A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 46
- 主要终点
- Number of women receiving pertussis vaccination
研究概览
简要总结
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time. This study builds off of a prior intervention, developed by Emory, at the practice, provider, and patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to improve vaccination uptake among pregnant women, and later, their children.
详细描述
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time.
This study uses a multi-level factorial design which randomizes at both the practice and the patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an intervention practice or a control practice. The women recruited in the practices and enrolled in the study will be randomly assigned to the intervention arm or the control arm.
Women randomized to the intervention arm will complete a computer-based questionnaire (administered via iPad with a preloaded study app) which asks for their basic demographic and contact information and asks questions about their vaccine knowledge, attitudes, and beliefs. Immediately following the questionnaire, participants will receive the individual level intervention (videos providing information on vaccines) on the same iPad. In order to best answer their questions and not provide information beyond the scope of what the study participants need or want, the videos provided to each participant will be selected based on responses to the survey questions. There are 6 videos: one discusses the dangers of the diseases prevented by vaccines, and the others address specific vaccine concerns (concerns include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the participant does not have any concerns, they will only see the video about dangers of vaccine preventable diseases. Participants expressing concerns in the survey will receive up to two videos addressing those concerns, based on an order of priority determined by the study researchers.
Women randomized to the control arm will also complete a computer-based questionnaire which includes their personal information and vaccine knowledge, attitudes, and beliefs questions but will then continue to receive usual prenatal care rather than view informational videos.
All enrolled women complete two follow-up surveys when their children are 30 days and 18 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have not previously participated in this study
- •Currently pregnant
- •Up to 26 weeks gestational age
- •Able to understand and communicate in English
排除标准
- •Have received pertussis vaccine during the current pregnancy
结局指标
主要结局
Number of women receiving pertussis vaccination
时间窗: Up to 34 weeks
Whether or not the participant chose to receive the pertussis vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Number of women receiving influenza vaccination
时间窗: Up to 34 weeks
Whether or not the participant chose to receive the flu vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Timely childhood vaccinations
时间窗: 20 months
Childhood vaccination will be assessed as timely uptake of childhood vaccines by calculating average days under-vaccinated. The total number of days under-vaccinated will be divided by the number of vaccines a child should have received, according to the Advisory Committee on Immunization Practices (ACIP) schedule, to give the average number of days under-vaccinated across all recommended vaccines. This can range from 0 to 415 days in the first 20 months of life. The average number of days under-vaccinated will be modeled as a continuous variable, and the distribution of days under-vaccinated will be evaluated, in total and by vaccine where possible, to identify specific patterns of interest for follow-up.
次要结局
- Changes in maternal vaccine attitudes(Up to 106 weeks (baseline visit until 18 months post delivery))
- Changes in maternal vaccine beliefs(Up to 106 weeks (baseline visit until 18 months post delivery))
- Changes in maternal vaccine knowledge(Up to 106 weeks (baseline visit until 18 months post delivery))
研究者
Robert Bednarczyk
Assistant Professor
Emory University