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Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.

ABSTRACT: The best treatment option for end-stage renal disease is usually a transplant, preferably a live donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about the risks, benefits, and process of LDKT remain unknown.We report the protocol of the Enhancing Living Donor Kidney Transplant Education (ELITE) Study, a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large, suburban U.S. transplant center. Five hundred potential transplant candidates are cluster randomized (by date of visit) to receive either: (1) standard-of-care ("usual") transplant education, or (2) intensive education that is based upon the Explore Transplant series of educational materials. Intensive transplant education includes viewing an educational video about LDKT, receiving print education, and meeting with a transplant educator. The primary outcome consists of knowledge of the benefits, risks, and process of LDKT, assessed one week after the transplant evaluation. As a secondary outcome, knowledge and understanding of LDKT are assessed 3 months after the evaluation. Additional secondary outcomes, assessed one week and 3 months after the evaluation, include readiness, self-efficacy, and decisional balance regarding transplant and LDKT, with differences assessed by race. Although the unit of randomization is the date of the transplant evaluation visit, the unit of analysis will be the individual potential transplant candidate.The ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT.Clinicaltrials.gov number NCT01261910.

SUBMITTER: Weng FL

PROVIDER: S-EPMC3840671 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.

Weng Francis L FL Brown Diane R DR Peipert John D JD Holland Bart B Waterman Amy D AD

BMC nephrology 20131119

<h4>Background</h4>The best treatment option for end-stage renal disease is usually a transplant, preferably a live donor kidney transplant (LDKT). The most effective ways to educate kidney transplant candidates about the risks, benefits, and process of LDKT remain unknown.<h4>Methods/design</h4>We report the protocol of the Enhancing Living Donor Kidney Transplant Education (ELITE) Study, a cluster randomized trial of an educational intervention to be implemented during initial transplant evalu ...[more]

PMID: 24245948

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Project description: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 and Hispanics are 3.4 and 1.5 times more likely, respectively, to develop end stage renal disease (ESRD) than Whites, they are less likely to receive LDKTs. To address this disparity, a new randomized controlled trial (RCT) will assess whether Black, Hispanic, and White transplant patients' knowledge, readiness to pursue LDKT, and receipt of LDKTs can be increased when they participate in the Your Path to Transplant (YPT) computer-tailored intervention.Nine hundred Black, Hispanic, and White ESRD patients presenting for transplant evaluation at University of California, Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) will be randomly assigned to one of two education conditions, YPT or Usual Care Control Education (UC). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored telephonic coaching sessions, feedback reports, video and print transplant education resources, and assistance with reducing any known socioeconomic barriers to LDKT. Patients receiving UC will only receive transplant education provided by UCLA-KPTP. Changes in transplant knowledge, readiness, pros and cons, and self-efficacy to pursue LDKT will be assessed prior to presenting at the transplant center (baseline), during transplant evaluation, and 4- and 8-months post-baseline, while completion of transplant evaluation and receipt of LDKTs will be assessed at 18-months post-baseline. The RCT will determine, compared to UC, whether Black, Hispanic, and White patients receiving YPT increase in their readiness to pursue LDKT and transplant knowledge, and become more likely to complete transplant medical evaluation and pursue LDKT. It will also examine how known patient, family, and healthcare system barriers to LDKT act alone and in combination with YPT to affect patients' transplant decision-making and behavior. Statistical analyses will be performed under an intent-to-treat approach.At the conclusion of the study, we will have assessed the effectiveness of an innovative and cost-effective YPT intervention that could be utilized to tailor LDKT discussion and education based on the needs of individual patients of different races in many healthcare settings.ClinicalTrials.gov, number NCT02181114.

Project description:ImportanceIt is unclear whether center-level factors are associated with racial equity in living donor kidney transplant (LDKT).ObjectiveTo evaluate center-level factors and racial equity in LDKT during an 11-year time period.Design, setting, and participantsA retrospective cohort longitudinal study was completed in February 2023, of US transplant centers with at least 12 annual LDKTs from January 1, 2008, to December 31, 2018, identified in the Health Resources Services Administration database and linked to the US Renal Data System and the Scientific Registry of Transplant Recipients.Main outcomes and measuresObserved and model-based estimated Black-White mean LDKT rate ratios (RRs), where an RR of 1 indicates racial equity and values less than 1 indicate a lower rate of LDKT of Black patients compared with White patients. Estimated yearly best-case center-specific LDKT RRs between Black and White individuals, where modifiable center characteristics were set to values that would facilitate access to LDKT.ResultsThe final cohorts of patients included 394 625 waitlisted adults, of whom 33.1% were Black and 66.9% were White, and 57 222 adult LDKT recipients, of whom 14.1% were Black and 85.9% were White. Among 89 transplant centers, estimated yearly center-level RRs between Black and White individuals accounting for center and population characteristics ranged from 0.0557 in 2008 to 0.771 in 2018. The yearly median RRs ranged from 0.216 in 2016 to 0.285 in 2010. Model-based estimations for the hypothetical best-case scenario resulted in little change in the minimum RR (from 0.0557 to 0.0549), but a greater positive shift in the maximum RR from 0.771 to 0.895. Relative to the observed 582 LDKT in Black patients and 3837 in White patients, the 2018 hypothetical model estimated an increase of 423 (a 72.7% increase) LDKTs for Black patients and of 1838 (a 47.9% increase) LDKTs for White patients.Conclusions and relevanceIn this cohort study of patients with kidney failure, no substantial improvement occurred over time either in the observed or the covariate-adjusted estimated RRs. Under the best-case hypothetical estimations, modifying centers' participation in the paired exchange and voucher programs and increased access to public insurance may contribute to improved racial equity in LDKT. Additional work is needed to identify center-level and program-specific strategies to improve racial equity in access to LDKT.

Project description:ImportanceIn the United States, substantial disparities in access to kidney transplant exist for wait-listed candidates with end-stage renal disease. The implications of transplant centers' willingness to accept kidney offers for access to transplant and mortality outcomes are unknown.ObjectiveTo determine the outcomes for wait-listed kidney transplant candidates after the transplant center's refusal of a deceased donor kidney offer.Design, setting, and participantsThis cohort study obtained data from the United Network for Organ Sharing Potential Transplant Recipient data set on all deceased donor kidney offers in the United States made between January 1, 2008, and December 31, 2015. The final study cohort included adult patients who were wait-listed for kidney transplant and received at least 1 allograft offer during the study period (N?=?280?041). Data analysis was conducted from June 1, 2018, to March 30, 2019.ExposureCandidate state of residence.Main outcomes and measuresWaiting list outcome event groups included received deceased donor allograft, received living donor allograft, died while on the waiting list, removed from the waiting list without a transplant, or still on the waiting list at the end of follow-up.ResultsAmong the 280?041 kidney transplant candidates included in the study, the mean (SD) age at wait-listing was 51.1 (13.1) years, and male patients were predominant (171 517 [61.2%]). In this cohort, 81 750 candidates (29.2%) received a deceased donor kidney allograft, 30 870 (11.0%) received a living donor allograft, 25 967 (9.3%) died while on the waiting list, and 59 359 (21.2%) were removed from the waiting list. Overall, 10 candidates with at least 1 previous allograft offer died each day during the study period. Time to first offer was similar for candidates who received deceased donor kidney allograft compared with those who died while waiting (median [interquartile range {IQR}] time, 79 [16-426] days vs 78 [17-401] days, respectively). Deceased donor allograft recipients had a median of 17 offers (IQR, 6-44) over 422 days (IQR, 106-909 days), whereas candidates who died while waiting received a median of 16 offers (IQR, 6-41) over 651 days (IQR, 304-1117 days). Most kidneys (84%) were declined on behalf of at least 1 candidate before being accepted for transplant. As reported by centers, organ or donor quality concerns accounted for 8 416 474 (92.6%) of all declined offers, whereas offers were infrequently refused because of patient-related factors (232 193 [2.6%]), logistical limitations (49 492 [0.5%]), or other concerns. The odds of death after an offer and the median number of offers received prior to death varied considerably by state.Conclusions and relevanceThis study found that transplant candidates appeared to receive a large number of viable deceased donor kidney offers that were refused on their behalf by transplant centers, potentially exacerbating the detrimental consequences of the organ shortage; increased transparency in organ allocation process and decisions may improve patient-centered care and access to kidney transplant.

Project description:Background and objectivesPrecise BP measurement to exclude hypertension is critical in evaluating potential living kidney donors. Ambulatory BP monitoring is considered the gold standard method for diagnosing hypertension, but it is cumbersome to perform. We sought to determine whether lower BP cutoffs using office and automated BP would reduce the rate of missed hypertension in potential living donors.Design, setting, participants, & measurementsWe measured BP in 578 prospective donors using three modalities: (1) single office BP, (2) office automated BP (average of five consecutive automated readings separated by 1 minute), and (3) ambulatory BP. Daytime ambulatory BP was considered the gold standard for diagnosing hypertension. We assessed both the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7) and the American College of Cardiology/American Heart Association (ACC/AHA) definitions of hypertension in the cohort. Empirical thresholds of office BP and automated BP for the detection of ambulatory BP-diagnosed hypertension were derived using Youden index, which maximizes the sum of sensitivity and specificity and gives equal weight to false positive and false negative values.ResultsHypertension was diagnosed in 90 (16%) prospective donors by JNC-7 criteria and 198 (34%) prospective donors by ACC/AHA criteria. Masked hypertension was found in 3% of the total cohort by JNC-7 using the combination of office or automated BP, and it was seen in 24% by ACC/AHA guidelines. Using Youden index, cutoffs were derived for both office and automated BP using JNC-7 (<123/82 and <120/78 mm Hg) and ACC/AHA (<119/79 and <116/76 mm Hg) definitions. Using these lower cutoffs, the sensitivity for detecting hypertension improved from 79% to 87% for JNC-7 and from 32% to 87% by ACC/AHA definition, with negative predictive values of 95% and 87%, respectively. Missed (masked) hypertension was reduced to 2% and 4% of the entire cohort by JNC-7and ACC/AHA, respectively.ConclusionsThe prevalence of hypertension was higher in living donor candidates using ACC/AHA compared JNC-7 definitions. Lower BP cutoffs in the clinic improved sensitivity and led to a low overall prevalence of missed hypertension in prospective living kidney donors.

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Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.

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Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates.

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