Access to Kidney Transplantation in Minority Populations (AKT-MP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Rate of KT evaluation completion
研究概览
简要总结
Hispanic/Latino (HL) and American Indian (AI) patients are more likely than whites to have kidney failure, but less likely to complete transplant evaluation or receive a kidney transplant (KT), the best treatment for kidney failure. Using comparative effectiveness research methods, we will conduct a pragmatic randomized trial to compare the efficacy and cost- effectiveness of two approaches to help HL and AI patients overcome barriers to completing transplant evaluation and receiving a KT: a streamlined KT evaluation process and a peer-assisted evaluation program; and, we will determine best practices to assist other transplant centers in implementing the better program. Findings from this work may help reduce disparities in transplant evaluation and KT.
详细描述
The AKT-MP study will assess whether Kidney Transplant Fast Track (KTFT), a streamlined KT evaluation process, or peer navigators (PN) who were former KT patients to help patients "navigate" their way through KT evaluation, can help vulnerable patients with kidney failure overcome barriers to transplant listing. After culturally and contextually adapting the two interventions, we will use a comparative effectiveness (CER) approach to conduct a pragmatic randomized trial of 398 kidney failure patients to compare the efficacy and effectiveness of the two approaches in disadvantaged groups at a university-affiliated transplant center with large HL and AI kidney failure patient populations, and we will compare results to historic comparison populations (local and national). We will assess facilitators and barriers to widespread implementation and conduct a cost effectiveness analysis. Although it is expected that KTFT will be more effective than PN, KTFT may also be more costly, requiring significant administrative and clinical changes in the transplant center, which may be impractical to maintain. Further, KTFT may lead to more patient ambivalence because the shortened evaluation period will give them less time to consider their treatment options. Thus, an important aspect of the proposed study is to comparative the effectiveness of the two methods. Ultimately, our study will inform transplant programs faced with disparities in KT about which disparity-reducing intervention to use given their particular needs and resources.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing kidney transplant evaluation at the University of New Mexico
- •Greater than or equal to 18 years of age
- •Mentally competent
排除标准
- •Children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of
- •Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients.
- •Waitlisted at another transplant center
- •Prior kidney transplant
- •Incarcerated patients
- •Pregnant women
- •Active systemic infection
- •Non-skin malignancy or melanoma in the past 2 years
- •Known cognitive impairment
研究组 & 干预措施
Arm 1
KTFT
干预措施: Kidney Transplant Fast Track (KTFT) (Other)
Arm 2
PN
干预措施: Peer Navigation (PN) (Other)
结局指标
主要结局
Rate of KT evaluation completion
时间窗: Through study completion, an average of 1 year
Completion of evaluation for KT and placement on the transplant waiting list.
次要结局
- Patient Reported Quality of Life(Through study completion, an average of 1 year)
- KT ambivalence(Through study completion, an average of 1 year)
研究者
Larissa Myaskovsky, PhD
Professor
University of New Mexico