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Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05116163
Enrollment
201
Registered
2021-11-10
Start date
2022-06-17
Completion date
2024-10-09
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Arthritis, Osteoarthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus

Keywords

Implicit Bias, Quality of Care, Rheumatology

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.

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.

Interventions

BEHAVIORALIndividuation 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.

OTHERImplicit bias educational modules

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Virginia Commonwealth University
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent of Quality Metrics Achieved30 daysDocumented 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).

Secondary

MeasureTime frameDescription
Patient SatisfactionAt time of appointment (baseline) during which audiorecording took place, reflecting the experience at the appointment immediately preceding survey completion.Differences in patient satisfaction score, comparing the intervention to non-intervention group. Score range from 20-70. Higher scores indicate greater patient satisfaction.
Everyday Discrimination ScaleA 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.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.
Adherence3 months after the start of the interventionAdherence 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.
Provider Communication: Positive Emotion WordsOne time baseline evaluation from the transcript of the audiorecording of the encounter of the patient with their rheumatologistProvider 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.
Patient TrustOne time baseline evaluation after the appointment reflecting experiences at the immediately preceding appointment.Patient trust in their providers, comparing the intervention to non-intervention group. Responses are summed (range 5-25) with higher scores indicating more trust.
Incidence Rate Ratio of Emergency Departments Visits6 months following the encounter of interestComparison of incidence rate of Emergency Department visits between patients of providers in the intervention compared to the control arms.
Perception of Patient CenterednessAt time of appointment (baseline) during which audiorecording took place, reflecting the experience at the appointment immediately preceding survey completion.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.
Incidence Rate Ratio of Hospitalizations6 months after physician encounterComparison of incidence rate of hospitalizations between patients of providers in the intervention compared to the control arms.
Implicit Association Test (IAT) Scores- Socioeconomic Status StereotypingBaseline compared to 6 months after the start of the intervention.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.
Implicit Association Test (IAT) Scores- Race Implicit BiasBaseline compared to 6 months after the start of the intervention.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.
Implicit Association Test (IAT) Scores- Race Stereotyping.Baseline compared to 6 months after the start of the intervention.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.
Implicit Association Test (IAT) Scores- Socioeconomic Status BiasBaseline compared to 6 months after the start of the intervention.. 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.
Incidence Rate Ratio of Outpatient Visits.6 months following the encounter of interestComparison of incidence rate of outpatient visits between patients of providers in the intervention compared to the control arms.

Countries

United States

Participant flow

Recruitment details

Rheumatologists were recruited from 6/17/2022-12/12/2023 at Brigham and Women's Hospital and Massachusetts General Hospital.

Pre-assignment details

Rheumatologists took Implicit Association Tests and were provided with implicit bias training and then randomized to either the control or intervention arm.

Participants by arm

ArmCount
Arm 1: Individuation Intervention Plus Implicit Bias Education: Rheumatologists
Rheumatologists watched implicit bias training modules and then were instructed to incorporate an individuation strategy into each of their clinical encounters.
10
Arm 2: Implicit Bias Education Only: Rheumatologists
Rheumatologists watched implicit bias training modules.
9
Patients of Arm 1- Chart Review Only
Patients of providers in Arm 1 who had their electronic health records reviewed but did not enroll/complete surveys
79
Patients of Arm 2- Chart Review Only
Patients of providers in Arm 2 who had their electronic health records reviewed but did not enroll/complete surveys
50
Patients of Arm 1 Providers With Audiorecordings and Surveys
Patients of providers in Arm 1 who enrolled for an audiorecorded encounter and surveys
20
Patients of Arm 2 Providers With Audiorecordings and Surveys
Patients of providers in Arm 2 who enrolled for an audiorecorded encounter and surveys
27
Total195

Baseline characteristics

CharacteristicPatients of Arm 2 Providers With Audiorecordings and SurveysTotalArm 1: Individuation Intervention Plus Implicit Bias Education: RheumatologistsArm 2: Implicit Bias Education Only: RheumatologistsPatients of Arm 1- Chart Review OnlyPatients of Arm 2- Chart Review OnlyPatients of Arm 1 Providers With Audiorecordings and Surveys
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants47 Participants1 Participants1 Participants26 Participants12 Participants3 Participants
Age, Categorical
Between 18 and 65 years
23 Participants148 Participants9 Participants8 Participants53 Participants38 Participants17 Participants
Baseline Medication Adherence58.9 units on a scale
STANDARD_DEVIATION 18.8
53.8 units on a scale
STANDARD_DEVIATION 19.5
49.3 units on a scale
STANDARD_DEVIATION 19.6
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants29 Participants0 Participants3 Participants9 Participants10 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants158 Participants9 Participants6 Participants67 Participants38 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants8 Participants1 Participants0 Participants3 Participants2 Participants1 Participants
Provider-Only Implicit Association Test- Race Bias-0.42 units on a scale
STANDARD_DEVIATION 0.54
-0.46 units on a scale
STANDARD_DEVIATION 0.54
-0.37 units on a scale
STANDARD_DEVIATION 0.57
Provider-Only Implicit Association Test - Socioeconomic status bias0.65 units on a scale
STANDARD_DEVIATION 0.47
0.75 units on a scale
STANDARD_DEVIATION 0.55
0.54 units on a scale
STANDARD_DEVIATION 0.35
Provider-Only Implicit Association Test - Socioeconomic status stereotyping0.51 units on a scale
STANDARD_DEVIATION 0.54
0.54 units on a scale
STANDARD_DEVIATION 0.6
0.48 units on a scale
STANDARD_DEVIATION 0.49
Provider-Only Implicit Association Tests - Race stereotyping-0.20 units on a scale
STANDARD_DEVIATION 0.6
-0.13 units on a scale
STANDARD_DEVIATION 0.76
-0.29 units on a scale
STANDARD_DEVIATION 0.37
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants4 Participants1 Participants2 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
23 Participants136 Participants0 Participants1 Participants61 Participants37 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants0 Participants0 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants14 Participants1 Participants0 Participants6 Participants5 Participants2 Participants
Race (NIH/OMB)
White
4 Participants37 Participants8 Participants6 Participants10 Participants6 Participants3 Participants
Region of Enrollment
United States
27 participants248 participants10 participants9 participants79 participants50 participants20 participants
Sex/Gender, Customized
Female
17 Participants128 Participants5 Participants5 Participants53 Participants37 Participants11 Participants
Sex/Gender, Customized
Male
2 Participants25 Participants5 Participants4 Participants6 Participants4 Participants4 Participants
Sex/Gender, Customized
Unknown
8 Participants42 Participants0 Participants0 Participants20 Participants9 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 90 / 1010 / 810 / 200 / 27
other
Total, other adverse events
0 / 100 / 90 / 1010 / 810 / 200 / 27
serious
Total, serious adverse events
0 / 100 / 90 / 1010 / 810 / 200 / 27

Outcome results

Primary

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).

Time frame: 30 days

Population: Patients of providers randomized to Arm 1 or Arm 2, which includes the eligible patients in the chart-review groups, and those who also participated in the audiorecordings and surveys

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersPercent of Quality Metrics Achieved62.14 Percent of Quality Metrics AchievedStandard Deviation 13.46
Patients of Arm 2 ProvidersPercent of Quality Metrics Achieved54.31 Percent of Quality Metrics AchievedStandard Deviation 14.46
p-value: <0.001t-test, 2 sided
Secondary

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.

Time frame: 3 months after the start of the intervention

Population: Subset of patients in the audiorecording/survey arms who returned completed 3 month follow up adherence surveys.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersAdherence54.96 score on a scaleStandard Deviation 14.15
Patients of Arm 2 ProvidersAdherence55.99 score on a scaleStandard Deviation 19.44
Comparison: Comparison of 3-month vs. baseline adherence scores in patients of providers in the intervention arm vs. controlp-value: 0.056Regression, Linear
Secondary

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.

Time frame: 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.

Population: Subset of patients who consented to participate in audiorecordings and returned completed surveys.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersEveryday Discrimination Scale0.96 score on a scaleStandard Deviation 0.84
Patients of Arm 2 ProvidersEveryday Discrimination Scale1.16 score on a scaleStandard Deviation 0.93
p-value: 0.4795t-test, 2 sided
Secondary

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.

Time frame: Baseline compared to 6 months after the start of the intervention.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersImplicit Association Test (IAT) Scores- Race Implicit Bias-0.27 units on a scaleStandard Deviation 0.47
Patients of Arm 2 ProvidersImplicit Association Test (IAT) Scores- Race Implicit Bias0.12 units on a scaleStandard Deviation 0.44
Comparison: Comparing post vs. pre IAT d-scores between the intervention and control groups.p-value: 0.3615t-test, 2 sided
Secondary

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.

Time frame: Baseline compared to 6 months after the start of the intervention.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersImplicit Association Test (IAT) Scores- Race Stereotyping.-0.25 units on a scaleStandard Deviation 0.61
Patients of Arm 2 ProvidersImplicit Association Test (IAT) Scores- Race Stereotyping.-0.39 units on a scaleStandard Deviation 0.5
Comparison: Comparing post vs pre IAT d-scores in the intervention vs. control arms.p-value: 0.9432t-test, 2 sided
Secondary

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.

Time frame: Baseline compared to 6 months after the start of the intervention.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersImplicit Association Test (IAT) Scores- Socioeconomic Status Bias0.48 units on a scaleStandard Deviation 0.37
Patients of Arm 2 ProvidersImplicit Association Test (IAT) Scores- Socioeconomic Status Bias0.60 units on a scaleStandard Deviation 0.56
Comparison: Post vs pre IAT d-scores for the intervention vs. control arms.p-value: 0.1453t-test, 2 sided
Secondary

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.

Time frame: Baseline compared to 6 months after the start of the intervention.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersImplicit Association Test (IAT) Scores- Socioeconomic Status Stereotyping0.50 units on a scaleStandard Deviation 0.37
Patients of Arm 2 ProvidersImplicit Association Test (IAT) Scores- Socioeconomic Status Stereotyping0.15 units on a scaleStandard Deviation 0.5
Comparison: Post vs. pre IAT d-scores comparing the intervention vs. control arms.p-value: 0.3882t-test, 2 sided
Secondary

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.

Time frame: 6 months following the encounter of interest

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersIncidence Rate Ratio of Emergency Departments Visits0.398 number of ED visitsStandard Deviation 0.971
Patients of Arm 2 ProvidersIncidence Rate Ratio of Emergency Departments Visits0.390 number of ED visitsStandard Deviation 0.934
Comparison: Comparing the incidence rate of ED visits for the intervention vs. control arms.95% CI: [0.63, 1.64]
Secondary

Incidence Rate Ratio of Hospitalizations

Comparison of incidence rate of hospitalizations between patients of providers in the intervention compared to the control arms.

Time frame: 6 months after physician encounter

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersIncidence Rate Ratio of Hospitalizations0.316 number of hospitalizationsStandard Deviation 1.06
Patients of Arm 2 ProvidersIncidence Rate Ratio of Hospitalizations0.779 number of hospitalizationsStandard Deviation 0.354
Comparison: Incidence rate ratio comparing the incidence rates of hospitalizations in the intervention vs. control arm patients.95% CI: [1.69, 9.73]
Secondary

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.

Time frame: 6 months following the encounter of interest

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersIncidence Rate Ratio of Outpatient Visits.7.34 Number of outpatient visitsStandard Deviation 6.22
Patients of Arm 2 ProvidersIncidence Rate Ratio of Outpatient Visits.6.05 Number of outpatient visitsStandard Deviation 5.88
Comparison: Incidence rate ratio comparing incidence rates of outpatient visits in the intervention vs. control arms.95% CI: [1.07, 1.36]
Secondary

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.

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

Population: Subset of patients who consented to participate in audiorecordings and returned completed surveys.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersPatient Satisfaction50.4 score on a scaleStandard Deviation 9
Patients of Arm 2 ProvidersPatient Satisfaction51.5 score on a scaleStandard Deviation 8
p-value: 0.6781t-test, 2 sided
Secondary

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.

Time frame: One time baseline evaluation after the appointment reflecting experiences at the immediately preceding appointment.

Population: Subset of patients who consented to participate in audiorecordings and returned completed surveys.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersPatient Trust16.4 score on a scaleStandard Deviation 4
Patients of Arm 2 ProvidersPatient Trust17.6 score on a scaleStandard Deviation 5
p-value: 0.3957t-test, 2 sided
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.

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

Population: Subset of patients who consented to participate in audiorecordings and returned completed surveys.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersPerception of Patient Centeredness27.5 score on a scaleStandard Deviation 9
Patients of Arm 2 ProvidersPerception of Patient Centeredness23.4 score on a scaleStandard Deviation 7
p-value: 0.1164t-test, 2 sided
Secondary

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.

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

Population: Patients who participated in audiorecordings and had transcripts for analysis.

ArmMeasureValue (MEAN)Dispersion
Patients of Arm 1 ProvidersProvider Communication: Positive Emotion Words0.99 Number of wordsStandard Deviation 0.5
Patients of Arm 2 ProvidersProvider Communication: Positive Emotion Words0.66 Number of wordsStandard Deviation 0.33
p-value: 0.017t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026