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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 4505
- Locations
- 1
- Primary Endpoint
- Tobacco abstinence at delivery
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tobacco abstinence at delivery
Time Frame: 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.
Secondary Outcomes
- 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)