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Collaborative Efforts to Increase Flu Vaccination (CollabFlu)

29. května 2015 aktualizováno: 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)

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Aktuální)

117175

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 měsíců až 18 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Behaviorální: 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.
Jiný: Usual care
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
Jiný: Usual care
This group will continue administering influenza vaccine to their patients in their practice as they normally do.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
high-risk children receipt of influenza vaccination
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Colorado, Denver

Spolupracovníci

Centers for Disease Control and Prevention

Vyšetřovatelé

  • Vrchní vyšetřovatel: Allison Kempe, MD, MPH, University of Colorado, Children's Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2009

Primární dokončení (Aktuální)

1. února 2015

Dokončení studie (Aktuální)

1. března 2015

Termíny zápisu do studia

První předloženo

14. července 2011

První předloženo, které splnilo kritéria kontroly kvality

25. července 2011

První zveřejněno (Odhad)

27. července 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

2. června 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2015

Naposledy ověřeno

1. května 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 10-0589
  • 1U01IP000320 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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