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 — OTHERParticipants 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 — OTHERCommunity health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
- Intervention Providers — OTHERIntervention 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 SupportParticipants 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 CareParticipants 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
- Lili Chan929-618-0350
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | Lili Chan Sabrina Clermont Lili Chan (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Health | New York | New York | 10016 | Michal Melamed Michal Melamed (PRINCIPAL_INVESTIGATOR) |
| Montefiore Einstein | The Bronx | New York | 10467 | Tanya Johns Tanya Johns (PRINCIPAL_INVESTIGATOR) |