Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116163
• Other study ID #: 2021P002882
• Secondary ID: 5P30AG064199
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: August 15, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis
• Lupus Erythematosus, Systemic
• Osteoarthritis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts General Hospital, National Institute on Aging (NIA), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients receiving high quality care	Documented receipt of high-quality care at the time of 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. This data will be measured for all patients with SLE and RA seen by the provider during the 6-month study period in addition to separate subgroup analysis focused on the patients who had their appointments audio recorded.	30 days
Secondary	Implicit Association Test (IAT) scores	Change in provider IAT scores pre and post intervention.	Baseline compared to 6 months after the start of the intervention.
Secondary	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.	Baseline (one time evaluation)
Secondary	Patient Satisfaction	Differences in patient satisfaction score, comparing the intervention to non-intervention group. Score range from 20-70.	Baseline (one time evaluation)
Secondary	Everyday Discrimination Scale	Change in daily discrimination encountered from baseline to 6 months using the Everyday Discrimination Scale, comparing the intervention to non-intervention group. Score range is 0-40. Higher scores indicate a worse outcome (higher scores indicate a greater amount of discrimination encountered).	Baseline (one time evaluation)
Secondary	Adherence	Change in adherence score (for rheumatology medications), comparing the intervention to non-intervention group. Score range is 0-100 with zero being the lowest adherence, and 100 being the best.	Baseline compared to 3 months after the start of the intervention.
Secondary	Number of emergency department visits and hospitalizations	The investigators will compare number of ED visits and hospitalizations	6 months following the encounter of interest
Secondary	Provider communication	Provider communication will be measured using the recorded transcripts and compared between arms. Measured only for patients enrolled in the study who had their appointment audio recorded.	Baseline (one time evaluation)
Secondary	Patient Trust	Change in patient trust score, comparing the intervention to non-intervention group. Responses are summed (range 5-25) with higher scores indicating more trust.	Baseline (one time evaluation)
Secondary	Number of outpatient visits	The investigators will compare the number of outpatient visits completed and outpatient visit no shows between the two arms.	6 months following the encounter of interest