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临床试验/NCT02812732
NCT02812732已完成不适用

DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates

Boston Medical Center0 个研究点目标入组 382 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
382
主要终点
Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.

研究概览

简要总结

After completing over 600 interviews with parents, adolescents, and clinicians to determine reasons why HPV vaccines are used or not used, the investigators recently piloted a communication-based educational intervention with healthcare clinicians to improve communication around HPV vaccination. The intervention combined education and quality improvement methods using a mechanism called Performance Improvement Continuing Medical Education. This type of intervention is attractive to clinicians because they improve their cancer prevention practices while fulfilling requirements for maintaining board certification. The intervention consists of seven education and feedback sessions along with baseline and follow-up chart reviews and facilitated group discussions of clinician and practice vaccination rates. The pilot intervention was effective: at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period.

The goal of the proposed research is to broadly test the intervention's effectiveness in a diverse group of pediatric and family medicine practices serving low-income and minority patients. First, the investigators will perform a randomized trial in five community health centers to determine the effectiveness of the intervention. Second, the investigators will examine what made the intervention successful and identify barriers to sustainability with the goal of ensuring that the intervention can be successfully replicated in other settings. Third, the investigators will explore the effects of the intervention on parent-clinician communication by surveying parents and clinicians and observing clinical encounters when vaccination is discussed.

The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians. Unlike programs that increase administrative burdens on busy clinicians, the proposed intervention allows clinicians to improve cancer prevention practices while simultaneously fulfilling requirements to maintain their board certification and improving the quality of cancer prevention care. It therefore has great potential for widespread dissemination.

详细描述

BACKGROUND

Human Papillomavirus (HPV) causes cervical, vaginal, vulvar, anal, and oral cancers, which disproportionately affect low-income and minority populations. Universal HPV vaccination has the potential to decrease burdens and to reduce disparities in these diseases. However, HPV vaccination rates for U.S. adolescents remain low. Clinician recommendation is the most important factor influencing HPV vaccine uptake; thus enhancing clinician communication about HPV vaccines is a critically important target for interventions to prevent cancer.

OBJECTIVE

In the past six years, the investigators' research has identified factors affecting HPV vaccine communication and utilization. the investigators recently piloted a communication intervention with clinicians, and at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period. The investigators aim to demonstrate the effectiveness of this intervention in a randomized trial, and to directly examine its effects on communication.

SPECIFIC AIMS

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
9 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Receive primary care at intervention sites
  • ages 9-26

排除标准

  • do not receive primary care
  • outside age range

结局指标

主要结局

Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.

时间窗: Outcomes are assessed up to 36 months from the start of the study.

Compare pre- and post-intervention rates of HPV vaccination

次要结局

未报告次要终点

研究者

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

Rebecca Perkins

Associate Professor

Boston Medical Center

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