APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO): Design and Rationale.

INTRODUCTION: Much of the higher risk for end-stage kidney disease (ESKD) in African American individuals relates to ancestry-specific variation in the apolipoprotein L1 gene (APOL1). Relative to kidneys from European American deceased-donors, kidneys from African American deceased-donors have shorter allograft survival and African American living-kidney donors more often develop ESKD. The National Institutes of Health (NIH)-sponsored APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is prospectively assessing kidney allograft survival from donors with recent African ancestry based on donor and recipient APOL1 genotypes. METHODS: APOLLO will evaluate outcomes from 2614 deceased kidney donor-recipient pairs, as well as additional living-kidney donor-recipient pairs and unpaired deceased-donor kidneys. RESULTS: The United Network for Organ Sharing (UNOS), Association of Organ Procurement Organizations, American Society of Transplantation, American Society for Histocompatibility and Immunogenetics, and nearly all U.S. kidney transplant programs, organ procurement organizations (OPOs), and histocompatibility laboratories are participating in this observational study. APOLLO employs a central institutional review board (cIRB) and maintains voluntary partnerships with OPOs and histocompatibility laboratories. A Community Advisory Council composed of African American individuals with a personal or family history of kidney disease has advised the NIH Project Office and Steering Committee since inception. UNOS is providing data for outcome analyses. CONCLUSION: This article describes unique aspects of the protocol, design, and performance of APOLLO. Results will guide use of APOL1 genotypic data to improve the assessment of quality in deceased-donor kidneys and could increase numbers of transplanted kidneys, reduce rates of discard, and improve the safety of living-kidney donation.

Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial.

BACKGROUND: The efficacy of video interventions to increase organ donation willingness remains unclear. METHODS: Three-arm web-based randomized controlled trial involving 2261 students at 3 northeastern Ohio universities. Intervention students watched a live-action (n = 755) or animated (n = 753) donation video. Control students (n = 753) viewed wellness information from the Centers for Disease Control and Prevention (CDC). The primary outcome was proportion of students who visited their state electronic donor registry to consent. The secondary outcome was intervention quality. Logistic regression assessed the effects of interventions on visiting the state registry to provide donation consent while controlling for baseline variables. RESULTS: Students in the live-action video arm visited their state registry more frequently than students in the CDC arm (OR = 1.86, 95% CI = 1.20-2.88). There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76). The quality of the live-action video was rated lower than the animated video and the CDC text (75% ± 18, 84% ± 16, 80% ± 16, respectively; P < 0.001). CONCLUSION: Students who watched the live-action video were more willing to visit their electronic donor registry to register as organ donors, but rated it lower in satisfaction. Future work should identify the most potent components of organ donation interventions.

Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial.

BACKGROUND: Low organ donation rates remain a major barrier to organ transplantation. OBJECTIVE: We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider. DESIGN: This was a randomized controlled trial between February 2013 and May 2014. SETTING: The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio. PATIENTS: The study included 915 patients over 15.5 years of age who had not previously consented to organ donation. INTERVENTIONS: Just prior to their clinical encounter, intervention patients (n = 456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n = 459) visited their provider per usual routine. MAIN MEASURES: The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter. KEY RESULTS: Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10-2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1-20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61-1.25). LIMITATION: How the observed increases in organ donation consent might translate into a greater organ supply is unclear. CONCLUSION: Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01697137.

Effect of an iPod video intervention on consent to donate organs: a randomized trial.

BACKGROUND: The gap between the supply of organs available for transplantation and demand is growing, especially among ethnic groups. OBJECTIVE: To evaluate the effect of a video designed to address concerns of ethnic groups about organ donation. DESIGN: Cluster randomized, controlled trial. Randomization was performed by using a random-number table with centralized allocation concealment. Participants and investigators assessing outcomes were not blinded to group assignment. (ClinicalTrials.gov registration number: NCT00870506) SETTING: Twelve branches of the Ohio Bureau of Motor Vehicles in northeastern Ohio. PARTICIPANTS: 952 participants aged 15 to 66 years. INTERVENTION: Video (intervention; n = 443) or usual Bureau of Motor Vehicles license practices (control; n = 509). MEASUREMENTS: The primary outcome was the proportion of participants who provided consent for organ donation on a newly acquired driver's license, learner's permit, or state identification card. Secondary outcomes included willingness to make a living kidney donation to a family member in need and personal beliefs about donation. RESULTS: More participants who viewed the video consented to donate organs than control participants (84% vs. 72%; difference, 12 percentage points [95% CI, 6 to 17 percentage points]). The video was effective among black participants (76% vs. 54%; difference, 22 percentage points [CI, 9 to 35 percentage points]) and white participants (88% vs. 77%; difference, 11 percentage points [CI, 5 to 15 percentage points]). At the end of the trial, fewer intervention than control participants reported having insufficient information about organ donation (34% vs. 44%; difference, -10 percentage points [CI, -16 to -4 percentage points]), wanting to be buried with all of their organs (14% vs. 25%; difference, -11 percentage points [CI, -16 to -6 percentage points]), and having conflicts with organ donation (7% vs. 11%; difference, -4 percentage points [CI, -8 to -2 percentage points]). LIMITATION: How the observed increases in consent to donate organs might translate into a greater organ supply in the region is unclear. CONCLUSION: Exposure to a brief video addressing concerns that ethnic groups have about organ donation just before obtaining a license, permit, or identification card increased consent to donate organs among white and black participants. PRIMARY FUNDING SOURCE: National Institutes of Health and the Robert Wood Johnson Foundation.

Communicating effectively about donation: an educational intervention to increase consent to donation.

CONTEXT: Families' refusal to consent to solid organ donation is a major contributor to the organ deficit in the United States. Previous research has identified organ procurement coordinators as best able to obtain consent from families; however, few studies have examined the effects of coordinator training programs on consent rates. OBJECTIVE: To test the effects of the Communicating Effectively About Donation intervention on the rate of family consent to solid organ donation. DESIGN: A nonrandomized repeated measures design. SETTING AND PARTICIPANTS: Participants included 17 hospitals, 502 donor-eligible patients and their families, and 22 coordinators from an organ procurement organization in Ohio. INTERVENTION: Coordinators were given in-service training on the use of effective relational and affective communication techniques through a day-long interactive workshop and simulated donation scenarios. MAIN OUTCOME MEASURES: Families' final donation decision and coordinators' donation-related behaviors. RESULTS: Training of coordinators was associated with increases in coordinators' comfort speaking with patients' families about donation and answering donation-related questions, in the amount of time coordinators spent discussing donation with family members, and in the number of donation-related topics discussed with families. Consent rates increased from 46.3% to 55.5% after the intervention. CONCLUSIONS: The results suggest that improving coordinators' communication skills may be a fruitful avenue for increasing the rate of family consent to donation; however, a more definitive test of the training is needed to confirm the intervention's effectiveness.

A multiethnic study of the relationship between fears and concerns and refusal rates.

This study builds on previous research that identified fears and concerns heard by procurement coordinators during the donation discussion and that classified those concerns according to the ease with which they can be addressed. In this study, 53 coordinators working for 4 procurement agencies provided data on 323 donation discussions, including fears and concerns expressed by families. The fears and concerns were analyzed by outcome (consent or refusal), race and ethnicity of the family, frequency of reports, and difficulty in addressing. This research confirms many of the findings of the earlier study. The results also indicate that the types of concerns expressed by donor and non-donor families vary somewhat by the family's race and ethnicity. The results can be used to provide training targeted at raising consent rates and to train minority requestors.