Recruiting

CHWs & KTx

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06655857

Conditions

Kidney Transplant Waitlisting

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Usual Care

Community Health Worker Assistance

Intervention Providers

Study Details

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).

Conditions

Kidney Transplant Waitlisting

Study ID

NCT06655857

Start date

Aug 5, 2025

Status verified date

Apr, 2026

Completion date

Dec 29, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support

Participants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services.

other: Usual Care

Participants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention.

Interventions

Usual Care

Participants are provided care as usual. Clinicians (CKD, HD, KTx) will educate participants on the kidney transplant process. Clinician will receive the education intervention to provide participants at study end.

Community Health Worker Assistance

Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services

Intervention Providers

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).

Primary outcome measure

  • Time to completion of kidney transplant waitlisting evaluation [ Time Frame: Baseline, and then every 6 months up to 2 years ]

Central Contacts and Locations

Central contacts

Lili Chan

929-618-0350lili.chan@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Lili Chan

lili.chan@mountsinai.org

Sabrina Clermont

sabrina.clermont@mountsinai.org

Principal Investigator:

Lili Chan

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-01.