Division of Nephrology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; College of Medicine, University of Cincinnati, Cincinnati, Ohio.
Division of Nephrology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; College of Medicine, University of Cincinnati, Cincinnati, Ohio.
Am J Kidney Dis. 2022 Mar;79(3):335-346. doi: 10.1053/j.ajkd.2021.06.021. Epub 2021 Aug 3.
RATIONALE & OBJECTIVE: Adolescent and young adult kidney transplant recipients have a high risk of rejection related to suboptimal adherence. Multicomponent interventions improve adherence in controlled trials, but clinical implementation is lacking. We describe an initiative to reduce allograft rejection using evidence-based adherence promotion strategies.
Interrupted time series.
SETTING & PARTICIPANTS: Kidney transplant recipients cared for at Cincinnati Children's Hospital ≥ 1 year after transplant and taking ≥1 immunosuppressive medication(s) from 2014 through 2017.
The following interventions, collectively called MAPS (Medication Adherence Promotion System), were implemented over 14 months: (1) adherence promotion training for clinical staff, 2) electronic health record-supported adherence risk screening, (3) systematic assessment of medication adherence barriers, (4) designation of specific staff to address adherence barriers, (5) shared decision-making with the patients to overcome adherence barriers, (6) follow-up evaluation to assess progress, and (7) optional electronic medication monitoring.
Primary Outcome: Late acute rejection. Process measures were conducted to assess barriers, identify barriers, and perform interventions. The secondary outcomes/balancing measures were de novo donor-specific antibodies (DSA), biopsy rate, and rejections per biopsy.
Time series analysis using statistical process control evaluated patient-days between acute rejections as well as monthly rejections per 100 patient-months before and after implementation. To control for known rejection risk factors including changes in treatment and case mix, multivariable analyses were performed.
The monthly rejection rate fell from 1.61 rejections per 100 patient-months in the 26 months before implementation to 0.88 rejections per 100 patient-months in the 22 months after implementation. In the multivariable analysis, MAPS was associated with a 50% reduction in rejection incidence (incidence rate ratio, 0.50 [95% CI, 0.27-0.91]; P = 0.02). DSA and time since transplant (per each additional year) were also associated with rejection incidence (incidence rate ratio, 2.27 [P = 0.02] and 0.87 [P = 0.02], respectively).
Single-center study, and potential confounding by unmeasured variables.
Clinical implementation of evidence-based adherence-promotion strategies was associated with a 50% reduction in acute rejection incidence over 2 years.
青少年和年轻成年肾移植受者由于依从性不佳而存在较高的排斥反应风险。在对照试验中，多组分干预措施可提高依从性，但临床实施情况尚不清楚。我们描述了一项使用循证依从性促进策略降低同种异体移植物排斥反应的计划。
间断时间序列。
2014 年至 2017 年，在辛辛那提儿童医院接受肾移植治疗且移植后至少 1 年，并且至少服用 1 种免疫抑制剂的肾移植受者。
共实施了 14 个月以下干预措施，统称为 MAPS（药物依从性促进系统）：（1）对临床工作人员进行依从性促进培训；（2）电子健康记录支持的依从性风险筛查；（3）对药物使用依从性障碍进行系统评估；（4）指定特定工作人员解决依从性障碍；（5）与患者共同做出决策以克服依从性障碍；（6）进行后续评估以评估进展情况；（7）可选的电子药物监测。
晚期急性排斥反应。进行了过程测量以评估障碍，识别障碍并进行干预。次要结局/平衡措施为新供体特异性抗体（DSA）、活检率和每次活检的排斥反应。
使用统计过程控制的时间序列分析评估了急性排斥反应之间的患者天数以及实施前后每月每 100 个患者月的排斥反应率。为了控制已知的排斥反应风险因素，包括治疗和病例组合的变化，进行了多变量分析。
在实施前的 26 个月中，每月排斥反应率为 1.61 次/100 个患者月，而在实施后的 22 个月中每月排斥反应率为 0.88 次/100 个患者月。在多变量分析中，MAPS 与排斥反应发生率降低 50%相关（发病率比，0.50 [95%CI，0.27-0.91]；P = 0.02）。DSA 和移植后时间（每年增加）也与排斥反应发生率相关（发病率比，2.27 [P = 0.02] 和 0.87 [P = 0.02]）。
单中心研究，潜在的混杂变量。
实施基于证据的依从性促进策略与 2 年内急性排斥反应发生率降低 50%相关。
