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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,505
This project is based on three strategic axes: * A gradation of the care offer allowing to adapt the means and resources mobilized on the territory * Personalized care by developing specific treatment paths based on the risk factors and/or vulnerabilities of the pregnant woman * Coordination of territorial resources to support pregnant women in quitting smoking These three key elements will make it possible to propose a partnership-based, multi-professional, coordinated and integrated approach to the territory, supported by the technical resources and expertise available in the territory. It invites a majority of non-specialized actors to invest in the process of supporting pregnant women in quitting smoking, multiplying and potentiating their actions with this population.
CHU de Bordeaux, Hôpital Saint-André
Bordeaux, France
RECRUITINGTobacco abstinence at delivery
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.
Time frame: At delivery (smoking status of the previous 7 days)
Average number of cigarettes smoked at inclusion
Average number of cigarettes smoked per day over the last 30 (or 7) days
Time frame: At inclusion
Average number of cigarettes smoked at postpartum
Average number of cigarettes smoked per day over the last 30 (or 7) days
Time frame: 6 months and 1 year after delivery
Attempts to reduce tobacco consumption
The number of attempts to reduce tobacco consumption (at least 1 cigarette)
Time frame: 1 to 3 days after delivery
Attempts to quit smoking
Number of attempts to quit smoking (at least 24 hours)
Time frame: 1 to 3 days after delivery
Continuous abstinence
Continuous abstinence (in number of days)
Time frame: 1 to 3 days after delivery
Birth weight
Birth weight (in kg) of the baby
Time frame: At baby birth, up to 3 days after delivery
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Gestational age
Gestational age (in months) of the baby (at birth).
Time frame: At baby birth, up to 3 days after delivery
Sustainability of professional practices
Prevalence of completion of each A of the 5A approach evaluated on a subgroup of women who have just given birth at a distance from the deployment of the intervention (18 months) via the questionnaire
Time frame: 18 months from the deployment of the intervention
Sustainability of the impact on health
Prevalence of women smoking tobacco at delivery over the last 7 days via two sources: the computer systems of the maternity units that have this information systematically (non-exhaustive because not all maternity units in the New Aquitaine region have a computer system) and on a sub-group of women who have just given birth
Time frame: 18 months from the deployment of the intervention
Postpartum relapse rate at 6 months
Relapse rate among women who quit smoking during pregnancy at 6 and 12 months postpartum defined as a resumption of at least 7 consecutive days of smoking in the past 6 months.
Time frame: At 6 months postpartum
Postpartum relapse rate at 12 months
Relapse rate among women who quit smoking during pregnancy at 6 and 12 months postpartum defined as a resumption of at least 7 consecutive days of smoking in the past 6 months.
Time frame: At 12 months postpartum
Continued abstinence
Continued abstinence (in number of days)
Time frame: 6 months and 1 year after delivery
Implementation of intervention
Barriers and levers to implementation in professionals
Time frame: Through study completion, an average of 3 years
Conditions of transferability
Conditions of transferability linked to the characteristics of the stakeholders and the context: contextual conditions for success within the centres, the characteristics of professionals and patients influencing outcomes
Time frame: Through study completion, an average of 3 years
Viability
Assessment of intervention deployment in a real-world setting, using 5 criteria: utility, affordability, evaluability, adaptability and acceptability. "Utility" dimension (as a complement to the secondary criteria) of viability through the recovery mechanisms identified as successful mental health recovery Affordability for professionals and beneficiaries (financial, geographical, social and cultural levers and brakes of the intervention) Evaluability of 5A-QUIT-N: carrying out this evaluation, the availability of professionals and beneficiaries to answer questionnaires and interviews, missing data in the questionnaires etc. Adaptability of 5A-QUIT-N: integration of the action into the context and the current organisation of the centres Acceptability of 5A-QUIT-N: by professionals and beneficiaries
Time frame: Through study completion, an average of 3 years