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临床试验/NCT04444518
NCT04444518已完成不适用

The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women

University of Rochester2 个研究点 分布在 1 个国家目标入组 12,760 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,760
试验地点
2
主要终点
Rate of Influenza Vaccination

研究概览

简要总结

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

详细描述

Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

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

性别
All
接受健康志愿者

入选标准

  • Sex is female
  • identified as being eligible for influenza or Tdap vaccine
  • any provider, nurse or staff associated with the participating sites

排除标准

  • 未提供

结局指标

主要结局

Rate of Influenza Vaccination

时间窗: 10/1/2021-6/30/2022 (intervention flu season)

Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

Rate of Tdap Vaccination

时间窗: 7/1/2021 - 6/30/2022 (intervention period)

Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

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

Cynthia Rand

Associate Professor

University of Rochester

研究点 (2)

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