Improving Adolescent Vaccination in Appalachian Kentucky
Condition: Adolescent Immunization
Study type: Interventional

Summary: 
      The proposed project develops a community and school-based intervention to enhance
      understanding of the importance all age-appropriate vaccinations, and uses an innovative,
      comprehensive approach (Project INSPIRE - Instilling Necessary Sickness Prevention with
      Immunizations Reaching Everyone) to ensure that all parents of adolescents are advised of all
      age-appropriate vaccines for sickness prevention. The investigator will develop a novel set
      of targeted video vignette persuasive informational decision aids (including target
      population representatives) to enhance lay understanding of recommended adolescent (or
      catch-up) vaccines. The Investigator will also partner with school districts to develop a
      replicable social marketing vaccination event program (Project INSPIRE) to encourage parents
      and teens to publicly vaccinate at community events and during drop-in school nursing clinic
      hours. The project will test the efficacy of the video-based health education intervention +
      standard of care to ideal standard of care (social marketing vaccination event program)
      approaches to immunize adolescents in this region.
    

Detailed description: 
      This is not an interventional study in which subject will be given a investigator drug or
      device.

      Part I of the INSPIRE intervention development will involve formative research interviews
      conducted with parents of adolescents. Interview questions will focus on reticence to
      vaccinate children. Participants will be a convenience sample recruited through contacts in
      local public health departments and community nurses recruited by flyer and the research
      study coordinators (UK study personnel). Interview sessions will be scheduled in advance and
      will take approximately 30 minutes.

      Part II of the INSPIRE intervention development will be evaluated in a small clinic-based
      pilot study using the same pre-test/post-test intervention design as in the planned (Part
      III) trial. For the pilot testing, the investigators will pilot the vaccination vignettes in
      a health department (clinical) setting with eligible parents of adolescents. Eligible parents
      who are coming in for non-acute care appointments will be asked by a research nurse to enroll
      in a research study. The Investigator will then administer a pretest survey, expose
      participants (parents) to vignette condition using the iPad in the clinic, and a post-test
      survey measuring intention to receive appropriate adolescent vaccines for their child as well
      as perceived message effectiveness (for the vignette). At the conclusion of the study, the
      research personnel administering the study will refer the adolescent to the clinic staff who
      will offer adolescent vaccines at the conclusion of the study (and/or a cue to schedule an
      appointment for the adolescent to visit the clinic) and will be able to examine actual
      behavior by receiving informed consent (from parents and adolescent) for limited medical
      record review (to track adolescent receipt of vaccinations). The Investigator will perform
      this pilot study in one Kentucky River Area District health department clinic with 30
      parents. This method has been used to pilot past interventions, and it is expected that this
      allow us to correct for any problems in either the design of the survey assessment or the
      intervention. If needed, the investigator can tweak the intervention and re-pilot using the
      same procedures before the randomized controlled trial. This pilot test will also provide the
      advantage of assuring us that the intervention procedure can translate to the clinic setting.
      The Investigator has experience with this translation from our 1-2-3 Pap video intervention
      which the investigators began in social settings (recruiting people at school and other
      community events) and moved into the clinic setting for dissemination.

      Part III of the INSPIRE project will be evaluated in a site-based group randomized controlled
      trial design, with individual-level randomization also occurring within the intervention
      group. Community vaccination clinic and health education sites (staffed by local health
      department contracted personnel and project nurses) in the intervention and control
      conditions will be matched on percentage of free/reduced school lunch and relevant
      demographics. At the end of Year 1, one health site in each pair will be randomized to the
      enhanced video educational intervention (video vignettes + standard of care social marketing
      vaccine event) or a standard of care vaccination campaign (standard of care health department
      vaccine event) comparison group. Individuals in the intervention group randomized condition
      also will be randomized when recruitment occurs in non-school based locations. Assessments
      will be conducted using Automated iPad Audio Assisted Interviewing techniques at pretest,
      immediate post-test, and then medical record review at 1 month and 9 month follow-up points.
      The medical record review will entail examining the medical record for each adolescent
      vaccine received by the patient. Thus, the investigators will be able to examine behavior
      change (i.e., receipt of vaccination) for each of the different vaccine types and their
      single or multi-dose outcomes.
    

Intervention name(s): Part II; Part III; Part I
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Parents will be exposed to an educational video intervention if they are enrolled in this intervention condition.; •video educational; Parental Interviews
Other intervention name(s): Video Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: adolescents; immunizations