Do evidence-based fact boxes improve informed decision-making about COVID-19 and influenza vaccination in more and less disadvantaged groups equally? - Study protocol for a multi-centre cluster randomised controlled trial in health and social care in Germany

Abstract

Abstract Background Evidence-based fact boxes have been shown to support informed decision-making. However, few studies have analysed how the boxes support decision-making in different social groups. Further, it is unclear whether fact boxes promote informed and shared decision making equally when implemented by health educators (HE) in different settings. Hence, there is a risk that fact boxes will only help less disadvantaged people to make informed health decisions. The aim of our study is to assess whether fact boxes can help people from different social groups make informed decisions about COVID-19 and influenza vaccination, and whether they contribute to reducing inequities in health care. Methods In a multi-centre cluster randomised controlled trial, HE from usual care (e.g. doctors) and outreach work (e.g. from social services) in Germany will be recruited. HE who are randomized to receive the intervention will receive a flyer with a QR code and a link to an online survey to pass on to those who are about to make a vaccination decision. The back of the flyer contains an evidence-based fact box about COVID-19 or the influenza vaccine, which can be used to inform. HE who are randomized to control will receive the flyer without the fact box. 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, vaccination intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision making. The statistical analysis plan includes the selection of appropriate measures of effect size, sample size calculation, and significance testing. Discussion Failing to consider inequalities when developing and evaluating interventions that influence health decisions - such as evidence-based health information - exacerbates health inequities. The aim of our study is to find out whether evidence-based fact boxes developed with an equity lens work well in different settings where health communication takes place. 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. Trial registration: clinicaltrials.gov (NCT06076421)