Improving Adolescent Vaccination in Appalachian Kentucky (INSPIRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Kentucky
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Elisia Cohen, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01838161
First received: April 4, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Adolescent Immunization
Behavioral: Part II
Behavioral: Part III

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Project INSPIRE: Improving Adolescent Vaccination in Appalachian Kentucky

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Part I - Parent Interviews [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Interview questions will focus on reticence to vaccinate children. Participants will be a convenience sample recruited through contacts in local public health departments, community nurses and the research study coordinators.


Secondary Outcome Measures:
  • Part II - Vaccination vignettes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The investigator will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents. The Investigator will then expose parents to vignette condition using the iPad, administer a pretest survey, the video vignette, and a post-test survey measuring intention to receive appropriate adolescent vaccines for their child as well as perceived message effectiveness (for the vignette).


Other Outcome Measures:
  • Part III - Site-based group randomized controlled trial design [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Community vaccination clinic sites in the intervention and control conditions will be matched on percentage of free/reduced school lunch and relevant demographics. One site in each pair will be randomized to the enhanced video educational intervention (video vignettes + standard of care health department vaccine event) or a standard of care vaccination campaign (standard of care health department vaccine event) comparison group. The medical record review will allow us to examine behavior change (i.e., receipt of age-appropriate vaccinations) for each of the different vaccine types and their single or multi-dose outcomes.


Estimated Enrollment: 700
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Part I - Parent Interviews
Interview questions will focus on reticence to vaccinate children.
Experimental: Part II

We will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents.

  • a pretest survey
  • the video vignette
  • and a post-test survey measuring intention to receive appropriate adolescent vaccines
Behavioral: Part II
Parents will be exposed to an educational video intervention if they are enrolled in this intervention condition.
Experimental: Part III
  • enhanced video educational intervention (video vignettes + standard of care vaccine event)
  • standard of care vaccination event
Behavioral: Part III
•video educational
Other Name: Video Education

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 expose participants (parents) to vignette condition using the iPad in the clinic administer a pretest survey, the video vignette, 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. Community vaccination clinic sites (staffed by local health department contracted personnel) 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. 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.

  Eligibility

Ages Eligible for Study:   11 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents/guardians with legal custody of a minor child
  • Parents of children 11-18 years of age.

Exclusion Criteria:

  • Parents under the age of 18
  • Allergy to vaccinations
  • Parent has made an informed decision not to vaccinate their child
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838161

Contacts
Contact: Elisia Cohen, PhD (859) 257-4102 elisia.cohen@uky.edu

Locations
United States, Kentucky
University of Kentucky Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Elisa Cohen, PhD    859-257-4702    Elisia.Cohen@uky.edu   
Principal Investigator: Elisia Cohen, PhD         
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40475
Contact: Elisia L Cohen, PhD    859-257-3323    elcohe2@uky.edu   
Sponsors and Collaborators
Elisia Cohen
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Elisia Cohen, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Elisia Cohen, sponsor-investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01838161     History of Changes
Other Study ID Numbers: 13-0026-P4S
Study First Received: April 4, 2013
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
adolescents
immunizations

ClinicalTrials.gov processed this record on July 20, 2014