一项关于促红细胞生成素刺激剂决策辅助工具用于肾病贫血治疗的随机对照试验方案。
Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.
作者信息
Beach Lauren B, Wild Marcus, Ramachandran Gowri, Ikizler H Omer, Cavanaugh Kerri L
机构信息
Division of Nephrology & Hypertension, Vanderbilt University Medical Center, 1161 21st Avenue South, S-3223 MCN, Nashville, TN, 37232, USA.
Vanderbilt Center for Kidney Disease, Nashville, TN, USA.
出版信息
BMC Nephrol. 2016 Jul 18;17(1):86. doi: 10.1186/s12882-016-0301-z.
BACKGROUND
Erythropoiesis-stimulating agents (ESAs) are commonly used for the treatment of anemia due to chronic kidney disease (CKD) and end stage renal disease (ESRD). Patients often lack an understanding of the potential risks and benefits of ESAs, despite government mandated education on this topic. Decision aids are tools commonly used to discuss important information in health care settings. To address this knowledge gap, we designed this study to evaluate the effectiveness of a novel ESA decision aid at promoting informed shared decision making (ISDM) between patients and providers related to ESA use for CKD- and ESRD-related anemia.
METHODS
Using the principles of informed shared decision making theory, we designed and piloted an ESA decision aid intended to increase CKD and ESRD patient understanding of the potential risks and benefits of ESAs. Informed by the findings during development, the ESA decision aid was modified and finalized for testing. We will perform a randomized clinical trial to assess if administration of the ESA decision aid improves patient understanding of the risks and benefits of ESA use compared to control patients receiving standard care. Participants with either CKD or ESRD and who are receiving ESAs will be eligible for participation. The primary outcome is patients' score on the Patient Anemia Knowledge in Kidney Disease (PAKKD) survey assessed at enrollment and 3 months after. Secondary outcomes include decisional conflict related to ESAs, and patient satisfaction with provider communication.
DISCUSSION
The Anemia Risk Communication for patients with Kidney Disease (ARC-KD) study will assess the effectiveness of a novel ESA decision aid to improve patient understanding of ESA use to manage CKD- and ESRD-related anemia. This decision aid is the first resource targeted to improve patient understanding of anemia management in the kidney health context. With the increasing options available for anemia management, this will serve as an important foundation to evolve in the future to optimize anemia-related shared decision making.
TRIAL REGISTRATION
ClinicalTrials.gov, number NCT01992926 . Registered 11/14/2013.
背景
促红细胞生成素（ESAs）常用于治疗慢性肾脏病（CKD）和终末期肾病（ESRD）所致的贫血。尽管政府已强制要求开展关于这一主题的教育，但患者往往对ESAs的潜在风险和益处缺乏了解。决策辅助工具是在医疗环境中用于讨论重要信息的常用工具。为填补这一知识空白，我们设计了本研究，以评估一种新型ESAs决策辅助工具在促进患者与医护人员之间就CKD和ESRD相关贫血使用ESAs进行知情共同决策（ISDM）方面的有效性。
方法
运用知情共同决策理论的原则，我们设计并试行一种ESAs决策辅助工具，旨在提高CKD和ESRD患者对ESAs潜在风险和益处的理解。根据开发过程中的研究结果，对ESAs决策辅助工具进行修改并最终确定用于测试。我们将进行一项随机临床试验，以评估与接受标准护理的对照患者相比，使用ESAs决策辅助工具是否能提高患者对使用ESAs的风险和益处的理解。患有CKD或ESRD且正在接受ESAs治疗的参与者将有资格参与。主要结局是患者在入组时和3个月后进行的肾脏病患者贫血知识（PAKKD）调查中的得分。次要结局包括与ESAs相关的决策冲突以及患者对医护人员沟通的满意度。
讨论
肾脏病患者贫血风险沟通（ARC-KD）研究将评估一种新型ESAs决策辅助工具在提高患者对用于管理CKD和ESRD相关贫血的ESAs使用的理解方面的有效性。这种决策辅助工具是首个旨在提高患者在肾脏健康背景下对贫血管理理解的资源。随着贫血管理的选择日益增多，这将成为未来不断发展以优化贫血相关共同决策的重要基础。
试验注册
ClinicalTrials.gov，编号NCT01992926。于2013年11月14日注册。
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