Caring for Frail Patients Through Vaccination (CAREVAX)

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.

Study Overview

• Status: Recruiting
• Conditions: Vaccination Uptake
• Intervention / Treatment: Other: creation of a clinical pathway to increase vaccination coverage in frail patients

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Patrizia Laurenti; Phone Number: +390630155701; Email: patrizia.laurenti@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Patrizia Laurenti; Phone Number: +390630155701; Email: patrizia.laurenti@policlinicogemelli.it
      • Principal Investigator: Patrizia Laurenti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology) of teaching hospital A. Gemelli and whose sanitary residence is in Lazio Region (This criteria was inserted because as of now the italian digital infrastructure of the vaccination registry allows easy access only for Regional data) .

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccinated against influenza at 24 months	Proportion of participants vaccinated against influenza 24 months after the beginning of the study	24 months
Vaccinated against influenza at 12 months	Proportion of participants vaccinated against influenza 12 months after the beginning of the study	12 months
Vaccinated against influenza at 6 months	Proportion of participants vaccinated against influenza 6 months after the beginning of the study	6 months
Vaccinated against COVID19 at 24 months	Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study	24 months
Vaccinated against COVID19 at 12 months	Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study	12 months
Vaccinated against COVID19 at 6 months	Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study	6 months
Algorithm clinician concordance - initial sample of patients	Concordance between the clinician's and the algorithm's judgments on patient eligibility for vaccination, measured on a sample of patients.	At the start
Algorithm clinician concordance	The proportion of vaccinations confirmed by physicians compared to those proposed by the algorithm.	24 months
Feasibility in reaching the patients	Number of patients successfully contacted to offer a vaccination appointment after being considered eligible compared to the number of patients flagged by the algorithm.	24 months
Acceptability of the vaccination offer	Number of patients consenting to vaccination appointments compared to the number of patients contacted.	24 months
Logistical feasibility of the vaccination pathway	Number of patients presenting to vaccination centers (Hospital or Local Health Authority) compared to the number who have booked a vaccination appointment.	24 months
Patients' drop out proportion	Number of patients who drop out or are lost to follow-up versus the total number of patients recruited.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccinated against Hepatitis B virus at 24 months	Proportion of participants vaccinated against Hepatitis B virus 24 months after the beginning of the study	24 months
Vaccinated against Herpes Zoster virus at 24 months	Proportion of participants vaccinated against Herpes Zoster virus 24 months after the beginning of the study	24 months
Vaccinated against Pneumococcus at 24 months	Proportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study	24 months
Vaccinated against Hepatitis B virus at 12 months	Proportion of participants vaccinated against Hepatitis B virus 12 months after the beginning of the study	12 months
Vaccinated against Herpes Zoster virus at 12 months	Proportion of participants vaccinated against Herpes Zoster virus 12 months after the beginning of the study	12 months
Vaccinated against Pneumococcus at 12 months	Proportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study	12 months
Vaccinated against Hepatitis B virus at 6 months	Proportion of participants vaccinated against Hepatitis B virus 6 months after the beginning of the study	6 months
Vaccinated against Herpes Zoster virus at 6 months	Proportion of participants vaccinated against Herpes Zoster virus 6 months after the beginning of the study	6 months
Vaccinated against Pneumococcus at 6 months	Proportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study	6 months
Alerts generated by the algorithm at 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	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Patrizia Laurenti, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2027

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 5819

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No