- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 99095
- University of California LA
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
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
|
|
Comparatore attivo: 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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Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of patients who received a second dose of influenza vaccine
Lasso di tempo: 3.5 months
|
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.
|
3.5 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Peter G Szilagyi, MD, MPH, University of California, Los Angeles
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 17-001889-AM-00013
- 5R01AI135029 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .