Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death
研究概览
简要总结
The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD. The project will have four (4) aims.
详细描述
The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Adults ≥ 18 years of age,
- •Adults who are not pregnant,
- •Adults who are not incarcerated,
- •Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.
排除标准
- •Previous kidney transplant
- •Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
- •On chronic dialysis
- •Conservative management or primary goal is palliation
- •Incarcerated
- •Pregnant*
- •Under 18 years of age
- •Moderate to severe dementia
- •Deaf persons
- •Lacking health insurance**
- •Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.
研究组 & 干预措施
Navigate-Kidney CHW Arm
Arm Description: A CHW will provide support during visits every 2 weeks for 3 months (i.e., 6 visits during first 3 months) followed by monthly visits until 1 year of study participation and then quarterly visits until 2 years of study participation. The CHW Navigate-Kidney intervention includes 4 functions: (1) Build trust through understanding of health experience; (2) Address multilevel social and challenges to facilitate health system navigation; (3) Provide patient-centered education; and (4) Enhance self-management. To provide patient-centered education, the CHW will use a Decision Aid created for this intervention.
干预措施: Community health worker intervention (Behavioral)
Standard Care
Arm Description: Arm Description: Participants will receive standard medical care following diagnosis. This care will include educational materials developed that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish
干预措施: Standard Care (in control arm) (Behavioral)
结局指标
主要结局
Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death
时间窗: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Composite outcome of time until participants in each arm either 1) begin dialysis (either as first KRT method or as a subsequent preparatory step for transplant) with a central venous catheter (CVC)), or 2) die from all-cause mortality, whichever occurs first.
次要结局
- Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death(From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years))
- Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start(From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years))
- Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone(From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years))
- Change in Estimated Glomerular Filtration Rate eGFR(Screening until End of Study or Death, whichever occurs first (up to 5 years))
- Change in Decisional Conflict Scale (DCS) scores(Baseline, Month 6, Month 12, Month 24)
- Change in Patient Activation (PAM-13) scores(Baseline, Month 6, Month 12, Month 24)
- Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores(Baseline, Month 6, Month 12, Month 24)
- Change in Social Determinants of Health, as measured by AHC-HRSN Responses(Baseline, Month 6, Month 12, Month 24)
- Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items)(Baseline, Month 6, Month 12, Month 24)
- Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI)(Baseline, Month 6, Month 12, Month 24)