Chronic Kidney DiseasesNCT07921342
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
A study testing Individuation + Implicit Bias Training and Implicit Bias Training Alone in people with Chronic Kidney Diseases, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Individuation + Implicit Bias Training and Implicit Bias Training Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Patients of any sex, race and ethnicity of the participating providers who are able to provide consent
- English-speaking
Show all 10Show fewer
- >=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
Who cannot join
- Patients who are incarcerated, pregnant or unable to consent
- Patients from our searches who have opted out of research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mass General Brigham
Somerville, Massachusetts, 02150
Julie Lauffenburger, PharmD, PhD
About this study
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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Individuation + Implicit Bias Training, Implicit Bias Training Alone
- Keywords
- Individuation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individuation + Implicit Bias TrainingBehavioural
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 AloneBehavioural
This includes nephrologists taking Implicit Association Tests (IATs) and an unconscious bias in medicine course (~45-60 min.)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Implicit bias training + individuation Receives: Behavioral: Individuation + Implicit Bias Training |
| Control | Experimental | Implicit bias training alone Receives: Behavioral: Implicit Bias Training Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Secondary outcomes (9)
Blood Pressure
Percent at goal (SBP <120) 6 months after appointment
Measured: 180 days
Change in creatinine/eGFR
Change in creatinine and eGFR at 6 months compared to baseline
Measured: 180 days
Change in spot albumin/creatinine ratio
Change in spot albumin/creatinine 6 months compared to baseline
Measured: 180 days
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.
Measured: Date of visit (+7 day lag time)
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.
Measured: Date of visit
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.
Measured: Date of visit
Patient satisfaction with care
Patient satisfaction with care assessed using the 'Patient Satisfaction Questionnaire'
Measured: Date of visit
Patient centeredness
Patient centeredness assessed using the 'Revised Patient Perception of Patient-Centeredness Questionnaire'
Measured: Date of visit
Patient interpersonal trust in the provider
Patient interpersonal trust in the provider assessed using the 'Trust in Physician Scale'
Measured: Date of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candace Hillary Feldman, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921342
- Sponsor's protocol ID
- 2026P002793
- Other IDs
- 5P30AG064199-07
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
- ClinicalTrials.gov ID
- NCT07921342
- Acronym / sponsor ID
- 2026P002793
- Conditions
- Chronic Kidney Diseases
- Keywords
- Individuation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Individuation + Implicit Bias TrainingImplicit bias training + individuation |
| Control | Experimental | Behavioral: Implicit Bias Training AloneImplicit bias training alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- Patients of any sex, race and ethnicity of the participating providers who are able to provide consent
- English-speaking
Key exclusion criteria (2 listed)
- Patients who are incarcerated, pregnant or unable to consent
- Patients from our searches who have opted out of research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individuation + Implicit Bias TrainingThis 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). | Behavioural | Intervention |
| Implicit Bias Training AloneThis includes nephrologists taking Implicit Association Tests (IATs) and an unconscious bias in medicine course (~45-60 min.) | Behavioural | Control |
Primary outcome
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)
9 secondary outcomes
Blood Pressure
Time frame: 180 days
Change in creatinine/eGFR
Time frame: 180 days
Change in spot albumin/creatinine ratio
Time frame: 180 days
Stereotype activation
Time frame: Date of visit (+7 day lag time)
Patient-provider care management discussion
Time frame: Date of visit
Providers' communication style
Time frame: Date of visit
Patient satisfaction with care
Time frame: Date of visit
Patient centeredness
Time frame: Date of visit
Patient interpersonal trust in the provider
Time frame: Date of visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individuation + Implicit Bias Training and Implicit Bias Training Alone in people with Chronic Kidney Diseases, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Lauffenburger, PharmD, PhD (857-282-1962, jlauffenburger@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CKD quality metrics achieved (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.