Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Training program and decision aid
* Behavioral: Refresher course


Participation Criteria
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Eligibility Criteria
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Patient-level inclusion criteria: Consider the GP they are seeing in consultation to be their primary care doctor Use tobacco daily (cigarettes, cigars, smokeless tobacco) ≥18 years of age at the time of inclusion Patient-level exclusion criteria: Consulting for an urgent complaint that precludes even a brief discussion of smoking cessation Inability to follow the procedures of the study, e.g. unable to read French-language consent materials, severe psychiatric disorders, dementia, etc. Previous enrolment in a smoking cessation trial <1 year prior Current daily user of a pharmacologic smoking cessation aid GP-level inclusion criteria: GP in private practice in French-speaking Switzerland (Vaud, Geneva, Jura, Neuchâtel, Fribourg or Valais) or metropolitan France Primarily French-speaking patients with >80 individual patients seen in a typical month GP-level exclusion criteria: Completed an intensive smoking cessation curriculum <2 years prior (ie. at least half-day of training) Have plans to retire or relocate outside of Switzerland or France in <12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care training<br>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. | Behavioral: Refresher course<br>* 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.<br>|
| Experimental: Intervention training<br>The training course and decision aid aim to make treatment of tobacco use the default choice | Behavioral: Training program and decision aid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral economics, Shared decision making, Default choice, Primary care