Completed

INSPIREProject INSPIRE: Improving Adolescent Vaccination in Appalachian Kentucky

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What is being tested

Part I

+ Part II

+ Part III

Behavioral
Who is being recruted

From 11 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: May 7, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Minnesota
Last updated: May 7, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

597 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 11 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Parents of children 11-18 years of age

Parents/guardians with legal custody of a minor child

3 exclusion criteria prevent from participating
Allergy to vaccinations

Parent has made an informed decision not to vaccinate their child

Parents under the age of 18

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Interview questions will focus on reticence to vaccinate children.

Group II

Experimental
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

Group III

Experimental
enhanced video educational intervention (video vignettes + standard of care vaccine event) standard of care vaccination event

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Kentucky

Lexington, United StatesOpen University of Kentucky in Google Maps

University of Kentucky

Lexington, United States
Completed2 Study Centers