Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

NCT05116163 | Completed Results

• 2 other identifiers: 2021P0028825P30AG064199
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus; Rheumatoid Arthritis; Inflammatory Arthritis; Osteoarthritis

Keywords

Implicit Bias; Quality of Care; Rheumatology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Perception of Patient Centeredness

  At time of appointment (baseline) during which audiorecording took place, reflecting the experience at the appointment immediately preceding survey completion.

• 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

  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

  3 months after the start of the intervention

• Provider Communication: Positive Emotion Words

  One time baseline evaluation from the transcript of the audiorecording of the encounter of the patient with their rheumatologist

Study Arms (2)

Arm 1: Individuation Intervention plus implicit bias education

EXPERIMENTAL

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; Other: Implicit bias educational modules

Arm 2: Implicit bias education only

ACTIVE COMPARATOR

10 rheumatologists randomized and stratified by hospital and gender

Other: Implicit bias educational modules

Interventions

Individuation Intervention plus implicit bias educational modules BEHAVIORAL

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.

Arm 1: Individuation Intervention plus implicit bias education

Implicit bias educational modules OTHER

Providers in the comparator arm will be given the same implicit bias educational modules to complete.

Arm 1: Individuation Intervention plus implicit bias education; Arm 2: Implicit bias education only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Virginia Commonwealth University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Arthritis; Osteoarthritis; Bias, Implicit

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Prejudice; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Candace Feldman
• Organization: Brigham and Women's Hospital

chfeldman@partners.org

617-525-1035

Study Officials

• Candace H Feldman, MD, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators plan to enroll 20 rheumatologists and a maximum of 200 patients randomized into two different control arms. The providers will observe the outcomes in each separate arm as well as evaluate the results of both arms to each other.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 10, 2021
• Study Start: June 17, 2022
• Primary Completion: September 27, 2024
• Study Completion: October 9, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)