- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04668417
Pediatric Second Influenza Dose Portal Reminder Recall
Patient Portal Reminder/Recall for Influenza Vaccination in the UCLA Health System- Pediatric Second Dose
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System.
The study design is a parallel 2-arm trial. The parallel arms are 1) a reminder letter for the second dose of influenza vaccine (reminder messages sent via the patient portal) with a direct appointment scheduling link included in the reminder and 2) a reminder letter for the second dose of influenza vaccine, but no direct appointment scheduling link included.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This trial is taking place in Los Angeles, CA among patients from primary care practices within the UCLA Health System, using a parallel 2-arm trial.
Sub-optimal vaccination rates are a significant problem in the U.S., despite their effectiveness in preventing morbidity and mortality from vaccine-preventable illness. In the U.S., annual epidemics of influenza cause substantial morbidity in the U.S. with up to 40,00-80,000 deaths/year and many hospitalizations, emergency and outpatient visits, and significant costs.
Young children-especially those younger than 2- are at high risk of developing serious flu-related complications. Children ages of 6 months to 8 years getting vaccinated for the first time with influenza vaccine should get two doses, and those who have only previously gotten one dose of influenza vaccine, should get a second dose (spaced at least 4 weeks apart).
Reminder/recall (R/R) messages, sent by phone, mail or other modality, can improve child vaccination rates. However, the majority of pediatric or adult primary care practices to not conduct R/R. Barriers are lack of finances, personnel, and algorithms to identify eligible patients. A technological breakthrough that might overcome these barriers involves patient portals-- secure, web-based communication systems, embedded within electronic health records (EHRs), for patients and providers to communicate with each other via email and the internet. Portals are increasingly used by healthcare systems.
This randomized controlled trial will assess the effectiveness of reminders messages, sent to the proxy of pediatric patients ages 6 months to <36 months of age eligible for a second dose of the influenza vaccine based on data in the EHR. Patients will be randomized into one of two arms to receive 1) a reminder letter for a second dose of influenza vaccine, with a direct appointment scheduling link included in the letter or 2) a reminder letter for a second dose of influenza vaccine, without a direct appointment scheduling link included in the letter.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 99095
- University of California LA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient within the UCLA Health System identified as a primary care patient per an internal algorithm
- Identified as being overdue for a second dose of influenza vaccine.
Exclusion Criteria:
- Patient within the UCLA Health System not identified as a primary care patient per an internal algorithm
- Not due for a second dose of influenza vaccine.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Reminders with direct scheduling link
Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with a link enabling direct scheduling
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Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with a direct scheduling link included, enabling the patient to directly schedule a flu vaccination only visit
|
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Comparateur actif: Reminders with no direct scheduling link
Patient proxy receives a reminder/recall messages regarding second dose influenza vaccination via the patient portal with no direct scheduling link
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Comportemental: Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link
Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of patients who received a second dose of influenza vaccine
Délai: 3.5 months
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Receipt of a second dose of influenza vaccine (between 12/15/2020 and 4/1/21) among patients.
Outcomes will be assessed via vaccine data extraction from the electronic health record and external claims and pharmacy data.
The patient must also be an active UCLA Health MyChart user (>= 1 login over the last 12 months from 12/15/2020), excluding activity on the user's initial profile activation date.
Individuals not affiliated with any primary care practice will be excluded from the analysis.
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3.5 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Peter G Szilagyi, MD, MPH, University of California, Los Angeles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 17-001889-AM-00013
- 5R01AI135029 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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