Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hospital-Based Vaccination Pathway.
- Who it may be relevant to
- Registry conditions: Chronic Disease, Immunocompromised, HIV Infection, Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model
Overview
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.
Detailed description
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.
Interventions
- Biological Hospital-Based Vaccination Pathway
Integration of vaccination counseling, prescription, and administration into hospital care pathways for vulnerable adult patients, including coordination with local public health vaccination services. No experimental vaccine is used; all vaccines are administered according to national guidelines.
Primary outcome measures
- Vaccination Offer Rate [Time frame: 12 months]
- Vaccination Uptake Rate [Time frame: 12 months]
- Number of Administered Vaccine Doses [Time frame: 12 months]
- Completion of Hospital-Based Vaccination Pathway [Time frame: 12 months]
Secondary outcome measures (3)
- Reasons for Vaccine Refusal [Time frame: 12 months]
- Referral to Territorial Vaccination Services [Time frame: 12 months]
- Specialist Evaluation for Contraindications [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Adults aged ≥18 years
- Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
- Written informed consent provided
Exclusion criteria
- Age <18 years
- Conditions not included among the predefined eligibility criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07391046 · 8272