Interventions for Promoting Kidney Transplant Empowerment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Time to completion of kidney transplant waitlisting evaluation
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Community Health Worker Assistance (Other)
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.
干预措施: Intervention Providers (Other)
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.
干预措施: Usual Care (Other)
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.
干预措施: Community Health Worker Assistance (Other)
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.
干预措施: Intervention Providers (Other)
结局指标
主要结局
Time to completion of kidney transplant waitlisting evaluation
时间窗: 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.
次要结局
- 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)
研究者
Lili Chan
Associate Professor
Icahn School of Medicine at Mount Sinai