Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician - a Cluster Randomized, Controlled and Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,400
- 试验地点
- 2
- 主要终点
- The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (those who will report having been vaccinated in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over
研究概览
简要总结
This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.
详细描述
This is an open-label trial with 2 arms: an interventional or "recall" arm and a "usual care" or control arm. Cluster randomization at the physician level was chosen to avoid contamination within the same patients group. Physicians will be randomized at the start of the vaccination campaign in one of the two arms (1:1), and all patients eligible (with a maximum of 210 per doctor) to be vaccinated will be recalled or not, depending on their GPs arm.
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
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for physicians are:
- •To be a GPs
- •To be based in Ile-de-France (Paris region, France)
- •To be a user of the Eo medical software
- •The patients inclusion criteria are:
- •belonging to the list of attending physicians of the participating GPs
- •being 65 years of age or older
- •having a medical file in the GP's Eo medical software
- •having been selected at random if the number of patients aged 65 or over exceeds 210 patients (for 44 participating GPs).
排除标准
- •Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)
结局指标
主要结局
The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (those who will report having been vaccinated in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over
时间窗: 12 months
The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (i.e., those who will report having been vaccinated during the vaccination campaign in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over.
次要结局
- 1/ Social inequalities related to the intervention, based on individual and ecological indicators (social deprivation index for example) will be estimated via absolute indicators (SII: slope of the inequality index) and relative (RII: relative inequality(1 year)
- 3/ Reasons for non-vaccination will be described (stratified by trial arm) based on the description of the patients answers to the related question in the questionnaires.This outcome is assessed by questionnaire.(1 year)
- 2/ Acceptability of reminders (in the intervention arm only) based on the description of the patients answers to the related question in the questionnaires. This outcome is assessed by questionnaire.(1 year)
- 4/ Characteristics of participating GPs based on the description of the physicians answers to the related question in the questionnaires. These outcomes are assessed by the physician questionnaire.(1 year)