Clinical trial NCT06655857: Interventions for Promoting Kidney Transplant Equity
Official title: Interventions for Promoting Kidney Transplant Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant Waitlisting
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-23
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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

Primary outcomes:
measure: Time to completion of kidney transplant waitlisting evaluation
timeFrame: Baseline, and then every 6 months up to 2 years
Secondary outcomes:
measure: Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
timeFrame: Baseline, and then every 6 months up to 2 years
measure: Discrimination in Medical Settings (DMS)
timeFrame: Baseline, and 12 months after first study visit
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2
timeFrame: Baseline, and 12 months after first study visit
measure: Initiation of KTx process
timeFrame: Baseline, and 12 months after first study visit
measure: Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment
timeFrame: Baseline, and 12 months after first study visit
measure: Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment
timeFrame: Baseline, and then every 6 months up to 2 years after patients first study visit
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Einstein
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Ichan School of Medicine at Mount Sinai Hospital
name: Lili Chan
role: PRINCIPAL_INVESTIGATOR
References: