School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri.
College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee.
Am J Transplant. 2020 Jan;20(1):125-136. doi: 10.1111/ajt.15528. Epub 2019 Aug 20.
This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.
这项研究旨在确定 SystemCHANGE™ 干预是否比注意力控制更有效,以增加成年肾移植受者在 6 个月干预阶段和随后的 6 个月(无干预)维持阶段的免疫抑制药物依从性并改善结果。SystemCHANGE™ 干预教导患者使用个人层面的质量改进策略,将依从性与既定的日常惯例、环境线索和支持性人员联系起来。89 名患者(平均年龄 51.8 岁,58%为男性,61%为非裔美国人)完成了 6 个月的干预阶段。采用意向治疗分析,在 6 个月时,SystemCHANGE™(中位数 0.91,IQR 0.76-0.96)和注意力控制(中位数 0.67,IQR 0.52-0.72)患者的药物依从性差异显著(中位数差异 0.24,95%CI 0.13-0.30,P<.001)。在随后的 6 个月维持阶段结束时,SystemCHANGE™(中位数 0.77,IQR 0.56-0.94)和注意力控制(中位数 0.60,IQR 0.44-0.73)患者的药物依从性差距仍然很大(中位数差异 0.17,95%CI 0.06-0.33,P=.004)。SystemCHANGE™ 患者在 12 个月时的肌酐和 BUN 平均值较低,在 6 个月和 12 个月时的感染更多。这是第一项针对 SystemCHANGE™ 进行的、旨在提高和维持肾移植受者药物依从性的完全随机对照试验,结果显示药物依从性有显著的、有临床意义的改善。临床试验注册:NCT02416479。