Screening for Hesitancy to Optimize Talk

Not Applicable

Completed

• Conditions: Preventive Health Services
• Interventions: Behavioral: Intervention Survey; Behavioral: Placebo Survey

• Registration Number: NCT02708745
• Lead Sponsor: Seattle Children's Hospital

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2018-06-11
• Study Completion: 2018-06-11
• Results First Submitted: 2019-06-10
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Results First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Intervention Survey	Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Placebo Arm	Placebo Survey	Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.

Primary Outcome Measures

Name	Time	Method
Child's Mean Percent Days Under-immunized	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 Outcome Measures

Name	Time	Method
Provider Perceptions of Barriers to the Vaccine Discussion	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
Number of Parents With a Highly Rated Visit Experience	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)