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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5A-QUIT-N intervention | Experimental | 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:
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. |
|
| 5A-QUIT-N control | No Intervention | Usual care in the care of pregnant women who smoke tobacco. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5A organizational innovation | Other | This project is based on three strategic axes:
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| Measure | Description | Time Frame |
|---|---|---|
| Tobacco 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. | At delivery (smoking status of the previous 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of cigarettes smoked at inclusion | Average number of cigarettes smoked per day over the last 30 (or 7) days | At inclusion |
| Average number of cigarettes smoked at postpartum | Average number of cigarettes smoked per day over the last 30 (or 7) days |
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In this research, there are 4 categories of research participants:
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:
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
Non-inclusion criteria for the intervention
Cluster 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Alla, Prof | Contact | +335 57 82 26 50 | francois.alla@u-bordeaux.fr | |
| Charlotte Kervran | Contact | charlotte.kervran@u-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Alla, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux, Hôpital Saint-André | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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In order to evaluate the effectiveness of 5A-QUIT-N, we will conduct a trial in New Aquitaine using a mixed quantitative and qualitative method.
The quantitative study is a stepped-wedge cluster randomized trial (SWCRT) with a transition phase (deployment). The duration of each period is set at 3 months.
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| 6 months and 1 year after delivery |
| Attempts to reduce tobacco consumption | The number of attempts to reduce tobacco consumption (at least 1 cigarette) | 1 to 3 days after delivery |
| Attempts to quit smoking | Number of attempts to quit smoking (at least 24 hours) | 1 to 3 days after delivery |
| Continuous abstinence | Continuous abstinence (in number of days) | 1 to 3 days after delivery |
| Birth weight | Birth weight (in kg) of the baby | At baby birth, up to 3 days after delivery |
| Gestational age | Gestational age (in months) of the baby (at birth). | 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 | 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 | 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. | 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. | At 12 months postpartum |
| Continued abstinence | Continued abstinence (in number of days) | 6 months and 1 year after delivery |
| Implementation of intervention | Barriers and levers to implementation in professionals | 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 | 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 | Through study completion, an average of 3 years |