Equity Evaluation of Fact Boxes on Informed COVID-19 and Influenza Vaccination Decisions - Study Protocol

NCT06076421 | Recruiting

• 1 other identifier: 57/2022
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Influenza

Keywords

health inequity; informed decision making; fact box; evidence-based health information; risk communication

Outcome Measures

Primary Outcomes (2)

• Knowledge

  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.

  at T1 (initial survey; study period: 3-6 month)

• Informed vaccination intention

  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).

  at T1 (initial survey; study period: 3-6 month)

Secondary Outcomes (3)

• Risk perception

  at T1 (initial survey; study period: 3-6 month)

• Decisional conflict

  at T1 (initial survey; study period: 3-6 month)

• Patient involvement in decision making

  at T1 (initial survey; study period: 3-6 month)

Other Outcomes (2)

• Health literacy

  at T1 (initial survey; study period: 3-6 month)

• Subjective socioeconomic status

  at T1 (initial survey; study period: 3-6 month)

Study Arms (2)

Evidence-based fact box on COVID-19 or influenza (intervention)

EXPERIMENTAL

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.

Other: Fact box

Usual education/care

NO INTERVENTION

Study participants whose HE will be randomised to the control will receive the same flyer but without a fact box on the reverse side.

Interventions

Fact box OTHER

Fact boxes provide a tabular or graphical overview of the benefits and harms of the COVID-19 or influenza vaccination through transparent risk communication. The fact boxes 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 in Arabic, German, Russian and Turkish.

Evidence-based fact box on COVID-19 or influenza (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Language other than Arabic, German, Russian, Turkish
• People without a current vaccination decision
• No informed consent

Sponsors & Collaborators

• Harding Center for Risk Literacy: lead

Study Sites (1)

Harding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam

Potsdam, Brandenburg, 14482, Germany

RECRUITING

Related Publications (9)

• Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.

  PMID: 11129362 BACKGROUND

• Pelikan JM, Link T, Strassmayr C, Waldherr K, Alfers T, Boggild H, Griebler R, Lopatina M, Miksova D, Nielsen MG, Peer S, Vrdelja M; HLS19 Consortium of the WHO Action Network M-POHL. Measuring Comprehensive, General Health Literacy in the General Adult Population: The Development and Validation of the HLS19-Q12 Instrument in Seventeen Countries. Int J Environ Res Public Health. 2022 Oct 29;19(21):14129. doi: 10.3390/ijerph192114129.

  PMID: 36361025 BACKGROUND

• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.

  PMID: 19879711 BACKGROUND

• Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.

  PMID: 20705870 BACKGROUND

• Rebitschek FG, Ellermann C, Jenny MA, Siegel NA, Spinner C, Wagner GG. Fact boxes that inform individual decisions may contribute to a more positive evaluation of COVID-19 vaccinations at the population level. PLoS One. 2022 Sep 12;17(9):e0274186. doi: 10.1371/journal.pone.0274186. eCollection 2022.

  PMID: 36095020 BACKGROUND

• Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001 Jun;4(2):99-108. doi: 10.1046/j.1369-6513.2001.00140.x.

  PMID: 11359540 BACKGROUND

• Durand MA, Yen RW, O'Malley AJ, Schubbe D, Politi MC, Saunders CH, Dhage S, Rosenkranz K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, Walling L, Marx CM, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bergin E, Goodwin C, Miller C, Harris C, Barth RJ Jr, Aft R, Feldman S, Cyr AE, Angeles CV, Jiang S, Elwyn G. What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata. Cancer. 2021 Feb 1;127(3):422-436. doi: 10.1002/cncr.33248. Epub 2020 Nov 10.

  PMID: 33170506 BACKGROUND

• Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.

  PMID: 21565651 BACKGROUND

• Ellermann C, Savaskan N, Rebitschek FG. Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of 'fact boxes' in health and social care in Germany. BMJ Open. 2024 Nov 1;14(10):e083515. doi: 10.1136/bmjopen-2023-083515.

  PMID: 39486820 DERIVED

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Christin Ellermann, MSc

  Harding Center for Risk Literacy

  PRINCIPAL INVESTIGATOR

• Felix G. Rebitschek, Dr.

  Harding Center for Risk Literacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christin Ellermann, MSc

CONTACT

+49 331 270 925 8; christin.ellermann@uni-potsdam.de

Felix G. Rebitschek, Dr.

CONTACT

+49 331-97998399; rebitschek@uni-potsdam.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Research Scientist and CEO

Model Details: Cluster randomised cross-sectional controlled trial with a 2x2-design with the between-subjects factors: format (usual care plus evidence-based fact box vs. usual care), health educator (cluster unit medical practice vs. cluster unit outreach work settings) taking into account various factors of disadvantage (e.g., low education).

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: November 17, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study.
• Access Criteria: All relevant data will be provided in the manuscript and supporting information or made available in a public repository (e.g., OSF) after completion of the study.

Locations

DE (1)