The Evaluation of Web-Based Communication Interventions to Support Decisions About COVID-19 Vaccination Among Patients With Underlying Medical Conditions: Protocol for a Randomized Controlled Trial

Minjung Lee; Bumjo Oh; Nan-He Yoon; Shinkyeong Kim; Young-Il Jung

doi:10.2196/42837

The Evaluation of Web-Based Communication Interventions to Support Decisions About COVID-19 Vaccination Among Patients With Underlying Medical Conditions: Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2023 Jan 19:12:e42837. doi: 10.2196/42837.

Authors

Minjung Lee^{1

2}, Bumjo Oh³, Nan-He Yoon⁴, Shinkyeong Kim⁵, Young-Il Jung⁶

Affiliations

¹ Institute of Health and Environment, Seoul National University, Seoul, Republic of Korea.
² Department of Dental Education, Seoul National University, Seoul, Republic of Korea.
³ Department of Family Medcine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.
⁴ Division of Social Welfare and Health Administration, Wonkwang University, Ik-san, Republic of Korea.
⁵ Department of Public Health Sciences, Graduate School of Public Health, Seoul National University, Seoul, Republic of Korea.
⁶ Department of Environmental Health, Korea National Open University, Seoul, Republic of Korea.

PMID: 36599054
PMCID: PMC9855572
DOI: 10.2196/42837

Abstract

Background: The timeliness of raising vaccine acceptance and uptake among the public is essential to overcoming COVID-19; however, the decision-making process among patients with underlying medical conditions is complex, leading individuals to vaccine hesitancy because of their health status. Although vaccine implementation is more effective when deployed as soon as possible, vaccine hesitancy is a significant threat to the success of vaccination programs.

Objective: This study aims to evaluate the effectiveness of a communication tool for patients with underlying medical conditions who should decide whether to receive a COVID-19 vaccine.

Methods: This 3-arm prospective randomized controlled trial will test the effect of the developed communication intervention, which is fully automated, patient decision aid (SMART-DA), and user-centered information (SMART-DA-α). The web-based intervention was developed to help decision-making regarding COVID-19 vaccination among patients with underlying medical conditions. Over 450 patients will be enrolled on the web from a closed panel access website and randomly assigned to 1 of 3 equal groups stratified by their underlying disease, sex, age, and willingness to receive a COVID-19 vaccine. SMART-DA-α provides additional information targeted at helping patients' decision-making regarding COVID-19 vaccination. Implementation outcomes are COVID-19 vaccination intention, vaccine knowledge, decisional conflict, stress related to decision-making, and attitudes toward vaccination, and was self-assessed through questionnaires.

Results: This study was funded in 2020 and approved by the Clinical Research Information Service, Republic of Korea. Data were collected from December 2021 to January 2022. This paper was initially submitted before data analysis. The results are expected to be published in the winter of 2023.

Conclusions: We believe that the outcomes of this study will provide valuable new insights into the potential of decision aids for supporting informed decision-making regarding COVID-19 vaccination and discovering the barriers to making informed decisions regarding COVID-19 vaccination, especially among patients with underlying medical conditions. This study will provide knowledge about the common needs, fears, and perceptions concerning vaccines among patients, which can help tailor information for individuals and develop policies to support them.

Trial registration: Korea Clinical Information Service KCT0006945; https://cris.nih.go.kr/cris/search/detailSearch.do/20965.

International registered report identifier (irrid): DERR1-10.2196/42837.

Keywords: COVID-19; decision-making; patient decision aid; randomized controlled trial; vaccine.

©Minjung Lee, Bumjo Oh, Nan-He Yoon, Shinkyeong Kim, Young-Il Jung. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.01.2023.