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

BackgroundThe 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...

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Main Authors: Minjung Lee, Bumjo Oh, Nan-He Yoon, Shinkyeong Kim, Young-Il Jung
Format: Article
Language:English
Published: JMIR Publications 2023-01-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2023/1/e42837
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author Minjung Lee
Bumjo Oh
Nan-He Yoon
Shinkyeong Kim
Young-Il Jung
author_facet Minjung Lee
Bumjo Oh
Nan-He Yoon
Shinkyeong Kim
Young-Il Jung
author_sort Minjung Lee
collection DOAJ
description BackgroundThe 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. ObjectiveThis 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. MethodsThis 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. ResultsThis 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. ConclusionsWe 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 RegistrationKorea Clinical Information Service KCT0006945; https://cris.nih.go.kr/cris/search/detailSearch.do/20965 International Registered Report Identifier (IRRID)DERR1-10.2196/42837
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spelling doaj.art-1cbacb2bc6564f3e9306342cd44926e52023-08-28T23:27:40ZengJMIR PublicationsJMIR Research Protocols1929-07482023-01-0112e4283710.2196/42837The Evaluation of Web-Based Communication Interventions to Support Decisions About COVID-19 Vaccination Among Patients With Underlying Medical Conditions: Protocol for a Randomized Controlled TrialMinjung Leehttps://orcid.org/0000-0002-0479-6523Bumjo Ohhttps://orcid.org/0000-0002-2468-0755Nan-He Yoonhttps://orcid.org/0000-0003-1268-0149Shinkyeong Kimhttps://orcid.org/0000-0003-2614-9711Young-Il Junghttps://orcid.org/0000-0002-4650-0524 BackgroundThe 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. ObjectiveThis 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. MethodsThis 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. ResultsThis 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. ConclusionsWe 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 RegistrationKorea Clinical Information Service KCT0006945; https://cris.nih.go.kr/cris/search/detailSearch.do/20965 International Registered Report Identifier (IRRID)DERR1-10.2196/42837https://www.researchprotocols.org/2023/1/e42837
spellingShingle Minjung Lee
Bumjo Oh
Nan-He Yoon
Shinkyeong Kim
Young-Il Jung
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 Research Protocols
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://www.researchprotocols.org/2023/1/e42837
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