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


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          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.

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          Low health literacy and health outcomes: an updated systematic review.

          Approximately 80 million Americans have limited health literacy, which puts them at greater risk for poorer access to care and poorer health outcomes. To update a 2004 systematic review and determine whether low health literacy is related to poorer use of health care, outcomes, costs, and disparities in health outcomes among persons of all ages. English-language articles identified through MEDLINE, CINAHL, PsycINFO, ERIC, and Cochrane Library databases and hand-searching (search dates for articles on health literacy, 2003 to 22 February 2011; for articles on numeracy, 1966 to 22 February 2011). Two reviewers independently selected studies that compared outcomes by differences in directly measured health literacy or numeracy levels. One reviewer abstracted article information into evidence tables; a second reviewer checked information for accuracy. Two reviewers independently rated study quality by using predefined criteria, and the investigative team jointly graded the overall strength of evidence. 96 relevant good- or fair-quality studies in 111 articles were identified: 98 articles on health literacy, 22 on numeracy, and 9 on both. Low health literacy was consistently associated with more hospitalizations; greater use of emergency care; lower receipt of mammography screening and influenza vaccine; poorer ability to demonstrate taking medications appropriately; poorer ability to interpret labels and health messages; and, among elderly persons, poorer overall health status and higher mortality rates. Poor health literacy partially explains racial disparities in some outcomes. Reviewers could not reach firm conclusions about the relationship between numeracy and health outcomes because of few studies or inconsistent results among studies. Searches were limited to articles published in English. No Medical Subject Heading terms exist for identifying relevant studies. No evidence concerning oral health literacy (speaking and listening skills) and outcomes was found. Low health literacy is associated with poorer health outcomes and poorer use of health care services. Agency for Healthcare Research and Quality.
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            Decision aids for people facing health treatment or screening decisions.

            Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.
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              Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

              Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                April 2021
                30 April 2021
                : 10
                : 4
                : e29161
                [1 ] Department of General Practice and Rural Health Otago Medical School – Dunedin Campus University of Otago Dunedin New Zealand
                [2 ] School of Pharmacy University of Otago Dunedin New Zealand
                [3 ] Department of Preventive and Social Medicine Otago Medical School – Dunedin Campus University of Otago Dunedin New Zealand
                Author notes
                Corresponding Author: Sharon Leitch sharon.leitch@ 123456otago.ac.nz
                Author information
                ©Sharon Leitch, Alesha Smith, Jiaxu Zeng, Tim Stokes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 28 March 2021
                : 12 April 2021
                : 15 April 2021
                : 16 April 2021

                triple whammy,medication safety,patient education,general practice,nsaid,digital intervention,primary care,safety,protocol,feasibility,randomized controlled trial,risk,kidney,renal,information,acceptability


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