Clinical trial NCT05355012: Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Pregnancy Related
Keywords: Smoking cessation
Pregnancy
5As
Healthcare optimization
Transferability
Healthcare sustainability
Organizational innovation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 4505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

  * Exclusion criteria:

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

Primary outcomes:
measure: Tobacco abstinence at delivery
timeFrame: At delivery (smoking status of the previous 7 days)
Secondary outcomes:
measure: Average number of cigarettes smoked at inclusion
timeFrame: At inclusion
measure: Average number of cigarettes smoked at postpartum
timeFrame: 6 months and 1 year after delivery
measure: Attempts to reduce tobacco consumption
timeFrame: 1 to 3 days after delivery
measure: Attempts to quit smoking
timeFrame: 1 to 3 days after delivery
measure: Continuous abstinence
timeFrame: 1 to 3 days after delivery
measure: Birth weight
timeFrame: At baby birth, up to 3 days after delivery
measure: Gestational age
timeFrame: At baby birth, up to 3 days after delivery
measure: Sustainability of professional practices
timeFrame: 18 months from the deployment of the intervention
measure: Sustainability of the impact on health
timeFrame: 18 months from the deployment of the intervention
measure: Postpartum relapse rate at 6 months
timeFrame: At 6 months postpartum
measure: Postpartum relapse rate at 12 months
timeFrame: At 12 months postpartum
measure: Continued abstinence
timeFrame: 6 months and 1 year after delivery
measure: Implementation of intervention
timeFrame: Through study completion, an average of 3 years
measure: Conditions of transferability
timeFrame: Through study completion, an average of 3 years
measure: Viability
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Saint-André
Study officials:
affiliation: University Hospital, Bordeaux
name: François Alla, Prof
role: PRINCIPAL_INVESTIGATOR
References: