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Clinical Trials/NCT02708745
NCT02708745
Completed
Not Applicable

Use of a Novel Parent-Report Measure to Improve Childhood Vaccine Uptake: The Screening for Hesitancy to Optimize Talk (SHOT) Study

Seattle Children's Hospital0 sites562 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preventive Health Services
Sponsor
Seattle Children's Hospital
Enrollment
562
Primary Endpoint
Child's Mean Percent Days Under-immunized
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The overall goal of this project is to determine whether integrating a novel parent-report measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance of childhood vaccines among vaccine-hesitant parents.

Detailed Description

The primary goal of this project is to evaluate the effectiveness of an innovative intervention designed to address these barriers-the Screening for Hesitancy to Optimize Talk (SHOT) intervention-in improving provider-parent vaccine discussions and increasing vaccine acceptance. The SHOT intervention involves administering a validated parent-report measure to parents and communicating their score and item-specific responses to their child's provider before their child's 2 and 6 month health supervision visits. The survey contains 15 questions regarding Health Belief Model concepts that influence parent vaccination behavior and has been shown to predict under-immunization. Our specific aims are to (1) evaluate the impact of the SHOT intervention on a child's immunization status using a matched-pair, cluster randomized controlled trial design; (2) assess how parents' ratings of their vaccine discussions with their child's provider change as a function of the SHOT intervention; and (3) compare pre- and post-study perceptions of barriers to quality vaccine discussions with parents between providers in the SHOT and control arm.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
June 11, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas Opel

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Parents: Parents must be English speaking, ≥18 years old, have a newborn singleton infant ≤2 months, born at ≥35 weeks gestation who is receiving pediatric care at an enrolled Kaiser Permanente or Allegro Pediatrics clinic, and be vaccine hesitant (defined as positive screening score on eligibility survey).
  • Newborns: Newborns 0 - 2 months old whose parents enroll in the study will be invited to participate.
  • Providers: All pediatric and family practice providers at Kaiser Permanente and Allegro Pediatrics primary clinics within a 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap Counties) will be eligible to participate.

Exclusion Criteria

  • Parents/Children: Parents who are not 18 years or older, require language interpretation for medical care, have an infant born \<35 weeks gestation, are not vaccine hesitant or will not be taking their child to a participating clinic for health supervision visits will be excluded.
  • Providers: Clinics and providers outside the 5 county region in western Washington (Snohomish, King, Pierce, Thurston, and Kitsap) will be excluded.

Outcomes

Primary Outcomes

Child's Mean Percent Days Under-immunized

Time Frame: Child's immunization status at 8 months of age

Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention

Secondary Outcomes

  • Provider Perceptions of Barriers to the Vaccine Discussion(Change post-intervention from pre-intervention)
  • Number of Parents With a Highly Rated Visit Experience(24-48 hours after the 6 month health supervision visit)

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