Evaluation of an intervention aimed at improving the support for smoking cessation of patients by general practitioners
| ISRCTN | ISRCTN10207960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10207960 |
- Submission date
- 11/09/2024
- Registration date
- 25/11/2024
- Last edited
- 25/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Each year, more than 75,000 deaths in France are attributable to smoking. Despite strong measures that have reduced smoking, the number of daily smokers has stagnated since 2019. Studies show that smokers accompanied by a health professional are at least 70% more likely to succeed in quitting smoking than those who try to quit smoking alone. However, the majority of smokers try to quit on their own, and health professionals underestimate the demand for support and its effectiveness. The objective of the study is to evaluate how well tools intended to support and encourage general practitioners in supporting smoking cessation work.
Who can participate?
General practitioners (GPs) from mainland France who do not work exclusively in a hospital, in a clinic and/or in a company.
What does the study involve?
GPs are recruited via an online panel and another contact file comprising around 37,000 GPs on the whole. GPs have to complete a recruitment questionnaire, at the end of which they are randomly allocated to one of two groups: (1) Control, receiving nothing, (2) Treatment, receiving a kit by post. The kit includes: 1/ an information sheet on carrying out a brief intervention in three stages: Screen, Advise and Refer; 2/ leaflets to be placed in the waiting room with a questionnaire to survey patients about their smoking, information on the benefits of cessation and the role of GPs in helping smoking cessation; 3/ a poster to attract patients' attention to the questionnaire. The use of the tools is planned over a period of 4 weeks, at the end of which a follow-up questionnaire is sent to GPs from both groups. GPs report the number of patients with whom they talked about smoking cessation, and if they proposed a support, during the last full working day. To evaluate the impact of the tools, the results in GPs who received these tools are compared to those of GPs who did not receive them.
What are the possible benefits and risks of participating?
Participants in the intervention group can continue to use the tools beyond the duration of the experiment. Participants in the control group can download the tools after answering the follow-up questionnaire. Participants in both groups receive compensation of 30 euros if they respond to both questionnaires (recruitment and follow-up). No risk is identified.
Where is the study run from?
Santé publique France, the French national public health agency, manages the study. The experiment takes place in general medicine practices.
When is the study starting and how long is it expected to run for?
September 2022 to May 2024
Who is funding the study?
Santé publique France and the French national health insurance.
Who is the main contact?
Romain Guignard, romain.guignard@santepubliquefrance.fr
Contact information
Public, Principal Investigator
Santé publique France
12, rue du Val d'Osne
Saint-Maurice
94415
France
 ORCID ID |
0000-0002-9630-2083 |
|---|---|
| Phone | +33 (0)1 71 80 15 75 |
| romain.guignard@santepubliquefrance.fr |
Scientific
Behavioural Insights Team
26 rue Henry Monnier
Paris
75009
France
| Phone | +33 (0) 6.50.05.37.31 |
|---|---|
| alice.escande@bi.team |
Study information
| Study design | Interventional two-arm simple-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | 46064 PIS TabacPro_recruitment_email.pdf |
| Scientific title | Effectiveness of the provision of tools for general practitioners to support smoking cessation, compared to no intervention |
| Study acronym | Tabac-Pro |
| Study objectives | 1. The intervention increases the number of patients with whom the doctor talks about smoking cessation 2. The intervention increases the likelihood that they will offer support to patients (medication prescriptions, referral to another healthcare professional, or suggestion of a follow-up appointment) 3. The intervention increases the number of patients for whom they screen smoking status 4. The intervention increases the proportion of smokers for whom they assess the level of dependence 5. The intervention increases the proportion of smokers for whom they assess the motivation to quit 6. The intervention increases the proportion of smokers for whom they suggest reducing their consumption 7. The intervention increases the proportion of smokers for whom they recall the benefits of quitting smoking |
| Ethics approval(s) |
Approved 08/01/2024, Behavioural Insights Team’s internal ethics committee (58 Victoria Embankment, London, EC4Y 0DS, United Kingdom; +44 7306118521; bobby.stuijfzand@bi.team), ref: FR000088 |
| Health condition(s) or problem(s) studied | Prevention of tobacco smoking |
| Intervention | General practitioners (GPs) have to complete an online recruitment questionnaire, at the end of which they are randomized to one of both groups by an integrated algorithm. GPs in the intervention group receive a kit by post with: - an information sheet on carrying out a brief intervention for smoking cessation in three stages: Screen, Advise and Refer. - leaflets to be placed in the waiting room with a questionnaire to survey patients about their smoking, information on the benefits of cessation and the role of GPs in the management of cessation - a poster to attract patients' attention to the questionnaire. GPs in the control group receive no intervention (usual care). The use of the tools is planned over a period of 4 weeks, at the end of which a follow-up questionnaire is sent to both groups. |
| Intervention type | Behavioural |
| Primary outcome measure | Number of patients with whom a GP talked about smoking cessation during the last full working day, at 4 weeks, self-reported in a follow-up questionnaire. |
| Secondary outcome measures | Probability that a GP offers smoking cessation support during the last full working day, at 4 weeks, self-reported in a follow-up questionnaire. |
| Overall study start date | 12/09/2022 |
| Completion date | 10/05/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1500 |
| Total final enrolment | 800 |
| Key inclusion criteria | 1. Practice in mainland France 2. Not work exclusively in a hospital, in a clinic and/or in a company |
| Key exclusion criteria | Work exclusively in a hospital, in a clinic and/or in a company |
| Date of first enrolment | 15/01/2024 |
| Date of final enrolment | 08/03/2024 |
Locations
Countries of recruitment
- France
Study participating centre
Saint-Maurice
94415
France
Sponsor information
Government
12, rue du Val d'Osne
Saint-Maurice
94415
France
| Phone | +33 (0)1 41 79 67 00 |
|---|---|
| dpps-raf@santepubliquefrance.fr | |
| Website | http://www.santepubliquefrance.fr/ |
"ROR" |
https://ror.org/00dfw9p58 |
Funders
Funder type
Government
No information available
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- French National Health Insurance Fund, National Fund for Health Insurance, CNAM
- Location
- France
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an English-language peer-reviewed journal and in a French professional journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Romain Guignard (romain.guignard@santepubliquefrance.fr). Anonymized data can be shared with external teams after analysis of the project by Santé publique France and signing of a confidentiality commitment. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/09/2024 | No | Yes |
Additional files
Editorial Notes
01/10/2024: Study's existence confirmed by the French National Health Insurance Fund.
