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Background: Live kidney donors (LKDs) account for nearly a third of kidney transplants in the United States. While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease. Routine screening presents an opportunity for the early detection and management of chronic conditions. Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Strategies to increase patient engagement in follow-up efforts while minimizing administrative burden are needed. We seek to evaluate the effectiveness of using small financial incentives to promote patient compliance with LKD follow-up., Methods/design: We are conducting a two-arm randomized controlled trial (RCT) of patients who undergo live donor nephrectomy at The Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) and the University of Maryland Medical Center Transplant Center (MDUM). Eligible donors will be recruited in-person at their first post-surgical clinic visit or over the phone. We will use block randomization to assign LKDs to the intervention ($25 gift card at each follow-up visit) or control arm (current standard of care). Follow-up compliance will be tracked over time. The primary outcome will be complete (all components addressed) and timely (60 days before or after expected visit date), submission of LKD follow-up data at required 6-month, 1-year, and 2-year time points. The secondary outcome will be transplant hospital-level compliance with federal reporting requirements at each visit. Rates will be compared between the two arms following the intention-to-treat principle., Discussion: Small financial incentivization might increase patient compliance in the context of LKD follow-up, without placing undue administrative burden on transplant providers. The findings of this RCT will inform potential center- and national-level initiatives to provide all LKDs with small financial incentives to promote engagement with post-donation monitoring efforts., Trial Registration: ClinicalTrials.gov number: NCT03090646 Date of registration: March 2, 2017 Sponsors: Johns Hopkins University, University of Maryland Medical Center Funding: The Living Legacy Foundation of Maryland.

Background: Previous studies have reported a wide range of prevalence of post-donation anxiety, depression, and regret in living kidney donors (LKDs). It is also unclear what risk factors are associated with these outcomes., Methods: We screened 825 LKDs for anxiety and depression using 2-item GAD-2 and PHQ-2 scales and asked about regret., Results: Overall, 5.5% screened positive for anxiety, 4.2% for depression, and 2.1% reported regretting their donation. While there was moderate correlation between positive anxiety and depression screens (r = 0.52), there was no correlation between regret and positive screens (r < 0.1 for both). A positive anxiety screen was more likely in LKDs with a positive depression screen (adjusted relative risk [aRR] 13.72, 95% confidence interval [CI] 6.78-27.74, p < 0.001). Similarly, a positive depression screen was more likely in LKDs with a positive anxiety screen (aRR 19.50, 95% CI 6.94-54.81, p < 0.001), as well as in those whose recipients experienced graft loss (aRR 5.38, 95% CI 1.29-22.32, p = 0.02). Regret was more likely in LKDs with a positive anxiety screen (aRR 5.68, 95% CI 1.20-26.90, p = 0.03). This was a single center cross-sectional study which may limit generalizability and examination of causal effects. Also, due to the low prevalence of adverse psychosocial outcomes, we may lack power to detect some associations between donor characteristics and anxiety, depression, or regret., Conclusions: Although there is a low prevalence of anxiety, depression, and regret of donation among LKDs, these are interrelated conditions and a positive screen for one condition should prompt evaluation for other conditions.