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NCT06655857 | NOT YET RECRUITING | Kidney Transplant Waitlisting

Interventions for Promoting Kidney Transplant Equity
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Lili Chan

Brief Summary:

This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).

Condition or disease

Kidney Transplant Waitlisting

Intervention/treatment

Usual Care

Community Health Worker Assistance

Intervention Providers

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 366 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Interventions for Promoting Kidney Transplant Equity
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2027-11-30
Estimated Study Completion Date : 2027-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient inclusion
    • * Provision of signed and dated informed consent from the patient.
    • * Stated willingness to comply with all study procedures and availability for the duration of the study.
    • * Age 18 - 75 years
    • * eGFR≤20 mL/min/1.73m2 or on maintenance in-center HD.
    • * Receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center.
    • * Community dwelling (i.e., not in a nursing home, currently incarcerated).
    • * Speak English and/or Spanish.
    • * Provider Inclusion
      • * Provision of signed and dated informed consent from the nephrologist.
      • * Stated willingness to comply with all study procedures and availability for the duration of the study.
      Exclusion Criteria
      • * Patient Exclusion
        • * Absolute contraindications to KTx
          • * Self-reported or documented diagnosis of dementia, or inability to understand the study and complete informed consent. When the participant's understanding is unclear, the CRC will use a modified MOCA screener to determine eligibility.
          • * Active malignancy (excluding local non-melanoma skin cancer, renal cell carcinoma \<5 cm, early thyroid cancer, and prostate cancer GS≤6).
          • * Pregnancy (can be re-evaluated post-delivery).
          • * Active infection. Patients excluded due to active infection will be evaluated at 30 days or after completing full treatment (whichever is later) to determine eligibility. Examples of active infection include
            • * Positive cultures or radiographic evidence of infection
            • * Infected intravascular devices, such as tunneled catheters and pacemakers
            • * Active histoplasmosis, cryptococcosis, tuberculosis (TB), and nontuberculous mycobacteria
            • * Previously evaluated by KTx and not listed for specific medical reasons.
            • * Patients previously evaluated and not listed will be carefully reviewed by site PI for eligibility
            • * Already listed for KTx.
            • * Patients on other types of dialysis other than in-center hemodialysis.
            • * Self-identify as already engaged with a CHW at participating sites to address unmet social needs.
            • * Planning to move out of the greater NY area in the next 1 year.
            • * Provider Exclusion
              • * Planning to leave their respective institutions in the next 1 year
Interventions for Promoting Kidney Transplant Equity

Location Details

NCT06655857

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

Montefiore Einstein

Bronx, New York, United States, 10467

Not yet recruiting

United States, New York

NYU Langone Health

New York, New York, United States, 10016

Not yet recruiting

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029