- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415308
REACH Implicit Bias Training Project
Development and Pilot Testing of an Implicit Bias Training Intervention for Providers to Advance Equity in Healthcare
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient Focus Groups
Identify patient preferences for constructs, and related outcomes, that reflect the expression of implicit bias in clinical encounters.
I
|
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.
|
Stakeholders Cognitive Interviews
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
|
Pilot Testing of Implicit Bias Training
Refined intervention emerging from Aim 2. T
|
Determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours (post-training)
|
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.
|
4 hours (post-training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variability in Any Trial Outcomes by Provider-related Characteristics
Time Frame: 4 hours (post-training)
|
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)
|
Change in IAT Outcomes From Baseline to Immediately Post-intervention
Time Frame: baseline, 4 hours (post-training)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary G Bennett, Ph.D, Duke University
- Study Director: Kimberly S Johnson, MD, Duke University
- Principal Investigator: Laura P Svetkey, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00088354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Communication
-
Insel Gruppe AG, University Hospital BernSwiss National Science Foundation; University of Bern; Fachhochschule NordwestschweizRecruitingCommunication Research | Communication, MultidisciplinarySwitzerland
-
Johns Hopkins UniversityCompletedCommunication | Obstetric Complication | High Risk Pregnancy | Multidisciplinary CommunicationUnited States
-
Dartmouth-Hitchcock Medical CenterAmerican Cancer Society, Inc.CompletedCommunicationUnited States
-
Stanford UniversityUniversity of Southern CaliforniaActive, not recruitingCommunicationUnited States
-
National Taiwan University HospitalCompleted
-
Boston Children's HospitalPatient-Centered Outcomes Research InstituteCompletedCommunicationUnited States, Canada
-
Medical College of WisconsinCompletedCommunicationUnited States
-
University of Wisconsin, MadisonPatient-Centered Outcomes Research Institute; Brigham and Women's Hospital; Oregon... and other collaboratorsCompleted
-
University of Southern CaliforniaSoar Technology; Creative Media and Behavioral Health Center; USC Center for...CompletedCommunicationUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteCompleted
Clinical Trials on Focus Groups
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust and other collaboratorsCompletedChild Sexual Abuse, Confirmed, SequelaUnited Kingdom
-
Queen's University, BelfastCompletedAge Related Macular DegenerationUnited Kingdom
-
Gia MuddWest Virginia UniversityCompletedAdverse Childhood ExperiencesUnited States
-
Greater Manchester Mental Health NHS Foundation...Manchester University NHS Foundation Trust; University of Manchester; Anna Freud... and other collaboratorsCompletedMental Health IssueUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterCompletedBreast Cancer | Colorectal Cancer | Lung CancerUnited States
-
Kara MarlattCompletedMenopause | Menopause Related ConditionsUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Virginia...CompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruitingSyringomyelia | Chiari MalformationFrance
-
Memorial Sloan Kettering Cancer CenterColumbia University; NYU Langone Health; Roswell Park Cancer Institute; Jacobi... and other collaboratorsRecruiting
-
University of TorontoCompletedBreastfeeding | Vulnerable Population | Breast Pumping | Infant NutritionCanada