Smoking Cessation5A-QUIT-NNCT05355012
Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine.
A study testing 5A organizational innovation in people with Smoking Cessation and Pregnancy Related, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Pregnancy Related
- What is being tested?
- 5A organizational innovation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,505 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
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- 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)
- 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
Who cannot join
- 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:
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- 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 locations and contacts
1 site in 1 country.
Charlotte Kervran contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux, Hôpital Saint-André
Bordeaux, 33000
François Alla, Pr, +33557822650, francois.alla@u-bordeaux.fr
Charlotte Kervran, charlotte.kervran@u-bordeaux.fr
About this study
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.
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
Read the 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.
- Conditions
- Smoking Cessation, Pregnancy Related
- Being tested
- 5A organizational innovation
- Keywords
- Smoking cessation, Pregnancy, 5As, Healthcare optimization, Transferability, Healthcare sustainability, Organizational innovation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5A organizational innovationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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. Receives: Other: 5A organizational innovation |
| 5A-QUIT-N control | No intervention | Usual care in the care of pregnant women who smoke tobacco. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery (smoking status of the previous 7 days)
Secondary outcomes (15)
Average number of cigarettes smoked at inclusion
Average number of cigarettes smoked per day over the last 30 (or 7) days
Measured: At inclusion
Average number of cigarettes smoked at postpartum
Average number of cigarettes smoked per day over the last 30 (or 7) days
Measured: 6 months and 1 year after delivery
Attempts to reduce tobacco consumption
The number of attempts to reduce tobacco consumption (at least 1 cigarette)
Measured: 1 to 3 days after delivery
Attempts to quit smoking
Number of attempts to quit smoking (at least 24 hours)
Measured: 1 to 3 days after delivery
Continuous abstinence
Continuous abstinence (in number of days)
Measured: 1 to 3 days after delivery
Birth weight
Birth weight (in kg) of the baby
Measured: At baby birth, up to 3 days after delivery
Gestational age
Gestational age (in months) of the baby (at birth).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 12 months postpartum
Continued abstinence
Continued abstinence (in number of days)
Measured: 6 months and 1 year after delivery
Implementation of intervention
Barriers and levers to implementation in professionals
Measured: 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
Measured: 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
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start3 Oct 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 4,505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Alla, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355012
- Sponsor's protocol ID
- CHUBX 2019/61
- Acronym
- 5A-QUIT-N
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05355012
- Acronym / sponsor ID
- 5A-QUIT-N / CHUBX 2019/61
- Conditions
- Smoking Cessation, Pregnancy Related
- Keywords
- Smoking cessation, Pregnancy, 5As, Healthcare optimization, Transferability, Healthcare sustainability, Organizational innovation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,505 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5A-QUIT-N intervention | Experimental | Other: 5A organizational innovationThe 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. |
| 5A-QUIT-N control | No intervention | –Usual care in the care of pregnant women who smoke tobacco. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (15 listed)
- Non-inclusion criteria for the intervention
- 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.
- Not speaking French,
- Have COVID during delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5A organizational innovationThis 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. | Other | 5A-QUIT-N intervention |
Primary outcome
Tobacco abstinence at delivery
Time frame: 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.
15 secondary outcomes
Average number of cigarettes smoked at inclusion
Time frame: At inclusion
Average number of cigarettes smoked at postpartum
Time frame: 6 months and 1 year after delivery
Attempts to reduce tobacco consumption
Time frame: 1 to 3 days after delivery
Attempts to quit smoking
Time frame: 1 to 3 days after delivery
Continuous abstinence
Time frame: 1 to 3 days after delivery
Birth weight
Time frame: At baby birth, up to 3 days after delivery
Gestational age
Time frame: At baby birth, up to 3 days after delivery
Sustainability of professional practices
Time frame: 18 months from the deployment of the intervention
Sustainability of the impact on health
Time frame: 18 months from the deployment of the intervention
Postpartum relapse rate at 6 months
Time frame: At 6 months postpartum
Postpartum relapse rate at 12 months
Time frame: At 12 months postpartum
Continued abstinence
Time frame: 6 months and 1 year after delivery
Implementation of intervention
Time frame: Through study completion, an average of 3 years
Conditions of transferability
Time frame: Through study completion, an average of 3 years
Viability
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Kervran contact
François Alla, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5A organizational innovation in people with Smoking Cessation and Pregnancy Related, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Alla, Prof (+335 57 82 26 50, francois.alla@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco abstinence at delivery (time frame: At delivery (smoking status of the previous 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.