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Not yet recruitingNCT07921342ClinicalTrials.gov record

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

Chronic Kidney Diseases

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
216 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Single masked
Intervention

Implicit bias training + individuation

Behavioral: Individuation + Implicit Bias Training

Control

Implicit bias training alone

Behavioral: Implicit Bias Training Alone

Individuation + Implicit Bias Training BEHAVIORAL

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).

Implicit Bias Training Alone BEHAVIORAL

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Percentage of CKD quality metrics achieved

Time frame: 90 days

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)

Secondary measures

Blood Pressure

Time frame: 180 days

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

Change in creatinine/eGFR

Time frame: 180 days

Change in creatinine and eGFR at 6 months compared to baseline

Change in spot albumin/creatinine ratio

Time frame: 180 days

Change in spot albumin/creatinine 6 months compared to baseline

Stereotype activation

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

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.

Patient-provider care management discussion

Time frame: Date of visit

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.

Providers' communication style

Time frame: Date of visit

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.

Patient satisfaction with care

Time frame: Date of visit

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.

Patient centeredness

Time frame: Date of visit

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.

Patient interpersonal trust in the provider

Time frame: Date of visit

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Mass General BrighamSomerville, Massachusetts, United StatesStatus unknown
Julie Lauffenburger, PharmD, PhDCONTACT
View location on map ↗

Study team and timeline

Lead sponsor
Brigham and Women's Hospital
Study start
2027-01 Estimated
Primary completion
2028-01 Estimated
Study completion
2028-12 Estimated
First posted
Nov 6, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Julie Lauffenburger, PharmD, PhDCONTACTjlauffenburger@bwh.harvard.edu857-282-1962
Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026