Caring for Frail Patients Through Vaccination

Vaccination Uptake Clinical Trial

— CAREVAX  

Official title:

Caring for Frail Patients Through Vaccination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127563
• Other study ID #: 5819
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 8, 2027

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: June 8, 2027
• Est. primary completion date: June 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination Uptake

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccinated against influenza at 24 months	Proportion of participants vaccinated against influenza 24 months after the beginning of the study	24 months
Primary	Vaccinated against influenza at 12 months	Proportion of participants vaccinated against influenza 12 months after the beginning of the study	12 months
Primary	Vaccinated against influenza at 6 months	Proportion of participants vaccinated against influenza 6 months after the beginning of the study	6 months
Primary	Vaccinated against COVID19 at 24 months	Proportion of participants fully vaccinated against Covid19 24 months after the beginning of the study	24 months
Primary	Vaccinated against COVID19 at 12 months	Proportion of participants fully vaccinated against Covid19 12 months after the beginning of the study	12 months
Primary	Vaccinated against COVID19 at 6 months	Proportion of participants fully vaccinated against Covid19 6 months after the beginning of the study	6 months
Secondary	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
Secondary	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
Secondary	Vaccinated against Pneumococcus at 24 months	Proportion of participants vaccinated against Pneumococcus 24 months after the beginning of the study	24 months
Secondary	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
Secondary	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
Secondary	Vaccinated against Pneumococcus at 12 months	Proportion of participants vaccinated against Pneumococcus 12 months after the beginning of the study	12 months
Secondary	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
Secondary	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
Secondary	Vaccinated against Pneumococcus at 6 months	Proportion of participants vaccinated against Pneumococcus 6 months after the beginning of the study	6 months
Secondary	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