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Recruiting NCT06127563

Caring for Frail Patients Through Vaccination

— Observational Vaccination Uptake

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: creation of a clinical pathway to increase vaccination coverage in frail patients.
Who it may be relevant to
Registry conditions: Vaccination Uptake. 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
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The CareVax project aims to find frail patients at Fondazione Policlinico Universitario 'A. Gemelli' IRCCS who could benefit from vaccinations against pneumococcal, Zoster, flu, HBV and SARS-CoV-2. This will reduce hospital stays, long-term effects, and deaths related to these diseases, as outlined in the PNPV (National Plan for Vaccine Prevention) 2017-2019 and Ministry of Health circulars from September, October, December 2022, and January 2023. Eligible patients, upon consent, will be identified by applying an automated algorithm to the patient's electronic health record and vaccination history contained in the regional vaccination registry. Identified patients will be contacted either directly if they are admitted to the inpatient wards of the Fondazione Policlinico Universitario "A.Gemelli" IRCCS (FPG) Hospital, or by messaging or e-mail in the case of access to the FPG for follow-up or routine visits or day hospital or day surgery service. Patients contacted, depending on their frail condition, will be booked for vaccination at an hospital vaccine clinic (extremely vulnerable patients) or a Local Health Unit (ASL Roma1) vaccine clinic respectively (frail patients). The project envisages a validation phase of the algorithm, through the evaluation of its concordance with the judgement of a blinded clinician on a small group of patients Patients' engagement and a proper communication system with them will be carried through an interoperable digital system aimed at booking the new vaccination appointment, reminding it and providing patients with all the information needed.

Interventions

  • Other creation of a clinical pathway to increase vaccination coverage in frail patients
    creation of a clinical pathway to increase vaccination coverage for frail patients, integrating hospital and local health units through an automated algorithm

Primary outcome measures

  • Vaccinated against influenza at 24 months [Time frame: 24 months]
  • Vaccinated against influenza at 12 months [Time frame: 12 months]
  • Vaccinated against influenza at 6 months [Time frame: 6 months]
  • Vaccinated against COVID19 at 24 months [Time frame: 24 months]
  • Vaccinated against COVID19 at 12 months [Time frame: 12 months]
  • Vaccinated against COVID19 at 6 months [Time frame: 6 months]
  • Algorithm clinician concordance - initial sample of patients [Time frame: At the start]
  • Algorithm clinician concordance [Time frame: 24 months]
  • Feasibility in reaching the patients [Time frame: 24 months]
  • Acceptability of the vaccination offer [Time frame: 24 months]
Secondary outcome measures (10)
  • Vaccinated against Hepatitis B virus at 24 months [Time frame: 24 months]
  • Vaccinated against Herpes Zoster virus at 24 months [Time frame: 24 months]
  • Vaccinated against Pneumococcus at 24 months [Time frame: 24 months]
  • Vaccinated against Hepatitis B virus at 12 months [Time frame: 12 months]
  • Vaccinated against Herpes Zoster virus at 12 months [Time frame: 12 months]
  • Vaccinated against Pneumococcus at 12 months [Time frame: 12 months]
  • Vaccinated against Hepatitis B virus at 6 months [Time frame: 6 months]
  • Vaccinated against Herpes Zoster virus at 6 months [Time frame: 6 months]
  • Vaccinated against Pneumococcus at 6 months [Time frame: 6 months]
  • Alerts generated by the algorithm at 24 months [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

\- Patients who do not fulfill 1 or more inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Publications

  • Lontano A, Regazzi L, Tona DM, Di Pumpo M, Porcelli M, Cacciuttolo MG, Parente P, Gasbarrini A, Grandaliano G, Panocchia N, Lopetuso L, Pasciuto T, Cadeddu C, Bruno S, Laurenti P, Pascucci D, Pastorino R. Digital integration between hospitals and local health authorities for enhanced vaccination coverage among frail patients: the CareVax study protocol. Front Public Health. 2025 Jan 30;13:1490244. PMID 39949559

Identifiers

NCT: NCT06127563 · 5819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗