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Caring for Frail Patients Through Vaccination

Caring for Frail Patients Through Vaccination

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06127563
Acronym
CAREVAX
Enrollment
1500
Registered
2023-11-13
Start date
2024-07-17
Completion date
2027-07-17
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination Uptake

Brief summary

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

OTHERcreation 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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patients' drop out proportion24 monthsNumber of patients who drop out or are lost to follow-up versus the total number of patients recruited.
Vaccinated against influenza at 12 months12 monthsProportion of participants vaccinated against influenza 12 months after the beginning of the study
Vaccinated against influenza at 6 months6 monthsProportion of participants vaccinated against influenza 6 months after the beginning of the study
Vaccinated against COVID19 at 24 months24 monthsProportion of participants fully vaccinated against Covid19 24 months after the beginning of the study
Vaccinated against COVID19 at 12 months12 monthsProportion of participants fully vaccinated against Covid19 12 months after the beginning of the study
Vaccinated against COVID19 at 6 months6 monthsProportion of participants fully vaccinated against Covid19 6 months after the beginning of the study
Algorithm clinician concordance - initial sample of patientsAt the startConcordance between the clinician's and the algorithm's judgments on patient eligibility for vaccination, measured on a sample of patients.
Algorithm clinician concordance24 monthsThe proportion of vaccinations confirmed by physicians compared to those proposed by the algorithm.
Feasibility in reaching the patients24 monthsNumber of patients successfully contacted to offer a vaccination appointment after being considered eligible compared to the number of patients flagged by the algorithm.
Acceptability of the vaccination offer24 monthsNumber of patients consenting to vaccination appointments compared to the number of patients contacted.
Logistical feasibility of the vaccination pathway24 monthsNumber of patients presenting to vaccination centers (Hospital or Local Health Authority) compared to the number who have booked a vaccination appointment.
Vaccinated against influenza at 24 months24 monthsProportion of participants vaccinated against influenza 24 months after the beginning of the study

Secondary

MeasureTime frameDescription
Vaccinated against Herpes Zoster virus at 24 months24 monthsProportion of participants vaccinated against Herpes Zoster virus 24 months after the beginning of the study
Vaccinated against Pneumococcus at 24 months24 monthsProportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study
Vaccinated against Hepatitis B virus at 12 months12 monthsProportion of participants vaccinated against Hepatitis B virus 12 months after the beginning of the study
Vaccinated against Herpes Zoster virus at 12 months12 monthsProportion of participants vaccinated against Herpes Zoster virus 12 months after the beginning of the study
Vaccinated against Pneumococcus at 12 months12 monthsProportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study
Vaccinated against Hepatitis B virus at 6 months6 monthsProportion of participants vaccinated against Hepatitis B virus 6 months after the beginning of the study
Vaccinated against Herpes Zoster virus at 6 months6 monthsProportion of participants vaccinated against Herpes Zoster virus 6 months after the beginning of the study
Vaccinated against Pneumococcus at 6 months6 monthsProportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study
Alerts generated by the algorithm at 24 months24 monthsNumber of vaccination alerts generated by the algorithm among the study participants in the first 24 months after the beginning of the study
Vaccinated against Hepatitis B virus at 24 months24 monthsProportion of participants vaccinated against Hepatitis B virus 24 months after the beginning of the study

Countries

Italy

Contacts

Primary ContactPatrizia Laurenti
patrizia.laurenti@policlinicogemelli.it+390630155701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026