Reducing Delay in Vaccination of Children: Logistic Barriers (REDIVAC-LB)
5. august 2019 opdateret af: Kaiser Permanente
The REDIVAC Study-Reducing Delay in Vaccination of Children Study
This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.
Studieoversigt
Detaljeret beskrivelse
Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population.
Parents identified will be randomized to the intervention arm or the usual care arm.
Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits.
Reminders will include scheduling information as well as access to a website with vaccine and scheduling information.
They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email).
There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits.
Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80231
- Kaiser Permanente Colorado Institute for Health Research
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 11 måneder (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Parents of children less than 11 months of age
- Currently enrolled at Kaiser Permanente Colorado at the time of identification
- The child is missing recommended vaccinations
Exclusion Criteria:
- Non-english speaking
- diagnosis code indicating parent vaccine refusal
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Usual Care
Parents will receive usual care for their child at Kaiser Permanente Colorado.
This includes recommendations for well child visits at 2, 4, 6 and 12 months of age as well as automated reminders for age eligible children to receive the flu shot during flu season.
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Eksperimentel: Reminders
Parents randomized to the reminder arm will receive automated reminders to complete a 6 month and 12 month vaccine visit for their child.
They will receive 2 reminders before the child is 6 and 12 months of age and 2 reminders after their child is 6 and 12 months of age.
Reminders will not occur if they have received vaccines within the eligible time frame to receive a vaccine or have a visit scheduled.
After randomization, participants in the intervention arm will have an opportunity to provide their preference on how they receive reminders (text, phone and/or email).
Participants not providing a preference will receive text reminders.
If a child is randomized into the study after the child is 7 months of age, the parent will only be eligible for reminders for the 12 month vaccine visit.
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Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vaccines received (Electronic Health Record)
Tidsramme: up to a year of follow up
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Vaccination records from the participants electronic health record will be used to measure vaccines received.
Vaccines received is a dichotomous variable indicating if any vaccines were received while enrolled in the study
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up to a year of follow up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vaccine dose (Electronic Health Record)
Tidsramme: up to a year of follow up
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Vaccination records from the participants electronic health record will be used to measure vaccine dose.
Vaccine dose is a measure of the vaccine doses that the child could have received while enrolled in the study, the number of vaccine doses received
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up to a year of follow up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jason Glanz, PhD, Kaiser Permanente
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2018
Primær færdiggørelse (Faktiske)
31. marts 2019
Studieafslutning (Faktiske)
31. marts 2019
Datoer for studieregistrering
Først indsendt
26. marts 2018
Først indsendt, der opfyldte QC-kriterier
3. maj 2018
Først opslået (Faktiske)
4. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2019
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01HD079457 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .