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| Name | Class |
|---|---|
| Tobacco Control Fund Switzerland | OTHER_GOV |
| Swiss Medical Association (FMH) | OTHER_GOV |
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The FIRST cluster randomized trial will evaluate the effect of 1) a training program encouraging general practitioners to offer smoking cessation treatment as a default choice to all current smokers consulting a general practitioner (GP), and 2) an interactive, electronic decision aid to guide smoking cessation treatment, on the proportion of current smokers seen in primary care who have quit smoking 6 months after a baseline visit to their GP, as compared to enhanced usual care.
Smoking cessation medications are underused in primary care, likely because general practitioners (GP) lack detailed knowledge about prescribing and the fact that smokers seen in primary care must "opt-in" to treatment. Currently GPs only offer treatment to patients who say they are ready to quit smoking and desire treatment, making the default choice no treatment. Those who are not ready to quit or are hesitant do not discuss quitting or learn about options to help them quit. Further, GPs often lack confidence to discuss smoking cessation medications or do not provide patients with a choice. A decision aid can both help to present quitting with a medication as the default choice and promote shared decision making by allowing patients to see the menu of options available.
The current study will combine the use of 'default choices' when approaching smokers and shared decision making with a decision aid for choosing between smoking cessation treatments. The investigators will train GPs to offer smoking cessation as the default choice while involving patients in key decisions using a decision aid. This innovative approach has not been tested in primary care and has the potential to increase the number of current smokers who make a quit attempt with a proven quit aid, thereby increasing the number of patients who quit smoking.
The investigators will implement the training as part of the Vivre sans tabac programme for GPs run by the Swiss Medical Association (FMH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care training | Active Comparator | A refresher training course will be the equivalent of 'enhanced' usual care. Enhanced because the course will likely augment short-term knowledge of smoking cessation treatments, and participation in the study could trigger more discussions about smoking cessation than routine practice. However, it will be impossible to have any blinding between groups without at least some training. |
|
| Intervention training | Experimental | The training course and decision aid aim to make treatment of tobacco use the default choice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training program and decision aid | Behavioral | 1) a one-time, in-person, 2.5-hour training program encouraging participating GPs to present quitting smoking with a quit aid as the default choice to their eligible patients, and 2) access to an electronic decision aid that presents available quit aids. The 2.5-hour training program consists of: 1.5 hours of didactic teaching, with information about pharmacologic quit aids, electronic cigarettes, presenting quitting as a default choice, the decision aid, and a video of a model consultation. This is followed by 1 hour of role plays to practice presenting quitting as a default choice using the decision aid. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation | Self-reported, 7-day point-prevalence smoking abstinence | 6 months follow-up after the baseline visit with a General Practitioner |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon monoxide - patient | Chemical confirmation of abstinence among those who report 7-day smoking abstinence | 6 month follow-up |
| Continuous abstinence - patient | Self-reported continuous abstinence from the patient's quit date among those who report 7-day smoking abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| Prescribing quit aids - general practitioner | The proportion of current smokers who are proposed a smoking cessation aid, as reported by GPs | After the training program (intention), at the end of patient recruitment, and at 12-months follow-up |
| Default choice approach - general practitioner |
Patient-level inclusion criteria:
Patient-level exclusion criteria:
GP-level inclusion criteria:
GP-level exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin J Selby, MD | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maison de santé Mermoz | Lyon | France | ||||
| Unisante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28640564 | Background | Jakob J, Cornuz J, Auer R, Jacot Sadowski I, Cardinaux R, Selby K. [Design and user-testing of a decision aid comparing medications for smoking cessation]. Rev Med Suisse. 2017 Jun 7;13(566):1191-1194. French. | |
| 36151529 | Background | Hempel-Bruder C, Habfast-Robertson I, Durand MA, Berlin I, Marti J, Khazaal Y, Quinto C, Faouzi M, Selby K. Combining default choices and an encounter decision aid to improve tobacco cessation in primary care patients: protocol for a cluster-randomized trial. BMC Prim Care. 2022 Sep 24;23(1):246. doi: 10.1186/s12875-022-01859-9. |
| Label | URL |
|---|---|
| Electronic decision aid used in trial | View source |
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Anonymised data available upon request
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Cluster randomized trial
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The smoking cessation experts administering the trainings will not be blinded. GPs will be not be blinded. GPs in the control group will likely realize their training is shorter, and GPs in the intervention group will realize their training is different from traditional teachings. Patients will be told that the study compares two training programs. To the extent possible, outcome assessors will be blinded to study arm when performing follow-up. The statistician performing the primary outcome analyses will be blinded to group assignments.
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| Refresher course | Behavioral | A 45-minute refresher training about smoking cessation that does not aim to change GP behaviour. It will include the same information about pharmacologic quit aids and electronic cigarettes. |
|
| 6 month follow-up |
| Smoking cessation - patient | Self-reported, 7-day point-prevalence smoking abstinence | 3 weeks and 3 months follow-up |
| Quit attempts - patient | Self-reported quit attempts (periods of abstinence to try to quit smoking) since the baseline visit | 6 month follow-up |
| Use of quit aids - patient | Self-reported use of a quit aid (pharmacologic, electronic cigarette, or additional medical visits to discuss quitting) since the baseline visit | 6 month follow-up |
| Patient participation - patient | Patient-reported participation in discussions about smoking cessation as measured by the CollaboRATE scale | 3 weeks follow-up |
Self-reported use of the default choice approach for smoking cessation |
| After the training program (intention), at the end of patient recruitment, and at 12-months follow-up |
| Use of decision aid - general practitioner | Self-reported use of the decision aid (electronic or paper) | After the training program (intention), at the end of patient recruitment, and at 12-months follow-up |
| Discontinuation rate - GP implementation outcome | Number of GPs who recruit at least 20 patients / number of GPs randomized | 12 months after training |
| Recruitment rate - patient implementation outcome | Number of patients who sign consent / number of patients provided information about the trial | 12 months after training |
| Discontinuation rate - patient implementation outcome | Number of patients who complete 6-month follow-up / number of patients who sign consent | 12 months after training |
| Lausanne |
| Canton of Vaud |
| 1011 |
| Switzerland |
| 39384691 | Derived | Selby K, Habfast-Robertson I, Durand MA, Hempel-Bruder C, Boesch A, Marti J, Kazaal Y, Faouzi M, Maisonneuve H, Berlin I. Combining Default Choices and an Encounter Decision Aid to Improve Tobacco Cessation in Primary Care Patients: A Pragmatic, Cluster-Randomized Trial. J Gen Intern Med. 2025 Sep;40(13):3078-3085. doi: 10.1007/s11606-024-09088-9. Epub 2024 Oct 9. |
| Paper decision aid used in trial | View source |