Clinical trial NCT06127563: Caring for Frail Patients Through Vaccination
Official title: Caring for Frail Patients Through Vaccination
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vaccination Uptake
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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) .

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.


Eligibility criteria: 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

Primary outcomes:
measure: Vaccinated against influenza at 24 months
timeFrame: 24 months
measure: Vaccinated against influenza at 12 months
timeFrame: 12 months
measure: Vaccinated against influenza at 6 months
timeFrame: 6 months
measure: Vaccinated against COVID19 at 24 months
timeFrame: 24 months
measure: Vaccinated against COVID19 at 12 months
timeFrame: 12 months
measure: Vaccinated against COVID19 at 6 months
timeFrame: 6 months
measure: Algorithm clinician concordance - initial sample of patients
timeFrame: At the start
measure: Algorithm clinician concordance
timeFrame: 24 months
measure: Feasibility in reaching the patients
timeFrame: 24 months
measure: Acceptability of the vaccination offer
timeFrame: 24 months
measure: Logistical feasibility of the vaccination pathway
timeFrame: 24 months
measure: Patients' drop out proportion
timeFrame: 24 months
Secondary outcomes:
measure: Vaccinated against Hepatitis B virus at 24 months
timeFrame: 24 months
measure: Vaccinated against Herpes Zoster virus at 24 months
timeFrame: 24 months
measure: Vaccinated against Pneumococcus at 24 months
timeFrame: 24 months
measure: Vaccinated against Hepatitis B virus at 12 months
timeFrame: 12 months
measure: Vaccinated against Herpes Zoster virus at 12 months
timeFrame: 12 months
measure: Vaccinated against Pneumococcus at 12 months
timeFrame: 12 months
measure: Vaccinated against Hepatitis B virus at 6 months
timeFrame: 6 months
measure: Vaccinated against Herpes Zoster virus at 6 months
timeFrame: 6 months
measure: Vaccinated against Pneumococcus at 6 months
timeFrame: 6 months
measure: Alerts generated by the algorithm at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Patrizia Laurenti
role: PRINCIPAL_INVESTIGATOR
References: