Caring for Frail Patients Through Vaccination

Study Overview
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Brief Summary
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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.

Official Title
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Caring for Frail Patients Through Vaccination

Conditions
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Vaccination Uptake

Intervention / Treatment
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* Other: creation of a clinical pathway to increase vaccination coverage in frail patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on hemodialysis and with medical residence in the Lazio Region who access the University Polyclinic Foundation A. Gemelli IRCCS for dialysis session. Patients on peritoneal dialysis and with health residence in the Lazio Region who access the University Polyclinic Foundation A. Gemelli IRCCS for dialysis session. Patients awaiting kidney transplantation and with health residence in the Lazio Region who access the University Polyclinic Foundation A. Gemelli IRCCS for kidney transplantation. Post-kidney transplant patients and with health residence in the Lazio Region accessing the University Polyclinic Foundation A. Gemelli IRCCS for kidney transplantation. Patients with chronic renal failure in pre-dialysis condition and with health residence in the Lazio Region who accessed the nephrology outpatient clinic of the University Polyclinic Foundation A. Gemelli IRCCS for follow-up. Patients with chronic inflammatory bowel disease being treated with biologic/immunomodulatory/corticosteroid drugs and with health residence in the Lazio Region accessing the CEMAD of the University Polyclinic Foundation A. Gemelli IRCCS for follow-up. Signing by the interested party of the informed consent for participation in the study and data processing for biomedical research purposes. Exclusion Criteria: Failure to sign informed consent for study participation and data processing for biomedical research purposes. Health residence in region other than Lazio Region.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: creation 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants vaccinated against influenza 24 months after the beginning of the study |  | 24 months | 
| Proportion of participants vaccinated against influenza 12 months after the beginning of the study |  | 12 months | 
| Proportion of participants vaccinated against influenza 6 months after the beginning of the study |  | 6 months | 
| Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study |  | 6 months | 
| Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study |  | 12 months | 
| Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants vaccinated against Hepatitis B 24 months after the beginning of the study |  | 24 months | 
| Proportion of participants vaccinated against Herpes Zoster 24 months after the beginning of the study |  | 24 months | 
| Proportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study |  | 24 months | 
| Proportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study |  | 12 months | 
| Proportion of participants vaccinated against Hepatitis B 12 months after the beginning of the study |  | 12 months | 
| Proportion of participants vaccinated against Herpes Zoster 12 months after the beginning of the study |  | 12 months | 
| Proportion of participants vaccinated against Herpes Zoster 6 months after the beginning of the study |  | 6 months | 
| Proportion of participants vaccinated against Hepatitis B 6 months after the beginning of the study |  | 6 months | 
| Proportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study |  | 6 months | 
| Number of vaccination alerts generated by the algorithm among the study participants in the first 24 months after the beginning of the study | Ratio. Total number of Alerts/Total number of participants | 24 months |