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Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

24 février 2015 mis à jour par: University of Colorado, Denver
In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. This study will be conducted in different types of primary care settings, such as public, private, and managed care clinics serving adolescent patients of diverse backgrounds, and will provide important information to help guide future public health efforts to achieve high rates of immunization in adolescents.

Aperçu de l'étude

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.

  1. Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination.
  2. Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care.
  3. 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
  4. 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.

  1. Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients.
  2. 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

Interventionnel

Inscription (Réel)

34581

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • University of Colorado Denver

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

11 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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.
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:
  • La messagerie texte
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Délai: 6 months
Percent of adolescents who received ANY needed vaccine or well-care visit
6 months

Mesures de résultats secondaires

Mesure des résultats
Délai
Percent of adolescent patients with 1 or more Tdap vaccine
Délai: 6 months
6 months
Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
Délai: 6 months
6 months
Percent of adolescent patients with 1 or more HPV vaccine
Délai: 6 months
6 months
Percent of adolescent patients with 3 or more HPV vaccines
Délai: 6 months
6 months
Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season
Délai: 6 months
6 months
Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
Délai: 6 months
6 months
Percent of adolescent patients with 2 or more MMR vaccines
Délai: 6 months
6 months
Percent of adolescent patients with 3 or more hepatitis B vaccines
Délai: 6 months
6 months
Percent of adolescent patients with 3 or more poliovirus vaccines
Délai: 6 months
6 months
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Allison Kempe, MD, MPH, University of Colorado Denver, The Children's Hospital of Colorado

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2012

Achèvement primaire (Réel)

1 août 2014

Achèvement de l'étude (Réel)

1 septembre 2014

Dates d'inscription aux études

Première soumission

12 avril 2012

Première soumission répondant aux critères de contrôle qualité

13 avril 2012

Première publication (Estimation)

16 avril 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 février 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 février 2015

Dernière vérification

1 février 2015

Plus d'information

Termes liés à cette étude

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

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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