Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial.

Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial.
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DOI:
10.1186/s12882-020-02117-9
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发表时间:
2020-11-09
期刊:
影响因子:
2.3
通讯作者:
Garonzik-Wang JM
Garonzik-Wang JM
中科院分区:
医学4区
文献类型:
--
作者:
Levan ML;Waldram MM;DiBrito SR;Thomas AG;Al Ammary F;Ottman S;Bannon J;Brennan DC;Massie AB;Scalea J;Barth RN;Segev DL;Garonzik-Wang JM

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在美国,活体肾脏捐赠者(LKDs)占肾脏移植的近三分之一。虽然供体肾切除术的术后风险很小,但lkd患者患高血压、糖尿病和终末期肾病等慢性疾病的调整后风险较高。常规筛查为慢性病的早期发现和管理提供了机会。移植医院报告要求在肾脏捐赠后6个月、1年和2年提交实验室和临床数据,但只有不到50%的医院能够遵守这一要求。需要采取战略提高患者对后续工作的参与度,同时尽量减少行政负担。我们试图评估使用小额财政奖励来促进患者对LKD随访的依从性的有效性。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)进行一项双组随机对照试验(RCT),患者接受活体供体肾切除术。合格的捐赠者将在他们的第一次术后诊所访问或通过电话招募。我们将采用分组随机法将lkd分配到干预组(每次随访时赠送25美元礼品卡)或对照组(目前的护理标准)。后续遵守情况将随时间进行跟踪。主要结局将是完整的(所有组成部分都得到解决)和及时的(在预期访问日期之前或之后60天),在规定的6个月、1年和2年时间点提交LKD随访数据。次要结果将是移植医院在每次就诊时遵守联邦报告要求的情况。将按照意向治疗原则比较两组之间的比率。在LKD随访的背景下,小额财政激励可能会增加患者的依从性,而不会给移植提供者带来不必要的行政负担。这项随机对照试验的结果将为潜在的中心和国家级举措提供信息,为所有LKDs提供小额财政激励,以促进参与捐赠后监测工作。ClinicalTrials.gov编号:NCT03090646注册日期:2017年3月2日赞助商:约翰霍普金斯大学,马里兰大学医学中心资助:马里兰生活遗产基金会在线版本包含补充材料,可在10.1186/s12882-020-02117-9获得。
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. 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 The online version contains supplementary material available at 10.1186/s12882-020-02117-9.
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发表时间: 2012-08
影响因子: 4.8
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