- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01390363
Study of Adolescent Immunization Recall Systems
12 april 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
420
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Children's Hospital Boston
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
13 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: 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.
|
|
Experimentell: Parent Only Group
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.
|
Experimentell: Parent and Adolescent Group
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
receipt of vaccine of interest at 28 days
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
receipt of vaccine of interest at 1 year
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kathryn S Brigham, MD, Boston Children's Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2010
Primärt slutförande (Faktisk)
31 juli 2011
Avslutad studie (Faktisk)
31 juli 2011
Studieregistreringsdatum
Först inskickad
7 juli 2011
Först inskickad som uppfyllde QC-kriterierna
7 juli 2011
Första postat (Uppskatta)
11 juli 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 april 2017
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 10-01-0025
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