Clinical trial NCT02181114: Your Path to Transplant: A Randomized Control Trial of A Tailored Computer Education Intervention for Living Donor Kidney Transplant
Official title: Computer Tailored Education Program to Reduce Disparities in Living Donor Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Coaching
Educational Materials
Expert System
Living Donor Kidney Transplant
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2014-07-03
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

The coach will then mail a folder containing the first set of educational materials which includes factsheets, brochures and the patient's personalized, tailored feedback report.

YPT intervention: ITE time point. The ITE session will occur at the UCLAKPTP during the patient's medical evaluation visits. It is expected to last 40 minutes. Patients will be taken to a semi-private area in the transplant center at either facility and re-assess the patient's readiness to pursue DDKT and LDKT as well as the perceived benefits and concerns. The patient's confidence for pursuing both DDKT and LDKT will also be re-assessed. We will provide feedback to the patient based on any changes in readiness, confidence, and perceived benefits or concerns that may have occurred since the initial assessment. DDKT feedback will occur directly after DDKT re-assessment and LDKT feedback will occur after LDKT re-assessment. The patient will then be asked to watch a 10 minute video while we print off the patient's personalized feedback report. Based on the patient's stage of change, one of two videos will be shown: "Pursuing Donation" to those patients who are in the pre-contemplation and contemplation phases and "Exploring Donation" will be for patients in all of the other stages. At the end of the session we will give the patient a second folder with educational materials, a DVD, and their personalized feedback report.

YPT intervention: 4 month and 8 month time point. We will contact the patient four months and eight months after their baseline survey. Pre-survey reminder postcards will be sent one month prior to the survey. It is estimated that each survey will last 45 minutes. These interviews will be similar to the baseline survey given at the beginning of the trial. However, we will not re-assess demographic information, comorbidities, or unmet needs. At both time points, we will provide tailored feedback throughout the interview. This will occur immediately after the re-assessment of potential barriers to pursuing transplant, knowledge, and transplant decision making for both DDKT and LDKT. During the eight month interview, we will ask the patient questions regarding the cultural competency of their medical providers, their decision about which treatment to pursue, and their ability to have made an informed decision as to whether or not pursue DDKT or LDKT. As with previous time points, individualized feedback reports and tailored education will be sent to the patients following the phone call.

YPT patients: 4, 8, and 18 month medical record review. Patients' medical records will be reviewed at 4, 8 and 18 months after their baseline survey in order to determine whether they had: 1) been waitlisted for transplant; 2) received a DDKT; 3) received an LDKT; 4) gone inactive or been determined ineligible for transplant; 5) died.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient LDKT Attitude & Decision-Making Measure: Readiness
timeFrame: up to 8 months post-Baseline
Secondary outcomes:
measure: Patient LDKT Attitude & Decision Making Measure: Decisional Balance
timeFrame: up to 8 months post-Baseline
measure: Patient LDKT Attitude & Decision Making Measure: Self-efficacy
timeFrame: up to 8 months post-Baseline
measure: Patient LDKT Attitude & Decision Making Measure: Small Steps towards LDKT and DDKT
timeFrame: up to 8 months post-Baseline
measure: Patient LDKT Attitude & Decision Making Measure: Transplant Knowledge
timeFrame: up to 8 months post-Baseline
measure: Final Outcome: Pursuit of Transplant
timeFrame: 18 months post-Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Division of Nephrology
state: California
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of California, Los Angeles
name: Amy D Waterman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waterman AD, Peipert JD, Cui Y, Beaumont JL, Paiva A, Lipsey AF, Anderson CS, Robbins ML. Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant. Am J Transplant. 2021 Mar;21(3):1186-1196. doi: 10.1111/ajt.16262. Epub 2020 Sep 15.
citation: Waterman AD, Robbins ML, Paiva AL, Peipert JD, Kynard-Amerson CS, Goalby CJ, Davis LA, Thein JL, Schenk EA, Baldwin KA, Skelton SL, Amoyal NR, Brick LA. Your Path to Transplant: a randomized controlled trial of a tailored computer education intervention to increase living donor kidney transplant. BMC Nephrol. 2014 Oct 14;15:166. doi: 10.1186/1471-2369-15-166.