ClinicalTrials.gg
Not yet recruitingNCT07921342Updated Nov 10, 2026

An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care

An interventional study of Individuation + Implicit Bias Training and Implicit Bias Training Alone in Chronic Kidney Diseases, sponsored by Brigham and Women's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to test whether an individuation intervention can improve the quality of chronic kidney disease (CKD) care for patients with low socioeconomic status (SES) and to understand the mechanisms through which the intervention may improve care delivery and clinical outcomes. The study will involve nephrologists and their patients with CKD, with a focus on reducing healthcare disparities associated with low SES. Researchers will compare nephrologists who receive the individuation intervention with those in the control group to determine whether encouraging physicians to better understand their patients as unique individuals, rather than relying on assumptions associated with socioeconomic status, improves the quality of CKD care for patients with low SES.

02

Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Individuation
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 216 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

For Providers:

Inclusion Criteria:

  • Nephrologists of any sex, race and ethnicity
  • >18 years of age
  • >=1 clinic at an MGB-affiliated clinic (BWH main campus, 850 Boylston, Foxborough, MGH main campus, 165 Cambridge Street, MGH West Waltham) where they care for patients that have chronic kidney disease (CKD)

For Patients:

Inclusion Criteria:

  • Patients of any sex, race and ethnicity of the participating providers who are able to provide consent
  • English-speaking
  • >=18 years old
  • Insured by Medicaid/Mass Health (as a proxy for low socioeconomic status) or dually insured by Medicaid/Medicare
  • Have a diagnosis of CKD or a referral to nephrology for evaluation of CKD
  • Have been seen \<=3 times in the past year by the nephrologist

Exclusion Criteria:

  • Patients who are incarcerated, pregnant or unable to consent
  • Patients from our searches who have opted out of research
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Intervention

    Implicit bias training + individuation

    Behavioral: Individuation + Implicit Bias Training

  • Experimental
    Control

    Implicit bias training alone

    Behavioral: Implicit Bias Training Alone

Interventions

  • BehavioralIndividuation + Implicit Bias Training

    This includes nephrologists taking Implicit Association Tests (IATs) and an unconscious bias in medicine course (\~45-60 min.) Those in the intervention arm will then meet with the study team for a 5-10-minute training on individuation, including examples of individuation-based questions. Nephrologists will be encouraged to design and tailor these questions to their own communication styles to facilitate natural conversations about patients' personal characteristics beyond their medical conditions. Each nephrologist will decide how to incorporate this into their visits (e.g., a smartphrase in a note template).

  • BehavioralImplicit Bias Training Alone

    This includes nephrologists taking Implicit Association Tests (IATs) and an unconscious bias in medicine course (\~45-60 min.)

06

What researchers measure

Primary outcomes

  1. Percentage of CKD quality metrics achieved

    This includes receipt of angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin II receptor blockers (ARBs), receipt of sodium-glucose co-transporter-2 inhibitors (SGLT2-Is), and measurement of spot albumin/creatinine ratio. For patients with CKD Stages 3a-5, this will also include measurement of hemoglobin, calcium, PTH, phosphate, 25-OH-vitamin D, referral for dialysis access placement (if indicated), and referral to transplant (if indicated)

    Time frame: 90 days

Secondary outcomes

  1. Blood Pressure

    Percent at goal (SBP \<120) 6 months after appointment

    Time frame: 180 days

  2. Change in creatinine/eGFR

    Change in creatinine and eGFR at 6 months compared to baseline

    Time frame: 180 days

  3. Change in spot albumin/creatinine ratio

    Change in spot albumin/creatinine 6 months compared to baseline

    Time frame: 180 days

  4. Stereotype activation

    After each encounter, providers will list the first three patient characteristics that come to mind, which 15 coders blinded to the study purpose will independently rate for low-SES stereotype content on a 1-5 scale, with ratings averaged across coders and characteristics to generate a patient-level stereotype activation score.

    Time frame: Date of visit (+7 day lag time)

  5. Patient-provider care management discussion

    The patient-provider care management discussion will be operationalized in 3 ways: (1) which quality metrics are discussed (yes/no), (2) their order (rank), and (3) discussion length (seconds). Recorded encounters will be transcribed verbatim with speaker designations and time stamps and analyzed in steps involving coding.

    Time frame: Date of visit

  6. Providers' communication style

    Providers' communication style will be analyzed using Linguistic Inquiry and Word Count (LIWC), which categorizes words into \>70 linguistic and psychological categories (e.g., pronouns, social words, affect) and calculates the percentage of words in each category.

    Time frame: Date of visit

  7. Patient satisfaction with care

    Patient satisfaction with care assessed using the 'Patient Satisfaction Questionnaire', with a minimum score of 1 and maximum score of 5. A higher score means a better outcome i.e. extremely satisfied.

    Time frame: Date of visit

  8. Patient centeredness

    Patient centeredness assessed using the 'Revised Patient Perception of Patient-Centeredness Questionnaire', with a minimum score of 1 and maximum score of 4. A higher score means a better outcome i.e. excellent patient centeredness.

    Time frame: Date of visit

  9. Patient interpersonal trust in the provider

    Patient interpersonal trust in the provider assessed using the 'Trust in Physician Scale', with a minimum score of 1 and maximum score of 5. A higher score means a better outcome i.e. high trust in the provider.

    Time frame: Date of visit

07

Study locations

1 site
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 12 months is below that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2028
CompletionEst.
Dec 2028
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
3 description edited
What changed in the outcomes
  • DescriptionPatient centeredness: how it is measured was reworded
  • DescriptionPatient interpersonal trust in the provider: how it is measured was reworded
  • DescriptionPatient satisfaction with care: how it is measured was reworded
Nov 10, 2026
Registered
First appeared on the registry
Nov 6, 2026
Show all 2 updates
  1. Nov 10, 2026
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionPatient centeredness: how it is measured was reworded
    • DescriptionPatient interpersonal trust in the provider: how it is measured was reworded
    • DescriptionPatient satisfaction with care: how it is measured was reworded
  2. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07921342
Responsible party
Candace Hillary Feldman, MD (Assistant Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Nov 6, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Julie Lauffenburger, PharmD, PhD
Contact
jlauffenburger@bwh.harvard.edu
857-282-1962

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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