Intrahospital Vaccination and Active Counseling Versus Active Counseling Alone to Increase Seasonal Influenza immUnization in Patients at High Cardiovascular Risk in Germany: The Randomized Controlled VACC-UP Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 482
- 试验地点
- 2
- 主要终点
- Influenza vaccination rate at the end of the index influenza season
研究概览
简要总结
The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk.
Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO)
- •Written informed consent
排除标准
- •Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and/or vaccination certificate
- •Laboratory-confirmed active influenza infection during the index hospitalization
- •Contraindication for vaccination (e.g., known allergy)
- •Inability to provide written informed consent
结局指标
主要结局
Influenza vaccination rate at the end of the index influenza season
时间窗: From randomization to the end of the index influenza season (March 31), up to approximately 7 months
Proportion of patients vaccinated against seasonal influenza at the end of the index season (defined as March 31). For intervention group patients vaccinated during the index hospitalization, vaccination status is documented from inpatient medical records. For control group patients and intervention group patients who declined intrahospital vaccination, self-reported vaccination status is assessed by telephone interview beginning April 1 and cross-validated with data from the treating general practitioner.
次要结局
- Influenza vaccination rate at the end of the post-index influenza season(From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months)
- Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status(Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months)
- Patient satisfaction with the offer of intrahospital influenza vaccination(During the index hospitalization, up to approximately 14 days)
研究者
Stephan Baldus
Principal Investigator, Director of Clinic III for Internal Medicine
University Hospital of Cologne