通过技术与药剂师干预改善移植用药安全（ISTEP）：一项整群随机对照试验方案
Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial.
作者信息
Hall Casey L, Fominaya Cory E, Gebregziabher Mulugeta, Milfred-LaForest Sherry K, Rife Kelsey M, Taber David J
机构信息
Health Equity & Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States.
Department of Pharmacy, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States.
出版信息
JMIR Res Protoc. 2019 Oct 1;8(10):e13821. doi: 10.2196/13821.
BACKGROUND
Medication errors, adverse drug events, and nonadherence lead to increased health care utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in veteran transplant patients, interventions should address interorganizational system failures and provider-level and patient-level factors.
OBJECTIVE
This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with usual care, in veteran organ transplant recipients.
METHODS
This is a 24-month prospective, parallel-arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 5 sites will then be randomized to each study arm. Approximately, 1600 veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites.
RESULTS
This study is ongoing. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021.
CONCLUSIONS
With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs.
CLINICAL TRIAL
ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13821.
背景
用药错误、药物不良事件和不依从导致实体器官移植受者的医疗保健利用率增加，以及包括移植物丢失在内的不良临床结局风险增加。接受器官移植的退伍军人是发生用药安全事件和护理协调碎片化问题的高危人群。为改善退伍军人移植患者的用药安全和长期临床结局，干预措施应解决组织间系统故障以及提供者层面和患者层面的因素。
目的
本研究旨在衡量与常规护理相比，由药剂师主导、采用技术支持的干预措施对退伍军人器官移植受者的临床和经济效果。
方法
这是一项为期24个月的前瞻性、平行组、整群随机对照多中心研究。与常规移植后护理相比，由药剂师主导的干预措施使用创新的仪表板系统来改善用药安全和健康结局。10个研究地点的药剂师将在随机分组前同意参与本研究，然后5个地点将被随机分配到每个研究组。在这10个地点中，大约1600名退伍军人移植患者将被纳入主要结局的评估。
结果
本研究正在进行中。2018年10月获得机构审查委员会批准，研究于2019年3月开始。由于干预措施计划在24个月内实施，到目前为止本研究尚无结果。预计首批结果将于2021年8月提交发表。
结论
通过本报告，我们描述了这项正在进行的临床试验将采用的研究设计、方法和结局指标。通过技术和药剂师干预改善移植用药安全研究的成功完成，将为一种可行且可扩展的技术支持干预措施在改善用药安全和成本方面的有效性提供实证证据。
临床试验
ClinicalTrials.gov NCT03860818；https://clinicaltrials.gov/ct2/show/NCT03860818。
国际注册报告识别号（IRRID）：PRR1-10.2196/13821。
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