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Collaborative Efforts to Increase Flu Vaccination (CollabFlu)

29 mai 2015 mis à jour par: University of Colorado, Denver

Strategies to Vaccinate All Children for Influenza in a Practice Setting

Beginning with the 2009-2010 season, influenza vaccine is universally recommended for children age 6 months to 18 years old, placing extra burden on health care providers across the U.S. The focus of this study is to develop new strategies and implement existing evidence-based strategies to enhance influenza immunization in these children. The intervention will involve collaboration from different types of primary care providers, the Colorado Immunization Information System (CIIS), public health departments and visiting nursing services (VNA). It will be designed and implemented by those involved with delivery with a focus on sustainability after the completion of the study. Parental input will be gathered during the planning year through focus groups to assist in developing the intervention. Qualitative assessments and examination of processes during the first year of implementation will guide modifications during the second implementation year in order to assure sustainability. Primary outcome measures in the intervention and control groups: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the rate of children 6 mo.-18 yr. who were fully immunized (received all required influenza injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12 yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Specific Aim 1: Within each of three types of clinical sites (urban pediatric, urban family medicine, and rural family medicine) recruit a group of similar practices (Year 1) 1a. Randomize practices within each type of clinical site to either the intervention or the control group

1b. Establish private-public collaborations for influenza vaccination delivery between county public health departments, visiting nursing associations and each of the intervention practices within the three clinical site types

Specific Aim 2: Conduct focus groups among parents of children seen at intervention practices, to assess attitudes and perceived barriers to possible practice-based and collaborative strategies to promote influenza vaccination (Year 1)

Specific Aim 3: Develop (Year 1) and implement (Years 2 and 3) a plan for comprehensive and collaborative delivery of influenza vaccine at intervention practices 3a. Develop practice-based intervention strategies focusing primarily on immunization of high-risk patients 3b. Develop private-public collaborative interventions between the intervention practices, their county public health department and visiting nursing associations focusing primarily on immunization of school-aged children 3c. Implement (Years 2 and 3) both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices

Specific Aim 4: Conduct a group-randomized trial to evaluate and compare the effectiveness of the comprehensive delivery model in improving influenza vaccination coverage for children 6 months to 18 years in three different types of clinical sites (urban pediatric, urban family medicine, and rural family medicine).

4a. Evaluate effectiveness of the comprehensive delivery model at each of the three types of clinical sites

  1. Compare the following primary outcome measures in the intervention and control groups: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years and 2) increase in the rate of children 6 months to 18 years who were fully immunized (received all required influenza injections) during the season.
  2. Compare the following secondary outcome measures: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children and 2) increase in the rate of high-risk children who were fully immunized during the season.
  3. Evaluate sustainability of the comprehensive delivery model on the above outcome measures

4b. Compare the effectiveness of the comprehensive delivery model in three different types of clinical sites (urban pediatric private practice, urban family medicine private practice, and rural family medicine private practice)

Specific Aim 5: Evaluate the process of implementation of the comprehensive delivery model for influenza delivery in each of the three types of sites.

5a. Assess process measures relevant to implementation of practice-based interventions and compare by type of clinical site 5b. Assess process measures relevant to implementation of private-public collaborative interventions and compare by type of clinical site 5c. Using key informant interviews, assess perceptions regarding facilitators and barriers to private-public collaborative delivery, alternative methods and means of improving the process among practice providers, administrators and among participating public health and visiting nurse personnel

Specific Aim 6: In two urban pediatric intervention practices and one rural family medicine practice, conduct surveys examining parental attitudes about methods of influenza delivery and their experience with their practice's participation in a comprehensive and collaborative private-public model for influenza delivery

Major Hypotheses:

SA4. Hypothesis 1. Effectiveness on receipt of ≥1 influenza vaccine: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices.

SA4. Hypothesis 2 Effectiveness - fully immunized: The increase in the likelihood of receiving all necessary influenza vaccines during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices.

SA4. Hypothesis 3. Effectiveness by age strata: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children in each of the following age strata will be greater in intervention than in control practices: 1) 6 months through 5 years; 2) 6 through 8 years; 3) 9 through 12 years; 4) 13 through 18 years.

SA4. Hypothesis 4. Effectiveness in high-risk children: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children 6 months to 18 years will be greater for high-risk children in intervention practices than in control practices.

SA4. Hypothesis 5. Sustainability: The increase in the likelihood of receiving ≥1 influenza vaccine during the second post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices. (Sustainability will also be evaluated for other outcomes above.)

SA4. Hypothesis 6. Differential effectiveness by clinical site type: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years for intervention vs. controls will differ by clinical site type

Type d'étude

Interventionnel

Inscription (Réel)

117175

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

  • États-Unis
    • Colorado
      • Aurora, Colorado, États-Unis, 80010
        • Tri County Health dept
      • Aurora, Colorado, États-Unis, 80012
        • Aurora Family Medicine
      • Aurora, Colorado, États-Unis, 80014
        • Forum Family Medicine
      • Brighton, Colorado, États-Unis, 80601
        • Premier Pediatrics
      • Broomfield, Colorado, États-Unis, 80021
        • Indian Crest Pediatrics
      • Centennial, Colorado, États-Unis, 80112
        • Pediatrics 5280
      • Centennial, Colorado, États-Unis, 80014
        • Centennial Pediatrics
      • Centennial, Colorado, États-Unis, 80015
        • Advanced Pediatrics
      • Centennial, Colorado, États-Unis, 80112
        • Greenwood Pediatrics
      • Centennial, Colorado, États-Unis, 80112
        • Pediatric Pathways
      • Denver, Colorado, États-Unis, 80246
        • CIIS
      • Englewood, Colorado, États-Unis, 80113
        • Hampden Medical Group
      • Ft. Morgan, Colorado, États-Unis, 80701
        • Family Practice Clinic
      • Ft. Morgan, Colorado, États-Unis, 80701
        • Ft. Morgan Medical Group
      • Haxtun, Colorado, États-Unis, 80731
        • Haxtun Family Medicine
      • Julesburg, Colorado, États-Unis, 80737
        • Valley Medical Center
      • Lakewood, Colorado, États-Unis, 80215
        • Jefferson County Health dept
      • Lakewood, Colorado, États-Unis, 80226
        • Kids First
      • Lakewood, Colorado, États-Unis, 80401
        • Denver West Pediatrics
      • Littleton, Colorado, États-Unis, 80123
        • Focus on Kids
      • Lone Tree, Colorado, États-Unis, 80124
        • Lone Tree Family Medicine
      • Parker, Colorado, États-Unis, 80138
        • Crown Point Pediatrics
      • Sterling, Colorado, États-Unis, 80751
        • Northeast County Health Dept
      • Thornton, Colorado, États-Unis, 80260
        • Mountain Land Pediatrics
      • Wheat Ridge, Colorado, États-Unis, 80033
        • Pediatrics West
      • Wray, Colorado, États-Unis, 80758
        • Wray Clinic
      • Yuma, Colorado, États-Unis, 80759
        • Yuma Clinic

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

6 mois à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Children age 6 mo - 18 yr in up to 20 practices

Exclusion Criteria:

  • Infants under the age of 6 mo or adults over the age of 18

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: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Increasing flu vaccination
Collect from billing records in the 10 intervention practice sites to test for an increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years during the season. The interventions include: 1. Develop practice-based intervention strategies (like use of reminder-recall of children due for influenza,2. Develop Private/public collaboration to increase flu vaccination between the intervention practices, their county public health department and visiting nursing associations, and 3. Implement both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices
Comportemental: Private/public collaboration to increase flu vaccination
Intervention practices will develop office-based interventions including methods to identify high-risk patients within their practices and methods of maximizing the immunization of these children within the practice, use of patient reminders, after-hours influenza clinics, walk-in provision of influenza vaccine and increased focus on education regarding the need for immunization. The practices will also collaborate with their county public health departments and visiting nursing associations to develop private-public collaborative interventions that may include large clinics for school-aged children for multiple practices and tracking of influenza supplies and redistribution of influenza vaccine between practices when supplies are delayed or inadequate.
Autre: Usual care
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
Autre: Usual care
This group will continue administering influenza vaccine to their patients in their practice as they normally do.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Evaluate the effectiveness of collaborations between public and private entities to increase influenza vaccination in children 6 mos to 18 yrs in 10 intervention sites in 3 counties throughout the state of CO during the '10-11 & '11-12 flu seasons.
Délai: Up to 4 months post intervention (December 2012)
Primary outcome measure is to increase the rate of receipt of ≥1 influenza vaccine during the post-intervention year(s) compared to the pre-intervention year among children 6 mos.-18 yrs in 10 intervention sites. Intervention practices will collaborate with their respective health departments and/or the VNA to help assist with the increase in volume of patients needing to be vaccinated against flu in the 2010-2011 and the 2011-2012 flu seasons. Billing data will be obtained from all 20 sites (intervention+control) and compared to evaluate the effectiveness of this collaboration.
Up to 4 months post intervention (December 2012)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
high-risk children receipt of influenza vaccination
Délai: baseline and intervention years 1 and 2
increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children
baseline and intervention years 1 and 2
high-risk children fully immunized during influenza season
Délai: baseline and intervention years 1 and 2
increase in the rate of high-risk children who were fully immunized during the season.
baseline and intervention years 1 and 2

Collaborateurs et enquêteurs

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

Parrainer

University of Colorado, Denver

Collaborateurs

Centers for Disease Control and Prevention

Les enquêteurs

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

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 2009

Achèvement primaire (Réel)

1 février 2015

Achèvement de l'étude (Réel)

1 mars 2015

Dates d'inscription aux études

Première soumission

14 juillet 2011

Première soumission répondant aux critères de contrôle qualité

25 juillet 2011

Première publication (Estimation)

27 juillet 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 juin 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10-0589
  • 1U01IP000320 (Subvention/contrat des NIH des États-Unis)

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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