Collaborative Efforts to Increase Flu Vaccination
Condition: Influenza; Collaboration
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      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)
    

Detailed description: 
      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
    

Intervention name(s): Private/public collaboration to increase flu vaccination; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; This group will continue administering influenza vaccine to their patients in their practice as they normally do.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research