Caring for Frail Patients Through Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Vaccinated against COVID19 at 24 months
研究概览
简要总结
The CareVax project aims to find frail patients at Fondazione Policlinico Universitario 'A. Gemelli' IRCCS who could benefit from vaccinations against pneumococcal, Zoster, flu, HBV and SARS-CoV-2. This will reduce hospital stays, long-term effects, and deaths related to these diseases, as outlined in the PNPV (National Plan for Vaccine Prevention) 2017-2019 and Ministry of Health circulars from September, October, December 2022, and January 2023. Eligible patients, upon consent, will be identified by applying an automated algorithm to the patient's electronic health record and vaccination history contained in the regional vaccination registry. Identified patients will be contacted either directly if they are admitted to the inpatient wards of the Fondazione Policlinico Universitario "A.Gemelli" IRCCS (FPG) Hospital, or by messaging or e-mail in the case of access to the FPG for follow-up or routine visits or day hospital or day surgery service. Patients contacted, depending on their frail condition, will be booked for vaccination at an hospital vaccine clinic (extremely vulnerable patients) or a Local Health Unit (ASL Roma1) vaccine clinic respectively (frail patients).
The project envisages a validation phase of the algorithm, through the evaluation of its concordance with the judgement of a blinded clinician on a small group of patients Patients' engagement and a proper communication system with them will be carried through an interoperable digital system aimed at booking the new vaccination appointment, reminding it and providing patients with all the information needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or more,
- •Patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology),
- •Medical residence in Lazio Region
排除标准
- •Patients who do not fulfill 1 or more inclusion criteria
结局指标
主要结局
Vaccinated against COVID19 at 24 months
时间窗: 24 months
Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study
Vaccinated against COVID19 at 12 months
时间窗: 12 months
Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study
Feasibility in reaching the patients
时间窗: 24 months
Number of patients successfully contacted to offer a vaccination appointment after being considered eligible compared to the number of patients flagged by the algorithm.
Vaccinated against influenza at 12 months
时间窗: 12 months
Proportion of participants vaccinated against influenza 12 months after the beginning of the study
Vaccinated against influenza at 6 months
时间窗: 6 months
Proportion of participants vaccinated against influenza 6 months after the beginning of the study
Vaccinated against COVID19 at 6 months
时间窗: 6 months
Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study
Vaccinated against influenza at 24 months
时间窗: 24 months
Proportion of participants vaccinated against influenza 24 months after the beginning of the study
Algorithm clinician concordance
时间窗: 24 months
The proportion of vaccinations confirmed by physicians compared to those proposed by the algorithm.
Algorithm clinician concordance - initial sample of patients
时间窗: At the start
Concordance between the clinician's and the algorithm's judgments on patient eligibility for vaccination, measured on a sample of patients.
Logistical feasibility of the vaccination pathway
时间窗: 24 months
Number of patients presenting to vaccination centers (Hospital or Local Health Authority) compared to the number who have booked a vaccination appointment.
Acceptability of the vaccination offer
时间窗: 24 months
Number of patients consenting to vaccination appointments compared to the number of patients contacted.
Patients' drop out proportion
时间窗: 24 months
Number of patients who drop out or are lost to follow-up versus the total number of patients recruited.
次要结局
- Vaccinated against Hepatitis B virus at 24 months(24 months)
- Vaccinated against Hepatitis B virus at 12 months(12 months)
- Vaccinated against Herpes Zoster virus at 12 months(12 months)
- Vaccinated against Pneumococcus at 12 months(12 months)
- Alerts generated by the algorithm at 24 months(24 months)
- Vaccinated against Herpes Zoster virus at 24 months(24 months)
- Vaccinated against Pneumococcus at 24 months(24 months)
- Vaccinated against Hepatitis B virus at 6 months(6 months)
- Vaccinated against Herpes Zoster virus at 6 months(6 months)
- Vaccinated against Pneumococcus at 6 months(6 months)