Background
Evidence-based health information (EBHI) and decision aids (DA) are key components for
improving health care by enabling more people to make informed decisions. However, despite
their overall effectiveness, there is a risk that only certain groups of the population will
benefit from them. Because although they are target group oriented, the factors that lead to
inequality in terms of shared and informed decision-making have not yet been sufficiently
taken into account in their development process. 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).
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.
Objective
In a Multi-center, cluster-randomised, cross-sectional study, the effectiveness of
evidence-based fact boxes (intervention) compared with usual health education/care (control)
on outcomes relevant to the decision to vaccinate will be investigated in people from
different backgrounds in Germany.
Fact boxes on COVID-19 and influenza vaccination have been adapted in several steps to meet
the information needs and requirements of the population. This included feedback from various
public health stakeholders on a COVID-19 fact box implemented in Germany in January 2021 by a
national Public Health institute, the identification of information needs and requirements of
the population in Germany based on secondary data analyses, and testing of COVID-19 fact
boxes in pre-studies in population-wide surveys with N=1,942 to N=6,056 respondents in
Germany. The data basis and individual studies have been described in detail elsewhere.
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, simplified COVID-19 and Influenza vaccination
fact boxes were first piloted with German-speaking laypeople and adapted based on their
feedback. Visualized COVID-19 fact boxes were also piloted with Arabic-, Turkish- and
Russian-speaking laypeople from disadvantaged neighbourhoods in Berlin. A visualized flu fact
box is currently being piloted by the University of Erfurt with German-speaking lay people.
Main research question
Do disadvantaged people 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
Compared to standard vaccine communication, fact boxes will lead to higher vaccination
knowledge.
Compared to standard vaccine communication, fact boxes will lead to more vaccination
intentions that are in line with attitudes and vaccination knowledge (informed
vaccination intentions; operationalised based on the multidimensional construct of
informed choice by Marteau et al. 2001).
Secondary HYP
Compared to standard vaccine communication, fact boxes will improve risk perception.
Compared to standard vaccine communication, fact boxes will increase patient involvement
in medical decision making.
Compared to standard vaccine communication, fact boxes will decrease decisional
conflict.
RQ2 Are fact boxes as effective for people with disadvantaging factors as for those without
factors associated with disadvantages?
Primary HYP
Compared to standard vaccine communication, fact boxes will lead to a greater alignment of
knowledge, informed vaccination intentions, and accuracy of risk perception between:
People with low and high education through fact boxes compared to usual care.
People with problematic or inadequate and excellent or sufficient level of health
literacy through fact boxes compared to usual care.
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), because the investigators not only provide information in the native language,
but also tested it with these target groups.
People with low and high reading literacy in different languages, because fact boxes are
a complexity-reduced format of health information and the investigators 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) Compared to standard vaccine communication fact boxes will more likely lead to more
informed vaccination intentions and shared decisions in outreach work than in regular health
care settings.
Explorative analyses
The investigators will analyse the effect of fact boxes on knowledge, vaccination
intentions, accuracy of risk perception between people with low and medium or high SSS
through fact boxes compared to usual care.
The investigators 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)
compared to usual care, controlling for other factors describing the social situation
(e.g., education, health literacy).