跳至主要内容
临床试验/NCT05570630
NCT05570630已完成不适用

VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

University of Rochester2 个研究点 分布在 1 个国家目标入组 6,911 人开始时间: 2022年10月21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
6,911
试验地点
2
主要终点
Rate of COVID-19 Vaccination (6 Month)

研究概览

简要总结

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

详细描述

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people overall.

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 COVID-19 vaccination rates for pregnant people. To address this, 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 COVID-19 intervention and the other half to standard of care. The multi-component VAX-MOM COVID-19 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
Female
接受健康志愿者

入选标准

  • Patient criteria:
  • Sex is female
  • Identified as being eligible for COVID-19 vaccine
  • Practice personnel criteria:
  • *Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites

排除标准

  • 未提供

结局指标

主要结局

Rate of COVID-19 Vaccination (6 Month)

时间窗: 6 months

Average rate of COVID-19 vaccination will be compared between intervention and control arms, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.

次要结局

  • Rate of COVID-19 Vaccination (9 Month)(9 months)

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)

Loading locations...

相似试验