An observational study in Communication, Bias, Racial and Relation, Doctor Patient, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Duke University · Observational
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's enrollment of 114 is close to the median of 104 across 132 observational studies indexed under Communication.
Browse Communication studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Aim 1, investigators will use the community population. Aims 2 and 3 focus specifically on providers and stakeholders at Duke medical center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aim 1:
Aim 2:
Aim 3:
Exclusion Criteria:
Aim 1:
Aim 2:
Aim 3:
Identify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters. I
Other: Focus Groups
Investigators will conduct a series of semi-structured interviews.
Other: Cognitive Interviews
Refined intervention emerging from Aim 2. T
Other: Pilot Testing of Implicit Bias Training
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.
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
Determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training.
Feasibility of Training Measured by Participation
Investigators will judge the trial as feasible if at least 50% of eligible providers agree to participate.
Time frame: 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.
Time frame: 4 hours (post-training)
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.
Time frame: 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.
Time frame: baseline, 4 hours (post-training)
| Milestone | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training |
|---|---|---|---|
| Started | 50 | 27 | 37 |
| Completed | 50 | 27 | 29 |
| Not completed | 0 | 0 | 8 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Scheduling conflicts | 0 | 0 | 7 |
Investigators will judge the trial as feasible if at least 50% of eligible providers agree to participate.
No measurements were reported for this outcome.
At least 80% of those enrolled complete the trial (attend both sessions); and achieve at least 75% adherence to all intervention activities and exercises.
| Participants | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training |
|---|---|---|---|
| Acceptability | — | — | 29 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 4 hours (post-training). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Focus Groups | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Stakeholders Cognitive Interviews | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Pilot Testing of Implicit Bias Training | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training | Total |
|---|---|---|---|---|
| Mean | 42.4 ± 15.9 | — | — | 42.4 ± 15.9 |
| Sex: Female, Male(Participants) | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training | Total |
|---|---|---|---|---|
| Female | 40 | 16 | 29 | 85 |
| Male | 10 | 11 | 8 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training | Total |
|---|---|---|---|---|
| Hispanic or Latino | 11 | 1 | 1 | 13 |
| Not Hispanic or Latino | 39 | 11 | 36 | 86 |
| Unknown or Not Reported | 0 | 15 | 0 | 15 |
| Race (NIH/OMB)(Participants) | Patient Focus Groups | Stakeholders Cognitive Interviews | Pilot Testing of Implicit Bias Training | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 10 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 20 | 8 | 2 | 30 |
| White | 26 | 18 | 24 | 68 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 4 | 0 | 0 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Jun 2022, 49 months.
Results were first posted in Mar 2024, 1 year 9 months after primary completion.
Of 51 non-industry observational studies under Communication, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 61. This study's 49 months is above that.
Counting every sponsor, half of 53 studies reached it within 25 months; a quarter within 9 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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