The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage in Adults At Risk in General Practice: a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vaccination coverage rate (VCR)
研究概览
简要总结
The goal of this cluster-randomized trial is to study the effect of Audit and Feedback loops on pneumococcal vaccination coverage rate in adults at risk in general practice.
The main questions it aims to answer are:
- To assess the effect of "clinical AUDIT and feedback" loops on the pneumococcal vaccination coverage rate in adults at risk in general practice.
- To explore whether the increase in vaccination coverage rate after implementation of Audit and Feedback loops is different in specific subgroups (risk groups, male/female, age, smoking status).
Every general practice center assigned to the control or intervention group will have access to a clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. The general practice centers in the intervention group will also receive an individualized extended electronic feedback report, with multiple components like benchmarked performances and action plans, at baseline and each 2 months from baseline onwards.
详细描述
Background and rationale:
In March 2020, the INTEGO group published a study on pneumococcal vaccination status in Flanders (De Burghgraeve et al. The incidence of lower respiratory tract infections and pneumococcal vaccination status in adults in Flemish primary care. 2020, Acta Clin Belg. (DOI: 10.1080/17843286.2020.1735113)). Unlike pediatric vaccination, there is a low pneumococcal vaccination coverage rate (VCR) in adults in Flanders (187/1000 risk patients), which is possibly a public health problem. Recently the Belgian Superior Health Council published a new scientific recommendation on pneumococcal vaccination in adults (https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/hgr_9562_vaccinatie_tegen_pneumokokken_vweb.pdf). It might be beneficial to use the INTEGO registry to monitor and improve the vaccination coverage rate. This could be done by including AUDIT and feedback (A&F) loops to evaluate and improve the quality of care provided to patients. A&F is a well-known quality intervention that according to the last Cochrane review leads to "small but potentially important improvements in professional practice" (Ivers N et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012, 6:Cd000259). Furthermore, the data generated by this study will also support the implementation of a Publicly Funded Program for pneumococcal vaccination for older adults in Flanders and generate the needed data and insights to prepare for the launches of future pneumococcal vaccines in Belgium. Therefore, this study will investigate the effect of A&F on pneumococcal vaccination coverage in adults at risk in general practice.
Design:
This study will be a cluster-randomized trial: primary care practices will be randomized and divided into a control and intervention group. Allocation of control and intervention groups will be done by simple balanced randomization (1:1).
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the study it is not possible to blind at the practice level. Physicians will always be aware to which group they belong. At Healthdata (data collection) practices included in the intervention group will be identified so the extended feedback report can be made available only to them.
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion in the study, general practice (GP) centers must conform to the following conditions:
- •It is a Flemish GP center in the INTEGO network.
- •The GP center uses an electronic health record (EHR), automatically linked to the INTEGO database.
- •The physician (one per center, in name of all GPs in that center) signs a specific study consent form.
- •To be eligible for inclusion in the study, patients must conform to the following conditions:
- •The patient belongs to a target group for pneumococcal vaccination (based on https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/hgr_9562_vaccinatie_tegen_pneumokokken_vweb.pdf):
- •A. Adults aged 16 - 85 years old with a high risk for a pneumococcal infection
- •Adults with an immunity disorder
- •Adults with anatomical and / or functional asplenia, sickle-cell disease or hemoglobinopathy
- •Adults with cerebrospinal fluid or cochlear implant leakage B. Adults (aged 50 - 85 years old) with comorbidity
- •Chronic cardiac disease
- •Chronic pulmonary disease or smoker
- •Chronic liver disease or ethylabusus
- •Chronic kidney disease
- •Chronic neurological or neuromuscular disorders with aspiration risk
- •Diabetes mellitus C. Healthy persons aged 65 - 85 years old
- •The patient has an electronic medical record (EMR) in the participating general practice centre. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.
排除标准
- •Patients excluded from feedback: patients not belonging to one of the target groups for pneumococcal vaccination.
- •Patients excluded from AUDIT: patients not belonging to one of the target groups for pneumococcal vaccination OR
- •Correctly vaccinated high-risk patients (PPV23 less than 5 years ago AND PCV13 ever received)
- •Correctly vaccinated adults with comorbidity (1) PCV13 ever received AND PPV23 less than 5 years ago, OR 2) PCV13 ever received AND 2x PPV23 vaccination more than 5 years ago)
- •Correctly vaccinated healthy persons (PPV23 ever received)
研究组 & 干预措施
Intervention group
The INTEGO practices (INTEGO is a GP morbidity registry in Flanders Belgium) that will be assigned to the intervention group will receive an extended electronic feedback report with multiple components, directly implemented in their EHR (electronic health record), on the pneumococcal vaccination coverage in adults at risk in their practice ('push system'). There will be a direct connection between the EHR of the practice and a SAS visual analytics tool in the Healthdata environment (single-sign-on connection), that will show the extended feedback. This report will be available at baseline and updated every two months based on the current situation.
干预措施: AUDIT and Feedback (Other)
Control group
Every GP center assigned to the control group will only have access to the clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. GP centers in the control group will not receive an extended feedback report at baseline and every 2 months afterwards.
干预措施: AUDIT and Feedback (Other)
结局指标
主要结局
Vaccination coverage rate (VCR)
时间窗: 12 months
Vaccination coverage rate (VCR) in the three defined risk groups for pneumococcal infections.
次要结局
- Vaccination coverage rate (VCR) in specific subgroups(12 months)
研究者
Bert Vaes
Associate Professor
KU Leuven