Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for a randomized controlled trial
Charide, R.; Stallwood, L.; Munan, M.; Sayfi, S.; Hartling, L.; Butcher, N. J.; Offringa, M.; Elliott, S.; Richards, D. P.; Mathew, J. L.; Akl, E. A.; Kredo, T.; Motillal, A.; Baba, A.; Prebeg, M.; Relihan, J.; Scott, S. D.; Suvada, J.; Falavigna, M.; Klugar, M.; Lotfi, T.; Stevens, A.; Pottie, K.; Schünemann, H. J.
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IntroductionThe COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the publics (youth, parents, and adult populations) understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (herein referred to as the RecMap). Methods and AnalysisThis is a protocol for a multi-method study. We will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCT) in three populations to test alternative formats of presenting health recommendations: adults (21 years of age or older), parents (18 years or above and are a parent or legal guardian of a child under 18 years old), and youth (15 to 24 years old), with at least 240 participants in each population. The research will consist of a randomized online survey and an optional one-on-one interview. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. In each population group, the intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (herein referred to as Standard Language Version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the two recommendation formats. Each populations results will be analyzed separately. However, we are planning a meta-analysis of the results across populations, and will also explore potential interaction and subgroup effects within each population. At the end of each survey, participants will be invited to participate in a one-on-one, virtual semi-structured interview to explore their user experience and their learning preferences and future research. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. Iterative member checking, triangulation, interpretation, and saturation of themes will be sought to enhance reliability. Ethics and DisseminationThrough Clinical Trials Ontario (CTO), the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). All potential participants will be required to provide informed consent. The findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. Strengths and limitations of this studyO_LIWe are following a multi-method approach: randomized controlled trials and qualitative interviews. The qualitative results will supplement and help explain our quantitative findings. C_LIO_LIThis protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which enhances transparency and completeness. The trials use previously validated outcomes from similar trials. This will strengthen the credibility of our results. C_LIO_LIOur study is testing an optimized plain language recommendation format, which makes our intervention relevant to our stakeholder groups, and is recruiting internationally, which ensures the inclusion of a diverse population. Recruitment will take place online using social media, and data will be collected using an online survey. This allows for self-selection and limits accessibility to those who have no or limited digital access, which in turn limits generalizability. C_LIO_LIWhile the recommendations are offered in multiple languages through the RecMap, the study is only testing English plain language recommendation summaries. C_LI
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