Do pre-transplant cultural factors predict health-related quality of life after kidney transplantation?

BACKGROUND: Post-transplant health-related quality of life (HRQOL) is associated with health outcomes for kidney transplant (KT) recipients. However, pretransplant predictors of improvements in post-transplant HRQOL remain incompletely understood. Namely, important pretransplant cultural factors, such as experience of discrimination, perceived racism in healthcare, or mistrust of the healthcare system, have not been examined as potential HRQOL predictors. Also, few have examined predictors of decline in HRQOL post-transplant. METHODS: Using data from a prospective cohort study, we examined HRQOL change pre- to post-transplant, and novel cultural predictors of the change. We measured physical, mental, and kidney-specific HRQOL as outcomes, and used cultural factors as predictors, controlling for demographic, clinical, psychosocial, and transplant knowledge covariates. RESULTS: Among 166 KT recipients (57% male; mean age 50.6 years; 61.4% > high school graduates; 80% non-Hispanic White), we found mental and physical, but not kidney-specific, HRQOL significantly improved post-transplant. No culturally related factors outside of medical mistrust significantly predicted change in any HRQOL outcome. Instead, demographic, knowledge, and clinical factors significantly predicted decline in each HRQOL domain: physical HRQOL-older age, more post-KT complications, higher pre-KT physical HRQOL; mental HRQOL-having less information pre-KT, greater pre-KT mental HRQOL; and, kidney-specific HRQOL-poorer kidney functioning post-KT, lower expectations for physical condition to improve, and higher pre-KT kidney-specific HRQOL. CONCLUSIONS: Instead of cultural factors, predictors of HRQOL decline included demographic, knowledge, and clinical factors. These findings are useful for identifying patient groups that may be at greater risk of poorer post-transplant outcomes, in order to target individualized support to patients.

Predicting Kidney Transplant Evaluation Non-attendance.

Non-attendance to kidney transplant evaluation (KTE) appointments is a barrier to optimal care for those with kidney failure. We examined the medical and socio-cultural factors that predict KTE non-attendance to identify opportunities for integrated medical teams to intervene. Patients scheduled for KTE between May, 2015 and June, 2018 completed an interview before their initial KTE appointment. The interview assessed various social determinants of health, including demographic (e.g., income), medical (e.g. co-morbidities), transplant knowledge, cultural (e.g., medical mistrust), and psychosocial (e.g., social support) factors. We used multiple logistic regression analysis to determine the strongest predictor of KTE non-attendance. Our sample (N = 1119) was 37% female, 76% non-Hispanic White, median age 59.4 years (IQR 49.2-67.5). Of note, 142 (13%) never attended an initial KTE clinic appointment. Being on dialysis predicted higher odds of KTE non-attendance (OR 1.76; p = .02; 64% of KTE attendees on dialysis vs. 77% of non-attendees on dialysis). Transplant and nephrology teams should consider working collaboratively with dialysis units to better coordinate care, (e.g., resources to attend appointment or outreach to emphasize the importance of transplant) adjusting the KTE referral and evaluation process to address access issues (e.g., using tele-health) and encouraging partnership with clinical psychologists to promote quality of life for those on dialysis.

Are cultural or psychosocial factors associated with patient-reported outcomes at the conclusion of kidney transplant evaluation?

BACKGROUND: Kidney transplant evaluation (KTE) is a period marked by many stressors for patients, which may lead to poorer patient-reported outcomes (PROs). Research on the association of cultural and psychosocial factors with PROs during KTE is lacking, even though cultural and psychosocial variables may mitigate the relationship between acceptance status and PROs. METHODS: Using a prospective cohort study of 955 adults referred for KTE, we examined whether cultural factors and psychosocial characteristics, assessed at the initiation of KTE, are associated with PROs at KTE completion, controlling for demographics and medical factors. Also, we analyzed whether these factors moderate the relationship between transplant acceptance status and PROs. RESULTS: In multivariable regression models, a stronger sense of mastery was associated with higher physical and mental QOL. A stronger sense of self-esteem was associated with higher kidney-specific QOL. Depression was associated with a lower mental QOL, but only in those who were accepted for transplant. Having low levels of external locus of control was associated with better mental QOL in those who were not accepted for transplant. Higher anxiety was associated with poorer kidney-specific QOL among those who were not accepted for KT, but trust in physician was only associated with greater satisfaction in transplant clinic service for those who were accepted for KT. CONCLUSIONS: Targeting interventions to increase patient mastery and external locus of control, and reduce depression and anxiety in patients undergoing kidney transplant evaluation may be useful approaches to improve their experience during this stressful period.

Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects.

BACKGROUND AND OBJECTIVE: The post-trial follow-up (PTFU) phase of a clinical trial can provide important information on maintenance of intervention effects. However, approaches for the PTFU are rarely described. This short communication describes our process for PTFU that involved recontacting older subjects who participated in a clinical trial between 2015 and 2019. We also describe correlates of response to our PTFU survey. METHODS: The parent clinical trial aimed to reduce depression symptoms among older spousally-bereaved adults. We attempted to recontact our sample during the early stages of the COVID-19 pandemic. Using logistic regression, we examined physical health, depression symptoms, cognitive status, and disability as correlates of participant response to the PTFU phase. RESULTS: Forty-two percent of participants responded to the PTFU survey. Disability - or the inability to participate in major life tasks and social roles - was significantly associated with response. Participants with greater disability were less likely to respond to the PTFU survey. CONCLUSIONS: Older adults with disabilities may need alternative and supportive strategies for engaging in the PTFU phase. CLINICAL TRIALS REGISTRATION: NCT02631291.

Incorporating technology in research with older bereaved adults: Lessons learned from conducting an internet-based randomized controlled trial.

Objective: Digital health interventions (DHI) involve multiple interactions between the user, technology platform, and study team, posing challenges for implementation. This paper describes the lessons learned while implementing an internet-based randomized controlled trial (RCT) for reducing depression symptom burden in older acutely-bereaved adults. Methods: The RCT was entitled "Widowed Elders' Lifestyle after Loss" (or WELL), which compared the efficacy of a DHI to an enhanced usual care (EUC) for reducing depression symptoms in adults 60+ years who lost their spouse/life partner within the previous 12 months. Participants randomized to the DHI used their own tablet, smartphone, or pc to record the timing and regularity of sleep, meals, and physical activity twice daily, for 12 weeks. The also received weekly health coaching sessions from a clinician certified in motivational interviewing. Participants randomized to the EUC arm received weekly calls from research staff and were assessed on the same schedule as intervention participants. All study procedures were conducted virtually. Methodological and procedural challenges were discussed weekly with study staff and the primary investigator. Results: Many challenges can be categorized as follows recruiting virtually, obtaining informed consent, training older adults to use technology, and establishing rapport with older adults. Solutions required researcher and interventionist flexibility in adapting to new strategies. For instance, we redesigned the informed consent process to include a user-friendly brochure that enhanced participants' understanding of the RCT and improved our enrollment rate. We also utilized user-engagement in refining an intervention protocol. Conclusion: We resolved implementation challenges without compromising internal validity via interdisciplinary collaborations with mobile programmers to ensure our technology met the unique and varied needs of aging users. The solutions from this study may promote the recruitment and retainment of older adults in research studies that use technology-based interventions.

A digital health intervention to stabilize the 24-hour rhythm of sleep, meals, and physical activity for reducing depression among older bereaved spouses: Protocol for a randomized controlled trial.

BACKGROUND: Despite the high prevalence of depression and disruption to 24-h sleep-wake routines following the death of a spouse in late-life, no bereavement interventions have been developed to re-entrain a regular sleep-wake routine among older widow(er)s. We describe the rationale and methodology of the NIH-funded WELL Study (Widowed Elders' Lifestyle after Loss), a randomized controlled trial (RCT) comparing the efficacy of a digital health intervention (DHI) to enhanced usual care (EUC) arm for reducing depression symptoms in older spousally-bereaved adults. METHODS: We will randomize approximately 200 recently bereaved (<12 months) adults aged 60+ years to one of two 12-week interventions: digital monitoring of the timing and regularity of sleep, meals, and physical activity plus weekly motivational health coaching; or enhanced usual care consisting of weekly telephone calls and similar assessment schedules. Participants will complete self-report and clinical assessments at baseline, post-intervention, and 3-, 6-, and 12-months post-intervention, and objective actigraphic assessments of their 24-h rest-activity rhythm (RAR) at baseline and 1-, 2-, and 3-months during the intervention. The primary outcome is change in depression symptoms burden (using the Hamilton Rating Scale for Depression) from pre- to post-intervention and over 12 months of follow-up. DISCUSSION: WELL Study findings will inform the development of widely generalizable and scalable technology-based interventions to support bereaved spouses in community-based settings. Clinical http://Trials.gov Identifier: NCT04016896.

The Combined Roles of Race/Ethnicity and Substance Use in Predicting Likelihood of Kidney Transplantation.

BACKGROUND: Racial/ethnic minorities face known disparities in likelihood of kidney transplantation. These disparities may be exacerbated when coupled with ongoing substance use, a factor also reducing likelihood of transplantation. We examined whether race/ethnicity in combination with ongoing substance use predicted incidence of transplantation. METHODS: Patients were enrolled between March 2010 and October 2012 at the time of transplant evaluation. Substance use data were retrieved from transplant evaluations. Following descriptive analyses, the primary multivariable analyses evaluated whether, relative to the referent group (White patients with no substance use), racial/ethnic minority patients using any substances at the time of evaluation were less likely to receive transplants by the end of study follow-up (August 2020). RESULTS: Among 1152 patients, 69% were non-Hispanic White, 23% non-Hispanic Black, and 8% Other racial/ethnic minorities. White, Black, and Other patients differed in percentages of current tobacco smoking (15%, 26%, and 18%, respectively; P = 0.002) and illicit substance use (3%, 8%, and 9%; P < 0.001) but not heavy alcohol consumption (2%, 4%, and 1%; P = 0.346). Black and Other minority patients using substances were each less likely to receive transplants than the referent group (hazard ratios ≤0.45, P ≤ 0.021). Neither White patients using substances nor racial/ethnic minority nonusers differed from the referent group in transplant rates. Additional analyses indicated that these effects reflected differences in waitlisting rates; once waitlisted, study groups did not differ in transplant rates. CONCLUSIONS: The combination of minority race/ethnicity and substance use may lead to unique disparities in likelihood of transplantation. To facilitate equity, strategies should be considered to remove any barriers to referral for and receipt of substance use care in racial/ethnic minorities.

Medication, Healthcare Follow-up, and Lifestyle Nonadherence: Do They Share the Same Risk Factors?

Barriers to medication adherence may differ from barriers in other domains of adherence. In this study, we assessed the association between pre-kidney transplantation (KT) factors with nonadherent behaviors in 3 different domains post-KT. METHODS: We conducted a prospective cohort study with patient interviews at initial KT evaluation (baseline-nonadherence predictors in sociodemographic, condition-related, health system, and patient-related psychosocial factors) and at ≈6 mo post-KT (adherence outcomes: medications, healthcare follow-up, and lifestyle behavior). All patients who underwent KT at our institution and had ≈6-mo follow-up interview were included in the study. We assessed nonadherence in 3 different domains using continuous composite measures derived from the Health Habit Survey. We built multiple linear and logistic regression models, adjusting for baseline characteristics, to predict adherence outcomes. RESULTS: We included 173 participants. Black race (mean difference in adherence score: -0.72; 95% confidence interval [CI], -1.12 to -0.32) and higher income (mean difference: -0.34; 95% CI, -0.67 to -0.02) predicted lower medication adherence. Experience of racial discrimination predicted lower adherence (odds ratio, 0.31; 95% CI, 0.12-0.76) and having internal locus of control predicted better adherence (odds ratio, 1.46; 95% CI, 1.06-2.03) to healthcare follow-up. In the lifestyle domain, higher education (mean difference: 0.75; 95% CI, 0.21-1.29) and lower body mass index (mean difference: -0.08; 95% CI, -0.13 to -0.03) predicted better adherence to dietary recommendations, but no risk factors predicted exercise adherence. CONCLUSIONS: Different nonadherence behaviors may stem from different motivation and risk factors (eg, clinic nonattendance due to experiencing racial discrimination). Thus adherence intervention should be individualized to target at-risk population (eg, bias reduction training for medical staff to improve patient adherence to clinic visit).

Protocol for the AKT-MP trial: Access to Kidney Transplantation in Minority Populations.

Background: Kidney transplant (KT) is the optimal treatment for kidney failure (KF), and although completion of KT evaluation is an essential step in gaining access to transplantation, the process is lengthy, time consuming, and burdensome. Furthermore, despite similar referral rates to non-Hispanic Whites, both Hispanic/Latinos and American Indians are less likely to be wait-listed or to undergo KT. Methods: The Access to Kidney Transplantation in Minority Populations (AKT-MP) Trial compares two patient-centered methods to facilitate KT evaluation: kidney transplant fast track (KTFT), a streamlined KT evaluation process; and peer navigators (PN), a peer-assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial will use a comparative effectiveness approach to assess whether KTFT or PN can help patients overcome barriers to transplant listing. We will randomly assign patients to the two conditions. We will track participants' medical records and conduct surveys prior to their initial evaluation clinic visit and again after they complete or discontinue evaluation. Conclusion: Our aims are to (1) compare KTFT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, KT concerns, KT knowledge, and KT ambivalence; and (3) develop a framework for widespread implementation of either approach. The results of this trial will provide key information for facilitating the evaluation process, improving patient care, and decreasing disparities in KT.

Social Determinants of Health and Race Disparities in Kidney Transplant.

BACKGROUND AND OBJECTIVES: Black patients have a higher incidence of kidney failure but lower rate of deceased- and living-donor kidney transplantation compared with White patients, even after taking differences in comorbidities into account. We assessed whether social determinants of health (e.g., demographics, cultural, psychosocial, knowledge factors) could account for race differences in receiving deceased- and living-donor kidney transplantation. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Via medical record review, we prospectively followed 1056 patients referred for kidney transplant (2010-2012), who completed an interview soon after kidney transplant evaluation, until their kidney transplant. We used multivariable competing risk models to estimate the cumulative incidence of receipt of any kidney transplant, deceased-donor transplant, or living-donor transplant, and the factors associated with each outcome. RESULTS: Even after accounting for social determinants of health, Black patients had a lower likelihood of kidney transplant (subdistribution hazard ratio, 0.74; 95% confidence interval, 0.55 to 0.99) and living-donor transplant (subdistribution hazard ratio, 0.49; 95% confidence interval, 0.26 to 0.95), but not deceased-donor transplant (subdistribution hazard ratio, 0.92; 95% confidence interval, 0.67 to 1.26). Black race, older age, lower income, public insurance, more comorbidities, being transplanted before changes to the Kidney Allocation System, greater religiosity, less social support, less transplant knowledge, and fewer learning activities were each associated with a lower probability of any kidney transplant. Older age, more comorbidities, being transplanted before changes to the Kidney Allocation System, greater religiosity, less social support, and fewer learning activities were each associated with a lower probability of deceased-donor transplant. Black race, older age, lower income, public insurance, higher body mass index, dialysis before kidney transplant, not presenting with a potential living donor, religious objection to living-donor transplant, and less transplant knowledge were each associated with a lower probability of living-donor transplant. CONCLUSIONS: Race and social determinants of health are associated with the likelihood of undergoing kidney transplant.

Does Racial Disparity in Kidney Transplant Waitlisting Persist After Accounting for Social Determinants of Health?

BACKGROUND: African Americans (AA) have lower rates of kidney transplantation (KT) compared with Whites (WH), even after adjusting for demographic and medical factors. In this study, we examined whether the racial disparity in KT waitlisting persists after adjusting for social determinants of health (eg, cultural, psychosocial, and knowledge). METHODS: We prospectively followed a cohort of 1055 patients who were evaluated for KT between 3 of 10 to 10 of 12 and followed through 8 of 18. Participants completed a semistructured telephone interview shortly after their first KT evaluation appointment. We used the Wilcoxon rank-sum and Pearson chi-square tests to examine race differences in the baseline characteristics. We then assessed racial differences in the probability of waitlisting while accounting for all predictors using cumulative incidence curves and Fine and Gray proportional subdistribution hazards models. RESULTS: There were significant differences in the baseline characteristics between non-Hispanic AA and non-Hispanic WH. AA were 25% less likely (95% confidence interval, 0.60-0.96) to be waitlisted than WH even after adjusting for medical factors and social determinants of health. In addition, being older, having lower income, public insurance, more comorbidities, and being on dialysis decreased the probability of waitlisting while having more social support and transplant knowledge increased the probability of waitlisting. CONCLUSIONS: Racial disparity in kidney transplant waitlisting persisted even after adjusting for medical factors and social determinants of health, suggesting the need to identify novel factors that impact racial disparity in transplant waitlisting. Developing interventions targeting cultural and psychosocial factors may enhance equity in access to transplantation.

Unexpected Race and Ethnicity Differences in the US National Veterans Affairs Kidney Transplant Program.

BACKGROUND: Racial/ethnic minorities have lower rates of deceased kidney transplantation (DDKT) and living donor kidney transplantation (LDKT) in the United States. We examined whether social determinants of health (eg, demographics, cultural, psychosocial, knowledge factors) could account for differences in the Veterans Affairs (VA) Kidney Transplantation (KT) Program. METHODS: We conducted a multicenter longitudinal cohort study of 611 Veterans undergoing evaluation for KT at all National VA KT Centers (2010-2012) using an interview after KT evaluation and tracking participants via medical records through 2017. RESULTS: Hispanics were more likely to get any KT (subdistribution hazard ratios [SHR] [95% confidence interval (CI)]: 1.8 [1.2-2.8]) or DDKT (SHR [95% CI]: 2.0 [1.3-3.2]) than non-Hispanic white in univariable analysis. Social determinants of health, including marital status (SHR [95% CI]: 0.6 [0.4-0.9]), religious objection to LDKT (SHR [95% CI]: 0.6 [0.4-1.0]), and donor preference (SHR [95% CI]: 2.5 [1.2-5.1]), accounted for some racial differences, and changes to Kidney Allocation System policy (SHR [95% CI]: 0.3 [0.2-0.5]) mitigated race differences in DDKT in multivariable analysis. For LDKT, non-Hispanic African American Veterans were less likely to receive an LDKT than non-Hispanic white (SHR [95% CI]: 0.2 [0.0-0.7]), but accounting for age (SHR [95% CI]: 1.0 [0.9-1.0]), insurance (SHR [95% CI]: 5.9 [1.1-33.7]), presenting with a living donor (SHR [95% CI]: 4.1 [1.4-12.3]), dialysis duration (SHR [95% CI]: 0.3 [0.2-0.6]), network of potential donors (SHR [95% CI]: 1.0 [1.0-1.1]), self-esteem (SHR [95% CI]: 0.4 [0.2-0.8]), transplant knowledge (SHR [95% CI]: 1.3 [1.0-1.7]), and changes to Kidney Allocation System policy (SHR [95% CI]: 10.3 [2.5-42.1]) in multivariable analysis eliminated those disparities. CONCLUSIONS: The VA KT Program does not exhibit the same pattern of disparities in KT receipt as non-VA centers. Transplant centers can use identified risk factors to target patients who may need more support to ensure they receive a transplant.

Protocol of the KTFT-TALK study to reduce racial disparities in kidney transplant evaluation and living donor kidney transplantation.

Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney disease (ESKD). The evaluation process for a kidney transplant is complex, time consuming, and burdensome to the ESKD patient. Also, race disparities exist in rates of transplant evaluation completion, transplantation, and LDKT. In December 2012 our transplant center implemented a streamlined, one-day evaluation process, dubbed Kidney Transplant Fast Track (KTFT). This paper describes the protocol of a two-part study to evaluate the effectiveness of KTFT at increasing transplant rates (compared to historical controls) and the TALK intervention (Talking About Live Kidney Donation) at increasing LDKT during KTFT. All participants will receive the KTFT evaluation as part of their usual care. Participants will be randomly assigned to TALK versus no-TALK conditions. Patients will undergo interviews at pre-transplant work-up and transplant evaluation. Transplant status will be tracked via medical records. Our aims are to: (1) test the efficacy and cost effectiveness of the KTFT in reducing time to complete kidney transplant evaluation, and increasing kidney transplant rates relative to standard evaluation practices; (2) test whether TALK increases rates of LDKT during KTFT; and (3) determine whether engaging in a streamlined and coordinated-care evaluation experience within the transplant center reduces negative perceptions of the healthcare system. The results of this two-pronged approach will help pave the way for other transplant centers to implement a fast-track system at their sites, improve quality of care by transplanting a larger number of vulnerable patients, and address stark race/ethnic disparities in rates of LDKT.

Has the Department of Veterans Affairs Found a Way to Avoid Racial Disparities in the Evaluation Process for Kidney Transplantation?

BACKGROUND: Minority groups are affected by significant disparities in kidney transplantation (KT) in Veterans Affairs (VA) and non-VA transplant centers. However, prior VA studies have been limited to retrospective, secondary database analyses that focused on multiple stages of the KT process simultaneously. Our goal was to determine whether disparities during the evaluation period for KT exist in the VA as has been found in non-VA settings. METHODS: We conducted a multicenter longitudinal cohort study of 602 patients undergoing initial evaluation for KT at 4 National VA KT Centers. Participants completed a telephone interview to determine whether, after controlling for medical factors, differences in time to acceptance for transplant were explained by patients' demographic, cultural, psychosocial, or transplant knowledge factors. RESULTS: There were no significant racial disparities in the time to acceptance for KT [Log-Rank χ = 1.04; P = 0.594]. Younger age (hazards ratio [HR], 0.98; 95% confidence interval [CI], 0.97-0.99), fewer comorbidities (HR, 0.89; 95% CI, 0.84-0.95), being married (HR, 0.81; 95% CI, 0.66-0.99), having private and public insurance (HR, 1.29; 95% CI, 1.03-1.51), and moderate or greater levels of depression (HR, 1.87; 95% CI, 1.03-3.29) predicted a shorter time to acceptance. The influence of preference for type of KT (deceased or living donor) and transplant center location on days to acceptance varied over time. CONCLUSIONS: Our results indicate that the VA National Transplant System did not exhibit the racial disparities in evaluation for KT as have been found in non-VA transplant centers.