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Aún no reclutaNCT07921342Registro de ClinicalTrials.gov

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

Chronic Kidney Diseases

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
216 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
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.)

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Percentage of CKD quality metrics achieved

Plazo: 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)

Medidas secundarias

Blood Pressure

Plazo: 180 days

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

Change in creatinine/eGFR

Plazo: 180 days

Change in creatinine and eGFR at 6 months compared to baseline

Change in spot albumin/creatinine ratio

Plazo: 180 days

Change in spot albumin/creatinine 6 months compared to baseline

Stereotype activation

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

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1 centros

Mass General BrighamSomerville, Massachusetts, United StatesEstado desconocido
Julie Lauffenburger, PharmD, PhDCONTACT
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Equipo y fechas

Patrocinador principal
Brigham and Women's Hospital
Inicio del estudio
2027-01 Estimado
Finalización primaria
2028-01 Estimado
Finalización del estudio
2028-12 Estimado
Primera publicación
6 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Julie Lauffenburger, PharmD, PhDCONTACTjlauffenburger@bwh.harvard.edu857-282-1962
Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026