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Идёт набор NCT06127563

Caring for Frail Patients Through Vaccination

— Наблюдательное Vaccination Uptake

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: creation of a clinical pathway to increase vaccination coverage in frail patients.
Кому может быть актуально
Состояния в реестре: Vaccination Uptake. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Vaccinated against influenza at 24 months [Срок оценки: 24 months]
  • Vaccinated against influenza at 12 months [Срок оценки: 12 months]
  • Vaccinated against influenza at 6 months [Срок оценки: 6 months]
  • Vaccinated against COVID19 at 24 months [Срок оценки: 24 months]
  • Vaccinated against COVID19 at 12 months [Срок оценки: 12 months]
  • Vaccinated against COVID19 at 6 months [Срок оценки: 6 months]
  • Algorithm clinician concordance - initial sample of patients [Срок оценки: At the start]
  • Algorithm clinician concordance [Срок оценки: 24 months]
  • Feasibility in reaching the patients [Срок оценки: 24 months]
  • Acceptability of the vaccination offer [Срок оценки: 24 months]
Вторичные конечные точки (10)
  • Vaccinated against Hepatitis B virus at 24 months [Срок оценки: 24 months]
  • Vaccinated against Herpes Zoster virus at 24 months [Срок оценки: 24 months]
  • Vaccinated against Pneumococcus at 24 months [Срок оценки: 24 months]
  • Vaccinated against Hepatitis B virus at 12 months [Срок оценки: 12 months]
  • Vaccinated against Herpes Zoster virus at 12 months [Срок оценки: 12 months]
  • Vaccinated against Pneumococcus at 12 months [Срок оценки: 12 months]
  • Vaccinated against Hepatitis B virus at 6 months [Срок оценки: 6 months]
  • Vaccinated against Herpes Zoster virus at 6 months [Срок оценки: 6 months]
  • Vaccinated against Pneumococcus at 6 months [Срок оценки: 6 months]
  • Alerts generated by the algorithm at 24 months [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

\- Patients who do not fulfill 1 or more inclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Публикации

  • 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. PMID 39949559

Идентификаторы

NCT: NCT06127563 · 5819

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗