Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05116163
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brigham and Women's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Candace H Feldman, MD, ScD
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Arthritis, Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

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.

Active Comparator: Arm 2: Implicit bias education only

10 rheumatologists randomized and stratified by hospital and gender

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115