Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06127563

Caring for Frail Patients Through Vaccination

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-12

1500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a clinical pathway designed to improve vaccination rates among frail patients at Fondazione Policlinico Universitario "A. Gemelli" IRCCS. The study focuses on increasing immunization against pneumococcal disease, herpes zoster, influenza, hepatitis B virus, and COVID-19 to reduce hospital stays, long-term complications, and deaths. This approach aligns with the National Plan for Vaccine Prevention and recent Ministry of Health guidelines from 2017 to 2023. The intervention uses an automated algorithm applied to patients' electronic health records and vaccination histories to identify those eligible for vaccination. Depending on their frailty, patients will be invited for vaccination either at hospital vaccine clinics for extremely vulnerable individuals or at Local Health Unit clinics for other frail patients. The study also includes validating the algorithm's agreement with clinician judgments and establishing a digital system for booking and reminding patients about vaccination appointments. Participants will be monitored up to 24 months, with assessments including vaccination rates at 6, 12, and 24 months for influenza, COVID-19, hepatitis B, herpes zoster, and pneumococcus. Researchers will evaluate the algorithm's accuracy, feasibility of reaching patients, acceptability of the vaccination offer, logistical aspects of the vaccination process, and patient dropout rates. The study aims to enhance communication with patients and improve vaccination coverage through coordinated care between hospital and local services.

CONDITIONS

Brief Title

Caring for Frail Patients Through Vaccination

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients who do not fulfill one or more inclusion criteria

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 24 months

Participants who undergo routine care are observed for vaccination status and adherence to the clinical pathway over time.

Assessments at 6, 12, and 24 months

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

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Research Team

P

Patrizia Laurenti

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Digital integration between hospitals and local health authorities for enhanced vaccination coverage among frail patients: the CareVax study protocol.

Alberto Lontano, Luca Regazzi, Diego Maria Tona...

https://pubmed.ncbi.nlm.nih.gov/39949559