Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 20, 2022
Date Accepted: Jan 3, 2023
Date Submitted to PubMed: Jan 4, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Development and evaluation of communication interventions to support decisions about COVID-19 vaccination among patients with underlying medical conditions: Protocol for a randomized controlled trial
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 due to their health status. While 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 develop and evaluate a communication tool for patients with underlying medical conditions who should decide whether they receive the COVID-19 vaccine.
Methods:
This is a three-arm prospective randomized controlled trial (RCT) will test the effect of the developed communication intervention, patient decision aid (SMART-DA), and user-centered information (SMART-DA-α) as implementation strategies to help decision-making on COVID-19 vaccination among patients with underlying medical conditions. Over 450 patients will be enrolled and randomly assigned to one of three equal groups stratified by their underlying disease, gender, age, and COVID-19 vaccine willingness. SMART-DA-α provides additional information which is targeted to help patients decision-making on COVID-19 vaccination. Implementation outcomes are COVID-19 vaccination intention and knowledge about the vaccine, decisional conflict, stress-related to decision-making, and attitudes towards the vaccination.
Results:
This study was funded in 2020 and approved by Clinical Research information Service, Republic of Korea. Data were collected from December 2021 to January 2022. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2022.
Conclusions:
We believe the outcomes from this study provide valuable new insights into the potential decision aids for supporting informed decision-making about COVID-19 vaccination and discovering barriers to making an informed decision, especially among patients with underlying medical conditions. This study will provide knowledge about common needs, fears, and perceptions towards vaccines among patients which can help tailor information for individuals and develop policies to support them. Ultimately this study aims to increase COVID-19 vaccine coverage among patients with underlying diseases via providing a web-based intervention that allows patients to learn about COVID-19 vaccination and promotes vaccination via stimulating informed decision-making. Clinical Trial: Korea Clinical Information Service, cris.nih.go.kr, KCT0006945. Registered on January 20, 2022.
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