PEGASUS-2: Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13: A Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 887
- 试验地点
- 2
- 主要终点
- Level of SDM adoption
研究概览
简要总结
This research project aims at assessing the effectiveness of a decision aid (DA) scaling intervention within the context of prenatal screening for trisomy 21, 18 and 13. The primary outcome is the level of involvement of pregnant women, their partners, and health professionals in shared decision-making (SDM) in the context of prenatal screening for trisomy 21, 18 and 13. The secondary outcome is the rate of use of online and paper versions of the DA by pregnant women, their partners and health professionals. The investigator hypothesize that the DA scaling strategies will increase the level of involvement of pregnant women, their partners (where appropriate), and health professionals in SDM.
详细描述
Making a decision about prenatal screening for trisomy 21, 18 and 13 can be difficult. This is why it is important for pregnant women and their partners to be informed, accompanied and supported by health care providers. Involving them in shared decision-making (SDM) would allow them to meet their decision-making needs in this context. In addition, the use of a decision aid (DA) would facilitate SDM. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a DA has been developed. The DA was developed according to recommendations from pregnant women and their partners as well as health professionals who found it relevant. Moreover, the DA scaling up strategies were developed. This research project aim is to assess the effectiveness of the DA scaling strategies on the level of involvement of pregnant women, their partners, and health professionals in SDM on prenatal screening for trisomy 21, 18 and 13. This study, conducted in Quebec, is a randomized cluster stepped wedge trial. The study will be conducted in five periods, each corresponding to a data collection period. During the first period, all groups of clusters will be in control conditions, where health professionals will provide usual prenatal care to pregnant women without DA scaling strategies. Then, following a regular interval of 10 weeks, each group will be exposed to the intervention in 4 stages at the beginning of the periods. Once a group has received the intervention, they will access it until the end of the study. Participants are prenatal services (randomization unit), health professionals (obstetricians-gynecologists, family physicians, midwives, nurses and all other health professionals involved in prenatal care) and pregnant women as well as their partners. The intervention will consist of a DA scaling strategies, including but not limited to an online version of the DA and an online training on SDM incorporating the use of the DA. The investigators will recruit at least 28 prenatal services (study sites) and 35 pregnant women per site. The primary outcome (the level of involvement of study participants in SDM in the context of prenatal screening for trisomy 21, 18 and 13) will be measured with the validated SDM-Q-9 scale, which will be completed by pregnant women and their partners. The primary secondary outcome will be the rate of use of online and paper versions of the DA by pregnant women and their partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation of prenatal services to groups and stages will be blinded by an independent, experienced biostatistician who will not be involved in the data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prenatal services (study sites) : To be eligible, prenatal services must
- •be located in Quebec province
- •be family medicine groups, gynecology and obstetrics departments or birth centers, other type of health facility involved in prenatal care
- •agree to participate in our study including the recruitment of approximately 35 pregnant women over a total period of 50 weeks
- •confirm that they will follow the research protocol.
- •Health professionals
- •To be eligible, health professionals must:
- •be involved in prenatal care and working in a site participating in this study
- •be involved in the follow-up of pregnancies
- •be involved in the decision-making process in the context of prenatal screening for trisomiy 21, 18 and 13,
- •be referred by their prenatal service
- •understand French or English,
- •consent to participate in the study
- •medical residents and interns in midwifery practice, referred by participating prenatal service, are eligible too.
- •Pregnant women and their partners To be eligible, pregnant women and their partners must
- •be 18 years of age or older
- •have not yet decided whether or not to have prenatal testing for trisomy 21, 18 or 13 (usually before 13 weeks of pregnancy)
- •be followed in one of the prenatal services participating in this study
- •be able to read and understand French or English
- •have the capacity to verbally consent to participate in the study or sign the consent form
排除标准
- •Pregnant women and their partners The pregnant woman who have any medical complications associated or not with pregnancy (e.g. diabetes, hypertension, multiple pregnancy) is not eligible to this study
- •Health professionals Health professionals working in more than one participating prenatal site as full- time or part-time employee are not eligible to this study
结局指标
主要结局
Level of SDM adoption
时间窗: At the 23rd week of pregnancy
The level of SDM adoption will be measured through the measurement of the level of involvement of health professionals and pregnant women (and their partners) in the decision regarding to have or not a prenatal screening test for trisomy 21, 18 and 13. The SDM adoption will be measured with the SDM-Q-9 scale, which is a validated measurement instrument. The SDM-Q-9 scale is well understood by patients and has the potential to collect valid data on the perceived involvement of patients in SDM. The SDM-Q-9 scale consists of 9 items, each corresponding to the expected behaviour of the health professional in the SDM. Each of the 9 items is rated by a six-point Likert scale (0 = Totally Disagree to 5 = Totally Agree) where higher scores reflect higher level of SDM adoption.
次要结局
- DA use fidelity for pregnant women and their partners(At the 23rd week of pregnancy)
- The rate of the DA utilization by pregnant women, their partners and health professionals(At the 23rd week of pregnancy (for pregnant women and their partners), and the research team will compile the information on the online and hard copies of DA utilization during weeks 10 to 50 of the study (Intervention phases))
- DA appreciation(At the 23rd week of pregnancy)
- Efforts and costs related to the use and the distribution of the DA(Immediately after the intervention)
- Perceived role in decision-making(At the 23rd week of pregnancy)
- Appreciation of the online SDM training(Immediately after the online training)
- Facilitators and barriers to the use of the DA(At the 23rd week of pregnancy)
- Efforts and costs related to the use of the DA(At the 23rd week of pregnancy)
- Decisions made and chosen tests(At the 23rd week of pregnancy)
- Duration of the prenatal consultation(At the 23rd week of pregnancy)
- Decisional conflict(At the 23rd week of pregnancy)
- DA use fidelity for healthcare providers(At the 23rd week of pregnancy)
- Long-term use of DA and proposed adaptations for the DA(At the 23rd week of pregnancy)
研究者
France Legare
Professor
CHU de Quebec-Universite Laval