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.