在有医学风险的儿童中推动 COVID-19 和流感疫苗接种:澳大利亚儿科门诊进行的随机对照试验的 EPIC 研究方案。
Nudging towards COVID-19 and influenza vaccination uptake in medically at-risk children: EPIC study protocol of randomised controlled trials in Australian paediatric outpatient clinics.
机构信息
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Adelaide, South Australia, Australia.
Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
出版信息
BMJ Open. 2024 Feb 17;14(2):e076194. doi: 10.1136/bmjopen-2023-076194.
INTRODUCTION
Children with chronic medical diseases are at an unacceptable risk of hospitalisation and death from influenza and SARS-CoV-2 infections. Over the past two decades, behavioural scientists have learnt how to design non-coercive 'nudge' interventions to encourage positive health behaviours. Our study aims to evaluate the impact of multicomponent nudge interventions on the uptake of COVID-19 and influenza vaccines in medically at-risk children.
METHODS AND ANALYSES
Two separate randomised controlled trials (RCTs), each with 1038 children, will enrol a total of approximately 2076 children with chronic medical conditions who are attending tertiary hospitals in South Australia, Western Australia and Victoria. Participants will be randomly assigned (1:1) to the standard care or intervention group. The nudge intervention in each RCT will consist of three text message reminders with four behavioural nudges including (1) social norm messages, (2) different messengers through links to short educational videos from a paediatrician, medically at-risk child and parent and nurse, (3) a pledge to have their child or themselves vaccinated and (4) information salience through links to the current guidelines and vaccine safety information. The primary outcome is the proportion of medically at-risk children who receive at least one dose of vaccine within 3 months of randomisation. Logistic regression analysis will be performed to determine the effect of the intervention on the probability of vaccination uptake.
ETHICS AND DISSEMINATION
The protocol and study documents have been reviewed and approved by the Women's and Children's Health Network Human Research Ethics Committee (HREC/22/WCHN/2022/00082). The results will be published via peer-reviewed journals and presented at scientific meetings and public forums.
TRIAL REGISTRATION NUMBER
NCT05613751.
简介
患有慢性疾病的儿童因流感和 SARS-CoV-2 感染而住院和死亡的风险高得令人无法接受。在过去的二十年中,行为科学家已经学会了如何设计非强制性的“推动”干预措施来鼓励积极的健康行为。我们的研究旨在评估多组分推动干预措施对有医疗风险的儿童接种 COVID-19 和流感疫苗的影响。
方法和分析
两项独立的随机对照试验(RCT),每项试验纳入 1038 名儿童,总共将纳入约 2076 名患有慢性疾病并正在南澳大利亚、西澳大利亚和维多利亚州的三级医院就诊的儿童。参与者将被随机分配(1:1)到标准护理或干预组。每个 RCT 的推动干预将包括三条带有四个行为推动的短信提醒,包括(1)社会规范信息,(2)通过链接到儿科医生、有医疗风险的儿童和父母以及护士的简短教育视频中的不同信息传递者,(3)承诺让他们的孩子或自己接种疫苗,以及(4)通过链接到当前指南和疫苗安全信息来突出信息。主要结局是在随机分组后 3 个月内至少接种一剂疫苗的有医疗风险的儿童比例。将进行逻辑回归分析,以确定干预对疫苗接种率的影响。
伦理和传播
该方案和研究文件已由妇女和儿童健康网络人类研究伦理委员会(HREC/22/WCHN/2022/00082)审查和批准。结果将通过同行评议的期刊发表,并在科学会议和公共论坛上展示。
试验注册号
NCT05613751。