Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine.
- Conditions
- Pregnancy RelatedSmoking Cessation
- Interventions
- Other: 5A organizational innovation
- Registration Number
- NCT05355012
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4505
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 5A-QUIT-N intervention 5A organizational innovation The 5A-QUIT-N intervention can be defined as multilevel, i.e., it is based on a territorial organization with expected results at the level of professional practice (structuring of practices around the 5A method) and therefore of the care of pregnant women who smoke tobacco. This project is based on three strategic axes: * A gradation of the care offer * Personalized care by developing specific treatment paths * Coordination of territorial resources to support pregnant women in quitting smoking. These 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.
- Primary Outcome Measures
Name Time Method Tobacco abstinence at delivery 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 Outcome Measures
Name Time Method Sustainability of professional practices 18 months from the deployment of the intervention 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
Postpartum relapse rate at 6 months At 6 months postpartum 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.
Postpartum relapse rate at 12 months At 12 months postpartum 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.
Continued abstinence 6 months and 1 year after delivery Continued abstinence (in number of days)
Attempts to quit smoking 1 to 3 days after delivery Number of attempts to quit smoking (at least 24 hours)
Birth weight At baby birth, up to 3 days after delivery Birth weight (in kg) of the baby
Conditions of transferability Through study completion, an average of 3 years 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
Average number of cigarettes smoked at inclusion At inclusion Average number of cigarettes smoked per day over the last 30 (or 7) days
Gestational age At baby birth, up to 3 days after delivery Gestational age (in months) of the baby (at birth).
Average number of cigarettes smoked at postpartum 6 months and 1 year after delivery Average number of cigarettes smoked per day over the last 30 (or 7) days
Attempts to reduce tobacco consumption 1 to 3 days after delivery The number of attempts to reduce tobacco consumption (at least 1 cigarette)
Continuous abstinence 1 to 3 days after delivery Continuous abstinence (in number of days)
Implementation of intervention Through study completion, an average of 3 years Barriers and levers to implementation in professionals
Sustainability of the impact on health 18 months from the deployment of the intervention 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
Viability Through study completion, an average of 3 years 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
Trial Locations
- Locations (1)
CHU de Bordeaux, Hôpital Saint-André
🇫🇷Bordeaux, France