Peralta Carmen A, Frigaard Martin, Rubinsky Anna D, Rolon Leticia, Lo Lowell, Voora Santhi, Seal Karen, Tuot Delphine, Chao Shirley, Lui Kimberly, Chiao Phillip, Powe Neil, Shlipak Michael
San Francisco VA Medical Center, 4150 Clement St., 111A1, San Francisco, CA, 94121, USA.
University of California, San Francisco, 533 Parnassus Avenue, San Francisco, CA, 94117, USA.
BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6.
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.
METHODS/DESIGN: 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.
NCT01978951 ; Date or Registration: 1/17/2014.
慢性肾脏病（CKD）筛查能否改善并发症高危人群的护理情况仍不确定。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“三联标志物”CKD筛查项目（肌酐、胱抑素C和白蛋白与肌酐比值）在一家退伍军人管理局医院改善初级保健中高血压退伍军人护理的可行性、实施情况和有效性。
方法/设计：年龄在18 - 80岁、无已知CKD的非糖尿病高血压退伍军人按初级保健提供者确定的群组（随机分组单位）随机分为三组。将常规护理与两种逐步强化的治疗策略进行比较：（1）进行CKD筛查，随后对患者和提供者进行教育；或（2）筛查-教育加上由临床药剂师主导的CKD和血压管理项目。主要临床结局是收缩压（BP）相对于基线的变化。次要临床结局是血压控制。主要过程结局是三联标志物筛查（在三组中进行），次要过程结局包括肾素 - 血管紧张素系统抑制剂（ACE/ARB）的总体使用情况以及在蛋白尿患者中的使用情况、初级保健医生对CKD的识别、非甾体抗炎药（NSAIDs）的使用以及初级保健医生对NSAIDs的教育。该设计使用退伍军人健康管理局电子健康记录（EHR）来识别参与者、实施干预措施并确定研究结局。项目实施评估将使用覆盖范围（Reach）、有效性（Effectiveness）、采用情况（Adoption）、实施情况（Implementation）和维持情况（Maintenance，RE - AIM）框架。研究持续时间为12个月。
在41个提供者群组中，共有1819名患者被随机分组。年龄中位数（四分位间距）为68岁（61 - 72岁），99%的参与者为男性。约16%为黑人，5%为西班牙裔。在试验的前6个月，已开出434次三联标志物筛查测试，其中217次（50%）已进行检测。在接受检测的人群中，共识别出48例新的CKD病例，初步检出率为22%。
我们成功实施了一项实用方案，该方案利用EHR识别和描述符合条件的参与者、实施干预措施，并以高参与率确定研究结局，参与者包括提供者和患者。本研究结果可为CKD领域实用试验的设计提供指导。
NCT01978951；注册日期：2014年1月17日。
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