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临床试验/NCT02708745
NCT02708745已完成不适用

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 个研究点目标入组 562 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
562
主要终点
Child's Mean Percent Days Under-immunized

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Day 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Placebo Arm

Placebo Comparator

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

干预措施: Placebo Survey (Behavioral)

Intervention Arm

Experimental

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

干预措施: Intervention Survey (Behavioral)

结局指标

主要结局

Child's Mean Percent Days Under-immunized

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Opel

Principal Investigator

Seattle Children's Hospital

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