Effects of an online plain language tool on health information quality: A randomised controlled trial

Objective: Complex and ineffective health communication is a critical and persistent source of inequity in our health systems. This occurs despite repeated policy directives to provide patients and community with health information that is easy to understand and that applies health literacy principles. This study sought to evaluate the effectiveness of the Sydney Health Literacy Lab (SHeLL) Health Literacy Editor, an easy-to-use online plain language tool that supports health information providers to apply health literacy guidelines to written health information. Design: Randomised controlled trial with analysts blind to intervention group. Setting: Online study, Australia Participants: 188 health information providers with no previous experience using the Health Literacy Editor (mean age 41.0 (SD=11.6); 154 female (85%)). Intervention: Participants were provided access to the Health Literacy Editor and a 30-minute online training program prior to editing three pre-specified health texts. The Health Literacy Editor gives objective, real-time, and fine-grained feedback on words and sentences. Control participants were asked to revise the texts using their own standard health information development processes. Main outcome measure: Pre-registered primary outcome was text grade reading score (using validated instrument, the Simple Measure of Gobbledygook). Secondary outcomes were use of complex language (% of the text) and passive voice (number of instances), subjective expert ratings (Patient Education Materials Assessment Tool), and acceptability ratings (System Usability Scale; Technology Acceptance Model). Results: Texts revised in the intervention group had significantly improved grade reading scores relative to control (Mean Difference (MD)=2.48, 95% CI=1.84 to 3.12, p<0.001, d=0.99), lower text complexity (MD=6.86, 95% CI=4.99 to 8.74, p<0.001, d=0.95) and less passive voice (MD=0.95, 95% CI=0.4 to 1.5, p<0.001, d=0.53) in intention-to-treat analyses. Experts rated texts in the intervention group more favourably for word choice and style than those in the control group (MD=0.44, 95% CI=0.25 to 0.63, p<0.001, d=0.63), with no loss of meaning or content. Participants rated the Health Literacy Editor an acceptable product (71.0/100, SD=13.7) that was useful (3.8/5, SD=0.7) and easy to use (4.0/5, SD=0.6). Conclusions and relevance: The Health Literacy Editor helped users simplify health information and apply health literacy guidelines to written text. It has high potential to improve development of health information for people who have low health literacy. As an online tool the Health Literacy Editor is also easy to access and implement at scale. Trial registration: ACTRN12623000386639 ### Competing Interest Statement The SHeLL Health Literacy Editor is a tool owned by the University of Sydney. It has been licensed to Health Literacy Solutions PTY Ltd to allow for commercialisation and enable wider public use. DMM, KJM, CB and JA are co-directors of Health Literacy Solutions PTY Ltd. DMM, KJM, CB and JA take no personal income from Health Literacy Solutions PTY Ltd or the SHeLL Health Literacy Editor. The University of Sydney retains IP and is a shareholder. ### Clinical Trial ACTRN12623000386639 ### Funding Statement JA is supported by a National Health and Medical Research Council fellowship (APP 2017278). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: the University of Sydney Human Research Ethics Committee (2023/276). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Deidentified data will be made available on reasonable request.