Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

Breaking Implicit Bias Habits: An Individuation Pilot to Promote Equity in Rheumatic Disease Care

The first aim of this study is to test the efficacy of a real-time provider-based individuation intervention to improve the receipt of high-quality rheumatic disease care among Black/African American and lower socioeconomic status (SES) individuals. The second aim is to determine the effect of the individuation intervention on provider-patient communication, adherence, provider trust and care satisfaction.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Inflammatory Arthritis
• Intervention / Treatment: Behavioral: Individuation Intervention plus implicit bias educational modules; Other: Implicit bias educational modules

Detailed Description

The goal of this pilot is to test the efficacy of an individuation-based intervention among rheumatologists and their patients at two large, multisite academic-based hospital practices to improve racial and SES equity in receipt of high quality care. The primary aim is not to reduce provider bias, but rather to reduce the reliance on implicit bias in care decisions for Black and lower SES patients to lessen the impact of structural racism and inequality on care.

The investigators plan to conduct a cluster-randomized controlled trial. The clusters are 20 rheumatologists at multisite BWH and MGH-affiliated clinics. Rheumatologists will be stratified by hospital and by gender and randomly assigned to one of two groups. Ten rheumatologists will be assigned to the intervention arm and ten to the control. Assessments will be conducted for 8-10 patients per rheumatologist (max 100 patients total in each arm, 200 total). Randomization will be stratified by BWH and MGH Rheumatology main campus hospitals (MGH or BWH/ Faulkner (FH)) and their rheumatology satellite clinic sites, and by provider gender (male or female). Inclusion and exclusion criteria for providers and patients are listed under Eligibility Criteria.

Providers who consent will be stratified by gender and site and randomized to the intervention or control arm. All providers in both arms will be asked to complete demographic surveys and four Implicit Association Tests (IATs). Two of the tests assess biases related to race and two parallel tests assess biases related to socioeconomic status. After providers take the IATs and complete the baseline demographics form, both arms will be given the link to freely available brief unconscious bias training module. The module that will be used has been approved by the MA Medical Society and is eligible for CME, which can be applied towards the unconscious bias training CMEs required for MA medical license renewal as of June 1, 2022. Upon completion of the unconscious bias module, providers in the intervention arm will meet with study team members to discuss their "individuation" countermeasure intervention and to view the brief presentation with a study team member about individuation.

At least one month after providers take the IATs, the study team will begin the process of recording 8-10 provider-patient interactions within each providers' practice. This will occur both at MGH and BWH rheumatology clinic sites. Providers will also be immediately informed before a patient encounter that will be recorded and will have the opportunity to decline. To record, a digital voice recorder will be used (placed in the room by a research team member with both patient and provider aware, and collected immediately following the encounter), and all data will be transferred to the project-specific MGB secure drive at the end of each day and then deleted from the device. These files will be transcribed verbatim using an MGB-approved vendor and all identifiable information will be removed. After 6 months, which is the estimate for recruitment time, providers will be asked to repeat the IATs.

Patients who consent to participate will be asked to have one clinical encounter with their provider recorded (preferably the next appointment) and then to complete a set of baseline surveys following that encounter including demographics, social determinants of health, everyday discrimination experiences, satisfaction with care, patient trust in the medical profession, patient perception of care centeredness and medication adherence. The investigators will also collect data from the patients' charts. These data include: demographics, social determinants of health, comorbidities/diagnoses, quality metrics related to their rheumatic disease, lab results, preventive care use (including immunizations), healthcare utilization (including ED visits, hospitalizations, outpatient visits and appointment no shows), medication use (including use of contraception as a quality metric), and medication refill data over the 6 months following the date of the recorded encounter. The investigators will review the note from the date of the encounter and determine whether the individuation statement was documented in the intervention group.

For patients with lupus, osteoarthritis, inflammatory arthritis, or RA seen at least once by participating providers in both the intervention and control arm, the study team will examine the charts of patients during the 6 months following provider enrollment, beginning 1 month after the date the provider takes the IATs. The study teams estimates that this will include approximately 1000 patients. The study team plan to collect demographics, social determinants of health, comorbidities/diagnoses, quality metrics related to their rheumatic disease, lab results, preventive care use (including immunizations), healthcare utilization (including ED visits, hospitalizations, outpatient visits and appointment no shows), medication use (including use of contraception as a quality metric), and medication refill data over the 6 months following the date of the recorded encounter. The investigators will also see if any of the individuation statements (smart phrases) were used for patients not specifically enrolled in the intervention.

At the end of the study, all data will be deidentified and analyzed in aggregate. Results in aggregate will be presented in an end-of-study Grand Rounds to both the BWH and MGH rheumatology divisions (there is a combined grand rounds). The team will also provide a list of online resources about implicit bias. For patients, after the completion of the 3-month adherence assessment, the study team will provide them with a score report indicating what their scores on each of the respective surveys mean.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Providers: Providers will be male or female adult rheumatologists with >=1 clinical sessions/week at BWH/FH or MGH main campus and satellite clinic sites. The providers will aim to include a range of provider ages and years in practice.
• Patients: The study team will include male and female patients of the participating providers who are able to provide consent, English-speaking, >=18 years old, Black or African American or insured by Medicaid/Mass Health (as a proxy for low socioeconomic status), have a diagnosis of SLE, osteoarthritis, or inflammatory arthritis which includes RA (or referred to rheumatology because of high suspicion for these conditions), and have been seen <2 times in the past year by the provider.

Exclusion Criteria:

• Providers: Drs. Feldman and Schoenfeld (and their respective patients) will be excluded from this study.
• Patients: The providers will exclude patients who incarcerated or unable to consent. The providers will exclude any patient from our searches who has opted out of research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Individuation Intervention plus implicit bias education; 10 rheumatologists who will have 10 patient interactions each (100 patients total) recorded Rheumatologists will watch implicit bias training modules and then will be instructed to incorporate an individuation strategy into each of their clinical encounters.	Behavioral: Individuation Intervention plus implicit bias educational modules; Providers in the intervention are will be instructed to watch a brief set of freely available educational lessons and then they will meet with study team members to discuss their "individuation" countermeasure intervention. Providers will be given a choice of several individuation-related questions to better understand the unique characteristics of each patient. Once the provider decides on his/her choice phrases, the research team will assist with the development of a smart phrase (also called "dot phrase") to allow them to incorporate this into a note. Once a week, providers in the intervention arm will receive an email reminding them to incorporate this question and the documentation into their encounters.; Other: Implicit bias educational modules; Providers in the comparator arm will be given the same implicit bias educational modules to complete.
Active Comparator: Arm 2: Implicit bias education only; 10 rheumatologists randomized and stratified by hospital and gender	Other: Implicit bias educational modules; Providers in the comparator arm will be given the same implicit bias educational modules to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Quality Metrics Achieved	Documented receipt of high-quality care at the appointment or within 30 days of the appointment. The quality metrics for Lupus and RA include but are not limited to: Hydroxychloroquine (HCQ) initiation and Folic acid if receiving methotrexate, respectively. These items will be added together to form a score and the number of items completed out of the total will be the primary outcome measure compared across groups. The denominator is the patient-specific quality metrics they are eligible for and the numerator is the number achieved. The final percent ranges from 0-100 (with 100 indicating that 100% of the quality metrics that the patient was eligible for were met).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of Patient Centeredness	Differences in perception of patient centeredness comparing the intervention to non-intervention group. Higher scores indicate less patient-centered experiences. 4-point Likert scale, score range from 14-56.	At time of appointment (baseline) during which audiorecording took place, reflecting the experience at the appointment immediately preceding survey completion.
Patient Satisfaction	Differences in patient satisfaction score, comparing the intervention to non-intervention group. Score range from 20-70. Higher scores indicate greater patient satisfaction.	At time of appointment (baseline) during which audiorecording took place, reflecting the experience at the appointment immediately preceding survey completion.
Everyday Discrimination Scale	Reflects experiences of everyday discrimination, comparing the intervention to non-intervention group. Score range is 0-40. Higher scores indicate a greater amount of discrimination encountered.	A time of the appointment when audiorecording took place (baseline) asking patients to describe the degree to which each item occurs in their day-to-day life.
Adherence	Adherence score (for rheumatology medications), comparing the 3-month adherence score to baseline for the intervention to non-intervention group at three months following the encounter date. Score range is 0-100 with zero being the lowest adherence, and 100 being the best.	3 months after the start of the intervention
Provider Communication: Positive Emotion Words	Provider communication will be measured using the recorded transcripts and compared between arms. We compared the mean (SD) of provider positive emotion words expressed during a clinical encounter. Measured only for patients enrolled in the study who had their appointment audiorecorded.	One time baseline evaluation from the transcript of the audiorecording of the encounter of the patient with their rheumatologist
Patient Trust	Patient trust in their providers, comparing the intervention to non-intervention group. Responses are summed (range 5-25) with higher scores indicating more trust.	One time baseline evaluation after the appointment reflecting experiences at the immediately preceding appointment.
Incidence Rate Ratio of Emergency Departments Visits	Comparison of incidence rate of Emergency Department visits between patients of providers in the intervention compared to the control arms.	6 months following the encounter of interest
Incidence Rate Ratio of Outpatient Visits.	Comparison of incidence rate of outpatient visits between patients of providers in the intervention compared to the control arms.	6 months following the encounter of interest
Incidence Rate Ratio of Hospitalizations	Comparison of incidence rate of hospitalizations between patients of providers in the intervention compared to the control arms.	6 months after physician encounter
Implicit Association Test (IAT) Scores- Socioeconomic Status Stereotyping	Change in provider IAT scores pre and post intervention. IAT scores range from -1 to 1. A score of 0 indicates no strong implicit bias. A score of 1 is pro-high socioeconomic status bias and a score of -1 is pro-low socioeconomic status bias.	Baseline compared to 6 months after the start of the intervention.
Implicit Association Test (IAT) Scores- Race Implicit Bias	Change in provider IAT scores pre and post intervention. IAT scores range from -1 to 1. A score of 0 indicates no strong implicit bias. A score of 1 is pro-White bias and a score of -1 is pro-Black bias.	Baseline compared to 6 months after the start of the intervention.
Implicit Association Test (IAT) Scores- Race Stereotyping.	Change in provider IAT scores pre and post intervention. IAT scores range from -1 to 1. A score of 0 indicates no strong implicit bias. A score of 1 is pro-White stereotyping and a score of -1 is pro-Black stereotyping.	Baseline compared to 6 months after the start of the intervention.
Implicit Association Test (IAT) Scores- Socioeconomic Status Bias	. Change in provider IAT scores pre and post intervention. IAT scores range from -1 to 1. A score of 0 indicates no strong implicit bias. A score of 1 is pro-high socioeconomic status bias and a score of -1 is pro-low socioeconomic status bias.	Baseline compared to 6 months after the start of the intervention.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; National Institute on Aging (NIA); Virginia Commonwealth University
• Investigators: Principal Investigator: Candace H Feldman, MD, ScD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Care; Rheumatology; Implicit Bias
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Skin and Connective Tissue Diseases; Social Behavior; Prejudice; Arthritis; Lupus Erythematosus, Systemic; Osteoarthritis; Arthritis, Rheumatoid; Bias, Implicit
• Other Study ID Numbers: 2021P002882; 5P30AG064199 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No