Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years

Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines

Written informed consent provided

Disqualifiers

Age <18 years

Conditions not included among the predefined eligibility criteria

Trial population

The study population includes adult patients (≥18 years) with chronic diseases or immunocompromising conditions who are eligible for recommended vaccinations according to the Italian National Immunization Plan 2023-2025. Patients are identified during outpatient visits, hospital admissions, or at discharge from the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. The population includes both male and female patients and reflects a broad spectrum of chronic and immunocompromising conditions, including cancer, solid organ transplantation, hematopoietic stem cell transplantation, autoimmune diseases, chronic kidney disease, HIV infection, asplenia, and frailty.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hospital-Based Vaccination Pathway

    Biological/Vaccine

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Vaccination Offer Rate

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

Time frame
12 months
2

Vaccination Uptake Rate

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

Time frame
12 months
3

Number of Administered Vaccine Doses

Number of doses administered by vaccine type

Time frame
12 months
4

Completion of Hospital-Based Vaccination Pathway

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

Time frame
12 months

Secondary outcomes

1

Reasons for Vaccine Refusal

Distribution of reported reasons for refusal among patients offered vaccination.

Time frame
12 months
2

Referral to Territorial Vaccination Services

Proportion of patients referred to local public health vaccination services.

Time frame
12 months
3

Specialist Evaluation for Contraindications

Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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