Department of Emergency Medicine, University of British Columbia, 855 West 12th Avenue, Vancouver, British Columbia, V5Z 1M9, Canada.
Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute, 828 West 10th Avenue, Vancouver, British Columbia, V5Z 1M9, Canada.
Trials. 2021 Feb 5;22(1):119. doi: 10.1186/s13063-021-05061-7.
Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE's implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months.
We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial's primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial's primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality.
These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials.
ClinicalTrials.gov NCT04568668 , NCT04574648 . Registered on 1 October 2020.
重复接触罪魁祸首药物是可预防药物不良反应的常见原因。医疗健康信息技术具有通过改善信息连续性来减少重复药物不良反应的潜力。然而，它们很少相互协作，以确保医疗服务提供者能够查看其他系统中记录的药物不良反应。我们设计了 ActionADE，通过与遗留系统集成，实现药物不良反应的快速记录，并在医疗健康部门之间进行标准化信息的交流。我们将利用 ActionADE 的实施，开展两项平行、随机试验：主要试验中患有药物不良反应的患者，以及次要试验中被诊断为不依从的患者。主要试验的主要目标是评估提供药物不良反应信息连续性对 12 个月内罪魁祸首药物再次配药的影响。次要试验的主要目标是评估提供信息连续性对 12 个月内依从性的影响。
我们将在加拿大不列颠哥伦比亚省参与医院开展两项平行分组、三盲随机对照试验。我们将招募因处方药出现药物不良反应而到医院就诊的成年人。临床医生将在 ActionADE 中记录药物不良反应。该软件将使用算法来确定患者是否符合条件，并将符合条件的患者分配到实验组或对照组。在实验组中，ActionADE 将向 PharmaNet 传输信息，当尝试再次配药时，社区药房将显示药物不良反应信息。在对照组中，ActionADE 将在本地记录中保留信息。我们将招募 3600 名患有药物不良反应的成年人参加主要试验。主要试验的主要结局是在 12 个月内再次配药罪魁祸首或同类药物；次要试验的主要结局将是罪魁祸首药物的依从性。次要结局包括卫生服务利用和死亡率。
这些研究有可能指导决策和投资，推动医疗健康信息技术的整合，以预防重复药物不良反应。我们展示了如何利用医疗健康信息技术的实施来开展实用随机对照试验的示例。
ClinicalTrials.gov NCT04568668，NCT04574648。于 2020 年 10 月 1 日注册。
