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OpenTrials
Completed

NCT Number: NCT02708745

Screening for Hesitancy to Optimize Talk

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.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Survey

Behavioral

Placebo Survey

Behavioral

Primary outcomes

  1. 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

  1. Number of Parents With a Highly Rated Visit Experience

    Time frame: 24-48 hours after the 6 month health supervision visit

    Score on a 15-item parent-completed visit experience survey (minimum score 15; maximum score 105, with higher scores suggesting a higher rated visit experience)

  2. Provider Perceptions of Barriers to the Vaccine Discussion

    Time frame: Change post-intervention from pre-intervention

    Provider-reported ratings of the significance of 3 barriers to the vaccine discussion: a) not having enough time to discuss parental vaccine concerns, b) not realizing until late in the visit that a parent had vaccine concerns, and c) not understanding a parent's specific vaccine concerns to be barriers pre- and post-intervention

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Kaiser Permanente
  • University of Washington

Registry information

Official study title

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

Acronym: SHOT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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