Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 524
- 试验地点
- 2
- 主要终点
- Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
研究概览
简要总结
Influenza virus has high morbidity rates during annual epidemics, with certain high-risk groups being particularly susceptible to complications and mortality. Vaccination is the main prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains low.
Some studies suggest that short, standardized interventions can improve coverage of several vaccines.
Hypothesis: Brief Intervention is an effective tool in improving vaccination coverage in people who have initially rejected it.
Objective: To determine the effectiveness of a Brief Intervention in increasing influenza vaccination (IIV) coverage compared with the usual advice in people who refuse it.
Method: cluster randomized clinical trial. The study population was individuals with high risk factors who initially refused the influenza vaccine. Professionals participants (doctors and nurses) were assigned randomly to the intervention group (brief intervention) and the control group (usual advice).
详细描述
General objective: To determine the effectiveness of the use of BI for IIV compared to the usual advice, in people who refuse to be vaccinated.
Specific objectives:
- To examine the effectiveness of Brief Intervention compared to the usual advice in different risk groups (> 60 healthy, > 60 years old with a Risk Factor [RF], <60 years old with RF).
- Quantify influenza vaccine coverage in people with the most frequent RF.
- Record the patients' reasons for refusing to be vaccinated.
METHOD A cluster randomized controlled clinical trial. The reference population consisted of patients assigned to and treated by urban and rural health centres in the centre of Catalonia, an area with a population of approximately 405,000. 135,648 were the risk factor population that could be vaccinated against influenza virus.
The study population consisted of individuals with high risk factors who were treated in healthcare centres during the 2017 influenza campaign.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals in high-risk groups for influenza (paediatric and adult)
- •Not intending to be vaccinated against the influenza virus during the current season.
- •Informed consent to participate. In case of paediatric patients, parents signed the consent and made decisions about vaccination.
排除标准
- •Language barrier
- •Mental or physical conditions which make it difficult for the patient or their relatives to make decisions.
- •Having previously participated in the pilot study.
结局指标
主要结局
Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
时间窗: up to 3 months
% of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history
Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
时间窗: up to 3 months
% of reluctant patients vaccinated against Influenza in the Intervention group or in the Control group. Measurement tool: Influenza vaccine registered in patient's medical history
次要结局
- Reasons for rejecting Influenza Vaccination(one day)
研究者
Raquel Muñoz Miralles
Primary Health Care Nurse
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina