Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Smoking Cessation Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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5A-QUIT-N intervention

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.

Group Type EXPERIMENTAL

5A organizational innovation

Intervention Type OTHER

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.

5A-QUIT-N control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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5A organizational innovation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Territory of maternity attractiveness in New Aquitaine

* 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

\- 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)

* 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

* Pilot territory (territory of attractiveness of the Arcachon maternity hospital)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No