一个患者随机临床试验的协议,以改善初级保健中的药物坚持
JoAnn M Sperl-Hillen1, Jacob L Haapala1, Steven P Dehmer1
1HealthPartners Institute, Bloomington, MN, United States.
Contemporary clinical trials
|November 13, 2023
概括
这项研究适应了一项试验协议,以改善心脏代谢疾病的药物坚持. 由于电子健康记录系统更新,药房关闭和COVID-19大流行,协议变更是必要的.
科学领域:
- 初级保健研究研究初级保健研究
- 临床试验设计 临床试验设计
- 医疗信息学 医疗信息学
背景情况:
- 药物坚持不良显著影响心脏代谢疾病的患者护理.
- 改善药物坚持对于管理高血压,糖尿病和脂质疾病至关重要.
研究的目的:
- 描述一项旨在提高药物坚持性的随机试验的原始和调整的协议.
- 评估与电子健康记录集成的临床决策支持工具的实施可行性,以改善遵守.
主要方法:
- 一个集群随机试验,将增强慢性疾病护理临床决策支持 (eCDC-CDS) 与通常护理进行比较.
- 干预包括EHR集成的CDS与患者/临床医生接口和药剂师推广.
- 参与者是18-74岁的成年人,他们没有满足HTN,DM或脂质的护理目标,药物坚持率低 (PDC<80%).
主要成果:
- 由于无法预见的实施挑战,需要调整协议.
- 挑战包括系统范围内的遵守数据的可用性,药房关闭和COVID-19中断.
- 该研究详细说明了对原始试验协议的必要修改.
结论:
- 协议适应对于在现实世界初级保健环境中成功执行临床试验至关重要.
- 该研究强调了医疗保健系统的动态性质以及需要灵活的研究协议.
- 从协议适应中吸取的经验教训可以为未来关于药物坚持干预的研究提供信息.
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