Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients

NCT07391046 — Not yet recruiting, 1500 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

RegistryNCT07391046, acronym AMBU-VAX
StatusNot yet recruiting
Study typeObservational
Enrollment1500 (Estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS (Other); collaborators: Pfizer
ConditionsChronic Disease, Immunocompromised, HIV Infection, Chronic Kidney Disease, Solid Organ Transplantation, Hematopoietic Stem Cell Transplantation, Cancer, Autoimmune Diseases, Inflammatory Bowel Disease, Asplenia, Frailty
InterventionsHospital-Based Vaccination Pathway (Biological)
Datesstart 2026-02-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-02-05, last updated 2026-02-05

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-Summary

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.

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+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.

+Arms and interventions

  • Hospital-Based Vaccination Pathway (Biological): 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.

+Outcome measures

Primary outcomes

  • Vaccination Offer Rate [12 months]: Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.
  • Vaccination Uptake Rate [12 months]: Proportion of patients who receive at least one vaccination among those evaluated.
  • Number of Administered Vaccine Doses [12 months]: Number of doses administered by vaccine type
  • Completion of Hospital-Based Vaccination Pathway [12 months]: Proportion of patients completing all scheduled vaccine doses within the hospital setting.

Secondary outcomes

  • Reasons for Vaccine Refusal [12 months]: Distribution of reported reasons for refusal among patients offered vaccination.
  • Referral to Territorial Vaccination Services [12 months]: Proportion of patients referred to local public health vaccination services.
  • Specialist Evaluation for Contraindications [12 months]: Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators