Organization of Smoking Cessation in Pregnant Women: Study of the Effectiveness, Transferability, Barriers and Facilitators of the Implementation of the 5A Strategy in French Context. A Cluster Randomized Controlled Trial in New Aquitaine.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,505
- 试验地点
- 2
- 主要终点
- Tobacco abstinence at delivery
研究概览
简要总结
The investigators are conducting a pragmatic cluster randomized trial in stepped-wedge of which objectives are to evaluate the effectiveness and the conditions of effectiveness of an organizational strategy for smoking cessation - 5A-QUIT-N - among pregnant women in New Aquitaine (NA), by using and optimizing existing resources
详细描述
In France, in 2016, 16.6% of pregnant women were smokers, the highest levels among European countries. Pregnancy is considered a teachable moment for smoking cessation. There are many tools, interventions and programs to reduce the smoking habits of pregnant women. The challenge is therefore not to propose new interventions but to understand what is hindering the implementation of existing interventions and proposing corrective measures. In this context, the scientific literature shows that interventions for smoking pregnant women only seem effective when based on a comprehensive approach that combines multiple interventions. In particular, interventions based on the 5A's model (Ask, Advise, Assess, Assist, Arrange) are largely recommended and have shown their effectiveness abroad. Factors facilitating or hindering the implementation of such strategies are mainly organizational. As organizations are context-dependent by nature, considering the generalization of such strategies in France therefore requires adapting them to the French health system and evaluating them in context, in a pragmatic approach, inserted into routine care and using the tools, procedures and existing organizations in the territories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •In this research, there are 4 categories of research participants:
- •Healthcare professionals: the target of the 5A-QUIT-N intervention from whom data will be collected to meet the secondary objective of the effectiveness conditions.
- •Stakeholders: individuals involved in the implementation of the research and intervention from whom data will be collected to meet the secondary objective of the effectiveness conditions.
- •Women who have just given birth and who smoke tobacco in early pregnancy: indirect beneficiaries of the intervention, from whom data will be collected to meet the primary objective of effectiveness.
- •Co-parent (partner) of the new-born child of the woman who has just given birth included in the study
- •Inclusion criteria for the intervention
- •The inclusion criteria for the clusters are :
- •Territory of maternity attractiveness in New Aquitaine
- •The inclusion criteria for care providers within the clusters are:
- •All institutions, structures and organizations and health professionals likely to participate in the follow-up of pregnant women
- •All institutions, structures and organizations and health professionals specializing in addictology or tobaccoology
- •The inclusion criteria for pregnant women within the clusters are :
- •All pregnant women who have smoked tobacco (at least 2 times a week, for at least 1 week) during the pregnancy (including the period when she was unaware of the pregnancy)
- •Inclusion criteria for the primary objective measures:
- •The inclusion criteria for women are (for data collection):
- •Have given birth in a New Aquitaine maternity hospital,
- •Reside in New Aquitaine
- •To have been followed for the pregnancy in the territory of the maternity of delivery
- •To have used tobacco during (at least 2 times a week, for at least 1 week) the pregnancy (including the period when she was unaware of the pregnancy)
- •Be over 18
- •Have given free, informed and express consent
排除标准
- •Non-inclusion criteria for the intervention
- •Cluster non-inclusion criteria:
- •Pilot territory (territory of attractiveness of the Arcachon maternity hospital)
- •Impossibility of collecting the main judgment criterion in the cluster Within these clusters, the health care providers and the pregnant women are all concerned and therefore do not have any non-inclusion criteria.
- •Non-inclusion criteria of measures for the primary objective:
- •The criteria for non-inclusion of women who have just given birth are:
- •Not speaking French,
- •Have COVID during delivery
- •Use only electronic cigarettes,
- •Under legal protection (guardianship, curatorship, safeguard of justice)
- •Women giving birth under X
- •Women giving birth to a stillborn baby
- •Women having made a denial of pregnancy
- •Women who have their child in neonatal intensive care
- •Women who have been fully monitored for their pregnancy outside of New Aquitaine
结局指标
主要结局
Tobacco abstinence at delivery
时间窗: At delivery (smoking status of the previous 7 days)
The point prevalence of abstinence at delivery, which is the proportion of women reporting abstinence from smoking for at least 7 days at delivery. This criterion is well documented in the literature assessing tobacco use. It has the advantage of detecting the delayed effects of an intervention and can be easily extrapolated.
次要结局
- Sustainability of professional practices(18 months from the deployment of the intervention)
- Postpartum relapse rate at 6 months(At 6 months postpartum)
- Postpartum relapse rate at 12 months(At 12 months postpartum)
- Continued abstinence(6 months and 1 year after delivery)
- Attempts to quit smoking(1 to 3 days after delivery)
- Birth weight(At baby birth, up to 3 days after delivery)
- Conditions of transferability(Through study completion, an average of 3 years)
- Average number of cigarettes smoked at inclusion(At inclusion)
- Gestational age(At baby birth, up to 3 days after delivery)
- Average number of cigarettes smoked at postpartum(6 months and 1 year after delivery)
- Attempts to reduce tobacco consumption(1 to 3 days after delivery)
- Continuous abstinence(1 to 3 days after delivery)
- Implementation of intervention(Through study completion, an average of 3 years)
- Sustainability of the impact on health(18 months from the deployment of the intervention)
- Viability(Through study completion, an average of 3 years)