Interventions for Promoting Kidney Transplant Empowerment (INSPIRE)

Mount Sinai Health System

Status: Enrolling

Conditions: Kidney Transplant Waitlisting

Treatments: Other: Intervention Providers; Other: Community Health Worker Assistance; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06655857

GCO 22-1921

U01DK137259 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support

Other group

Description:

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.

Treatment:

Other: Community Health Worker Assistance

Other: Intervention Providers

Usual Care

Other group

Description:

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.

Treatment:

Other: Usual Care

Other: Community Health Worker Assistance

Other: Intervention Providers