Caring for Frail Patients Through Vaccination

NCT06127563 | Recruiting

• 1 other identifier: 5819
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination Uptake

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (10)

• Vaccinated against Hepatitis B virus at 24 months

  24 months

• Vaccinated against Herpes Zoster virus at 24 months

  24 months

• Vaccinated against Pneumococcus at 24 months

  24 months

• Vaccinated against Hepatitis B virus at 12 months

  12 months

• Vaccinated against Herpes Zoster virus at 12 months

  12 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• years old or more,
• Patients who have accessed one of the enrolled departments (Dermatology, Oncological gynaecology, Geriatry, Nephrology, Gastroenterology),
• Medical residence in Lazio Region

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Related Publications (1)

• 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. doi: 10.3389/fpubh.2025.1490244. eCollection 2025.

  PMID: 39949559 DERIVED

Study Officials

• Patrizia Laurenti

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Laurenti

CONTACT

+390630155701; patrizia.laurenti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: November 13, 2023
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-07

Locations

IT (1)