Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans.
Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans.
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DOI：
10.1186/s12882-017-0541-6
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发表时间：
2017-04-12
期刊：
影响因子：
2.3
通讯作者：
Shlipak M
中科院分区：
文献类型：
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作者：
Peralta CA;Frigaard M;Rubinsky AD;Rolon L;Lo L;Voora S;Seal K;Tuot D;Chao S;Lui K;Chiao P;Powe N;Shlipak M
慢性肾脏病 (CKD) 筛查是否可以改善并发症高危人群的护理仍不确定。我们描述了一项试点、整群随机实用试验的设计和早期实施经验，以评估“三标记”CKD 筛查计划（肌酐、胱抑素 C 和白蛋白与肌酐比率）的可行性、实施和有效性，以改善在退伍军人管理局医院初级保健中就诊的高血压退伍军人的护理。没有已知 CKD 的 18-80 岁非糖尿病高血压退伍军人被随机分组，由初级保健提供者（随机化单位）确定为三组。将常规护理与两种逐渐强化的治疗策略进行比较：(1) 筛查 CKD，然后对患者和提供者进行教育；(2) 筛查教育加上临床药剂师主导的 CKD 和血压管理计划。主要临床结果是收缩压（BP）相对于基线的变化。次要临床结果是血压控制。主要过程结果是三重标志物筛查（跨三个组），次要过程结果包括肾素-血管紧张素系统 (ACE/ARB) 抑制剂的整体使用和蛋白尿患者的使用、PCP 对 CKD 的识别、非甾体抗炎药 (NSAID) 的使用以及 PCP 进行的 NSAID 教育。该设计使用退伍军人健康管理局的电子健康记录 (EHR) 来识别参与者、提供干预措施并确定研究结果。计划实施的评估将使用范围、有效性、采用、实施和维护 (RE-AIM) 框架。学习期限为 12 个月。共有 1,819 名患者被随机分配到 41 个医疗服务提供者集群中。中位年龄（四分位距）为 68 岁 (61-72)，99% 的参与者为男性。大约 16% 是黑人，5% 是西班牙裔。在试验的前 6 个月中，已订购 434 项三重标记筛选测试，其中 217 项（50%）已完成测试。在接受检测的患者中，总共发现了 48 例新的 CKD 病例，初步诊断率为 22%。我们已经成功实施了一项务实的协议，该协议使用 EHR 来识别和描述合格的参与者、提供干预措施并确定研究结果，并且提供者和患者的参与率很高。这项研究的结果可以指导 CKD 领域的实用试验设计。 NCT02059408；日期或注册：2014 年 1 月 17 日。本文的在线版本 (doi:10.1186/s12882-017-0541-6) 包含补充材料，可供授权用户使用。
Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a “triple marker” CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital. Non-diabetic hypertensive veterans age 18–80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months. A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61–72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%. We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD. NCT02059408; Date or Registration: 1/17/2014. The online version of this article (doi:10.1186/s12882-017-0541-6) contains supplementary material, which is available to authorized users.