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临床试验/NCT03609242
NCT03609242Unknown不适用

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 4. Comparison of the Bundle (Communication Skills, Performance Feedback and Prompts) and Standard of Care

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年8月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
试验地点
2
主要终点
Change in the rate of missed vaccination opportunities among consenting clinicians

研究概览

简要总结

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of HPV vaccine communication, performance feedback reports and provider prompts (the bundle) to reduce MOs and increase HPV vaccination rates.

详细描述

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of a bundled intervention training providers first in HPV vaccine communication skills (done through online educational modules and live office practice sessions), with the addition of performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) followed by the addition of provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.

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

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The practice provides HPV vaccination services to adolescents.
  • The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
  • The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
  • The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

排除标准

  • The practice plans to change EHR systems in the next three years.
  • The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
  • Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).
  • Patient inclusion criteria:
  • All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.
  • Patient exclusion criteria:
  • None apart from age of patients (above).

结局指标

主要结局

Change in the rate of missed vaccination opportunities among consenting clinicians

时间窗: Monthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.

Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among consenting clinicians

Change in the rate of missed vaccination opportunities among all clinicians

时间窗: Monthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.

Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among all clinicians

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

Peter G Szilagyi, MD MPH

Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics

University of California, Los Angeles

研究点 (2)

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The STOP-HPV Trial 4: Bundle Intervention | 临床试验