Interventions for Promoting Kidney Transplant Empowerment
Overview
- Phase
- N/A
- Intervention
- Community Health Worker Assistance
- Conditions
- Kidney Transplant Waitlisting
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 5
- Locations
- 6
- Primary Endpoint
- Time to completion of kidney transplant waitlisting evaluation
- Status
- Recruiting
- Last Updated
- yesterday
Overview
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).
Investigators
Lili Chan
Associate Professor
Icahn School of Medicine at Mount Sinai
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.
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.
Arms & Interventions
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.
Intervention: Community Health Worker Assistance
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.
Intervention: Intervention Providers
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.
Intervention: Usual Care
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.
Intervention: Community Health Worker Assistance
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.
Intervention: Intervention Providers
Outcomes
Primary Outcomes
Time to completion of kidney transplant waitlisting evaluation
Time Frame: Baseline, and then every 6 months up to 2 years
Patient medical records will be reviewed, and the patient will be asked directly for the status of their kidney transplant evaluation.
Secondary Outcomes
- Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)(Baseline, and then every 6 months up to 2 years)
- Discrimination in Medical Settings (DMS)(Baseline, and 12 months after first study visit)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2(Baseline, and 12 months after first study visit)
- Initiation of KTx process(Baseline, and 12 months after first study visit)
- Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment(Baseline, and 12 months after first study visit)
- Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment(Baseline, and then every 6 months up to 2 years after patients first study visit)