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-center Cluster RCT in Health and Social Care in Germany
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Knowledge
研究概览
简要总结
The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Furthermore, the study will investigate whether evidence-based fact boxes can contribute to more equitable health care by improving shared decision-making.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults of legal age with current residence in Germany and who speak Arabic, German, Russian, Turkish
- •People who are currently facing a decision about COVID-19 or influenza vaccination for themselves or a family member (e.g. caring relatives)
- •Informed online consent
排除标准
- •Language other than Arabic, German, Russian, Turkish
- •People without a current vaccination decision
- •No informed consent
研究组 & 干预措施
Evidence-based fact box on COVID-19 or influenza (intervention)
Health educators (HE) will receive a flyer with a brief description of the study, a Quick Response-code (QR-code) and a link to an online survey, including either a fact box as tabular format or a visualization on the reverse side about COVID-19 or the flu vaccine to distribute to potential study participants. HE are free to decide if and how to use the fact boxes: whether during, before or after vaccination education, and who to target.
Participants who receive the flyer from their HE can decide on their own to participate in the study by using the QR-code or link on the flyer.
干预措施: Fact box (Other)
Usual education/care
Study participants whose HE will be randomised to the control will receive the same flyer but without a fact box on the reverse side.
结局指标
主要结局
Knowledge
时间窗: at T1 (initial survey; study period: 3-6 month)
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 intention
时间窗: at T1 (initial survey; study period: 3-6 month)
Based on vaccination knowledge, 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. 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).
次要结局
- Risk perception(at T1 (initial survey; study period: 3-6 month))
- Patient involvement in decision making(at T1 (initial survey; study period: 3-6 month))
- Decisional conflict(at T1 (initial survey; study period: 3-6 month))
研究者
Felix G. Rebitschek
Head Research Scientist and CEO
Harding Center for Risk Literacy