Kidney
Eleven clinical trials have tested interventions to reduce disparities in living donor kidney transplant (LDKT): six trials focused on educational interventions, three focused on enhanced support for patients identifying living donors, and two focused on changing care delivery for potential living donors. Three studies were ongoing at the time of our query
Educational Interventions:
The Enhancing Living Donor Kidney Transplant Education (ELITE) Study was a cluster randomized trial assessing the ability of an educational intervention to improve knowledge of LDKT. Five hundred potential transplant candidates were cluster-randomized to receive either: (1) usual standard-of-care transplant education or (2) intensive education based upon the Explore Transplant educational materials [
119]. The intensive education resulted in higher knowledge compared with usual care (12.7 vs 11.7;
P = .0008) and increased willingness to take steps toward LDKT. However, there were no differences in post-evaluation readiness for LDKT [
120].
A multisite randomized controlled trial evaluated the efficacy of exposure to a bilingual, culturally-targeted website (titled
Infórmate) for increasing Hispanic patients’ knowledge about LDKT. Website content (including images, telenovela scripts, and messages) was informed by focus groups composed of adult Hispanic kidney transplant recipients, living kidney donors, dialysis patients, and the Hispanic community [
121]. Following implementation, website exposure was associated with a mean increase of 22% in knowledge of LDKT which was sustained at 3 weeks post-exposure, compared with control scores that increased by 12% (
P = .0001). Website exposure was also associated with a 10% greater knowledge score at three-week follow-up (
P < .0001), and 93% of patients reported a plan to return to
Infórmate in the future [
122]. A separate pretest/posttest intervention study was conducted among adult Hispanic patients undergoing dialysis at five dialysis centers and showed website exposure was associated with a mean 17% same-day knowledge score increase between pretest and posttest (
P < .001) that was sustained at 3 weeks. Most participants (95%) “agreed” or “strongly agreed” that they would recommend the website to other Hispanic patients [
123].
A multicenter randomized controlled trial tested the effectiveness of a revised Living ACTS (About Choices in Transplantation and Sharing) intervention to increase knowledge of LDKT and willingness to discuss LDKT with family members. The web-based intervention Living ACTS was developed for Black patients with kidney disease and included five educational modules: Introduction, Benefits and Risks, The Kidney Transplant Process, Identifying a Potential Kidney Donor, and ACT Now (which encourages communication with friends and family about transplantation) [
124]. Intervention participants demonstrated a significantly greater increase in knowledge of LDKT and greater willingness to talk to their families about LDKT than did control participants. However, the effect of the intervention was not sustained at six-month follow-up [
125].
A parallel group, two-arm randomized controlled trial is testing an educational and behavioral intervention designed to increase receipt of LDKT among Black transplant candidates [
126]. Candidates on the waitlist are randomly assigned to one of two conditions: (1) a control group that will receive usual care, or (2) an intervention group that will receive Destination Transplant, a nine-month intervention that includes an in-person group-based education session, postcards at monthly intervals, and a follow-up phone call from a transplant educator. At baseline and during 18 months of follow-up, demographic, clinical, and other variables are to be collected, such as transplant derailers (factors that might be sources of delay, difficulty, or challenge to pursuing transplant), transplant knowledge, health literacy, small steps taken to pursue LDKT, readiness for LDKT, decisional balance and self-efficacy measures, decisional conflict, family support, availability of potential living donors, and general health status.
Your Path to Transplant is a randomized controlled trial of a computer-based education intervention to increase LDKT. The education intervention consists of individually-tailored telephonic coaching sessions, feedback reports, video- and print-based transplant education resources, and assistance with reducing any known socioeconomic barriers to LDKT [
127].
Talking About Live Kidney Donation (TALK) is a two-phase mixed-methods study to design and test culturally-sensitive interventions to improve patients’ consideration of LDKT. Phase 1 involved the development of written and audiovisual educational materials and an accompanying social worker intervention to encourage patients’ engagement in consideration of LDKT [
128]. Phase 2 is a randomized controlled trial where patients with CKD are assigned to receive: (1) usual care by their nephrologists, (2) usual care plus the educational materials, or (3) usual care plus the educational materials and social worker intervention. The primary outcome is self-reported rates of consideration of LDKT, including family and patient-physician discussions and identification of a living kidney transplant donor.
Enhanced support for patients identifying living donors
House Calls is an intervention to directly engage the social network of CKD patients in LDKT education. The intervention consisted of a single 60 to 90-min session delivered to the patient and their social network by health educators in the patient’s home. The randomized trial had three intervention arms in which health educators delivered an intervention to: (1) the patient and his/her guests in the patient’s home (House Calls arm [HC]), (2) clusters of patients and their guests in the transplant center (Group-Based arm [GB]), or (3) the individual patient alone in the transplant center (Individual Counseling arm [IC]). At the two-year endpoint, HC patients were more likely than GB and IC patients to have at least one donor inquiry (82% vs 61% vs 47%;
P = .001) and evaluation (65% vs 39% vs 27%;
P < .001). HC patients also were more likely than other patients to have higher knowledge, fewer concerns, and higher willingness to talk to others about donation 6 weeks post-intervention [
129]. A subsequent secondary analysis of data collected as part of the House Calls trial assessed LDKT readiness stage, knowledge, concerns, and willingness to talk to others about living donation at 2 years post-intervention. 60% of patients were not considering or not yet ready to pursue LDKT, while only 11% had taken action to talk to family members or friends about the possibility of living kidney donation. Patients in later stages of LDKT readiness (i.e., had talked to others about donation or were preparing to do so) had significantly more knowledge (
P < .001), fewer concerns (
P = .002), and more willingness (
P = .001) to talk to others about living donation than those in earlier readiness stages [
130].
The Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED) Study was a six-month randomized controlled trial of Black patients with ESRD who had recently initiated in-center hemodialysis. Participants were randomly assigned to receive: (1) usual dialysis care in the dialysis facility, (2) informational decision aids (i.e., a video and a book describing LDKT and other forms of renal replacement therapy, referred to as “PREPARED information”), or (3) the PREPARED information plus a living kidney donor financial assistance program [
131]. In total, 62% of participants reported that interventions helped their decision-making about renal replacement treatments, but there were no statistically significant improvements in LDKT actions among groups at 6 months and no participants utilized the living donor financial assistance benefit [
132].
The Talking about Living Kidney Donation Support (TALKS) study in an ongoing trial designed to evaluate the effectiveness of three interventions by conducting a randomized controlled trial in which patients on the deceased donor waitlist receive: (1) usual care while on the transplant waitlist, (2) an educational and social worker intervention, or (3) an educational and social worker intervention plus the option of participating in a financial assistance program. The primary outcome of the study measures potential recipients’ live kidney donor activation (a composite rate of live donor inquiries, newly completed live donor evaluations, or live kidney donation) at 1 year [
133].
Changing care delivery for potential living donors
An ongoing, two-part study to evaluate the effectiveness of a streamlined single-day evaluation process (dubbed KTFT-TALK) is comprised of (1) Kidney Transplant Fast Track (KTFT) aimed at increasing transplant rates), and (2) the Talking About Live Kidney Donation (TALK) educational intervention aimed at increasing LDKT. The KTFT approach involves completing most or all testing on the same day when candidates arrive for their first pre-transplant clinic appointment. Patients were randomly assigned to the TALK intervention after initial study recruitment [
134]. Another ongoing trial based on the TALK interventions uses an effectiveness-implementation hybrid design involving pre-post intervention evaluation with matched controls to implement a complex culturally-targeted intervention at two transplant centers in Dallas, Texas and Phoenix, Arizona. The goal of the TALK component here is to evaluate the effect of Northwestern Medicine’s® Hispanic Kidney Transplant Program’s (HKTP) key culturally-targeted components (outreach, communication, education) on Hispanic LDKT rates over 5 years [
135].
Eleven retrospective studies of national databases described inequities in LDKT
These studies have demonstrated lower rates of LDKT among racial/ethnic minority patients [
136‐
140], including preemptive transplant from living donors [
141], women [
137,
142], and patients with low education and SES level [
137,
140,
143,
144]. At the transplant-center level, increased racial disparity has been associated with higher percentages of Black candidates, preemptively listed candidates and low rates of LDKT [
145]. Nondirected living donation specifically has been shown to cluster at certain US-based centers with a consistently low rate of receipt by Black patients [
146].
Six regional and single-center retrospective studies investigated disparities in LDKT
The findings echoed those of larger studies, that neither interest in nor pursuit of LDKT were associated with knowledge, health literacy, or medical mistrust [
147]. More Black patients than others initiated dialysis without prior care for CKD; these patients experienced longer time to transplant in the absence of nephrology care [
148]. Ineligible recipients were also more commonly Black patients [
149‐
152].
Two studies reported clinician perceptions of inequities in LDKT
Although we found no surveys of clinician opinions about disparities in LDKT, the Live Donor Community of Practice within the American Society of Transplantation held a Consensus Conference on Best Practices in Live Kidney Donation in June 2014. Following the conference, the committee suggested several system-level interventions to improve equity in LDKT. These included removal of financial disincentives to kidney donation, implementation for education programming that is culturally-tailored and community-based, use of transplant liaisons between transplant centers and community nephrology care, and additional research to improve understanding LDKT disparities and LKD differences [
153,
154].
A survey of ApoL1 genetic testing practices for living kidney donors was disseminated via email to nephrologists and transplant surgeons at 63 transplant centers in the US that currently have had at least 10 Black living donors per year according to the 2015 UNOS data [
155]. A high degree of variability in ApoL1 testing practices was found across transplant centers, potentially reflecting the continued clinical uncertainty of the role that ApoL1 testing has in most potential at-risk donors. The approach taken by most transplant centers consisted of a donor candidate’s self-report of race. Less than 20% of surveyed clinicians expressed concern about ApoL1 testing stigmatizing minorities.
Eleven studies reported patient perspectives about inequities in LDKT
Lack of knowledge and misinformation are commonly reported barriers to LDKT among racial and ethnic minority patients. Although patients with ESRD report being willing to accept a kidney from a living donor, they also admit discomfort with asking someone to donate [
156]. Donors report having encountered negative responses from others about their desire to donate and also refusal of recipients to accept an LDKT offer [
157]. Black donors also reported concerns related to experiences of racial discrimination by healthcare clinicians [
158]. Various types of social support have helped donors and recipients navigate the transplant process, including coping strategies. Recipients identified faith as a coping mechanism, while donors identified normalization of donation as their method of coping [
104]. Attitudes toward dialysis are moderated by both trust in LDKT and trust in racial equity as related to LDKT [
159]. Decisional balance and self-efficacy are important mediators of trust and discomfort among all races and education levels [
160].
Women report less interest in receiving LDKT than men, despite being nearly twice as likely as men to receive unsolicited offers for kidney transplant. Women are also less likely than men to have been evaluated for a kidney transplant [
161]. However, women make more living donor requests than men, irrespective of race. The barrier to a living donor transplant for most women was not the size of their social support network or lack of requesting a living donor, but rather undefined factors related to the network members themselves [
162].
Costs of care and concern for financial strain are commonly reported barriers for donors and recipients. Out-of-pocket expenses were greater for transplant recipients than donors, even though worries about future medical costs were common in both groups [
98]. Racial and ethnic minorities in particular expressed unique concerns related to socioeconomic stresses and ways of coping with the stress of donation [
158]. Non-English-speaking recipients reported concerns about disqualification of prospective family member donors due to medical issues, inability to miss work, undocumented residency status, inability to support their family if they donate, and declining social support because of illness [
163]. This may influence participation in evaluation processes, where consistent attendance has been associated with concerns about finding a living donor (
P = .038) and higher perceived general knowledge about transplantation (
P < .001) [
97].