Caring for Frail Patients Through Vaccination

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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) .

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Vaccinated against influenza at 24 months

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

Time frame
24 months
2

Vaccinated against influenza at 12 months

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

Time frame
12 months
3

Vaccinated against influenza at 6 months

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

Time frame
6 months
4

Vaccinated against COVID19 at 24 months

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

Time frame
24 months

Secondary outcomes

1

Vaccinated against Hepatitis B virus at 24 months

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

Time frame
24 months
2

Vaccinated against Herpes Zoster virus at 24 months

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

Time frame
24 months
3

Vaccinated against Pneumococcus at 24 months

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

Time frame
24 months
4

Vaccinated against Hepatitis B virus at 12 months

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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