Fukuma Shingo, Ikenoue Tatsuyoshi, Sasaki Shusaku, Saigusa Yusuke, Misumi Toshihiro, Saito Yoshiyuki, Yamada Yukari, Goto Rei, Taguri Masataka
Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Graduate School of Economics, Kyoto University, Kyoto, Japan.
Contemp Clin Trials Commun. 2019 Aug 16;16:100429. doi: 10.1016/j.conctc.2019.100429. eCollection 2019 Dec.
BACKGROUND/AIMS: Strategies for an effective intervention after chronic kidney disease (CKD) screening have not been well examined. We describe the rationale and design of a protocol of a pragmatic randomized controlled trial (RCT) to test the effect of a behavioral intervention using the nudge approach in behavioral economics on CKD patients' visiting behaviors to physicians and change in their kidney function after CKD screening.
The RCT will include CKD patients (N = 4500) detected at screening (estimated glomerular filtration rate [eGFR] <60 mL/min/1.74 m or urine protein ≥1+), aged 40-63 years. The two intervention groups will receive a "usual letter" and "nudge-based letter," while the control group will only receive a conventional follow-up. Our primary outcome is proportion of patients' visiting physicians for 6 months after the intervention; the secondary outcome is change in the eGFR at 2 years after the intervention.
We developed an efficient intervention program after CKD screening and designed the pragmatic RCT to assess its effectiveness in the real world. Our trial is unique in that it investigates the effect of the nudge approach in behavioral economics. By the end of 2018, we have enrolled 1,692 participants, and randomized 677 participants into the usual letter group, 677 participants into the nudge-based letter group, and 338 participants into the control group. We have confirmed that health checkup data could identify a large number of eligible participants.
The trial's results will contribute to filling in the gap between screening and subsequent medical interventions for preventing CKD progression.
背景/目的:慢性肾脏病(CKD)筛查后有效干预策略尚未得到充分研究。我们描述了一项实用随机对照试验(RCT)方案的基本原理和设计,以测试行为经济学中的助推方法对CKD患者就诊行为以及CKD筛查后肾功能变化的影响。
该RCT将纳入筛查时检测出的CKD患者(N = 4500)(估计肾小球滤过率[eGFR]<60 mL/min/1.74 m²或尿蛋白≥1+),年龄在40 - 63岁之间。两个干预组将分别收到一封“普通信件”和“基于助推的信件”,而对照组仅接受常规随访。我们的主要结局是干预后6个月内患者就诊的比例;次要结局是干预后2年时eGFR的变化。
我们在CKD筛查后制定了一个有效的干预方案,并设计了实用RCT来评估其在现实世界中的有效性。我们的试验独特之处在于它研究了行为经济学中助推方法的效果。截至2018年底,我们已招募了1692名参与者,将677名参与者随机分配到普通信件组,677名参与者随机分配到基于助推的信件组,338名参与者随机分配到对照组。我们已确认健康检查数据能够识别大量符合条件的参与者。
该试验结果将有助于填补筛查与后续预防CKD进展的医疗干预之间的空白。