Do summaries of evidence enable informed decision-making about COVID-19 and flu vaccination equitably across more and less disadvantaged groups? - Study protocol for a multi-center cluster RCT with ‘fact boxes’ in health and social care in Germany

Do summaries of evidence enable informed decision-making about COVID-19 and flu vaccination equitably across more and less disadvantaged groups? - Study protocol for a multi-center cluster RCT with ‘fact boxes’ in health and social care in Germany | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Do summaries of evidence enable informed decision-making about COVID-19 and flu vaccination equitably across more and less disadvantaged groups? - Study protocol for a multi-center cluster RCT with ‘fact boxes’ in health and social care in Germany Christin Ellermann, Nicolai Savaskan, Felix G. Rebitschek This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3401234/v3 This work is licensed under a CC BY 4.0 License Status: Posted Version 3 posted You are reading this latest preprint version Show more versions Abstract Introduction Summaries of the best available evidence on the benefits and harms of different treatment options support informed decision making of well-educated participants under controlled conditions. However, few studies have investigated how such formats support decision-making across different social groups. There is a risk that these evidence summaries will only help less disadvantaged people to make informed health decisions – possibly increasing the health equity gap. It is also unclear whether they support decision-making in the field at all. The aim of our study is to assess whether evidence summaries based on the fact box format can help people from different social groups make informed decisions about COVID-19 and influenza vaccination, and to investigate whether these fact boxes can help reduce inequities in health communication. Methods and analysis In a multicentre, cluster-randomised, controlled trial, health educators (HEs) from usual care (e.g. physicians) and outreach work (e.g. social services) in Germany will be randomised to provide either usual health communication plus an evidence summary (‘fact box’) or usual health communication. As part of their health education programme, HEs provide people who are about to make a decision about COVID-19 or flu vaccination with a flyer containing a link to an online study either with (intervention) or without (control) fact box on the reverse side. The flyer and online study will be available in Arabic, German, Turkish and Russian language. The primary outcome is informed vaccination intention, based on vaccination knowledge, attitudes, intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision making. Data analysis will initially be based on descriptive statistics as well as frequency distributions and histograms to identify outliers and missing data. We will use linear mixed models to analyse the influence of both individual (e.g. education status, health literacy) and cluster level factors (e.g. setting) and account for the expected cluster variability in realising usual health communication or the intervention. The statistical analysis plan includes the selection of appropriate measures of effect size and power calculation. Ethics and dissemination The study and its pre-studies have been reviewed and approved by the ethics committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022). We plan to disseminate our findings through publications in peer-reviewed journals, national and international conferences, and relevant working groups and networks, also targeting relevant community stakeholder. Trial registration: clinicaltrials.gov (NCT06076421) Health inequity informed decision making fact box evidence-based information risk communication Figures Figure 1 Figure 2 Strengths and limitations of this study Evidence summaries on the benefits and harms of COVID-19 and influenza vaccination have been developed with the participation of various stakeholders, including scientists from different disciplines, representatives of health authorities and outreach work, and lay people from different social backgrounds (mother tongues: Arabic, German, Russian, Turkish). The study design allows conclusions to be drawn about whether evidence summaries using the fact box format add value compared with conventional health education in usual health care and outreach work settings – and for different social groups. The study design allows health educators to determine how best to integrate it in their health education practice. We cannot control for differences in prior knowledge and selection of study participants, as health educators should decide who they want to approach and who not to approach to avoid losing trust. At present (September 2023), the German Standing Committee on Vaccination (STIKO) recommends an annual influenza vaccination or corona vaccination for anyone at increased risk of severe illness. This includes people aged 60 and over, pregnant women from the 2nd trimester, chronically ill people of all ages, and residents of old people's and nursing homes. This could have implications for the generalizability of the results to the younger population. Introduction Ensuring informed consent is considered an ethical principle for medical research involving human subjects and is enshrined in the Declaration of Helsinki 1 . The basis of informed consent is the patient's informed decision about whether he or she wants to undergo a medical procedure, prefers another one, or refuses it 2 . Informed decisions for or against medical interventions require evidence-based health information that provides comprehensible and transparent information about the benefits and harms of all treatment options 3 4 . However, information often fails to meet evidence-based and risk communication criteria 5-7 , which means that not all people facing a health decision are able to make a decision based on evidence-based knowledge and in line with their personal preferences (informed choice) 3 . In addition, despite their general effectiveness, public health interventions, e.g. public health messaging, can lead to the disadvantage of certain social groups ( intervention generated inequalities ) if equal access to them is not ensured 8-10 . What are possible barriers? Known social determinants of health work to the disadvantage of certain groups 10 11 . They are also a key determinants of health literacy 12 : individual differences in the ability to search for, understand, evaluate, critical assess and use health information to make informed choices 13 14 . In addition to socio-demographic factors such as education, income or older age, it is not uncommon for language barriers to impede access to health-related information 15 . Thus, multiple communication channels, translations and initiatives to bring health information to those facing health decisions are required. Often health information consists only of words, although there is evidence that visual representations and images - particularly icons with few words - may improve knowledge/understanding, especially in populations with low health literacy 16 . Furthermore, text-heavy health information (e.g. package leaflets) is often written at a higher reading level, making it inaccessible to people with lower health literacy 16 . As a result, uninformed decisions are made, that is, decisions are made without sufficient knowledge of the benefits and harms and of treatment options and alternatives, which are not consistent with attitudes for or against the medical treatment 3 . Why is this a problem? Overall, uninformed decisions are more likely to lead to decisional regret, reduced ability to use medicines appropriately, poorer health outcomes and let people less likely opt for a follow-up treatment (e.g., booster vaccinations) 17 . Unfortunately, disadvantaged groups less often make informed decisions and are more likely to experience higher decision regret than advantaged groups 10 18 . A representative observational study from 2015 found that among women invited to the nation-wide mammography screening programme in Germany for the first time, women with low and medium levels of education were more likely to make an uninformed decision than high level educated women. Women with an immigrant background were only slightly more likely to make an uninformed decision than women without an immigrant background. However, women with a Turkish immigrant background were more likely to make an uninformed choice than women with no immigrant background 18 . In 2019, these differences were still found in terms of knowledge, which is central to informed decision making. Women with less education and an immigrant background were more likely to have insufficient knowledge about the benefits and possible harms of mammography screening. Sufficient knowledge was again associated with higher education and was lowest among Turkish women 19 . To reduce inequities and achieve high quality health care, structures and approaches must enable disadvantaged people to access and navigate the health system to effectively manage their health and care 20 . Evidence-based health information (EBHI) and decision aids (DAs) are key components for improving health care by enabling more people to make informed and shared decisions 21 . Taking into account the best evidence currently available, they present information on the course and effects of diseases and on the benefits and harms of medical interventions (including early detection, diagnosis and treatment) in a transparent and understandable manner, based on patient-relevant outcomes 22 . In contrast to DAs, EBHI often has a broader focus and is not directly aimed at preference-based decision making. DAs use tools (value clarification tools) to help identify these 23 . The benefits of DAs over standard care (no evidence-based information or no intervention) are already clear. In a Cochrane review 23 the effect of DAs on people who are about to make a decision for or against a medical intervention (e.g. surgery, cancer screening, drug treatment) was investigated. Different formats of DAs (including written, web-based, video) in different settings were analysed in the 105 randomized controlled trials included. The review found that DAs have a positive effect on knowledge, information and perception of values, and that decision makers are likely to take a more active role in the decision-making process and have a better perception of risk 23 . However, despite their overall effectiveness, there is a risk that only certain groups of the population will benefit from EBHI and DAs. Because although they are “target group oriented”, the factors that lead to inequity in terms of shared and informed decision-making have not yet been sufficiently taken into account in their development process 10 24 . For example, there are many patient-oriented materials written at an advanced level, which makes the materials less accessible to people with reading difficulties, lower education, health literacy or socioeconomic status (SES) 16 25 26 . In general, only few studies have looked specifically at the impact of shared decision making (SDM) or informed decision making in groups that are more likely to have communication barriers due to their racial or ethnic background and/or level of education 24 27 . In a systematic review with meta-analysis of randomized controlled trials, the authors 27 examined whether patient DAs and other SDM interventions improve outcomes or reduce health inequalities in socially disadvantaged populations. The authors found that SDM interventions for disadvantaged populations improve for example knowledge and informed choice. However, they could not determine which interventions were most effective in promoting SDM and whether there are key features from which all or the disadvantaged can benefit. Further, the authors state that there is a lack of evidence on the effectiveness of decision-making interventions for disadvantaged people compared to non-disadvantaged people. Nevertheless, they conclude that their research suggests that targeted interventions - interventions that are tailored to a very specific group (e.g. people with limited health literacy) - might narrow the gap in care between disadvantaged and non-disadvantaged populations 28 . Preliminary results from an ongoing systematic review by the authors of this manuscript 29 , which is registered through PROSPERO (CRD42018103456), also indicate that only few studies have examined the extent to which disadvantaged groups have been considered in evaluating (evidence-based) health information and decision aids in randomized controlled trials, and whether and to what extent inequity is reduced. Another review from 2016 21 looked at the extent to which disadvantaged groups were considered in the development and evaluation of cancer screening and treatment decision aids in trials in the USA. 23 of the 39 included studies evaluated decision aids that considered socially disadvantaged groups. Only 17 trials involved disadvantaged people in the development of the decision aids. The authors note that a number of issues and medical interventions that would be relevant to specific disadvantaged groups because of their higher morbidity and mortality are not yet addressed in decision aids in the US. In addition, disadvantaged groups are more likely to be unaware of treatment alternatives, such as watchful waiting or not participating in screening, and more likely to have the misconception that decision aids are designed to increase screening participation rather than to support decision making 21 . The aim of our study is to assess whether evidence-based summaries using the fact box format can facilitate informed decisions for laypeople from different social backgrounds. Further, we aim at exploring whether these evidence-based fact boxes contribute to reducing inequity in health care by improving shared decision-making. Fact boxes provide a tabular or graphical overview of the benefits and harms of medical options through transparent risk communication 30 . They are used to inform a range of health decisions, such as medical treatments, cancer screening and vaccinations. By reducing complexity and balancing evidence, they aim to promote informed decisions rather than predetermined behavioral change 31 . As such, they go hand in hand with current Western health standards and ethical principles that oppose persuasion or nudging, which can collide with informed choice and pose the risk of undermining the trustworthiness and credibility of the communicator and vaccinator 31 32 . Fact boxes are developed according to the recommendations of the German guideline evidence-based health information (19, 30). This includes development and evaluation according to the Medical Research Council (MRC) guideline Development and Evaluation of Complex Interventions 33 . They are developed in a multi-stage process, and their individual elements are tested and adapted, where possible 34 . Several experiments have shown that fact boxes support informed decisions by improving for example risk perception, short-term knowledge/knowledge recall, comprehension 31 35-38 . At present it is unclear whether fact boxes can be an effective format outside (online) laboratory conditions. Further, fact boxes have been tested with the lay public, but only three studies analysed its effect by vulnerability factors. A recent randomised controlled pilot study of three numerical presentation formats of fact boxes to laypeople found indications that the acquisition of verbatim knowledge was lower among participants with lower than among participants with higher levels of education for the formats percentages and graphic chart. However, there were no differences in gist knowledge and the frequency format showed comparable results between the two levels of education 38 . In another study examining the effect of COVID-19 vaccine fact boxes on vaccination knowledge and assessment of the benefit-harm ratio of mRNA vaccination, the effect was greater among people with higher education or income than among people with lower education 31 . In a study of whether fact boxes or text-only formats on antibiotics for ear infections or flu vaccines with the same content led to better understanding of the potential harms and benefits of each treatment option, fact boxes appeared to improve understanding at all levels of numeracy 37 . Another aim of our study is to find out to what extent evidence-based summaries using the fact box format can be integrated into the communication of health educators (e.g. doctors) in standard care and outreach settings, and what added value they have in supporting SDM compared with conventional information or no information at all. SDM means that the doctor and the patient make decisions about health care together in an interactive and equal process, provided that health professionals make available their knowledge, experience and the latest scientific evidence, but also that patients are fully informed and involved in all important aspects of medical decision-making 39 40 . While SDM interventions have varying effects on patient-relevant outcomes such as mortality, morbidity and health-related quality of life the grade of informed choice can be considered a baseline outcome of SDM 2 . Although there is evidence for the benefits of SDM interventions (e.g. decision aids, DAs) in improving people's knowledge of risks and benefits, feeling informed, and clarity about their values in a variety of decision-making contexts 23 , and thus for their use in clinical practice, the real-world effects of implementing EBGI as an SDM intervention are still unclear. What are the prerequisites, facilitators and barriers for people to benefit from them in practice? What are the prerequisites and barriers for clinicians to implement them? Already in 2013, the authors of a review called for more research into the extent to which EBHI and DAs are effective in medical care, as they are not yet widely used in medical practice 41 . Moreover, in 2019 only 21% of DAs were introduced after trials and further 7% were part of implementation studies. Barriers included outdated evidence in DAs and disagreement among clinicians about the use of DAs 42 . This paper reports on the study protocol of an implementation study and equity evaluation of evidence-based summaries on COVID-19 and influenza vaccination in different health education settings in Germany using fact box formats. The trial was prospectively registered on clinicaltrials.gov (NCT06076421). Methods and analysis The protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guideline 43 to improve the transparency and quality of reporting on study protocols of randomized controlled trials, and CONSORT (Consolidated Standards of Reporting Trials) Equity Reporting Guideline 2017 44 , which aims to improve the reporting of the impact of interventions on health equity in randomized controlled trials, for trials assessing changes in effect measures, and for trials focusing on disadvantaged populations 44 . Disadvantaged populations In our study, we will focus on the differences in intervention effects between groups of people with disadvantaged factors that are associated with unequal living and working conditions and poorer health outcomes. Some of these factors are unavoidable (e.g. biological variation) or should not be changed for ethical reasons (free choice), while others are avoidable (e.g. factors beyond an individual's control) and cause health inequity 8 . Inequitable factors are defined by the PROGRESS Plus framework as: place of residence, race/ethnicity/culture/language, occupation, sex/gender, religion, education, socioeconomic status and social capital 8 . Ignoring these factors can exacerbate health inequalities, even if public health interventions (e.g., education, communication and information) are generally effective 9 . This means that an intervention will be more successful in improving health (care) for instance in groups at lower risk (advantaged people) than in groups at higher risk of disease burden (disadvantaged people). In our study, we will examine the impact of the intervention, taking into account the following factors: education, subjective socio-economic status (SSS), health literacy as well as mother tongue (German, Arabic, Turkish, Russian, other) and language (subjective native reading literacy, perception of own German language skills). Accordingly, we will define people as being disadvantaged upon the following criteria: They have a low educational attainment (without a degree or a degree equivalent to a maximum of nine years at school (Haupt-/Volksschule)), Rate their social position as low (SSS of 1-4), Have problematic or inadequate health literacy (see 45 for operationalisation), They rate their ability to read in their mother tongue as rather poor or very poor, If their mother tongue is not German, and they rate their knowledge of German as poor or very poor. Main research question Do disadvantaged people (as defined above) benefit to the same extent as non-disadvantaged people in terms of informed and shared decision-making from receiving COVID-19 and influenza vaccination fact boxes as opposed to standard vaccination communication in medical practices and outreach work (field settings)? Research questions (RQ) and main hypotheses (HYP) RQ1 Is the use of fact boxes more effective than standard vaccine communication (control condition) in the field? Primary HYP a) We hypothesise that implementation of fact boxes in medical practices and outreach work will lead to higher vaccination knowledge compared to standard vaccine communication. A number of studies have shown that fact boxes improve short-term knowledge and recall and comprehension 31 35-38 , enabling people to weigh the benefits and harms of an intervention, and b) Because knowledge is a component of informed choice and attitudes about vaccines’ benefit-harm ratios are not biased by the presentation of a vaccine fact box 31 , we hypothesise further that compared to standard vaccine communication, the implementation of fact boxes in medical practices and outreach work will lead to more vaccination intentions that are in line with attitudes and vaccination knowledge (informed vaccination intentions; see the section outcomes for operationalisation). Secondary HYP a) We hypothesise that the implementation of fact boxes will improve risk perception compared to standard vaccine communication, as a study found that studying the fact boxes improved accuracy of numerical COVID-19 risk perception compared to the control presentation (ANOVA interaction effect: F (1,357) = 10.05, p = .002, η p 2 = 0.03) without affecting vaccination intentions 31 . b) We hypothesise that implementation of fact boxes will increase patient involvement in medical decision making compared to standard vaccine communication. This hypothesis is based on data from a Cochrane Review that evidence-based tools aimed at enabling informed decision making have the potential to increase patient involvement 23 . c) We suggest that implementation of fact boxes do decrease decisional conflict , as a study 36 found that, compared with controls, participants who received fact boxes experienced less decisional conflict about antibiotic use (unstandardised beta (b) = -8.35, 95% confidence interval (CI), -12.43, -4.28) and artificial hydration (b = -6.02, 95% CI, -9.84, -2.20) at one month compared with baseline. RQ2 Are fact boxes as effective for people with disadvantaging factors as for those without factors associated with disadvantages? Primary HYP We will analyse the effect of fact boxes compared to usual care among people with more and less advantaging factors (e.g., in terms of education), taking into account known baseline differences between advantaged and disadvantaged people. The added value of evidence-based tools (e.g., DAs) over traditional (non-evidence-based or usual) health care and interventions tailored to specific target groups (e.g. people with low levels of education) has already been demonstrated 23 27 . We therefore expect that the gap will narrow between more and less advantaged people in terms of outcomes relevant for informed vaccination decisions. We hypothesise that implementation of fact boxes will lead to a greater alignment of knowledge, informed vaccination intentions, and accuracy of risk perception between: a) People with low and high education through fact boxes compared to usual care. b) People with problematic or inadequate and excellent or sufficient level of health literacy through fact boxes compared to usual care. c) Non-native (Arabic, Turkish and Russian speaking participants, only with low German skills) and native German speakers (including non-native speakers with high German skills) through fact boxes compared to usual care, because we not only provide information in the native language, but also tested it with these target groups. d) People with low and high reading literacy in different languages compared to usual care because fact boxes are a complexity-reduced format of health information and we tried to address accessibility through pilot testing with different groups. RQ3 Does the use of fact boxes in outreach work promote more shared and informed decision-making than in regular health care settings? HYP a) We assume that fact boxes more likely lead to more informed vaccination intentions and shared decisions in outreach work than in regular health care settings. In order to respond to the needs of especially people with disadvantaging factors and to reach them in a more effective way, community-based health services are becoming more and more important 46 . The use of non-primary care professionals (e.g. social workers, community nurses or community health workers), who can build trust and provide psychoeducational interventions has been shown to be effective in providing health knowledge, improving health care, changing health behaviour and improving health status 46 47 . Explorative analyses a) We will analyse the effect of fact boxes on knowledge, vaccination intentions, accuracy of risk perception (see Outcomes for operationalisation) between people with low and medium or high SSS through fact boxes compared to usual care. b) We will analyse the effect of fact boxes on vaccination intentions, knowledge, risk perception, patient involvement, and decisional conflict among people with migration-related indicators (e.g., residential status, length of stay in Germany; see Outcomes for operationalisation) compared to usual care, controlling for other factors describing the social situation (e.g., education, health literacy). This may be because people with immigrant history are less receptive to information from authorities or health providers in Germany, the host country (even if it is translated), because they have less trust in them 48 . But also because traditional media campaigns or formats that work for the majority of the host population may not be the right channel for communicating with immigrant groups 48 . An increased length of stay is associated with a greater orientation towards the host society and thus a change in lifestyle habits, health perceptions and health behaviour 49 50 . On the other hand, a shorter duration of stay, as well as not having German citizenship or a residence permit, may be associated with higher barriers to access to the German health care system (e.g. due to lack of social and health insurance or more difficult access to (multilingual) health information) 49 . Participants Inclusion and Exclusion Study participants in general Study participants are adults of legal age with current residence in Germany and who speak German, Russian, Turkish or Arabic. The trial is open to people who are currently facing a decision about vaccination for themselves or a family member (e.g. caring relatives). All participants must confirm their informed consent online to take part in our study. Patients who do not speak any of the four languages and who do not give informed consent will be excluded. Design and Setting We will conduct a cluster randomized controlled trial with a 2x2-cross-sectional design with the between-subjects factors: format (usual health communication plus fact box vs. usual health communication), health educator (cluster unit medical practice vs. cluster unit outreach work settings) (see Figure 1 ) taking into account various factors of disadvantage (e.g., low education). Health professionals in particular are still first-contact for people seeking health information in Germany 51 . Therefore, the cluster units will include all those who communicate about health issues (e.g. doctors and other health professionals, community health workers) in Germany, as well as settings where traditional communication about disease prevention takes place (e.g. doctors' offices) and where communication about health issues is carried out in the context of outreach work (mothers' and fathers' cafés, intercultural meeting places) if more than one person per unit participates. We will refer to these units as health educators. Key requirement for involving health educators is that they provide information on health-related topics and have access to potential study participants. Furthermore, informed written consent is a prerequisite. Health educator recruitment To reach health educators, we will contact German public health authorities and ask them to distribute the study call to all kind of health educators in their respective areas of responsibility (districts). We will use professional contacts to involve health authorities for recruiting. In addition, we will use other existing structures, such as the German general practitioners' association and other relevant networks, to reach the respective health educators. All health educators will first be given general information about the study and asked for their consent. Health educators who express interest in participating in the study via mail or telephone will receive a flyer that includes a brief description of the study, a QR code and, a link to an online survey to share with those who are about to make a vaccination decision. Health educators will not be remunerated, as providing information about the benefits and risks of vaccination - at least for health care providers - is part of their professional and ethical duties. Our study will be conducted in close cooperation with the health departments in Germany, which provides access to the planned cluster settings and the target groups. The close cooperation with the health departments and those involved in the implementation of our study will help us to increase the success of our research. In addition, through the recruitment of health educators by health authorities, we hope to reach particularly disadvantaged people who would otherwise be difficult to reach. We will not involve these target groups, as they were already involved in the pre-studies aiming at developing and improving the intervention formats according to their information needs and preferences (see intervention ). Participant recruitment Health educators will distribute the study flyer to potential participants as part of or after the health communication. Health educators are asked to inform all potential participants about the study. People who are approached by their health educators can decide for themselves whether they would like to participate in the study by using the link or the QR code on the flyer. On request, health educators can also receive a paper copy of the questionnaire to give to their patients. Health educators will not know if someone is participating unless participants tell them themselves. Thus, those who have been approached will not suffer any negative consequences if they decide not to take part in the study. Participants who are interested in taking part in the study will receive detailed information about the study and about data protection in their preferred language via the link or the QR code and can give their consent online. In order to make the study as accessible as possible, information about the study and about data protection will be provided in plain language. Those who decide to take part in our study will complete an online survey, providing information on their vaccination status, attitudes towards vaccination, knowledge of the benefits and harms of vaccination and intentions to vaccinate, as well as socio-demographic information. As some of the tools we use to collect results are already established, low-barrier accessibility cannot be guaranteed for all questions. However, there will be a read-aloud function for the questionnaire in all languages. After completing the initial online survey (T1), participants will have the opportunity to provide their email address for a follow-up survey four weeks later (T2). At the end of this second survey, participants will be rewarded with a voucher worth 14 Euro. How do we plan to reach disadvantaged groups? When we recruit health educators, we make it clear that we want to reach people from different linguistic and social backgrounds. They will therefore be sensitised to approach these groups of people about taking part in the study and to provide them with the flyer. Through the health educators and the different cluster units that also do outreach work, we hope to reach people with different disadvantages. Intervention Health educators in the intervention group will receive a flyer with a brief description of the study, a QR code and a link to an online survey, including a fact box on the reverse side about COVID-19 or the flu vaccine for their age group in Arabic, German, Russian or Turkish to reach people whose spoken language is one of these. Fact boxes will be available either in tabular form for influenza or as a visualisation for COVID-19, each in all languages and for both age groups. Further, health educators will be provided with additional information about evidence-based fact boxes and how they could use them as part of a telephone information service. COVID-19 and flu vaccine fact boxes in a tabular and visualised format are available for two different age groups each: COVID-19 vaccination for people aged 18 to 59 and over 60, influenza vaccination for people aged 16 to 64 and over 65. Health educators are free to decide if and how to use the fact boxes, whether during, before or after vaccination education, and who to target. Control condition Health educators in the control condition will also receive the flyer with a brief description of the study, a QR code and a link to the online study to distribute to potential study participants, but without the fact box on the back. Patient and public involvement In several pre-studies fact boxes on COVID-19 and influenza vaccination underwent a development process in order to meet the information needs and requirements of people from the general population. The process included feedback from various public health stakeholders on a COVID-19 fact box implemented in January 2021 by the Robert Koch Institute (RKI), the German national health authority. Further, identification of information needs and requirements of the population in Germany based on secondary data analyses and results from piloting of COVID-19 fact boxes in population-wide surveys with N=1,942 to N=6,056 respondents in Germany were incorporated in updates. The data basis and individual studies have been described in detail elsewhere 31 . The Influenza vaccination fact box was updated in 2021 based on current evidence and is available on the Harding Center website for older people (65 years and older) and for people aged 16 to 65. During cognitive interviews 52 , simplified COVID-19 and Influenza vaccination fact boxes first were tested for comprehensibility with German-speaking participants and then adapted. Visualised COVID-19 fact boxes were then tested with Arabic-, Turkish- and Russian-speaking participants from disadvantaged neighbourhoods in Berlin in their respective mother tongues. The results of these language- and education-sensitive fact boxes were transferred to the tabular Covid-19 fact boxes and the flu vaccination fact boxes. A visualised flu fact box is currently being piloted by the University of Erfurt with German-speaking lay people with low numeracy. The study design, outcomes, strategies for reaching vulnerable target groups and the questionnaire were discussed with various expert groups (e.g. scientists from different disciplines, representatives of health authorities and outreach work). Randomization and allocation concealment First, health educators will be randomized, either at the individual level or at the institutional level if there is more than one health educator per setting. Health educators who express interest in participating in the study will be assigned a study ID number and randomly assigned to one of the two study conditions: 1) usual care plus fact box (intervention) or 2) no information/usual care (control) (see Figur e 2) by an independent researcher using computer-generated random numbers in a 1:1 ratio. Health educators will then distribute their assigned flyer format to individuals who are about to make a vaccination decision about the COVID-19 or the influenza vaccine, taking into account their reference group (age group). For this purpose, the health educators will be provided with a package containing the relevant flyers. The link/QR code will bring them to an online survey that accounts for the respective condition (intervention or control), setting in which they received the flyer (health care or outreach work), language (Arabic, German, Turkish, Russian), disease addressed in the counselling session (influenza or COVID-19), and age group (aged below 65 vs. aged over 65). Potential study participants will receive only one flyer with the respective information. If participants in the intervention group receive the wrong Flyer (e.g., wrong age group or disease) they will be asked questions about the fact box that led them to the study. Health educators and study participants will not know which study condition they belong to. Health educators in the control group will also have the opportunity to receive the fact boxes for their health communication post-trial. Blinding Health educators will only be informed about the aim of the study but not about being part of an intervention or control group. Awareness that a group of health educators are receiving information and that the study is about finding out what impact this has on the informed decision making of those being educated might alternatively lead them to adapt their health education. Accordingly, the study participants are also only informed about the aim of the study, but not about the condition to which they, respectively their health educator, have been assigned. Health educators will be assigned by a person independent of the study, which means that the assignment will be blinded. The data analyst will also be blinded. Outcomes Study participants Socio-demographic information and outcomes will be collected after people receive the flyer from their health educator and access the study link or QR code. As the study is voluntary and those who approach people do not know who among those approached will participate in the study, we will not be able to control who participates in the study and we will not be able to follow up with those approached. All information will be collected at the time of the first survey (T1), as participation in the second survey (T2) four weeks after the initial survey is also voluntary (see Figure 2). Primary outcomes The primary endpoints are knowledge and informed vaccination intention. Knowledge will be assessed by 10 items: five items on basic knowledge of the disease (e.g. how is Corona or the flu contracted and what are the possible baseline risks) and uncertainty (e.g. quality of evidence), each with 4 possible answers, of which only one is correct. A further five questions that can only be answered through the fact box, including one question on the benefits of vaccination gist and three questions on the benefits and harms of vaccination verbatim. Responses will be graded according to the best available evidence in July 2023. Informed vaccination intentions will be operationalised on the basis of the multidimensional construct of informed choice by Marteau et al. 2001 3 . We will measure informed vaccination intention based on vaccination knowledge gained from education with fact boxes compared to standard education without fact boxes, as well as a person's attitudes and vaccination intentions. Knowledge will be measured as described above. Attitudes will be measured using an 11-point Likert scale that captures the personal assessment of the balance between the potential benefits and risks of the respective vaccine 31 . Vaccination intention will be measured by asking whether participants would have themselves or their relatives vaccinated at the next opportunity, on a scale of 1-5 (Definitely yes, probably yes, probably not, definitely not, I cannot yet say / am still undecided). Vaccination decision will be assessed at T2 by asking whether they (or their relatives) have been vaccinated since the last survey (T1). Subjects will be classified as having made an informed intention to vaccinate if they (a) score higher than 6 out of 10 on the knowledge scale (sum score), attitude is equal or higher (>5/10) than the midpoint of the 11-point Likert scale and vaccination intention or decision is 1 or 2, or report having been vaccinated or if they (b) score higher than 6 out of 10 on the knowledge scale (sum score), attitude is lower than the midpoint of the 11-point Likert scale (<5/10) and vaccination intention is 3 or 4, or people have not had a vaccination. Participants who fail to meet either set of criteria will be classified as not meeting the criteria for informed vaccination intention. Secondary outcome measures Risk perception will be measured by using a frequency format (Please imagine 10 people like yourself: How many of them will be re-infected with COVID-19 after a previous coronavirus infection if they come into contact with a person who is infected with the coronavirus variant XBB.1.5?; How many will contract influenza in a year if the virus is widespread?): Correct responses (reflected the best available evidence, which can be found in the fact boxes together with the medical references 31 . The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) screening test 53 will be used to measure decisional conflict (if yes: 1, if no: 0; a score of < 4 is a positive result for decisional conflict). Patient involvement in decision making will be measured with the 9-item Shared Decision Making Questionnaire (SDM-Q-9) 39 . Participant characteristics and socio-demographic information For descriptive purposes, we will also collect the following participant characteristics and socio-demographic information from study participants: We will assess health literacy using the established and validated HLS19-Q12 45 , a 12-item short form questionnaire of the HLS19-Q47 for measuring comprehensive, general health literacy (HL) in general adult populations. It is already available in German, Turkish, Arabic and Russian language. We will collect socio-demographic information like age, gender, educational attainment, subjective socioeconomic status, as well as information about the migration history and in which language the conversation about the vaccination took place. Subjective socioeconomic status (SSS) will be assessed by using the MacArthur Scale of Subjective Social status, which measures the subjective perception of social position within society on a 10-point scale 54 (with SSS low: 1-4, middle: 5-6, high: 7-10). In addition to indicators describing the social situation, we collect information about migration history with a reduced scope of the minimum set according to the recommendations for the collection and analysis of migration-related determinants in public health research 49 55 56 , by asking about in which country a person and his/her parents were born (non-migrant vs. first or second generation migrants), nationality, residential status (residence permit: yes or no) as well as mother tongue (Arabic, German, Russian, Turkish, other), the year of immigration to Germany , and how they rate their reading ability in their mother tongue (very good, rather good, rather poor, very poor). Study participants will be also asked whether the fact box was used as part of the counselling process and how they judge it. Health educators Pre-intervention (T0) health educators will be asked about their demographics (age, gender, mother tongue), the type of health education setting (doctor's office or outreach work (alone or in a community setting/ group practice)) and the number of vaccinations per person seen in the 4 weeks before intervention starts (see Figure 2). They will be asked again about the number of vaccinations per person seen in the 4 weeks from start of the intervention (T1). Health educators in the intervention group will also be asked how they used the fact boxes (during, before or after vaccination communication) and about involving patients from their perspective (SDM-Q-Doc) 57 . Sample size We aim to demonstrate moderately large main effects (equal to Cohen’s d = 0.50) of the study intervention on informed intentions (10% expected in usual care) and a knowledge sum score (equal to proportion of correct responses; with expected variance of 0.20). Taking into account a cluster correlation coefficient (ICC=0.10) common for primary care studies with patient endpoints 58 , we will target three health educators (e.g., doctors' offices) per study arm with 40 patients/clients per health educator 59 . So, 240 participants in each subgroup undergoing the same analysis are required (Supplementary Table S1). Furthermore, to demonstrate small-to-moderate interaction effects (equal to Cohen’s d = 0.375) of the study intervention in respective settings on informed intentions and knowledge, we have to target instead seven health educators per study arm with 40 patients/clients per health educator (N=560). In total, we aim at 800 participants because the proportion of subgroup members cannot be predicted, and we cannot rule out that interaction effects in the field are smaller than expected from experimental evidence (e.g., d = 0.20 would call for up to 20 health educators per study arm). Further details on the assumptions underlying the sample size calculations in the power calculation with respect to the critical hypotheses and outcomes are provided in Table S1 in the supplementary section. Data collection and management After giving their online consent, participants will complete an online survey via SoSciSurvey. The survey (T1) is completely anonymous for the study participants. Personal data (e-mail address) will be only collected if there is interest in participating in the follow-up survey (T2) and in the renumeration, for which also first name and surname will be recorded. For this purpose, a computer-generated random ID will be generated by someone independent of the study, which is stored with the unblinding list separately from the collected personal and survey data at the Harding Center (HC) on password-protected computers and is only accessible to researchers of the HC until the end of the data collection. The pre- and post-survey of the health educators will be conducted under pseudonym. The random generated ID, personal and survey data will be separated from the contact information immediately after completion of the post-survey, and the de-blinding list is also kept until the end of the data collection. All relevant data will be provided in the manuscript and supporting information or made available in a public repository after completion of the study. Statistical analysis Data analysis will initially be based on descriptive statistics as well as frequency distributions and histograms to identify outliers and missing data. Baseline data of the study arms will be compared to see if the distribution is balanced between study sites/the clusters. SPSS will be used to conduct all analyses. All participants will be asked to indicate at T1 whether they received the intervention to allow for intention-to-treat (ITT) and as-treat analyses. Statistical methods for analysing primary and secondary outcomes. We use linear mixed models to analyse the influence of both individual (e.g. education status, health literacy) and cluster level factors (e.g. setting) and account for the expected cluster variability in realising usual care or the intervention. Regarding the primary and secondary hypotheses of RQ1: Main effects of presentation format on vaccination knowledge, the informed vaccination intention (higher for the fact box), accuracy of risk perception (more accurate for the fact box), patient involvement (more involvement if the fact box is presented), and decisional conflict (decrease with the fact box). In a secondary analysis, we restrict the main effect analysis to participants who reported that they had received the flyer with the study link in a counselling session when a potential vaccination had been discussed. This would examine the specific role of the intervention in health counselling. Regarding the primary hypotheses of RQ2: Main effects of presentation format on the vaccination intention (higher for the fact box), knowledge (higher for the fact box), and accuracy of risk perception (more accurate for the fact box) in each of the following disadvantaged groups: low educated people, people with problematic or inadequate level of health literacy, people with low reading literacy, and non-native German speakers with low German skills). Furthermore, to show fact-box-driven alignment of informed vaccination intentions, knowledge, and accuracy of risk perception between more and less disadvantaged groups, we analyse four interaction effects of presentation format with education, health literacy, German language skills, and reading literacy in mother tongue. We expect that differences between respective groups remain in the usual condition only. In a secondary analysis, we repeat the interaction analysis with a dummy-coded variable representing more and less disadvantaged groups (at least low educated, with problematic or inadequate level of health literacy, with low reading literacy, or being non-native German speaker with low German skills), according to which differences between more and less disadvantaged groups remain in the usual condition only. Under control of the co-variate health literacy: main effects of presentation format on the vaccination intention (higher for the fact box), knowledge (higher for the fact box), and accuracy of risk perception (more accurate for the fact box) in each of the subgroups of low educated, people with low subjective socioeconomic status (SSS), people with low reading literacy, and non-native German speakers with low German skills). Interaction effect of presentation format and mother tongue on knowledge score, according to which non-native German participants benefit from the fact box over proportion; under control of health literacy, subjective reading skills and education. Regarding the primary hypotheses of RQ3: Interaction effects of presentation format and setting on informed intentions and patient involvement, according to which the fact box effect is more effective in outreach work in this regard. Missing data We will record the number of flyer distributed per cluster (see Figure 2 ). As potential participants approached can participate in the trial voluntarily, anonymously and without the knowledge of their health educator, we will not be able to send a reminder and record the response rate accurately. However, we will record the numbers of the total randomised sample for each group, as well as the reasons for exclusion. In order to avoid missing data in the first survey (T1), it is compulsory for participants to answer all questions. As participation in the follow-up survey is voluntary, we will record the number of drop-outs from the first to the second survey. Ethics approval and dissemantion The evaluation study and its pre-studies have been reviewed and approved by the ethics committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022). The study will be conducted in accordance with the Declaration of Helsinki. All subjects must agree to participate in the study. Written informed consent will be obtained by the health educators prior to randomisation. Informed consent will be obtained online from study participants and/or their legal guardians after opening the QR code/link to the study on the flyer and all study and ethical information has been provided. Any changes to the protocol that affect the conduct of the trial, as well as changes to the study design, patient population, sample size, primary outcomes, or statistical analysis plan, will be made transparent in the trial registration and final report. We plan to disseminate our findings through publications in peer-reviewed journals, national and international conferences, and relevant working groups and networks (e.g. German Network for Evidence-Based Medicine, German Society for Public Health and Population Medicine), also targeting relevant community stakeholder. Relevance The existing evidence on health inequalities and the lack of evaluation of evidence-based health information on health disparities demonstrate the need for research in this area. The aim of our study is to fill this gap and to evaluate the development of evidence summaries using the fact box format designed with an equity lens, outside of an experimental setting. The results will help determine if and how fact boxes can be used to improve health care in and outside of traditional primary care structures, especially for disadvantaged groups, and will thus provide valuable insights into advancing health care equity. Abbreviations COVID-19: Coronavirus Disease 2019 DA: Decision aid EBHI: Evidence-based health information HC: Harding Center HE: Health educators HL: Health literacy ITT: Intention-to-treat MRC: Medical research council RKI : Robert Koch-Institute SDM: Shared decision making SES: Socioeconomic status SSS: Subjective socioeconomic status References 1. 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Declarations Authors' contributions CE and FGR designed the study. FGR has developed the statistical analysis plan. All authors conceptualised and designed the protocol. CE wrote the first draft of the manuscript and made the revisions. NS and FGR contributed to and critically revised the manuscript. All authors finally approved the manuscript. Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Availability of data and materials Not applicable as no data has been generated or analysed yet. Competing interests The authors report no conflicts of interest in the conduct and reporting of this study. Acknowledgements We would like to thank the Robert Koch Institute and Christoph Wilhelm for the initial development and further development of the materials that we will use in the study. We would also like to thank those who provided valuable feedback on early drafts of the fact boxes, and Marike Pohlmann from the University of Erfurt, who tested the visualised flu fact box with German-speaking people with low numeracy skills as part of her master's thesis. And we would like to thank Prof. Dr. Rahim Hajji from the University of Applied Sciences Magdeburg-Stendal for his constructive feedback on the study design and the operationalisation of vulnerability characteristics. We would also like to thank Tobias Prey from the Berlin Mitte District Office, Department of Quality Development, Planning and Coordination of the Public Health Service for his support in recruiting health educators. Additional Declarations No competing interests reported. Supplementary Files TableS1.docx S1 Table. Assumptions underlying sample size calculations in power calculation with regard to critical hypotheses and outcomes. 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Rebitschek","email":"","orcid":"https://orcid.org/0000-0001-7653-8278","institution":"Harding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam; Max Planck Institute for Human Development, Berlin, Germany","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Felix","middleName":"G.","lastName":"Rebitschek","suffix":""}],"badges":[],"createdAt":"2023-09-30 17:14:13","currentVersionCode":3,"declarations":"","doi":"10.21203/rs.3.rs-3401234/v3","doiUrl":"https://doi.org/10.21203/rs.3.rs-3401234/v3","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":47211504,"identity":"354551ae-251c-4895-b016-dc5145d383af","added_by":"auto","created_at":"2023-11-28 16:39:53","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":396927,"visible":true,"origin":"","legend":"\u003cp\u003eStudy design\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3401234/v3/7a35fe77ee690cc6a034079e.png"},{"id":47211506,"identity":"2fa8d289-10a5-4c6b-b65c-db07e83305a9","added_by":"auto","created_at":"2023-11-28 16:39:54","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":231451,"visible":true,"origin":"","legend":"\u003cp\u003eStudy allocation and data collection\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-3401234/v3/554cb7d0035afbbc79e2f1f8.png"},{"id":47212225,"identity":"3564f340-8978-4dbf-9998-11ae933b1f68","added_by":"auto","created_at":"2023-11-28 16:47:54","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1226648,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3401234/v3/4ff881a1-1893-47ef-9dc0-d305c0283ed3.pdf"},{"id":47211505,"identity":"6809c767-4908-4eb8-befe-2616e800d5f1","added_by":"auto","created_at":"2023-11-28 16:39:54","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":16487,"visible":true,"origin":"","legend":"\u003cp\u003eS1 Table. Assumptions underlying sample size calculations in power calculation with regard to critical hypotheses and outcomes.\u003c/p\u003e","description":"","filename":"TableS1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3401234/v3/fcf69ff71d12261f34747b56.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eDo summaries of evidence enable informed decision-making about COVID-19 and flu vaccination equitably across more and less disadvantaged groups? - Study protocol for a multi-center cluster RCT with ‘fact boxes’ in health and social care in Germany\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Strengths and limitations of this study","content":"\u003cul\u003e\n \u003cli\u003eEvidence summaries on the benefits and harms of COVID-19 and influenza vaccination have been developed with the participation of various stakeholders, including scientists from different disciplines, representatives of health authorities and outreach work, and lay people from different social backgrounds (mother tongues: Arabic, German, Russian, Turkish).\u003c/li\u003e\n \u003cli\u003eThe study design allows conclusions to be drawn about whether evidence summaries using the fact box format add value compared with conventional health education in usual health care and outreach work settings \u0026ndash; and for different social groups.\u003c/li\u003e\n \u003cli\u003eThe study design allows health educators to determine how best to integrate it in their health education practice.\u003c/li\u003e\n \u003cli\u003eWe cannot control for differences in prior knowledge and selection of study participants, as health educators should decide who they want to approach and who not to approach to avoid losing trust.\u003c/li\u003e\n \u003cli\u003eAt present (September 2023), the German Standing Committee on Vaccination (STIKO) recommends an annual influenza vaccination or corona vaccination for anyone at increased risk of severe illness. This includes people aged 60 and over, pregnant women from the 2nd trimester, chronically ill people of all ages, and residents of old people\u0026apos;s and nursing homes. This could have implications for the generalizability of the results to the younger population.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eEnsuring informed consent is considered an ethical principle for medical research involving human subjects and is enshrined in the Declaration of Helsinki\u003csup\u003e1\u003c/sup\u003e. The basis of informed consent is the patient\u0026apos;s informed decision about whether he or she wants to undergo a medical procedure, prefers another one, or refuses it\u003csup\u003e2\u003c/sup\u003e. Informed decisions for or against medical interventions require evidence-based health information that provides comprehensible and transparent information about the benefits and harms of all treatment options\u003csup\u003e3 4\u003c/sup\u003e. However, information often fails to meet evidence-based and risk communication criteria\u003csup\u003e5-7\u003c/sup\u003e, which means that not all people facing a health decision are able to make a decision based on evidence-based knowledge and in line with their personal preferences (informed choice)\u003csup\u003e3\u003c/sup\u003e.\u0026nbsp;In addition,\u0026nbsp;despite their general effectiveness, public health interventions, e.g. public health messaging, can lead to the disadvantage of certain social groups (\u003cem\u003eintervention generated inequalities\u003c/em\u003e) if equal access to them is not ensured\u003csup\u003e8-10\u003c/sup\u003e. What are possible barriers? Known social determinants of health work to the disadvantage of certain groups\u003csup\u003e10 11\u003c/sup\u003e. They are also a key determinants of health literacy\u003csup\u003e12\u003c/sup\u003e: individual differences in the ability to search for, understand, evaluate, critical assess and use health information to make informed choices\u003csup\u003e13 14\u003c/sup\u003e. In addition to socio-demographic factors such as education, income or older age, it is not uncommon for language barriers to impede access to health-related information\u003csup\u003e15\u003c/sup\u003e. Thus, multiple communication channels, translations and initiatives to bring health information to those facing health decisions are required.\u003c/p\u003e\n\u003cp\u003eOften health information consists only of words, although there is evidence that visual representations and images - particularly icons with few words - may improve knowledge/understanding, especially in populations with low health literacy\u003csup\u003e16\u003c/sup\u003e. Furthermore, text-heavy health information (e.g. package leaflets) is often written at a higher reading level, making it inaccessible to people with lower health literacy\u003csup\u003e16\u003c/sup\u003e. As a result, uninformed decisions are made, that is, decisions are made without sufficient knowledge of the benefits and harms and of treatment options and alternatives, which are not consistent with attitudes for or against the medical treatment\u003csup\u003e3\u003c/sup\u003e. Why is this a problem? Overall, uninformed decisions are more likely to lead to decisional regret, reduced ability to use medicines appropriately, poorer health outcomes and let people less likely opt for a follow-up treatment (e.g., booster vaccinations)\u003csup\u003e17\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eUnfortunately, disadvantaged groups less often make informed decisions and are more likely to experience higher decision regret than advantaged groups\u003csup\u003e10 18\u003c/sup\u003e. A representative observational study from 2015 found that among women invited to the nation-wide mammography screening programme in Germany for the first time, women with low and medium levels of education were more likely to make an uninformed decision than high level educated women. Women with an immigrant background were only slightly more likely to make an uninformed decision than women without an immigrant background. However, women with a Turkish immigrant background were more likely to make an uninformed choice than women with no immigrant background\u003csup\u003e18\u003c/sup\u003e. In 2019, these differences were still found in terms of knowledge, which is central to informed decision making. Women with less education and an immigrant background were more likely to have insufficient knowledge about the benefits and possible harms of mammography screening. Sufficient knowledge was again associated with higher education and was lowest among Turkish women\u003csup\u003e19\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eTo reduce inequities and achieve high quality health care, structures and approaches must enable disadvantaged people to access and navigate the health system to effectively manage their health and care\u003csup\u003e20\u003c/sup\u003e.\u0026nbsp;Evidence-based health information (EBHI) and decision aids (DAs) are key components for improving health care by enabling more people to make informed and shared decisions\u003csup\u003e21\u003c/sup\u003e. Taking into account the best evidence currently available, they present information on the course and effects of diseases and on the benefits and harms of medical interventions (including early detection, diagnosis and treatment) in a transparent and understandable manner, based on patient-relevant outcomes\u003csup\u003e22\u003c/sup\u003e. In contrast to DAs, EBHI often has a broader focus and is not directly aimed at preference-based decision making. DAs use tools (value clarification tools) to help identify these\u003csup\u003e23\u003c/sup\u003e. The benefits of DAs over standard care (no evidence-based information or no intervention) are already clear. In a Cochrane review\u003csup\u003e23\u003c/sup\u003e the effect of DAs on people who are about to make a decision for or against a medical intervention (e.g. surgery, cancer screening, drug treatment) was investigated. Different formats of DAs (including written, web-based, video) in different settings were analysed in the 105 randomized controlled trials included. The review found that DAs have a positive effect on knowledge, information and perception of values, and that decision makers are likely to take a more active role in the decision-making process and have a better perception of risk\u003csup\u003e23\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHowever, despite their overall effectiveness, there is a risk that only certain groups of the population will benefit from EBHI and DAs. Because although they are \u0026ldquo;target group oriented\u0026rdquo;, the factors that lead to inequity in terms of shared and informed decision-making have not yet been sufficiently taken into account in their development process\u003csup\u003e10 24\u003c/sup\u003e. For example, there are many patient-oriented materials written at an advanced level, which makes the materials less accessible to people with reading difficulties, lower education, health literacy or socioeconomic status (SES)\u003csup\u003e16 25 26\u003c/sup\u003e. In general, only few studies have looked specifically at the impact of shared decision making (SDM) or informed decision making in groups that are more likely to have communication barriers due to their racial or ethnic background and/or level of education\u003csup\u003e24 27\u003c/sup\u003e. In a systematic review with meta-analysis of randomized controlled trials, the authors\u003csup\u003e27\u003c/sup\u003e examined whether patient DAs and other SDM interventions improve outcomes or reduce health inequalities in socially disadvantaged populations. The authors found that SDM interventions for disadvantaged populations improve for example knowledge and informed choice. However, they could not determine which interventions were most effective in promoting SDM and whether there are key features from which all or the disadvantaged can benefit. Further, the authors state that there is a lack of evidence on the effectiveness of decision-making interventions for disadvantaged people compared to non-disadvantaged people. Nevertheless, they conclude that their research suggests that targeted interventions - interventions that are tailored to a very specific group (e.g. people with limited health literacy) - might narrow the gap in care between disadvantaged and non-disadvantaged populations\u003csup\u003e28\u003c/sup\u003e. Preliminary results from an ongoing systematic review by the authors of this manuscript\u003csup\u003e29\u003c/sup\u003e, which is registered through PROSPERO\u0026nbsp;(CRD42018103456),\u0026nbsp;also indicate that only few studies have examined the extent to which disadvantaged groups have been considered in evaluating (evidence-based) health information and decision aids in randomized controlled trials, and whether and to what extent inequity is reduced.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnother review from 2016\u003csup\u003e21\u003c/sup\u003e looked at the extent to which disadvantaged groups were considered in the development and evaluation of cancer screening and treatment decision aids in trials in the USA. 23 of the 39 included studies evaluated decision aids that considered socially disadvantaged groups. Only 17 trials involved disadvantaged people in the development of the decision aids. The authors note that a number of issues and medical interventions that would be relevant to specific disadvantaged groups because of their higher morbidity and mortality are not yet addressed in decision aids in the US. In addition, disadvantaged groups are more likely to be unaware of treatment alternatives, such as watchful waiting or not participating in screening, and more likely to have the misconception that decision aids are designed to increase screening participation rather than to support decision making\u003csup\u003e21\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe aim of our study is to assess whether evidence-based summaries using the fact box format can facilitate informed decisions for laypeople from different social backgrounds. Further, we aim at exploring whether these evidence-based fact boxes contribute to reducing inequity in health care by improving shared decision-making.\u003c/p\u003e\n\u003cp\u003eFact boxes provide a tabular or graphical overview of the benefits and harms of medical options through transparent risk communication\u003csup\u003e30\u003c/sup\u003e. They are used to inform a range of health decisions, such as medical treatments, cancer screening and vaccinations. By reducing complexity and balancing evidence, they aim to promote informed decisions rather than predetermined behavioral change\u003csup\u003e31\u003c/sup\u003e. As such, they go hand in hand with current Western health standards and ethical principles that oppose persuasion or nudging, which can collide with informed choice and pose the risk of undermining the trustworthiness and credibility of the communicator and vaccinator\u003csup\u003e31 32\u003c/sup\u003e. Fact boxes are developed according to the recommendations of the German guideline evidence-based health information (19, 30). This includes development and evaluation according to the Medical Research Council (MRC) guideline Development and Evaluation of Complex Interventions\u003csup\u003e33\u003c/sup\u003e. They are developed in a multi-stage process, and their individual elements are tested and adapted, where possible\u003csup\u003e34\u003c/sup\u003e. Several experiments have shown that fact boxes support informed decisions by improving for example risk perception, short-term knowledge/knowledge recall, comprehension\u003csup\u003e31 35-38\u003c/sup\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt present it is unclear whether fact boxes can be an effective format outside (online) laboratory conditions. Further, fact boxes have been tested with the lay public, but only three studies analysed its effect by vulnerability factors. A recent randomised controlled pilot study of three numerical presentation formats of fact boxes to laypeople found indications that the acquisition of verbatim knowledge was lower among participants with lower than among participants with higher levels of education for the formats percentages and graphic chart. However, there were no differences in gist knowledge and the frequency format showed comparable results between the two levels of education\u003csup\u003e38\u003c/sup\u003e. In another study examining the effect of COVID-19 vaccine fact boxes on vaccination knowledge and assessment of the benefit-harm ratio of mRNA vaccination, the effect was greater among people with higher education or income than among people with lower education\u003csup\u003e31\u003c/sup\u003e. In a study of whether fact boxes or text-only formats on antibiotics for ear infections or flu vaccines with the same content led to better understanding of the potential harms and benefits of each treatment option, fact boxes appeared to improve understanding at all levels of numeracy\u003csup\u003e37\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnother aim of our study is to find out to what extent evidence-based summaries using the fact box format can be integrated into the communication of health educators (e.g. doctors) in standard care and outreach settings, and what added value they have in supporting SDM compared with conventional information or no information at all. SDM means that the doctor and the patient make decisions about health care together in an interactive and equal process, provided that health professionals make available their knowledge, experience and the latest scientific evidence, but also that patients are fully informed and involved in all important aspects of medical decision-making\u003csup\u003e39 40\u003c/sup\u003e. While SDM interventions have varying effects on patient-relevant outcomes such as mortality, morbidity and health-related quality of life the grade of informed choice can be considered a baseline outcome of SDM\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAlthough there is evidence for the benefits of SDM interventions (e.g. decision aids, DAs) in improving people\u0026apos;s knowledge of risks and benefits, feeling informed, and clarity about their values in a variety of decision-making contexts\u003csup\u003e23\u003c/sup\u003e, and thus for their use in clinical practice, the real-world effects of implementing EBGI as an SDM intervention are still unclear. What are the prerequisites, facilitators and barriers for people to benefit from them in practice? What are the prerequisites and barriers for clinicians to implement them? Already in 2013, the authors of a review called for more research into the extent to which EBHI and DAs are effective in medical care, as they are not yet widely used in medical practice\u003csup\u003e41\u003c/sup\u003e. Moreover, in 2019 only 21% of DAs were introduced after trials and further 7% were part of implementation studies. Barriers included outdated evidence in DAs and disagreement among clinicians about the use of DAs\u003csup\u003e42\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis paper reports on the study protocol of an implementation study and equity evaluation of evidence-based summaries on COVID-19 and influenza vaccination in different health education settings in Germany using fact box formats. The trial was prospectively registered on clinicaltrials.gov (NCT06076421).\u003c/p\u003e"},{"header":"Methods and analysis","content":"\u003cp\u003eThe protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guideline\u003csup\u003e43\u003c/sup\u003e to improve the transparency and quality of reporting on study protocols of randomized controlled trials, and CONSORT (Consolidated Standards of Reporting Trials) Equity Reporting Guideline 2017\u003csup\u003e44\u003c/sup\u003e, which aims to improve the reporting of the impact of interventions on health equity in randomized controlled trials, for trials assessing changes in effect measures, and for trials focusing on disadvantaged populations\u003csup\u003e44\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDisadvantaged populations\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn our study, we will focus on the differences in intervention effects between groups of people with disadvantaged factors that are associated with unequal living and working conditions and poorer health outcomes. Some of these factors are unavoidable (e.g. biological variation) or should not be changed for ethical reasons (free choice), while others are avoidable (e.g. factors beyond an individual\u0026apos;s control) and cause health inequity\u003csup\u003e8\u003c/sup\u003e. Inequitable factors are defined by the PROGRESS Plus framework as: place of residence, race/ethnicity/culture/language, occupation, sex/gender, religion, education, socioeconomic status and social capital\u003csup\u003e8\u003c/sup\u003e. Ignoring these factors can exacerbate health inequalities, even if public health interventions (e.g., education, communication and information) are generally effective\u003csup\u003e9\u003c/sup\u003e. This means that an intervention will be more successful in improving health (care) for instance in groups at lower risk (advantaged people) than in groups at higher risk of disease burden (disadvantaged people).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn our study, we will examine the impact of the intervention, taking into account the following factors: education, subjective socio-economic status (SSS), health literacy as well as mother tongue (German, Arabic, Turkish, Russian, other) and language (subjective native reading literacy, perception of own German language skills).\u0026nbsp;\u0026nbsp;Accordingly, we will define\u0026nbsp;people as being disadvantaged upon the following criteria:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThey have a low educational attainment (without a degree or a degree equivalent to a maximum of nine years at school (Haupt-/Volksschule)),\u003c/li\u003e\n \u003cli\u003eRate their social position as low (SSS of 1-4),\u003c/li\u003e\n \u003cli\u003eHave problematic or inadequate health literacy (see\u003csup\u003e45\u003c/sup\u003e for operationalisation),\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThey rate their ability to read in their mother tongue as rather poor or very poor,\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eIf their mother tongue is not German, and they rate their knowledge of German as poor or very poor.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMain research question\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDo disadvantaged people (as defined above) benefit to the same extent as non-disadvantaged people in terms of informed and shared decision-making from receiving COVID-19 and influenza vaccination fact boxes as opposed to standard vaccination communication in medical practices and outreach work (field settings)?\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eResearch questions (RQ) and main hypotheses (HYP)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRQ1\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIs the use of fact boxes more effective than standard vaccine communication (control condition) in the field?\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary HYP\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea) We hypothesise that implementation of fact boxes in medical practices and outreach work will lead to \u003cstrong\u003e\u003cem\u003ehigher vaccination knowledge\u0026nbsp;\u003c/em\u003e\u003c/strong\u003ecompared to standard vaccine communication. A number of studies have shown that fact boxes improve short-term knowledge and recall and comprehension\u003csup\u003e31 35-38\u003c/sup\u003e, enabling people to weigh the benefits and harms of an intervention, and\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eb) Because knowledge is a component of informed choice and attitudes about vaccines\u0026rsquo; benefit-harm ratios are not biased by the presentation of a vaccine fact \u0026nbsp;box\u003csup\u003e31\u003c/sup\u003e, we hypothesise further that compared to standard vaccine communication, the implementation of fact boxes in medical practices and outreach work will lead to \u003cstrong\u003e\u003cem\u003emore vaccination intentions that are in line with attitudes and vaccination knowledge\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e(informed vaccination intentions; see the section \u003cstrong\u003e\u003cem\u003eoutcomes\u003c/em\u003e\u003c/strong\u003e for operationalisation).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary HYP\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea) We hypothesise that the implementation of fact boxes will \u003cstrong\u003e\u003cem\u003eimprove\u003c/em\u003e\u003c/strong\u003e \u003cstrong\u003e\u003cem\u003erisk perception\u003c/em\u003e\u003c/strong\u003e compared to standard vaccine communication, as a study found that studying the fact boxes improved accuracy of numerical COVID-19 risk perception compared to the control presentation (ANOVA interaction effect: \u003cem\u003eF\u003c/em\u003e(1,357) = 10.05, \u003cem\u003ep\u003c/em\u003e = .002, \u0026eta;\u003csub\u003ep\u003c/sub\u003e\u003csup\u003e2\u0026nbsp;\u003c/sup\u003e= 0.03) without affecting vaccination intentions\u003csup\u003e31\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eb)\u0026nbsp;We hypothesise that\u0026nbsp;implementation of\u0026nbsp;fact boxes will \u003cstrong\u003e\u003cem\u003eincrease patient involvement\u003c/em\u003e\u003c/strong\u003e in medical decision making compared to standard vaccine communication. This hypothesis is based on data from a Cochrane Review that evidence-based tools aimed at enabling informed decision making have the potential to increase patient involvement\u003csup\u003e23\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ec) We suggest that implementation of fact boxes do \u003cstrong\u003e\u003cem\u003edecrease\u003c/em\u003e\u003c/strong\u003e \u003cstrong\u003e\u003cem\u003edecisional conflict\u003c/em\u003e\u003c/strong\u003e, as a study\u003csup\u003e36\u003c/sup\u003e found that, compared with controls, participants who received fact boxes experienced less decisional conflict about antibiotic use (unstandardised beta (b) = -8.35, 95% confidence interval (CI), -12.43, -4.28) and artificial hydration (b = -6.02, 95% CI, -9.84, -2.20) at one month compared with baseline.\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRQ2\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAre fact boxes as effective for people with disadvantaging factors as for those without factors associated with disadvantages?\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary HYP\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will analyse the effect of fact boxes compared to usual care among people with more and less advantaging factors (e.g., in terms of education), taking into account known baseline differences between advantaged and disadvantaged people. The added value of evidence-based tools (e.g., DAs) over traditional (non-evidence-based or usual) health care and interventions tailored to specific target groups (e.g. people with low levels of education) has already been demonstrated\u003csup\u003e23 27\u003c/sup\u003e.\u0026nbsp;We therefore expect that the gap will narrow between more and less advantaged people in terms of outcomes relevant for informed vaccination decisions.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe hypothesise that implementation of fact boxes will lead to a greater alignment of knowledge, informed vaccination intentions, and accuracy of risk perception between:\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ea) People with low and high education through fact boxes compared to usual care.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eb) People with problematic or inadequate and excellent or sufficient level of health literacy through fact boxes compared to usual care.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ec) Non-native (Arabic, Turkish and Russian speaking participants, only with low German skills) and native German speakers (including non-native speakers with high German skills) through fact boxes compared to usual care, because we not only provide information in the native language, but also tested it with these target groups.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ed) People with low and high reading literacy in different languages compared to usual care because fact boxes are a complexity-reduced format of health information and we tried to address accessibility through pilot testing with different groups.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRQ3\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDoes the use of fact boxes in outreach work promote more shared and informed decision-making than in regular health care settings?\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eHYP\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea) We assume that fact boxes more likely lead to more informed vaccination intentions and shared decisions in outreach work than in regular health care settings. In order to respond to the needs of especially people with disadvantaging factors and to reach them in a more effective way, community-based health services are becoming more and more important\u003csup\u003e46\u003c/sup\u003e. The use of non-primary care professionals (e.g. social workers, community nurses or community health workers), who can build trust and provide psychoeducational interventions has been shown to be effective in providing health knowledge, improving health care, changing health behaviour and improving health status\u003csup\u003e46 47\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eExplorative analyses\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea)\u0026nbsp;We will analyse the effect of fact boxes on knowledge, vaccination intentions, accuracy of risk perception (see \u003cstrong\u003e\u003cem\u003eOutcomes\u0026nbsp;\u003c/em\u003e\u003c/strong\u003efor operationalisation)\u0026nbsp;between people with low and medium or high SSS through fact boxes compared to usual care.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eb) We will analyse the effect of fact boxes on vaccination intentions, knowledge, risk perception, patient involvement, and decisional conflict among people with migration-related indicators (e.g., residential status, length of stay in Germany; see \u003cstrong\u003e\u003cem\u003eOutcomes\u0026nbsp;\u003c/em\u003e\u003c/strong\u003efor operationalisation) compared to usual care, controlling for other factors describing the social situation (e.g., education, health literacy). This may be because people with immigrant history are less receptive to information from authorities or health providers in Germany, the host country (even if it is translated), because they have less trust in them\u003csup\u003e48\u003c/sup\u003e. But also because traditional media campaigns or formats that work for the majority of the host population may not be the right channel for communicating with immigrant groups\u003csup\u003e48\u003c/sup\u003e. An increased length of stay is associated with a greater orientation towards the host society and thus a change in lifestyle habits, health perceptions and health behaviour\u003csup\u003e49 50\u003c/sup\u003e. On the other hand, a shorter duration of stay, as well as not having German citizenship or a residence permit, may be associated with higher barriers to access to the German health care system (e.g. due to lack of social and health insurance or more difficult access to (multilingual) health information)\u003csup\u003e49\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion and Exclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy participants in general\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStudy participants are adults of legal age with current residence in Germany and who speak German, Russian, Turkish or Arabic. The trial is open to people who are currently facing a decision about vaccination for themselves or a family member (e.g. caring relatives). All participants must confirm their informed consent online to take part in our study. Patients who do not speak any of the four languages and who do not give informed consent will be excluded.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDesign and Setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe will conduct a cluster randomized controlled trial with a 2x2-cross-sectional design with the between-subjects factors: format (usual health communication plus fact box vs. usual health communication), health educator (cluster unit medical practice vs. cluster unit outreach work settings)\u0026nbsp;(see\u0026nbsp;\u003cstrong\u003e\u003cem\u003eFigure\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;1\u003c/em\u003e)\u0026nbsp;taking into account various factors of disadvantage (e.g., low education).\u0026nbsp;Health professionals in particular are still first-contact for people seeking health information in Germany\u003csup\u003e51\u003c/sup\u003e. Therefore, the cluster units will include all those who communicate about health issues (e.g. doctors and other health professionals, community health workers) in Germany, as well as settings where traditional communication about disease prevention takes place (e.g. doctors\u0026apos; offices) and where communication about health issues is carried out in the context of outreach work (mothers\u0026apos; and fathers\u0026apos; caf\u0026eacute;s, intercultural meeting places)\u0026nbsp;if more than one person per unit participates. We will refer to these units as health educators.\u0026nbsp;Key requirement for involving health educators is that they provide information on health-related topics and have access to potential study participants. Furthermore, informed written consent is a prerequisite.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eHealth educator recruitment\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo reach health educators, we will contact German public health authorities and ask them to distribute the study call to all kind of health educators in their respective areas of responsibility (districts). We will use professional contacts to involve health authorities for recruiting. In addition, we will use other existing structures, such as the German general practitioners\u0026apos; association and other relevant networks, to reach the respective health educators.\u0026nbsp;All health educators will first be given general information about the study and asked for their consent.\u0026nbsp;Health educators who express interest in participating in the study via mail or telephone will\u0026nbsp;receive a flyer that includes a brief description of the study, a QR code and, a link to an online survey to share with those who are about to make a vaccination decision.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHealth educators will not be remunerated, as providing information about the benefits and risks of vaccination - at least for health care providers - is part of their professional and ethical duties.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur study will be conducted in close cooperation with the health departments in Germany, which provides access to the planned cluster settings and the target groups. The close cooperation with the health departments and those involved in the implementation of our study will help us to increase the success of our research. In addition, through the recruitment of health educators by health authorities, we hope to reach particularly disadvantaged people who would otherwise be difficult to reach.\u003c/p\u003e\n\u003cp\u003eWe will not involve these target groups, as they were already involved in the pre-studies aiming at developing and improving the intervention formats according to their information needs and preferences (see \u003cstrong\u003e\u003cem\u003eintervention\u003c/em\u003e\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant recruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHealth educators will distribute the study flyer to potential participants as part of or after the health communication. Health educators are asked to inform all potential participants about the study.\u003c/p\u003e\n\u003cp\u003ePeople who are approached by their health educators can decide for themselves whether they would like to participate in the study by using the link or the QR code on the flyer. On request, health educators can also receive a paper copy of the questionnaire to give to their patients. Health educators will not know if someone is participating unless participants tell them themselves. Thus, those who have been approached will not suffer any negative consequences if they decide not to take part in the study.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants who are interested in taking part in the study will receive detailed information about the study and about data protection in their preferred language via the link or the QR code and can give their consent online. In order to make the study as accessible as possible, information about the study and about data protection will be provided in plain language. Those who decide to take part in our study will complete an online survey, providing information on their vaccination status, attitudes towards vaccination, knowledge of the benefits and harms of vaccination and intentions to vaccinate, as well as socio-demographic information. As some of the tools we use to collect results are already established, low-barrier accessibility cannot be guaranteed for all questions. However, there will be a read-aloud function for the questionnaire in all languages.\u0026nbsp;After completing the initial online survey (T1), participants will have the opportunity to provide their email address for a follow-up survey four weeks later (T2). At the end of this second survey, participants will be rewarded with a voucher worth 14 Euro.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHow do we plan to reach disadvantaged groups? When we recruit health educators, we make it clear that we want to reach people from different linguistic and social backgrounds. They will therefore be sensitised to approach these groups of people about taking part in the study and to provide them with the flyer. Through the health educators and the different cluster units that also do outreach work, we hope to reach people with different disadvantages.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIntervention\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHealth educators in the intervention group will receive a flyer with a brief description of the study, a QR code and a link to an online survey, including a fact box on the reverse side about COVID-19 or the flu vaccine for their age group in Arabic, German, Russian or Turkish to reach people whose spoken language is one of these. Fact boxes will be available either in tabular form for influenza or as a visualisation for COVID-19, each in all languages and for both age groups.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFurther, health educators will be provided with additional information about evidence-based fact boxes and how they could use them as part of a telephone information service. COVID-19 and flu vaccine fact boxes in a tabular and visualised format are available for two different age groups each: COVID-19 vaccination for people aged 18 to 59 and over 60, influenza vaccination for people aged 16 to 64 and over 65. Health educators are free to decide if and how to use the fact boxes, whether during, before or after vaccination education, and who to target.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eControl condition\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHealth educators in the control condition will also receive the flyer with a brief description of the study, a QR code and a link to the online study to distribute to potential study participants, but without the fact box on the back.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePatient and public involvement\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn several pre-studies fact boxes on COVID-19 and influenza vaccination underwent a development process in order to meet the information needs and requirements of people from the general population. The process included feedback from various public health stakeholders on a COVID-19 fact box implemented in January 2021 by the Robert Koch Institute (RKI), the German national health authority. Further, identification of information needs and requirements of the population in Germany based on secondary data analyses and results from piloting of COVID-19 fact boxes in population-wide surveys with N=1,942 to N=6,056 respondents in Germany were incorporated in updates. The data basis and individual studies have been described in detail elsewhere\u003csup\u003e31\u003c/sup\u003e. The Influenza vaccination fact box was updated in 2021 based on current evidence and is available on the Harding Center website for older people (65 years and older) and for people aged 16 to 65.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring cognitive interviews\u003csup\u003e52\u003c/sup\u003e, simplified COVID-19 and Influenza vaccination fact boxes first were tested for comprehensibility with German-speaking participants and then adapted. Visualised COVID-19 fact boxes were then tested with Arabic-, Turkish- and Russian-speaking participants from disadvantaged neighbourhoods in Berlin in their respective mother tongues. The results of these language- and education-sensitive fact boxes were transferred to the tabular Covid-19 fact boxes and the flu vaccination fact boxes. A visualised flu fact box is currently being piloted by the University of Erfurt with German-speaking lay people with low numeracy.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study design, outcomes, strategies for reaching vulnerable target groups and the questionnaire were discussed with various expert groups (e.g. scientists from different disciplines, representatives of health authorities and outreach work).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRandomization and allocation concealment\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFirst, health educators will be randomized, either at the individual level or at the institutional level if there is more than one health educator per setting. Health educators who express interest in participating in the study will be assigned a study ID number and randomly assigned to one of the two study conditions: 1) usual care plus fact box (intervention) or 2) no information/usual care (control) (see \u003cstrong\u003e\u003cem\u003eFigur\u003c/em\u003e\u003c/strong\u003ee 2) by an independent researcher using computer-generated random numbers in a 1:1 ratio. Health educators will then distribute their assigned flyer format to individuals who are about to make a vaccination decision about the COVID-19 or the influenza vaccine, taking into account their reference group (age group). For this purpose, the health educators will be provided with a package containing the relevant flyers. The link/QR code will bring them to an online survey that accounts for the respective condition (intervention or control), setting in which they received the flyer (health care or outreach work), language (Arabic, German, Turkish, Russian), disease addressed in the counselling session (influenza or COVID-19), and age group (aged below 65 vs. aged over 65). Potential study participants will receive only one flyer with the respective information. If participants in the intervention group receive the wrong Flyer (e.g., wrong age group or disease) they will be asked questions about the fact box that led them to the study. Health educators and study participants will not know which study condition they belong to. Health educators in the control group will also have the opportunity to receive the fact boxes for their health communication post-trial.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBlinding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHealth educators will only be informed about the aim of the study but not about being part of an intervention or control group. Awareness that a group of health educators are receiving information and that the study is about finding out what impact this has on the informed decision making of those being educated might alternatively lead them to adapt their health education. Accordingly, the study participants are also only informed about the aim of the study, but not about the condition to which they, respectively their health educator, have been assigned. Health educators will be assigned by a person independent of the study, which means that the assignment will be blinded. The data analyst will also be blinded.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSocio-demographic information and outcomes will be collected after people receive the flyer from their health educator and access the study link or QR code. As the study is voluntary and those who approach people do not know who among those approached will participate in the study, we will not be able to control who participates in the study and we will not be able to follow up with those approached. All information will be collected at the time of the first survey (T1), as participation in the second survey (T2) four weeks after the initial survey is also voluntary (see\u0026nbsp;\u003cstrong\u003e\u003cem\u003eFigure\u003c/em\u003e\u003c/strong\u003e 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary outcomes\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary endpoints are knowledge and informed vaccination intention. \u003cstrong\u003e\u003cem\u003eKnowledge\u003c/em\u003e\u003c/strong\u003e will be assessed by 10 items: five items on basic knowledge of the disease (e.g. how is Corona or the flu contracted and what are the possible baseline risks) and uncertainty (e.g. quality of evidence), each with 4 possible answers, of which only one is correct. A further five questions that can only be answered through the fact box, including one question on the benefits of vaccination gist and three questions on the benefits and harms of vaccination verbatim. Responses will be graded according to the best available evidence in July 2023.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eInformed vaccination intentions will be\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eoperationalised on the basis of the multidimensional construct of informed choice by Marteau et al. 2001\u003csup\u003e3\u003c/sup\u003e. We will measure informed vaccination intention based on vaccination knowledge gained from education with fact boxes compared to standard education without fact boxes, as well as a person\u0026apos;s attitudes and vaccination intentions. \u003cstrong\u003e\u003cem\u003eKnowledge\u003c/em\u003e\u003c/strong\u003e will be measured as described above. \u003cstrong\u003e\u003cem\u003eAttitudes\u003c/em\u003e\u003c/strong\u003e will be measured using an 11-point Likert scale that captures the personal assessment of the balance between the potential benefits and risks of the respective vaccine\u003csup\u003e31\u003c/sup\u003e. \u003cstrong\u003e\u003cem\u003eVaccination intention\u003c/em\u003e\u003c/strong\u003e will be measured by asking whether participants would have themselves or their relatives vaccinated at the next opportunity, on a scale of 1-5 (Definitely yes, probably yes, probably not, definitely not, I cannot yet say / am still undecided). \u003cstrong\u003e\u003cem\u003eVaccination decision\u003c/em\u003e\u003c/strong\u003e will be assessed at T2 by asking whether they (or their relatives) have been vaccinated since the last survey (T1).\u003c/p\u003e\n\u003cp\u003eSubjects will be classified as having made an informed intention to vaccinate if they (a) score higher than 6 out of 10 on the knowledge scale (sum score), attitude is equal or higher (\u0026gt;5/10) than the midpoint of the 11-point Likert scale and vaccination intention or decision is 1 or 2, or report having been vaccinated or if they (b) score higher than 6 out of 10 on the knowledge scale (sum score), attitude is lower than the midpoint of the 11-point Likert scale (\u0026lt;5/10) and vaccination intention is 3 or 4, or people have not had a vaccination. Participants who fail to meet either set of criteria will be classified as not meeting the criteria for informed vaccination intention.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary outcome measures\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRisk perception\u0026nbsp;\u003c/em\u003e\u003c/strong\u003ewill be measured by using a frequency format (Please imagine 10 people like yourself: How many of them will be re-infected with COVID-19 after a previous coronavirus infection if they come into contact with a person who is infected with the coronavirus variant XBB.1.5?; How many will contract influenza in a year if the virus is widespread?): Correct responses (reflected the best available evidence, which can be found in the fact boxes together with the medical references\u003csup\u003e31\u003c/sup\u003e. The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) screening test\u003csup\u003e53\u003c/sup\u003e will be used to measure \u003cstrong\u003e\u003cem\u003edecisional conflict\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e(if yes: 1, if no: 0; a score of \u0026lt; 4 is a positive result for decisional conflict).\u003cstrong\u003e\u0026nbsp;\u003cem\u003ePatient involvement in decision making\u003c/em\u003e\u0026nbsp;\u003c/strong\u003ewill be measured with the 9-item Shared Decision Making Questionnaire (SDM-Q-9)\u003csup\u003e39\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eParticipant characteristics and socio-demographic information\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFor descriptive purposes, we will also collect the following participant characteristics and socio-demographic information from study participants:\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe will assess \u003cstrong\u003e\u003cem\u003ehealth literacy\u003c/em\u003e\u003c/strong\u003e using the established and validated HLS19-Q12\u003csup\u003e45\u003c/sup\u003e, a 12-item short form questionnaire of the HLS19-Q47 for measuring comprehensive, general health literacy (HL) in general adult populations. It is already available in German, Turkish, Arabic and Russian language.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will collect \u003cstrong\u003e\u003cem\u003esocio-demographic information\u003c/em\u003e\u003c/strong\u003e like age, gender, educational attainment, subjective socioeconomic status, as well as information about the migration history and in which language the conversation about the vaccination took place.\u003cstrong\u003e\u0026nbsp;\u003cem\u003eSubjective socioeconomic status\u003c/em\u003e\u003c/strong\u003e (SSS) will be assessed by using the MacArthur Scale of Subjective Social status, which measures the subjective perception of social position within society on a 10-point scale\u003csup\u003e54\u003c/sup\u003e (with SSS low: 1-4, middle: 5-6, high: 7-10). In addition to indicators describing the social situation, we collect information about \u003cstrong\u003e\u003cem\u003emigration history\u0026nbsp;\u003c/em\u003e\u003c/strong\u003ewith a reduced scope of the minimum set according to the recommendations for the collection and analysis of migration-related determinants in public health research\u003csup\u003e49 55 56\u003c/sup\u003e, by asking about\u0026nbsp;in which\u0026nbsp;country a person and his/her parents were born (non-migrant vs. first or second generation migrants), nationality, residential status (residence permit: yes or no) as well as mother tongue (Arabic, German, Russian, Turkish, other), the year of immigration to Germany , and how they rate their reading ability in their mother tongue (very good, rather good, rather poor, very poor).\u003c/p\u003e\n\u003cp\u003eStudy participants will be also asked whether the fact box was used as part of the counselling process and how they judge it.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHealth educators\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePre-intervention (T0) health educators will be asked about their demographics (age, gender, mother tongue), the type of health education setting (doctor\u0026apos;s office or outreach work (alone or in a community setting/ group practice)) and the number of vaccinations per person seen in the 4 weeks before intervention starts (see \u003cstrong\u003e\u003cem\u003eFigure\u003c/em\u003e\u003c/strong\u003e 2). They will be asked again about the number of vaccinations per person seen in the 4 weeks from start of the intervention (T1). Health educators in the intervention group will also be asked how they used the fact boxes (during, before or after vaccination communication) and about involving patients from their perspective (SDM-Q-Doc)\u003csup\u003e57\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe aim to demonstrate moderately large main effects (equal to Cohen\u0026rsquo;s d = 0.50) of the study intervention on informed intentions (10% expected in usual care) and a knowledge sum score (equal to proportion of correct responses; with expected variance of 0.20). Taking into account a cluster correlation coefficient (ICC=0.10) common for primary care studies with patient endpoints\u003csup\u003e58\u003c/sup\u003e, we will target three health educators (e.g., doctors\u0026apos; offices) per study arm with 40 patients/clients per health educator\u003csup\u003e59\u003c/sup\u003e. So, 240 participants in each subgroup undergoing the same analysis are required (Supplementary Table S1). Furthermore, to demonstrate small-to-moderate interaction effects (equal to Cohen\u0026rsquo;s d = 0.375) of the study intervention in respective settings on informed intentions and knowledge, we have to target instead seven health educators per study arm with 40 patients/clients per health educator (N=560). In total, we aim at 800 participants because the proportion of subgroup members cannot be predicted, and we cannot rule out that interaction effects in the field are smaller than expected from experimental evidence (e.g., d = 0.20 would call for up to 20 health educators per study arm). Further details on the assumptions underlying the sample size calculations in the power calculation with respect to the critical hypotheses and outcomes are provided in Table S1 in the supplementary section.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter giving their online consent, participants will complete an online survey via SoSciSurvey. The survey (T1) is completely anonymous for the study participants. Personal data (e-mail address) will be only collected if there is interest in participating in the follow-up survey (T2) and in the renumeration, for which also first name and surname will be recorded. For this purpose, a computer-generated random ID will be generated\u0026nbsp;by someone independent of the study, which is stored with the unblinding list separately from the collected personal and survey data at the Harding Center (HC) on password-protected computers and is only accessible to researchers of the HC until the end of the data collection.\u003c/p\u003e\n\u003cp\u003eThe pre- and post-survey of the health educators will be conducted under pseudonym. The random generated ID, personal and survey data will be separated from the contact information immediately after completion of the post-survey,\u0026nbsp;and the de-blinding list is also kept until the end of the data collection.\u003c/p\u003e\n\u003cp\u003eAll relevant data will be provided in the manuscript and supporting information or made available in a public repository after completion of the study.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData analysis will initially be based on descriptive statistics as well as frequency distributions and histograms to identify outliers and missing data. Baseline data of the study arms will be compared to see if the distribution is balanced between study sites/the clusters. SPSS will be used to conduct all analyses.\u003c/p\u003e\n\u003cp\u003eAll participants will be asked to indicate at T1 whether they received the intervention to allow for intention-to-treat (ITT) and as-treat analyses.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStatistical methods for analysing primary and secondary outcomes.\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe use linear mixed models to analyse the influence of both individual (e.g. education status, health literacy) and cluster level factors (e.g. setting) and account for the expected cluster variability in realising usual care or the intervention.\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eRegarding the primary and secondary hypotheses of RQ1: Main effects of presentation format on vaccination knowledge, the informed vaccination intention (higher for the fact box), accuracy of risk perception (more accurate for the fact box), patient involvement (more involvement if the fact box is presented), and decisional conflict (decrease with the fact box).\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eIn a secondary analysis, we restrict the main effect analysis to participants who reported that they had received the flyer with the study link in a counselling session when a potential vaccination had been discussed. This would examine the specific role of the intervention in health counselling.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eRegarding the primary hypotheses of RQ2: Main effects of presentation format on the vaccination intention (higher for the fact box), knowledge (higher for the fact box), and accuracy of risk perception (more accurate for the fact box) in each of the following disadvantaged groups:\u0026nbsp;low educated people, people with problematic or inadequate level of health literacy, people with low reading literacy, and non-native German speakers with low German skills). Furthermore, to show fact-box-driven alignment of informed vaccination intentions, knowledge, and accuracy of risk perception between more and less disadvantaged groups, we analyse four interaction effects\u0026nbsp;of presentation format with education, health literacy, German language skills, and reading literacy in mother tongue. We expect that differences between respective groups remain in the usual condition only.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eIn a secondary analysis, we repeat the interaction analysis with a dummy-coded variable representing more and less disadvantaged groups (at least\u0026nbsp;low educated, with problematic or inadequate level of health literacy, with low reading literacy, or being non-native German speaker with low German skills), according to which differences between more and less disadvantaged groups remain in the usual condition only.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eUnder control of the co-variate health literacy: main effects of presentation format on the vaccination intention (higher for the fact box), knowledge (higher for the fact box), and accuracy of risk perception (more accurate for the fact box) in each of the subgroups of\u0026nbsp;low educated, people with low subjective socioeconomic status (SSS), people with low reading literacy, and\u0026nbsp;non-native German speakers with low German skills).\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eInteraction effect of presentation format and mother tongue on knowledge score, according to which non-native German participants benefit from the fact box over proportion; under control of health literacy, subjective reading skills and education.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eRegarding the primary hypotheses of RQ3: Interaction effects of presentation format and setting on informed intentions and patient involvement, according to which the fact box effect is more effective in outreach work in this regard.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMissing data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe will record the number of flyer distributed per cluster (see\u0026nbsp;\u003cstrong\u003e\u003cem\u003eFigure\u003c/em\u003e\u003c/strong\u003e \u003cstrong\u003e\u003cem\u003e2\u003c/em\u003e\u003c/strong\u003e). As potential participants approached can participate in the trial voluntarily, anonymously and without the knowledge of their health educator, we will not be able to send a reminder and record the response rate accurately. However, we will record the numbers of the total randomised sample for each group, as well as the reasons for exclusion. In order to avoid missing data in the first survey (T1), it is compulsory for participants to answer all questions. As participation in the follow-up survey is voluntary, we will record the number of drop-outs from the first to the second survey.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and dissemantion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe evaluation study and its pre-studies have been reviewed and approved by the ethics committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022). The study will be conducted in accordance with the Declaration of Helsinki. All subjects must agree to participate in the study. Written informed consent will be obtained by the health educators prior to randomisation. Informed consent will be obtained online from study participants and/or their legal guardians after opening the QR code/link to the study on the flyer and all study and ethical information has been provided.\u003c/p\u003e\n\u003cp\u003eAny changes to the protocol that affect the conduct of the trial, as well as changes to the study design, patient population, sample size, primary outcomes, or statistical analysis plan, will be made transparent in the trial registration and final report.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe plan to disseminate our findings through publications in peer-reviewed journals, national and international conferences, and relevant working groups and networks (e.g. German Network for Evidence-Based Medicine, German Society for Public Health and Population Medicine), also targeting relevant community stakeholder.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevance\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe existing evidence on health inequalities and the lack of evaluation of evidence-based health information on health disparities demonstrate the need for research in this area. The aim of our study is to fill this gap and to evaluate the development of evidence summaries using the fact box format designed with an equity lens, outside of an experimental setting. The results will help determine if and how fact boxes can be used to improve health care in and outside of traditional primary care structures, especially for disadvantaged groups, and will thus provide valuable insights into advancing health care equity.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCOVID-19: Coronavirus Disease 2019\u003c/p\u003e\n\u003cp\u003eDA: Decision aid\u003c/p\u003e\n\u003cp\u003eEBHI:\u0026nbsp;Evidence-based health information\u003c/p\u003e\n\u003cp\u003eHC: Harding Center\u003c/p\u003e\n\u003cp\u003eHE: Health educators\u003c/p\u003e\n\u003cp\u003eHL: Health literacy\u003c/p\u003e\n\u003cp\u003eITT: Intention-to-treat\u003c/p\u003e\n\u003cp\u003eMRC: Medical research council\u003c/p\u003e\n\u003cp\u003eRKI\u003cstrong\u003e:\u0026nbsp;\u003c/strong\u003eRobert Koch-Institute\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSDM: Shared decision making\u003c/p\u003e\n\u003cp\u003eSES: Socioeconomic status\u003c/p\u003e\n\u003cp\u003eSSS: Subjective socioeconomic status\u003c/p\u003e"},{"header":"References","content":"\u003cp\u003e1. 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Rekrutierung von Hausarztpraxen f\u0026uuml;r Forschungsprojekte. \u003cem\u003eZeitschrift f\u0026uuml;r Allgemeinmedizin\u003c/em\u003e 2012;88(4):173-81.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCE and FGR designed the study. FGR has developed the statistical analysis plan. All authors conceptualised and designed the protocol. CE wrote the first draft of the manuscript and made the revisions. NS and FGR contributed to and critically revised the manuscript. All authors finally approved the manuscript.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable as no data has been generated or analysed yet.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors report no conflicts of interest in the conduct and reporting of this study.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank the Robert Koch Institute and Christoph Wilhelm for the initial development and further development of the materials that we will use in the study.\u003cins cite=\"mailto:Christin%20Ellermann\" datetime=\"2023-11-27T10:03\"\u003e\u0026nbsp;\u003c/ins\u003eWe would also like to thank those who provided valuable feedback on early drafts of the fact boxes, and Marike Pohlmann from the University of Erfurt, who tested the visualised flu fact box with German-speaking people with low numeracy skills as part of her master\u0026apos;s thesis. And we would like to thank Prof. Dr. Rahim Hajji from the University of Applied Sciences Magdeburg-Stendal for his constructive feedback on the study design and the operationalisation of vulnerability characteristics. We would also like to thank Tobias Prey from the Berlin Mitte District Office, Department of Quality Development, Planning and Coordination of the Public Health Service for his support in recruiting health educators.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Health inequity, informed decision making, fact box, evidence-based information, risk communication","lastPublishedDoi":"10.21203/rs.3.rs-3401234/v3","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3401234/v3","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSummaries of the best available evidence on the benefits and harms of different treatment options support informed decision making of well-educated participants under controlled conditions. However, few studies have investigated how such formats support decision-making across different social groups. There is a risk that these evidence summaries will only help less disadvantaged people to make informed health decisions – possibly increasing the health equity gap. It is also unclear whether they support decision-making in the field at all. The aim of our study is to assess whether evidence summaries based on the fact box format can help people from different social groups make informed decisions about COVID-19 and influenza vaccination, and to investigate whether these fact boxes can help reduce inequities in health communication.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods and analysis\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn a multicentre, cluster-randomised, controlled trial, health educators (HEs) from usual care (e.g. physicians) and outreach work (e.g. social services) in Germany will be randomised to provide either usual health communication plus an evidence summary (‘fact box’) or usual health communication. As part of their health education programme, HEs provide people who are about to make a decision about COVID-19 or flu vaccination with a flyer containing a link to an online study either with (intervention) or without (control) fact box on the reverse side. The flyer and online study will be available in Arabic, German, Turkish and Russian language. The primary outcome is informed vaccination intention, based on vaccination knowledge, attitudes, intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision making. Data analysis will initially be based on descriptive statistics as well as frequency distributions and histograms to identify outliers and missing data. We will use linear mixed models to analyse the influence of both individual (e.g. education status, health literacy) and cluster level factors (e.g. setting) and account for the expected cluster variability in realising usual health communication or the intervention. The statistical analysis plan includes the selection of appropriate measures of effect size and power calculation.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eEthics and dissemination\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study and its pre-studies have been reviewed and approved by the ethics committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022).\u003c/p\u003e\n\u003cp\u003eWe plan to disseminate our findings through publications in peer-reviewed journals, national and international conferences, and relevant working groups and networks, also targeting relevant community stakeholder.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003e\u003c/em\u003eclinicaltrials.gov (NCT06076421)\u003c/p\u003e","manuscriptTitle":"Do summaries of evidence enable informed decision-making about COVID-19 and flu vaccination equitably across more and less disadvantaged groups? - Study protocol for a multi-center cluster RCT with ‘fact boxes’ in health and social care in Germany","msid":"","msnumber":"","nonDraftVersions":[{"code":3,"date":"2023-11-28 16:39:48","doi":"10.21203/rs.3.rs-3401234/v3","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":2,"date":"2023-11-09 19:25:38","doi":"10.21203/rs.3.rs-3401234/v2","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":1,"date":"2023-10-09 21:47:20","doi":"10.21203/rs.3.rs-3401234/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"532393c8-f99c-4f09-8132-cf8f6e3bb51f","owner":[],"postedDate":"November 28th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2023-10-13T10:14:34+00:00","versionOfRecord":[],"versionCreatedAt":"2023-11-28 16:39:48","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v3","identity":"rs-3401234","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3401234","identity":"rs-3401234","version":["v3"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}