Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine. (5A-QUIT-N)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Pregnancy Related; Smoking Cessation

Treatments: Other: 5A organizational innovation

Study type: Interventional

Funder types: Other

Identifiers

NCT05355012

CHUBX 2019/61

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,505 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4,505 participants in 2 patient groups

5A-QUIT-N intervention

Experimental group

Description:

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.

Treatment:

Other: 5A organizational innovation

5A-QUIT-N control

No Intervention group

Description:

Usual care in the care of pregnant women who smoke tobacco.