- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01577979
Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Specific Aim 1: Within different types of primary care practices (pediatric practices in public, private, and managed care settings) serving adolescent patients of diverse socioeconomic and racial/ethnic backgrounds, to assess provider and staff attitudes regarding the desirability, feasibility, and potential sustainability of evidence-based and innovative strategies to promote adolescent vaccination in primary care practices.
Specific Aim 2: Among parents of adolescents (and/or adolescent patients) seen at primary care practices, to assess knowledge of existing national and state programs to promote vaccination, and to assess attitudes regarding, perceived barriers to, and acceptability of various practice-based strategies to promote adolescent vaccination.
Specific Aim 3: To implement and evaluate the effectiveness of a multi-faceted quality improvement program to promote adolescent vaccination within the medical home.
- Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination.
- Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care.
- Compare the following primary outcome measure between intervention and usual care patients, overall and stratified by the type of practice setting: 1)percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
- Compare the following secondary outcome measures between intervention and usual care patients, overall and stratified by practice setting: 1) percent of adolescent patients with ≥ 1 Tdap vaccine; 2) percent of adolescent patients with ≥ 1 meningococcal (MCV4) vaccine; 3) percent of adolescent patients with ≥ 1 HPV vaccine; 4) percent of adolescent patients with ≥ 3 HPV vaccines; 5) percent of adolescent patients receiving ≥ 1 influenza vaccine during the preceding influenza season; 6) percent of adolescent patients with either a documented history of varicella disease or ≥ 2 varicella vaccines; 7) percent of adolescent patients with ≥ 2 MMR vaccines; 8) percent of adolescent patients with ≥ 3 hepatitis B vaccines; 9) percent of adolescent patients with ≥ 3 poliovirus vaccines; and 10) percent of adolescent patients with ≥ 1 missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines.
Specific Aim 3 (Kaiser Only): Design, implement and evaluate an HPV reminder/recall intervention based on obtaining the parents' and adolescents' preferences for reminder method and recipient at the time of the first dose of HPV.
- Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients.
- Assess process measures related to feasibility and fidelity of implementation
Specific Aim 4: Evaluate the effect of a multi-faceted vaccination quality improvement program on the receipt of non-vaccination clinical preventive services recommended for adolescents.
a) Compare the following outcome measures between intervention and usual care patients, overall and stratified by the type of practice setting: 1) receipt of ≥ 1 health maintenance visits within a 12 month interval; 2) receipt of blood pressure screening; and 3) growth assessment, as documented by the measurement of weight and height and calculation of body mass index at a clinic visit.
Specific Aim 5: Assess the cost to participating practices of implementing a multi-faceted vaccination quality improvement program designed to promote adolescent vaccination.
Specific Aim 6: After conducting a multi-faceted quality improvement program to promote adolescent vaccination, to assess provider and staff attitudes about the program, in particular the perceived benefits of the program and factors which may facilitate or hamper the sustainability of the program within study practices.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Denver
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 11-17 years old
- Active patient (visit in last 2 years) of clinics in study
- Need one or more vaccines or well-care visit
Exclusion Criteria:
- Up to date on vaccines and well-care
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Reminder/Recall Strategy
The experimental group will consist of patients randomly selected from participating clinics.
Patients from private practices and the safety net provider may be exposed to a reminder/recall strategy involving text messaging.
Text messages will be used to notify parents that their child is due for an immunization or well-care visit.
Parents will be able to reply with one of three response options.
Patients presenting to the randomly selected experimental managed care clinics for the first HPV vaccination dose will be offered the ability to provide the clinic with their preferred contact method.
The preferred method of contact will be used for the second and third HPV dose reminder/recalls.
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Adolescents will be randomly selected from the participating private practices and safety net organization clinics.
Parents of selected adolescents will receive a text message to alert them that their child is due for a vaccine or well-care visit.
The text message will provide response instructions.
The responses can be one of three options: 1) the parent will call the clinic to schedule a visit, 2) the parent would like the clinic to call them to schedule a visit, or 3) the parent would like to stop any future text message reminders.
Parents who would like the clinic to call them to schedule an appointment will be contacted by their child's provider to set up a visit.
Parents may receive up to 3 text message reminders, unless they chose to stop any future messages.
Ostatní jména:
Parents of adolescents being seen within the managed care organization's intervention clinics will be asked about their reminder method preference at their child's 1st HPV immunization.
The preference options include phone call, text message, or email.
The preference for contact method will be recorded and utilized for the 2nd and 3rd dose reminders.
The clinics' usual method of reminder will be used for all other parents.
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Žádný zásah: Usual Care
The patients in the usual care group will receive the clinic's usual care in terms of immunization and well-care reminder/recall.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Časové okno: 6 months
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Percent of adolescents who received ANY needed vaccine or well-care visit
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Percent of adolescent patients with 1 or more Tdap vaccine
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 1 or more HPV vaccine
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 3 or more HPV vaccines
Časové okno: 6 months
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6 months
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Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season
Časové okno: 6 months
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6 months
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Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 2 or more MMR vaccines
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 3 or more hepatitis B vaccines
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 3 or more poliovirus vaccines
Časové okno: 6 months
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6 months
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Percent of adolescent patients with 1 or more missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines
Časové okno: 6 months
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6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Allison Kempe, MD, MPH, University of Colorado Denver, The Children's Hospital of Colorado
Publikace a užitečné odkazy
Obecné publikace
- Kempe A, O'Leary ST, Shoup JA, Stokley S, Lockhart S, Furniss A, Dickinson LM, Barnard J, Daley MF. Parental Choice of Recall Method for HPV Vaccination: A Pragmatic Trial. Pediatrics. 2016 Mar;137(3):e20152857. doi: 10.1542/peds.2015-2857. Epub 2016 Feb 26.
- O'Leary ST, Lee M, Lockhart S, Eisert S, Furniss A, Barnard J, Eblovi DE, Shmueli D, Stokley S, Dickinson LM, Kempe A. Effectiveness and Cost of Bidirectional Text Messaging for Adolescent Vaccines and Well Care. Pediatrics. 2015 Nov;136(5):e1220-7. doi: 10.1542/peds.2015-1089. Epub 2015 Oct 5. Erratum In: Pediatrics. 2016 Sep;138(3):null.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 10-1209
- U01IP000310 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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