Interventions for Promoting Kidney Transplant Empowerment

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06655857
Status
Recruiting

Conditions

  • Kidney Transplant Waitlisting

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — OTHER
    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 — OTHER
    Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
  • Intervention Providers — OTHER
    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).

Study Details

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).

Key Dates

Start date
Aug 5, 2025
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 29, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Sabrina Clermont
Lili Chan (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Michal Melamed
Michal Melamed (PRINCIPAL_INVESTIGATOR)
Montefiore EinsteinThe BronxNew York10467
Tanya Johns (PRINCIPAL_INVESTIGATOR)

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