A Randomized Controlled Clinical Trial
A Randomized Controlled Clinical Trial
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Haley M. Gonzales;J. Fleming;M. Gebregziabher;M. Posadas-Salas;Zemin Su;J. McGillicuddy;D. Taber
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文献类型：
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作者：
Haley M. Gonzales;J. Fleming;M. Gebregziabher;M. Posadas-Salas;Zemin Su;J. McGillicuddy;D. Taber
背景和目的药物安全事件是导致肾移植受者移植预后不佳的主要因素。本研究的目的是检验通过药剂师主导的、基于健康的流动干预提高用药安全性的有效性。设计，环境，参与者，这是一项为期12个月，单中心，前瞻性，平行，双臂，单盲，随机对照试验。移植后6-36个月的成人肾受者符合条件。随机分配到干预组的参与者通过基于移动健康的应用程序接受补充临床药师主导的药物治疗监测和管理，并结合风险引导电视和家庭血压和血糖监测。该应用程序提供了准确的用药方案、及时的提醒和副作用调查。对照组和干预组均接受常规护理，包括连续实验室监测和定期门诊就诊。主要结局是评估用药错误和不良事件的发生率和严重程度。结果共纳入136例肾移植受者，每组68例。平均年龄51岁，57%为女性，64%为黑人。接受干预的参与者用药错误发生率显著降低（风险率降低61%；事件风险比0.39；95%可信区间，0.28至0.55；P,0.001）， 3级或以上不良事件发生率显著降低（事件风险比0.55,95%可信区间，0.30至0.99;P50.05）。对于住院的次要结局，干预组的住院率显著降低（事件风险比为0.46；95%可信区间为0.27 ~ 0.77;P50.005）。结论：我们证明，使用药剂师主导的、基于健康的移动干预，用药错误、不良事件和住院率显著降低。中国生物工程学报（英文版）16:776-784,2021。相对于透析，肾移植是肾衰竭患者的首选治疗方案，因为它对成本和患者生存都有有益的影响。随着肾移植受者的总人数今天接近25万，由于年龄增长和慢性健康状况，再加上美国支离破碎的医疗保健系统，后续护理变得更加复杂。现代免疫抑制的使用已经大大降低了急性排斥反应的发生率，目前1年的发生率约为8%。然而，移植物长期存活的改善仍然相对停滞（1-3）。免疫抑制不良事件（ae）和药物依从性导致的排斥反应是导致移植物存活不佳的主要原因（4-6）。尽管现代免疫抑制剂非常有效，但这些方案的毒性负担和相对复杂性使移植受者容易发生不良反应和药物安全问题，包括药物错误(7)。先前的研究表明，多达三分之二的肾移植受者发生用药错误，每八个受者中就有一个住院（2,8）。此外，临床显著的用药错误与移植物丢失、ae、再入院和急性排斥反应的风险相当高有关(9)。我们证明了药物错误与免疫抑制不良事件之间的相关性，经历药物错误的患者发生多种不良事件的风险高出2.3倍（P50.02）(8)。这些研究强调需要创新方法来提高高风险患者（如肾移植受者）的用药安全性。利用移动设备（如移动电话）补充支持医疗和公共卫生做法已成为卫生部的新途径
Background and objectivesMedication safety events are predominant contributors to suboptimal graft outcomes in kidney transplant recipients. The goal of this studywas to examine the efficacy of improvingmedication safety through a pharmacist-led, mobile health–based intervention. Design, setting, participants, Thiswas a 12-month, single-center, prospective, parallel, two-arm, single-blind, randomized controlled trial. Adult kidney recipients 6–36 months post-transplant were eligible. Participants randomized to intervention received supplemental clinical pharmacist–led medication therapy monitoring and management via a mobile health–based application, integrated with risk-guided televisits and home-based BP and glucose monitoring. The application provided an accurate medication regimen, timely reminders, and side effect surveys. Both the control and intervention arms received usual care, including serial laboratorymonitoring and regular clinic visits. The coprimary outcomeswere to assess the incidence and severity of medication errors and adverse events. Results In total, 136 kidney transplant recipients were included, 68 in each arm. The mean age was 51 years, 57%weremale, and 64%were Black individuals. Participants receiving the intervention experienced a significant reduction in medication errors (61% reduction in the risk rate; incident risk ratio, 0.39; 95% confidence interval, 0.28 to 0.55; P,0.001) and a significantly lower incidence risk of Grade 3 or higher adverse events (incident risk ratio, 0.55, 95% confidence interval, 0.30 to 0.99; P50.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates of hospitalizations (incident risk ratio, 0.46; 95% confidence interval, 0.27 to 0.77; P50.005). ConclusionsWe demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health–based intervention. CJASN 16: 776–784, 2021. doi: https://doi.org/10.2215/CJN.15911020 Introduction Kidney transplantation is the preferred treatment option over dialysis for patients with kidney failure, due to its beneficial effect on cost and patient survival. With the total number of kidney transplant recipients alive today approaching 250,000, follow-up care has becomemore complex due to increasing age and chronic health conditions, coupled with the fragmented health care system in the United States. The use of contemporary immunosuppression has produced a substantial decrease in the incidence of acute rejection, which has dropped to a current 1-year rate of roughly 8%. However, improvements in long-term graft survival have remained relatively stagnant (1–3). Immunosuppression adverse events (AEs) and rejection as a result of medication nonadherence are among the chief contributors to suboptimal graft survival (4–6). Although modern immunosuppressive agents are highly effective, the toxicity burden and relative complexity of these regimens leave transplant recipients vulnerable to developing AEs and medication safety issues, including medication errors (7). Previous research demonstrated that medication errors occur in as many as two thirds of kidney transplant recipients, and result in the hospitalization of one in every eight recipients (2,8). Further, clinically significant medication errors were linked to a considerably higher risk of graft loss, AEs, readmissions, and acute rejections (9). We demonstrated a correlation between medication errors and immunosuppression AEs, with patients experiencing medication errors at 2.3-fold higher risk of developing multiple AEs (P50.02) (8). These studies highlight the need for innovative approaches to improve medication safety in patients who are high risk, such as kidney transplant recipients. Supplemental support of medical and public health practices using mobile devices, such as mobile phones, has emerged as a new pathway for Department of