Interventions for Promoting Kidney Transplant Empowerment

Overview

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).

Interventions

• Other 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.
• Other Community Health Worker Assistance
  Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
• Other 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 measures

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

Secondary outcome measures (6)

• Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN) [Time frame: Baseline, and then every 6 months up to 2 years]
• Discrimination in Medical Settings (DMS) [Time frame: Baseline, and 12 months after first study visit]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 [Time frame: Baseline, and 12 months after first study visit]
• Initiation of KTx process [Time frame: Baseline, and 12 months after first study visit]
• Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment [Time frame: Baseline, and 12 months after first study visit]
• Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment [Time frame: Baseline, and then every 6 months up to 2 years after patients first study visit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 3 centers

• NYU Langone Health — New York
• Mount Sinai Hospital — New York
• Montefiore Einstein — The Bronx

Identifiers

NCT: NCT06655857 · GCO 22-1921 · U01DK137259

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗