Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study of Adolescent Immunization Recall Systems

12. april 2017 oppdatert av: Kathryn S. Brigham, Boston Children's Hospital

Adolescent Immunization Recall Systems: A Randomized Controlled Trial

The purpose of this study is to determine whether contacting the parents of adolescents overdue for routine vaccines or contacting both the parents AND adolescents overdue to routine vaccines improves immunization rates as compared to usual care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This randomized controlled trial is a 3-armed study designed to evaluate an immunization recall system in adolescents. In the control arm (Group 1), the adolescents will receive usual care, in which they will primarily receive immunizations at annual physical exams, or as recommended by providers at urgent care visits. In one intervention arm (Group 2), the parent/guardian will receive a telephone call informing them that the adolescent is overdue for one or more immunizations (conjugated Neisseria meningitidis (MCV4) vaccine, tetanus-diphtheria-pertussis (Tdap) booster, and/or the second varicella (VZV) vaccine). In the second intervention arm (Group 3), both the parent/guardian and the adolescent will receive a telephone call informing them that the adolescent is overdue for one or more immunizations. Immunization rates will be compared between the 3 groups at a four week and a twelve month follow up period.

Studietype

Intervensjonell

Registrering (Faktiske)

420

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Children's Hospital Boston

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

13 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • at least 13 years of age and under 18 years of age
  • had a billing code for an annual physical exam in the past 3 years at the Adolescent/Young Adult Medical Practice at Children's Hospital Boston
  • immunization record shows one of the following: no tetanus containing vaccine in the previous 5 years; no MCV4 vaccine; and/or has received the 1st VZV vaccine but not the 2nd VZV vaccine and has no documented history of the chicken pox

Exclusion Criteria:

  • immunization record shows no vaccines or only influenza vaccines
  • sibling enrolled in the study
  • in the custody of the Department of Youth Services
  • in the custody of the Department of Child and Family Services

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: control
This study arm will receive usual clinical care, but no specific intervention will be made to inform the parent or adolescent that the adolescents is overdue for a routine vaccine.
Eksperimentell: Parent Only Group
Parent Only Phone Call
Annen: Parent Only Phone Call
A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites.
Eksperimentell: Parent and Adolescent Group
Parent and Adolescent Phone Call
Annen: Parent and Adolescent Phone Call
A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites. We will also ask permission to speak with the adolescent as well, and if granted, will make up to 4 phone calls to the adolescent to convey the same message.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
receipt of vaccine of interest at 28 days
Tidsramme: 28 days
Vaccination records are assessed 28 days after the intervention to see if Tdap, MCV4, or the 2nd VZV vaccine were administered.
28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
receipt of vaccine of interest at 1 year
Tidsramme: 1 year
Immunization records are assessed 1 year after the intervention to assess for receipt of Tdap, MCV4, and/or the 2nd VZV vaccine.
1 year
receipt of other vaccines at 28 days
Tidsramme: 28 days
Immunization records are assessed 28 days after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.
28 days
receipt of other vaccines at 1 year
Tidsramme: 1 year
Immunization records are assessed 1 year after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.
1 year
receipt of prior vaccines at 28 days
Tidsramme: 28 days
We will assess the immunization record at 28 days to see if it has been updated with vaccines given prior to the enrollment date to see if we successfully obtained copies of immunization records at other healthcare sites.
28 days
receipt of prior vaccines at 1 year
Tidsramme: 1 year
We will assess the immunization record at 1 year to see if it has been updated with vaccines given prior to the enrollment date to see if we successfully obtained copies of immunization records at other healthcare sites.
1 year

Samarbeidspartnere og etterforskere

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

Sponsor

Boston Children's Hospital

Etterforskere

  • Hovedetterforsker: Kathryn S Brigham, MD, Boston Children's Hospital

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.

Generelle publikasjoner

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. mai 2010

Primær fullføring (Faktiske)

31. juli 2011

Studiet fullført (Faktiske)

31. juli 2011

Datoer for studieregistrering

Først innsendt

7. juli 2011

Først innsendt som oppfylte QC-kriteriene

7. juli 2011

Først lagt ut (Anslag)

11. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 10-01-0025

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 Påminnelsessystemer

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Peru

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere