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临床试验/NCT01786525
NCT01786525已完成不适用

House Calls and Web-based Decision Support: Improving Access to Live Donor Kidney Transplantation

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants

研究概览

简要总结

The main purpose of this research program is to reduce the burden of end-stage organ disease on individuals, families, healthcare systems, and society by increasing the availability of donor organs for transplantation. Consistent with this aim, the project further examines strategies to increase access to and reduce disparities - racial, economic, gender - in live donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an innovative House Calls intervention developed by the principal investigator by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. The main study hypothesis is that participants receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have a higher proportion of LDKT's by the 2-year study endpoint.

详细描述

For most adults in late Chronic Kidney Disease (CKD Stage 4 or 5), kidney transplantation yields superior outcomes compared to long-term dialysis. Unfortunately, the demand for kidney transplantation far exceeds the supply of deceased donor organs. For those patients with healthy and willing living kidney donors, live donor kidney transplantation (LDKT) produces superior graft and patient survival rates, lower acute rejection rates, more rapid improvements in functional status, and lower healthcare costs. However, there are profound racial and income disparities in access to LDKT. Minorities, especially Blacks and Hispanics, are substantially less likely to receive LDKT compared to Whites. Also, the overall decline in LDKTs in the United States in recent years has been more pronounced for Blacks and patients with less household income. These lower LDKT rates contribute to longer waiting times for transplantation, more dialysis exposure, higher likelihood of death before transplantation, declining functional capacity, less optimal graft outcomes after transplantation, and higher healthcare costs. Therefore, interventions that expand access to LDKT, especially those targeting minority and low-income populations, are needed given the current and projected shortage of deceased donor organs.

There are several hypothesized barriers to LDKT for minorities and low-income patients, including perceived discrimination, health care mistrust, social network differences, higher rates of conditions that preclude living kidney donation, higher indirect costs of living donation, less knowledge and more concerns about LDKT, and failure to provide culturally competent education to patients and their support systems. In the last decade, the PI has developed and evaluated an innovative House Calls intervention designed to remove LDKT barriers.28-30 Health educators deliver a comprehensive and interactive program on kidney transplantation and living donation in the patient's home with members of their social network present. Relative to standard clinic-based educational programs, the House Calls intervention is superior at improving LDKT knowledge, reducing LDKT concerns, increasing LDKT willingness, and increasing rates of LDKT, particularly in minority and low-income patients (see Preliminary Studies section). However, the effectiveness of the House Calls intervention may be limited by the absence of decision-making aids, exposure to appropriate peer models, and assistance in developing an LDKT action plan beyond the House Calls intervention. This limitation and feedback from study participants have informed our strategy to enhance the House Calls intervention by incorporating a Patient-Centered Decision Support component. Additionally, there is a pressing need to identify factors that are most critical to the success of the House Calls intervention and to determine whether it can reduce the gender disparity in living kidney donation.8 Therefore, in the proposed study, we plan to pursue two primary aims and one exploratory aim:

Primary Aims

  1. Evaluate the differential benefit of adding a patient-centered decision support component to the House Calls intervention. In a randomized controlled trial, we will compare House Calls (HC) alone to House Calls + Decision Support (HC+DS) in a sample of minorities and low-income patients. It is hypothesized that, compared to HC alone, the HC+DS group will have a higher proportion of patients with LDKT by the 2-yr study endpoint (primary outcome) and higher proportions of patients with ≥1 live donor inquiry, ≥1 live donor evaluation, and in LDKT Readiness Stages 4/5 by the 12-wk assessment (secondary outcomes).
  2. Identify mediators of the relationship between the interventions and the occurrence of LDKT. We will investigate a set of mediators through which House Calls may increase the occurrence of LDKT, including increased LDKT knowledge, change in LDKT readiness, reduced LDKT concerns, reduced health care mistrust, the amount of time discussing LDKT with others and the quality of those interactions, and improvement in self-efficacy discussing LDKT with others.

Exploratory Aim 3. Examine whether the House Calls intervention reduces the gender disparity in rates of living kidney donation. Women comprise 60% of all living kidney donors in the past decade. We have shown that the House Calls intervention directly educates significantly more potential living donors, including men, compared to standard clinic-based educational approaches. We hypothesize that a higher proportion of patients receiving the House Calls intervention (either HC alone or HC+DS) will have at least one potential male donor evaluated and be more likely to receive a LDKT from a male living donor, relative to a non-intervention control group, controlling for patient race/ethnicity, gender, age, and household income.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •non-White race/Hispanic ethnicity/low-income (250% below federal poverty guidelines)
  • •meets eligibility criteria for kidney transplant waiting list
  • •21 years old or older
  • •self-reports being in LDKT Readiness Stage I, II, or III
  • •Resides within 3 hours driving time from transplant center

排除标准

  • •Awaiting combined kidney-liver transplant
  • •Awaiting simultaneous pancreas-kidney transplant
  • •Know or suspected cognitive impairment
  • •Prior participation in House Calls intervention study

研究组 & 干预措施

House Calls only

Experimental

60-minute educational intervention in patient's home which will be delivered by a health educator.

干预措施: House Calls (Behavioral)

House Calls + Web-Based Decision Support

Active Comparator

Home based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention.

干预措施: House Calls (Behavioral)

House Calls + Web-Based Decision Support

Active Comparator

Home based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention.

干预措施: Web-Based Patient-Centered Decision Support Intervention (Behavioral)

Control

No Intervention

100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention

结局指标

主要结局

The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants

时间窗: 2 years

次要结局

  • Higher proportion of enrolled patients with live donor inquires and evaluations; higher proportion of patients will be in LDKT Readiness stages 4/5 by the 12-week assessment.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Rodrigue

Associate Professor

Beth Israel Deaconess Medical Center

研究点 (1)

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