Leitch Sharon, Smith Alesha, Zeng Jiaxu, Stokes Tim
Department of General Practice and Rural Health, Otago Medical School - Dunedin Campus, University of Otago, Dunedin, New Zealand.
School of Pharmacy, University of Otago, Dunedin, New Zealand.
JMIR Res Protoc. 2021 Apr 30;10(4):e29161. doi: 10.2196/29161.
Non-steroidal anti-inflammatory drugs (NSAIDs) are a common cause of renal damage, especially when taken together with angiotensin-converting enzyme inhibitors (ACE-i) or angiotensin II receptor blockers (ARBs) plus a diuretic - a combination known as the "triple whammy." New Zealand patients are at high risk of the "triple whammy" because they can easily purchase NSAIDs without a prescription and in nonpharmacy retail settings (eg, the supermarket), there is no legal requirement to include patient information sheets with medication, and direct-to-consumer drug advertising is permitted. A patient information package has been developed for those at greatest risk of the "triple whammy," consisting of a printable PDF and an interactive online learning activity. This information package aims to inform patients about their elevated risk of harm from NSAIDS and discourage use of NSAIDs. A randomized control trial was planned to assess the effect of the information package.
This study aims to pilot the trial procedures for recruiting patients and providing patient information online and to assess the acceptability of the patient information package.
A two-armed randomized feasibility trial will be undertaken in Northland, New Zealand. We will recruit 50 patients who are at least 18 years old from those who have signed up to receive email alerts through their general practice. Patients eligible for this study have been prescribed an ACE-i or ARB plus a diuretic in the past 3 months. They will be randomly allocated to 2 study arms. The intervention arm will receive access to an information package plus usual care; the control arm will receive usual care alone. Online surveys will be used to assess NSAID knowledge and NSAID use at baseline and after 2 weeks for both arms. The intervention arm will also evaluate the information package in an additional survey based on Normalization Process Theory (NPT) concepts. We will report the number and proportion of participants who are eligible and consent to participate in the trial. Response and drop-out rates will be reported for each trial arm. The numbers of patients who interact with the education package will be reported together with the patient evaluation of it.
Funding has been obtained from the Health Research Council of New Zealand (HRC 18-031). The University of Otago Human Research Ethics Committee (H21/016) has approved this trial. Consultation has been undertaken with The Ngai Tahu research consultation committee. The trial commenced on April 12, 2021.
This feasibility trial will test the study processes prior to commencing a randomized controlled trial and will determine the acceptability of the patient information package. We anticipate this work will provide useful information for other researchers attempting similar work.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29161.
非甾体抗炎药（NSAIDs）是导致肾损伤的常见原因，尤其是与血管紧张素转换酶抑制剂（ACE-i）或血管紧张素II受体阻滞剂（ARBs）以及利尿剂联合使用时——这种组合被称为“三重打击”。新西兰患者面临“三重打击”的风险很高，因为他们可以轻松地在无处方的情况下购买非甾体抗炎药，而且在非药店零售场所（如超市），法律没有要求随药品附上患者信息单，并且允许直接面向消费者的药品广告。已为面临“三重打击”风险最高的人群开发了一个患者信息包，其中包括一个可打印的PDF文件和一个交互式在线学习活动。这个信息包旨在告知患者使用非甾体抗炎药会增加伤害风险，并劝阻使用非甾体抗炎药。计划进行一项随机对照试验来评估该信息包的效果。
本研究旨在试行招募患者并在线提供患者信息的试验程序，并评估患者信息包的可接受性。
将在新西兰北部地区进行一项双臂随机可行性试验。我们将从那些已注册通过其全科医疗接收电子邮件提醒的人群中招募50名年龄至少18岁的患者。符合本研究条件的患者在过去3个月内已被开具了ACE-i或ARB以及一种利尿剂的处方。他们将被随机分配到两个研究组。干预组将获得信息包并接受常规护理；对照组将仅接受常规护理。将使用在线调查来评估两组在基线时以及2周后的非甾体抗炎药知识和非甾体抗炎药使用情况。干预组还将基于规范化过程理论（NPT）概念在另一项调查中评估该信息包。我们将报告符合条件并同意参与试验的参与者的数量和比例。将报告每个试验组的应答率和退出率。将报告与教育包互动的患者数量以及患者对其的评价。
已从新西兰卫生研究委员会（HRC 18 - 031）获得资金。奥塔哥大学人类研究伦理委员会（H21/016）已批准该试验。已与 Ngai Tahu 研究咨询委员会进行了磋商。该试验于2021年4月12日开始。
这项可行性试验将在开展随机对照试验之前测试研究过程，并将确定患者信息包的可接受性。我们预计这项工作将为其他尝试类似工作的研究人员提供有用信息。
国际注册报告标识符（IRRID）：PRR1 - 10.2196/29161。
