Using an Information Package to Reduce Patients' Risk of Renal Damage: Protocol for a Randomized Feasibility Trial

Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.