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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415308
Other study ID # Pro00088354
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 18, 2018
Est. completion date June 1, 2022

Study information

Verified date March 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Focus Groups
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 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
Pilot Testing of Implicit Bias Training
Determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training.

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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. 4 hours (post-training)
Secondary 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. baseline, 4 hours (post-training)
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