- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01577979
Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Denver
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Percent of adolescent patients with 1 or more Tdap vaccine
Délai: 6 months
|
6 months
|
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Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
Délai: 6 months
|
6 months
|
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Percent of adolescent patients with 1 or more HPV vaccine
Délai: 6 months
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6 months
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Percent of adolescent patients with 3 or more HPV vaccines
Délai: 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
Délai: 6 months
|
6 months
|
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Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
Délai: 6 months
|
6 months
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Percent of adolescent patients with 2 or more MMR vaccines
Délai: 6 months
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6 months
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Percent of adolescent patients with 3 or more hepatitis B vaccines
Délai: 6 months
|
6 months
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Percent of adolescent patients with 3 or more poliovirus vaccines
Délai: 6 months
|
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
Délai: 6 months
|
6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Allison Kempe, MD, MPH, University of Colorado Denver, The Children's Hospital of Colorado
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 10-1209
- U01IP000310 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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