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Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State

24. april 2020 oppdatert av: Peter G Szilagyi, MD MPH, University of California, Los Angeles
Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually, leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The investigators will disseminate the state immunization information system-based reminder/recall system to all states for use for seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

Studieoversikt

Detaljert beskrivelse

Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US with high rates of hospitalizations, emergency department visits, outpatient visits, and medical costs. Children experience significant morbidity from influenza and also play a key role in instigating and expanding epidemics. In addition, concerns about pandemic influenza heighten the importance of new mechanisms to rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.

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. For the 2012-2013 season, only 56% of children 2-17y were vaccinated. Modeling studies suggest that as many as 19 million cases of influenza could be prevented if child vaccination rates were raised to 70% nationally. The most effective strategy recommended by CDC and the Task Force on Community Preventive Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent by phone or mail, notifying parents of the need to vaccinate their child. The published literature suggests R/R can improve influenza vaccination rates. However, few practices use R/R; barriers are practice costs, insufficient staff time and expertise, and lack of predictability regarding receipt of vaccine supplies.

Statewide immunization information systems (IISs) now exist in all states to track vaccinations. They have not yet been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based reminder/recall. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine reminder/recall, 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 reminder/recall systems. The investigators will also develop tools to aid other states in creating efficient IIS reminder/recall systems for seasonal and possible pandemic influenza outbreaks.

The 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 reminder/recall of different intensity (1 v.2 v. 3 messages) and usual care (0 messages) and 2) effectiveness and cost-effectiveness of reminder/recall 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 reminder/recall for autodialer failures vs. autodialer-alone reminder/recall on influenza vaccination rates using a 2-arm randomized controlled trial.

Aim 4 (dissemination aim) will develop a toolkit for state IIS-based influenza vaccine reminder/recall 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.

Studietype

Intervensjonell

Registrering (Forventet)

100000

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • A record in the New York State Immunization Information System
  • In need of at least one influenza vaccination at time of study
  • Affiliated with a participating practice

Exclusion Criteria:

  • Up to date on influenza vaccine

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: No intervention: Usual Care
Patients in this group will not receive any influenza vaccine reminder notifications.
Eksperimentell: 1 Notice
Patients in this group will receive one influenza vaccine reminder notification via autodialer across the 2016 influenza season.
1 Reminder notification via autodialer
Andre navn:
  • reminders, notifications
Eksperimentell: 2 Notices
Patients in this group will receive up to two influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.
2 Reminder notifications via autodialer
Eksperimentell: 3 Notices
Patients in this group will receive up to three influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.
3 Reminder notifications via autodialer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of subjects receiving influenza vaccine
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of subjects receiving influenza vaccine based on demographic subgroups
Tidsramme: 6 months
This outcome will categorize the number of influenza vaccines administered by subgroups, e.g. Urban/rural, Pediatrics/Family Practice, and age from 6 months-1.9 years, 2-10.9 years and 11-17.9 years.
6 months
Number of subjects <9 years of age that will receive an additional vaccine
Tidsramme: 1 month
1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2016

Primær fullføring (Faktiske)

2. mai 2017

Studiet fullført (Faktiske)

2. mai 2017

Datoer for studieregistrering

Først innsendt

23. september 2016

Først innsendt som oppfylte QC-kriteriene

3. oktober 2016

Først lagt ut (Anslag)

5. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 15-001552
  • 1R01AI114903 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på 1 Notice

3
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