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Recruiting

NCT Number: NCT06127563

Caring for Frail Patients Through Vaccination

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.

Recruiting

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Key information

Conditions

Vaccination Uptake

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Patrizia Laurenti

CONTACT

[email protected]

+390630155701

Patrizia Laurenti

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

creation of a clinical pathway to increase vaccination coverage in frail patients

Other

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

Primary outcomes

  1. Vaccinated against influenza at 24 months

    Time frame: 24 months

    Proportion of participants vaccinated against influenza 24 months after the beginning of the study

  2. Vaccinated against influenza at 12 months

    Time frame: 12 months

    Proportion of participants vaccinated against influenza 12 months after the beginning of the study

  3. Vaccinated against influenza at 6 months

    Time frame: 6 months

    Proportion of participants vaccinated against influenza 6 months after the beginning of the study

  4. Vaccinated against COVID19 at 24 months

    Time frame: 24 months

    Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study

  5. Vaccinated against COVID19 at 12 months

    Time frame: 12 months

    Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study

  6. Vaccinated against COVID19 at 6 months

    Time frame: 6 months

    Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study

  7. Algorithm clinician concordance - initial sample of patients

    Time frame: At the start

    Concordance between the clinician's and the algorithm's judgments on patient eligibility for vaccination, measured on a sample of patients.

  8. Algorithm clinician concordance

    Time frame: 24 months

    The proportion of vaccinations confirmed by physicians compared to those proposed by the algorithm.

  9. Feasibility in reaching the patients

    Time frame: 24 months

    Number of patients successfully contacted to offer a vaccination appointment after being considered eligible compared to the number of patients flagged by the algorithm.

  10. Acceptability of the vaccination offer

    Time frame: 24 months

    Number of patients consenting to vaccination appointments compared to the number of patients contacted.

  11. Logistical feasibility of the vaccination pathway

    Time frame: 24 months

    Number of patients presenting to vaccination centers (Hospital or Local Health Authority) compared to the number who have booked a vaccination appointment.

  12. Patients' drop out proportion

    Time frame: 24 months

    Number of patients who drop out or are lost to follow-up versus the total number of patients recruited.

Secondary outcomes

  1. Vaccinated against Hepatitis B virus at 24 months

    Time frame: 24 months

    Proportion of participants vaccinated against Hepatitis B virus 24 months after the beginning of the study

  2. Vaccinated against Herpes Zoster virus at 24 months

    Time frame: 24 months

    Proportion of participants vaccinated against Herpes Zoster virus 24 months after the beginning of the study

  3. Vaccinated against Pneumococcus at 24 months

    Time frame: 24 months

    Proportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study

  4. Vaccinated against Hepatitis B virus at 12 months

    Time frame: 12 months

    Proportion of participants vaccinated against Hepatitis B virus 12 months after the beginning of the study

  5. Vaccinated against Herpes Zoster virus at 12 months

    Time frame: 12 months

    Proportion of participants vaccinated against Herpes Zoster virus 12 months after the beginning of the study

  6. Vaccinated against Pneumococcus at 12 months

    Time frame: 12 months

    Proportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study

  7. Vaccinated against Hepatitis B virus at 6 months

    Time frame: 6 months

    Proportion of participants vaccinated against Hepatitis B virus 6 months after the beginning of the study

  8. Vaccinated against Herpes Zoster virus at 6 months

    Time frame: 6 months

    Proportion of participants vaccinated against Herpes Zoster virus 6 months after the beginning of the study

  9. Vaccinated against Pneumococcus at 6 months

    Time frame: 6 months

    Proportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study

  10. Alerts generated by the algorithm at 24 months

    Time frame: 24 months

    Number of vaccination alerts generated by the algorithm among the study participants in the first 24 months after the beginning of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Laurenti

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: CAREVAX

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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