Screening for Hesitancy to Optimize Talk (SHOT)

Seattle Children's Healthcare System

Status: Completed

Conditions: Preventive Health Services

Treatments: Behavioral: Intervention Survey; Behavioral: Placebo Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT02708745

1R21HD083770-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 562 patients

Sex: All

Ages: 1+ day old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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562 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.

Treatment:

Behavioral: Placebo Survey

Intervention Arm

Experimental group

Description:

Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.

Treatment:

Behavioral: Intervention Survey