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临床试验/NCT07391046
NCT07391046尚未招募不适用

Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 1,500 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
主要终点
Vaccination Offer Rate

研究概览

简要总结

AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.

The study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.

The study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.

详细描述

Vaccination coverage among hospitalized and chronically ill patients remains suboptimal despite strong national and international recommendations. Hospital settings represent a strategic opportunity to identify vulnerable patients, reduce missed vaccination opportunities, and improve access to preventive services.

AMBU-VAX is a prospective observational study conducted at Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome. The study targets adult patients affected by chronic diseases or immunocompromising conditions eligible for recommended vaccinations according to the Italian National Immunization Plan 2023-2025.

Patients are identified during outpatient visits, hospital admissions, or at discharge. Vaccination is actively proposed and, when accepted, administered within the hospital vaccination clinic or ward. When appropriate, patients are referred to local vaccination services to complete their immunization schedule.

Primary outcomes include vaccination offer, vaccine uptake, number of administered doses, and completion of vaccination pathways within the hospital setting. Secondary outcomes include reasons for vaccine refusal and referral to territorial vaccination services.

The study aims to assess the feasibility, effectiveness, and sustainability of a hospital-based vaccination model that can be replicated in other healthcare settings.

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

入选标准

  • Adults aged ≥18 years
  • Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
  • Written informed consent provided

排除标准

  • Age <18 years
  • Conditions not included among the predefined eligibility criteria

结局指标

主要结局

Vaccination Offer Rate

时间窗: 12 months

Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.

Vaccination Uptake Rate

时间窗: 12 months

Proportion of patients who receive at least one vaccination among those evaluated.

Number of Administered Vaccine Doses

时间窗: 12 months

Number of doses administered by vaccine type

Completion of Hospital-Based Vaccination Pathway

时间窗: 12 months

Proportion of patients completing all scheduled vaccine doses within the hospital setting.

次要结局

  • Reasons for Vaccine Refusal(12 months)
  • Referral to Territorial Vaccination Services(12 months)
  • Specialist Evaluation for Contraindications(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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