Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 815
- 试验地点
- 4
- 主要终点
- Patient LDKT Attitude & Decision-Making Measure: Readiness
研究概览
简要总结
Because of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they are less likely to receive LDKTs. To address this disparity, this randomized controlled trial will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can be increased when they receive access to the Your Path to Transplant computerized Expert System (YPT). This trial will also examine how other known patient, family, and healthcare system barriers to LDKT impact YPT's effectiveness.
Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored feedback reports, coaching, and socioeconomic resource guidance associated with reducing barriers to access to LDKT. Control patients will receive usual care transplant education provided by UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and self-efficacy will be assessed at four time points: prior to presenting at the transplant center (baseline), during transplant evaluation (approximately 2 months post-baseline), and 4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will be assessed 18-months post-baseline.
At the conclusion of the study, we will have developed an innovative and cost-effective YPT Computerized Expert System that could be utilized to tailor LDKT discussion and education in different medical settings based on the needs of individual patients of different races.
详细描述
This longitudinal, parallel randomized control trial has two treatment conditions with equal allocation, the YPT intervention and the standard of care transplant education as provided by UCLAKPT. Patients in both groups will be assessed at four time points: 1) a phone survey at baseline; 2) a phone survey at 4 months post-baseline; 3) a phone survey at 8 months post-baseline; and 4) a medical records review at 4, 8 and 18 months post-baseline. Additionally, patients in the YPT intervention group will receive individualized YPT transplant education at various time points: 14 days post-baseline by phone, the in-person transplant education (ITE) session, during the 4 month post-baseline survey, and during the 8 month post-baseline survey. The date of the ITE education session cannot be fixed because it may occur at different points in each patient's transplant evaluation process.
As patient records are received via the transplant database, a data manager will determine which are eligible for the study, then assign eligible patients a PIN that has been pre-randomized to treatment group before uploading the record to the recruitment database. Randomization will be completed by using a computer software program called TTMX (Transtheoretical Model Expert). Knowledge of treatment assignment is required at and after this stage so that the YPT expert system can be delivered to patients randomized to the intervention condition. Patients will be randomized into one of two groups: usual care or intervention group.
Usual Care Control Group-UCLA The control group for this trial consists of the usual care for transplant education which, for this facility, begins when a referral is made. A physician, patient medical group or dialysis center can make the referral. Once UCLAKPTP receives the patient's information via a patient information form and their insurance has been verified, the patient is called to schedule an Education Seminar and a one-on-one evaluation appointment. Next, both UCLAKPTP mail out an "Appointment Letter" for the patient to complete and bring with them to Evaluation Day. These packets include a UCLAKPTP Appointment Letter and a Doctor's Information Worksheet. Patients are asked to fill out and bring the Information Worksheet with them on their appointment day. The evaluation day is a full day of group education, physician appointment, meetings with several coordinators of care and if necessary completing several medical tests with blood and urine collection. During the two hour group education a power point presentation is given that reviews different transplantation options including living and deceased donors as well as high risk donors. The social worker concludes the education by reviewing important insurance information with the group. Next, the patients have a series of individual appointments with the transplant physician (either a nephrologist or a surgeon), a social worker and the transplant coordinator where they can ask questions and will receive additional information on transplant. Psychosocial evaluations are completed by the social workers to identify any risk factors or red flags which would contradict transplant as a treatment. This routine is standard for all patients evaluated for transplant. Patients in this group will be surveyed at baseline, 4 months and 8 months post baseline. These surveys will be conducted over the phone and can last up to 50 minutes each.
YPT Intervention Group Patients in the intervention group with receive individualized YPT transplant education at four time points. Their total participation is estimated to be 2.5 hours. Printed materials and videos will be sent to the patients after each time point. Patients will also receive individualized feedback reports based on their stage of readiness to pursue DDKT and LDKT. In addition to being tailored to the individual's stage of readiness, these reports will address any concerns the patient has mentioned as well as answers to knowledge questions the patient may have missed.
YPT intervention: baseline time point. We will first administer verbal consent form and assess for ineligibility criteria. After consent has been given and eligibility determined, we will conduct a baseline assessment of the patient's demographics, knowledge, decision making, readiness, and self-efficacy for both DDKT and LDKT. Family support and living donor availability will also be assessed for LDKT. This time point is estimated to last 40 minutes. At the end of the survey the patient will be asked schedule a time to conduct the first education session.The education session will occur at any time up to 14 days after the baseline assessment and will last between 20-30 minutes. The coach will then discuss the patient's readiness to pursue DDKT. This will be guided by the patient's stage of change. Next, the coach addresses the benefits of DDKT and provides coaching for any concerns the patient mentioned in the assessment. After this, the coach will discuss the patient's over all confidence for pursuing DDKT and then provide itemized feedback for problems the patient believes will prevent them from pursuing DDKT. The coach will then provide the same education and coaching for LDKT. At the end of the education session the coach will inform the patient that they will meet the patient on the day of their ITE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as Black, White, or Hispanic
- •Must not have been deemed kidney transplant ineligible by UCLA Kidney and Pancreas Transplant Program
- •Cannot be listed at another transplant center
- •Can read English
排除标准
- •Does not self-identify as Black, White, or Hispanic
- •Deemed ineligible to receive a kidney transplant by UCLA Kidney and Transplant Program
- •Listed at another transplant center
- •Cannot read English
结局指标
主要结局
Patient LDKT Attitude & Decision-Making Measure: Readiness
时间窗: up to 8 months post-Baseline
Using validated measures, patients will be asked how ready they are to get a DDKT by reporting whether they are "not considering getting a DDKT in the next six months" (Precontemplation), "considering getting a DDKT in the next six months" (Contemplation), "preparing to get a DDKT in the next 30 days" (Preparation), "undergoing evaluation to get a DDKT" (Action) or "listed and waiting to get a DDKT" (Maintenance). Patients will also be asked how ready they are to pursue LDKT and to rate whether they are "not considering taking actions in the next six months to pursue LDKT" (Precontemplation), "considering taking actions in the next six months to pursue LDKT" (Contemplation), "preparing to take actions in the next 30 days to pursue LDKT" (Preparation), or "taking actions to pursue LDKT" (Action).
次要结局
- Patient LDKT Attitude & Decision Making Measure: Self-efficacy(up to 8 months post-Baseline)
- Patient LDKT Attitude & Decision Making Measure: Small Steps towards LDKT and DDKT(up to 8 months post-Baseline)
- Final Outcome: Pursuit of Transplant(18 months post-Baseline)
- Patient LDKT Attitude & Decision Making Measure: Decisional Balance(up to 8 months post-Baseline)
- Patient LDKT Attitude & Decision Making Measure: Transplant Knowledge(up to 8 months post-Baseline)
研究者
Amy D. Waterman
Director, Patient Engagement, Diversity, and Education
The Methodist Hospital Research Institute