Levan Macey L, Waldram Madeleine M, DiBrito Sandra R, Thomas Alvin G, Al Ammary Fawaz, Ottman Shane, Bannon Jaclyn, Brennan Daniel C, Massie Allan B, Scalea Joseph, Barth Rolf N, Segev Dorry L, Garonzik-Wang Jacqueline M
Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.
Department of Acute and Chronic Care, Johns Hopkins School of Nursing, Baltimore, MD, USA.
BMC Nephrol. 2020 Nov 9;21(1):465. doi: 10.1186/s12882-020-02117-9.
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.
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.
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.
在美国，活体肾供者（LKDs）占肾移植手术的近三分之一。虽然供肾切除术的术后风险极小，但活体肾供者患慢性疾病如高血压、糖尿病和终末期肾病的校正风险有所升高。常规筛查为慢性病的早期发现和管理提供了机会。移植医院的报告要求规定在肾捐赠后6个月、1年和2年提交实验室和临床数据，但不到50%的医院能够遵守。需要采取策略提高患者对随访工作的参与度，同时尽量减少行政负担。我们旨在评估使用小额经济激励措施促进患者遵守活体肾供者随访的有效性。
方法/设计：我们正在约翰霍普金斯医院综合移植中心（MDJH）和马里兰大学医学中心移植中心（MDUM）对接受活体供肾切除术的患者进行双臂随机对照试验（RCT）。符合条件的供者将在术后首次门诊就诊时或通过电话亲自招募。我们将使用区组随机化将活体肾供者分配到干预组（每次随访发放25美元礼品卡）或对照组（当前的标准护理）。随时间跟踪随访依从性。主要结局将是在要求的6个月、1年和2年时间点完整（所有项目均涵盖）且及时（预期就诊日期前后60天内）提交活体肾供者随访数据。次要结局将是每次就诊时移植医院层面符合联邦报告要求的情况。将按照意向性分析原则比较两组的发生率。
小额经济激励措施可能会提高活体肾供者随访中的患者依从性，而不会给移植提供者带来过多行政负担。这项随机对照试验的结果将为潜在的中心层面和国家层面举措提供信息，以便为所有活体肾供者提供小额经济激励措施，促进其参与捐赠后监测工作。
ClinicalTrials.gov编号：NCT03090646 注册日期：2017年3月2日 主办方：约翰霍普金斯大学、马里兰大学医学中心 资助：马里兰生命遗产基金会
