| Patient Focus Groups | Identify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. I Receives: Other: Focus Groups | |
| Stakeholders Cognitive Interviews | Investigators will conduct a series of semi-structured interviews. Receives: Other: Cognitive Interviews | |
| Pilot Testing of Implicit Bias Training | Refined 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.
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)
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)
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)
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.
- First posted30 Jan 2018
- Study start18 Apr 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary G Bennett, Ph.D, Principal investigator, Duke UniversityKimberly S Johnson, MD, Study director, Duke UniversityLaura P Svetkey, MD, Principal investigator, Duke University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of an Implicit Bias Training Intervention for Providers to Advance Equity in Healthcare
- ClinicalTrials.gov ID
- NCT03415308
- Acronym / sponsor ID
- Pro00088354
- Conditions
- Communication, Bias, Racial, Relation, Doctor Patient
- Keywords
- Implicit Bias, Healthcare Equity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Focus Groups | – | Other: Focus GroupsIdentify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. I |
| Stakeholders Cognitive Interviews | – | Other: Cognitive InterviewsInvestigators will conduct a series of semi-structured interviews. |
| Pilot Testing of Implicit Bias Training | – | Other: Pilot Testing of Implicit Bias TrainingRefined intervention emerging from Aim 2. T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- Had at least 2 non-urgent ambulatory care visits any Healthcare facility in the past year (via self-report)
- Proficient in English
- Providers from Durham-based ambulatory clinics in the Duke Health System or Stakeholder
- Providers from the Duke Health System providing care to a continuity patient panel.
Key exclusion criteria (9 listed)
- Less than 2 non-urgent visits
- Patient not identifying as black, white or Hispanic
- Non-English speaking
- Not a Duke provider or stakeholder
- Not a Duke Health system provider/affiliated provider
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 |
|---|---|---|
| Focus GroupsInvestigators 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. | Other | Patient Focus Groups |
| Cognitive InterviewsTo 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 | Other | Stakeholders Cognitive Interviews |
| Pilot Testing of Implicit Bias TrainingDetermine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training. | Other | Pilot Testing of Implicit Bias Training |
Primary outcome
Feasibility of Training Measured by Participation
Time frame: 4 hours (post-training)
Investigators will judge the trial as feasible if at least 50% of eligible providers agree to participate.
Acceptability
Time frame: 4 hours (post-training)
At least 80% of those enrolled complete the trial (attend both sessions); and achieve at least 75% adherence to all intervention activities and exercises.
2 secondary outcomes
Variability in Any Trial Outcomes by Provider-related Characteristics
Time frame: 4 hours (post-training)
Change in IAT Outcomes From Baseline to Immediately Post-intervention
Time frame: baseline, 4 hours (post-training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38903809Svetkey 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.
- Individual participant dataSharing planned: Undecided
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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.
Gary G Bennett, Ph.D principal investigator
Duke University
Kimberly S Johnson, MD study director
Duke University
Laura P Svetkey, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.