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Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado

20. juni 2019 oppdatert av: University of Colorado, Denver

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado

This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission.

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 (R/R) 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: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) on improving influenza vaccination rates.

The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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 two types of R/R (autodial v. mail R/R) 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.

In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus standard-of-care control on raising influenza vaccination rates among children 6m-17 years of age.

The investigators propose a 3-arm RCT study design with the following study arms:

  1. Standard of care control
  2. Autodialer (3 reminders)- with brief education message + practice name + practice phone #
  3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone #

Studietype

Intervensjonell

Registrering (Faktiske)

25531

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado

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 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • have record in Colorado Immunization Information System
  • from 6 months through 17 years of age
  • have not received an influenza vaccine by start of trial
  • must be affiliated with one of our 42 randomly selected primary care practices in Colorado

Exclusion Criteria:

  • those without a record
  • received an influenza vaccine post 9/1/2017
  • not affiliated with an eligible study

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: Control
These patients will receive no reminders from the health department and will receive usual care.
Eksperimentell: Autodialer R/R
Autodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone #
Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.
Eksperimentell: Mail R/R
Mailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone #
Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state
Tidsramme: 6 months
Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.
6 months

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)

6. september 2017

Primær fullføring (Faktiske)

30. april 2019

Studiet fullført (Faktiske)

30. april 2019

Datoer for studieregistrering

Først innsendt

7. august 2017

Først innsendt som oppfylte QC-kriteriene

9. august 2017

Først lagt ut (Faktiske)

11. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Aggregate results will be prepared for publications at the end of the trial.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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