Helping people get on the kidney transplant waitlist using community health workers and provider training.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cluster randomized trial in which nephrology providers are randomized to either an intervention or usual care and all their patients follow the same assignment. The intervention pairs community health workers (CHWs) who address unmet social needs and symptoms and link patients to clinical and community services with provider education on working with CHWs, reducing bias, and improving affirming language in the electronic health record. Providers and their patients are followed to see whether the combined approach increases placement on the kidney transplant waitlist. The trial enrolls adults with eGFR ≤20 mL/min/1.73m2 or on maintenance in-center hemodialysis who receive care at participating New York centers and speak English or Spanish.

Why it matters

Who can join: the full rules

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

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting
• NYU Langone Health
  New York, New York, United States Not yet recruiting
• Montefiore Einstein
  The Bronx, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Lili Chan — Ichan School of Medicine at Mount Sinai Hospital
• Study coordinator: Lili Chan
• Email: lili.chan@mountsinai.org
• Phone: 929-618-0350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.