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

Interventions for Promoting Kidney Transplant Empowerment

This project tests whether giving patients support from community health workers plus training for their kidney providers helps adults with advanced kidney failure at participating New York centers get on the transplant waitlist compared with usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT06655857 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced kidney disease (eGFR ≤20 mL/min/1.73m2) or on in-center hemodialysis who receive care at the participating New York centers and speak English or Spanish are the ideal candidates.

Not a fit: Patients with absolute contraindications to transplant (for example, dementia or inability to consent) or those not receiving care at the listed participating centers are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the intervention could increase the number of patients who complete transplant evaluation and are placed on the transplant waitlist.

How similar studies have performed: Previous programs using community health workers and clinician education have shown promise for improving transplant education and evaluation completion, but randomized evidence specifically showing increased waitlisting is limited.

Eligibility 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

Where this trial is running

New York, New York and 2 other locations

• NYU Langone Health — New York, New York, United States (Not_yet_recruiting)
• Mount Sinai Hospital — New York, New York, United States (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

Conditions Kidney Transplant Waitlisting