COVER-ME：开发和评估基于社区的干预措施，以促进东伦敦少数族裔和服务不足人群对新冠病毒和流感疫苗的接种——一项试点随机对照试验方案

COVER-ME: developing and evaluating community-based interventions to promote vaccine uptake for COVID-19 and influenza in East London minority ethnicity (ME) and underserved individuals - protocol for a pilot randomised controlled trial.

作者信息

Chaudhry Tahreem, Tum Patricia, Tam Hui Zhen, Brentnall Adam, Smethurst Hector, Kielmann Karina, Kunst Heinke, Hargreaves Sally, Campbell Colin N J, Griffiths Chris, Zenner Dominik

机构信息

Wolfson Institute of Population Health, Queen Mary University of London, London, UK

Wolfson Institute of Population Health, Queen Mary University of London, London, UK.

出版信息

BMJ Open. 2025 Mar 18;15(3):e092568. doi: 10.1136/bmjopen-2024-092568.

DOI:10.1136/bmjopen-2024-092568

PMID:40107676

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11927436/

Abstract

INTRODUCTION

Under-vaccination among underserved groups remains low due to existing disparities. This is particularly the case with postpandemic COVID-19 vaccinations and other vaccine-preventable diseases, including measles, mumps, rubella or influenza. Therefore, we aim to (1) determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and influenza vaccinations and (2) define the appropriate level of support needed for healthcare providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and influenza vaccinations.

METHODS AND ANALYSIS

This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster levels. For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation, six GP (General Practitioner) practices will be randomised 1:1 and divided into two tranches at two separate time points. Both groups will receive training and software activation. Data will be analysed using statistical software R (V.4.0 or greater) or STATA (V.17 or greater). Baseline characteristics will be summarised and presented in groups based on an intention-to-treat basis with categorical data, including demographics, socioeconomic variables, comorbidities and vaccination status.

ETHICS AND DISSEMINATION

Ethical approval was granted by the Westminster Ethics Committee (ref: 316860). Our dissemination strategy targets three audiences: (1) policy makers, public and health service managers, and clinicians responsible for delivering vaccines and infection prevention services; (2) patients and public from underserved population groups and (3) academics.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov (NCT05866237).

摘要

引言

由于现存的差异，服务不足群体的疫苗接种率仍然较低。在大流行后的新冠疫苗接种以及其他疫苗可预防疾病（包括麻疹、腮腺炎、风疹或流感）方面尤其如此。因此，我们旨在：（1）确定实施患者参与工具（PET）的可行性和实用性，并获取重要见解，以规划后续的确定性随机对照试验（RCT），以评估该工具对提高新冠疫苗和流感疫苗接种率的有效性；（2）确定现场层面的医疗保健提供者确保PET成功实施所需的适当支持水平，并确定实施新冠疫苗和流感疫苗接种干预措施所需的支持活动。

方法与分析

这是一项随机对照可行性研究，评估共同设计的PET，涉及个体和群组层面的随机化。对于个体随机化，患者将按1:1的比例个体随机分组，以接受干预措施（PET）或常规护理；而对于群组随机化，六个全科医生诊所将按1:1的比例随机分组，并在两个不同的时间点分为两批。两组都将接受培训和软件激活。数据将使用统计软件R（版本4.0或更高）或STATA（版本17或更高）进行分析。基线特征将根据意向性分析进行汇总，并按组呈现分类数据，包括人口统计学、社会经济变量、合并症和疫苗接种状况。