- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02761551
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates: Colorado
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S. with high rates of hospitalizations, emergency department and outpatient visits, and medical costs. Children experience significant morbidity from influenza, and also play a critical role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccination for all children >6 months of age. However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated. Low rates are a concern for both seasonal influenza and in preparation for pandemic influenza. One of the nationally recommended strategies for raising childhood influenza vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R despite many studies showing its effectiveness.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for R/R for influenza vaccine because of the lack of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of intensity of recall (1 v. 2 v. 3 reminders) over usual care. The investigators will also develop tools to aid other states in creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks.
This study has four aims.
Aim 1 is to develop the protocols, clinical decision support, and message content for state IISs to conduct reminder/recall for influenza vaccinations.
Aim 2 is to conduct a pragmatic trial, with randomization at the level of the patient within practices randomly selected to be proportionate to each state, to compare: 1) effectiveness and cost-effectiveness of centralized R/R of different intensity (1 vs. 2 vs. 3 messages) and usual care (0 messages) and 2) effectiveness and cost-effectiveness of R/R in specified subgroups (family medicine vs pediatric provider, rural vs urban, age of child) on receipt of influenza vaccination.
Aim 3 will measure the effect of adding mailed or text message R/R for autodialer failures vs. autodialer-alone R/R on influenza vaccination rates using a 2-arm Randomized Controlled Trial (RCT).
Aim 4 (dissemination aim) will develop a toolkit for state IIS-based influenza vaccine R/R for seasonal and pandemic influenza, and work with key stakeholders on a sustainability plan.
By the end of the study the investigators will have a feasible and cost-effective model to raise child seasonal or possibly pandemic influenza vaccination rates to prevent influenza. The investigators will disseminate the IIS model to all states.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- A record in the Colorado Immunization Information System,
- In need of at least one influenza vaccination at time of study,
- Affiliated with a participating practice, or
- Randomly selected among unaffiliated patients.
Exclusion Criteria:
- Opted out of participating in CIIS, or
- Are up-to-date on influenza vaccine
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Usual Care
Patients in this group will not receive any reminders for influenza vaccine.
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Experimental: 1 notice
Patients in this group will receive one reminder for influenza vaccine across the 2016 influenza season.
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Experimental: 2 notices
Patients in this group will receive up to two reminders for influenza vaccine across the 2016 season.
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Experimental: 3 notices
Patients in this group will receive up to three reminders for influenza vaccine across the 2016 season.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of subjects receiving influenza vaccine based on zero notices versus those receiving 1, 2 or 3 notices.
Zeitfenster: 6 months
|
The primary outcome is receipt of influenza vaccine by children receiving zero notices compared to those receiving 1, 2 or 3 notices.
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of subjects receiving influenza vaccine based on demographic subgroups.
Zeitfenster: 6 months
|
This outcome will categorize the number of influenza vaccines administered by subgroups, e.g.: Urban/Rural, Pediatrics/Family Practice, and age from 6m-1.9 yr., 2-10.9 yr. and 11-17.9
yr.
|
6 months
|
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Number of subjects <9 years of age that will receive an additional vaccine.
Zeitfenster: 1 month
|
If the subject is <9 years of age, they are required to received a second vaccine at least 1 month after receiving the initial vaccine.
|
1 month
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Kempe A, Saville AW, Dickinson LM, Beaty B, Eisert S, Gurfinkel D, Brewer S, Shull H, Herrero D, Herlihy R. Collaborative centralized reminder/recall notification to increase immunization rates among young children: a comparative effectiveness trial. JAMA Pediatr. 2015 Apr;169(4):365-73. doi: 10.1001/jamapediatrics.2014.3670.
- Kempe A, Saville AW, Albertin C, Helmkamp L, Zhou X, Vangela S, Dickinson LM, Tseng CH, Campbell JD, Whittington M, Gurfinkel D, Roth H, Hoefer D, Szilagyi P. Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial. Acad Pediatr. 2020 Apr;20(3):374-383. doi: 10.1016/j.acap.2019.10.015. Epub 2019 Nov 5.
- Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart S, Calonge N. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial. Am J Public Health. 2013 Jun;103(6):1116-23. doi: 10.2105/AJPH.2012.301035. Epub 2012 Dec 13.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 15-0570
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