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临床试验/NCT03399396
NCT03399396已完成不适用

Increasing HPV Vaccination in Community-Based Pediatric Practices

Pamela Hull2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
试验地点
2
主要终点
Age-appropriate completion rate (ages 13-17)

研究概览

简要总结

The central goal of this study is to identify the optimal approach to implementing an evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.

AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices. The investigators will compare the traditional In-person Coaching PF modality to a lower-resource Web-Based Coaching PF modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality.

AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination. The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.

详细描述

Background:

The human papillomavirus (HPV) vaccine offers the unprecedented opportunity to prevent nearly all cervical and anal cancers and a high proportion of vaginal, oropharyngeal, vulvar and penile cancers, where HPV is the etiologic agent. HPV vaccination is recommended for all children ages 11-12, with catch up for females to age 26 and males to age 21. However, despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%. Provider recommendation is the strongest determinant of HPV vaccination, but slow translation of guidelines for preventive services, such as immunizations, into practice is a known challenge. Practice Facilitation (PF), also called quality improvement coaching, is a multicomponent quality improvement intervention approach that has well-established efficacy, in which external support and resources are provided to build the internal capacity of practices to improve quality of care and patient outcomes.

Objectives:

The central goal of the study is to identify the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.

AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices.

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
None

盲法说明

Due to the nature of the intervention, it is not possible to blind the practices or study staff to study arm allocation. To minimize bias, allocation will be masked until after baseline data collection of outcome measures, when it is time for each practice to initiate the intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All providers and staff at each practice

排除标准

  • 未提供

结局指标

主要结局

Age-appropriate completion rate (ages 13-17)

时间窗: Annually, up to 3 years post baseline

Percentage of active patients ages 13-17 who completed the HPV vaccine series before 13th birthday

次要结局

  • Age-appropriate initiation rate (ages 13-17)(Monthly, up to 36 months post baseline)
  • Age-appropriate completion rate (at age 13)(Monthly, up to 36 months post baseline)
  • Overall completion rate (ages 13-17)(Monthly, up to 36 months post baseline)
  • Overall initiation rate (ages 13-17)(Monthly, up to 36 months post baseline)
  • Dose received rate (well visits)(Monthly, up to 36 months post baseline)
  • Age at vaccination(Monthly, up to 36 months post baseline)
  • Age-appropriate initiation rate (at age 13)(Monthly, up to 36 months post baseline)
  • Dose received rate (all visits)(Monthly, up to 36 months post baseline)
  • Time to series completion(Monthly, up to 36 months post baseline)

研究者

发起方
Pamela Hull
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pamela Hull

Assistant Professor

University of Kentucky

研究点 (2)

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