Smoking Cessation
Conditions
Keywords
Behavioral economics, Shared decision making, Default choice, Primary care
Brief summary
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
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).
Interventions
BEHAVIORALTraining program and decision aid
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.
BEHAVIORALRefresher course
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.
Sponsors
Tobacco Control Fund Switzerland
Swiss Medical Association (FMH)
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation | 6 months follow-up after the baseline visit with a General Practitioner | Self-reported, 7-day point-prevalence smoking abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Carbon monoxide - patient | 6 month follow-up | Chemical confirmation of abstinence among those who report 7-day smoking abstinence |
| Continuous abstinence - patient | 6 month follow-up | Self-reported continuous abstinence from the patient's quit date among those who report 7-day smoking abstinence |
| Smoking cessation - patient | 3 weeks and 3 months follow-up | Self-reported, 7-day point-prevalence smoking abstinence |
| Quit attempts - patient | 6 month follow-up | Self-reported quit attempts (periods of abstinence to try to quit smoking) since the baseline visit |
| Use of quit aids - patient | 6 month follow-up | Self-reported use of a quit aid (pharmacologic, electronic cigarette, or additional medical visits to discuss quitting) since the baseline visit |
| Patient participation - patient | 3 weeks follow-up | Patient-reported participation in discussions about smoking cessation as measured by the CollaboRATE scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Default choice approach - general practitioner | After the training program (intention), at the end of patient recruitment, and at 12-months follow-up | Self-reported use of the default choice approach for smoking cessation |
| Use of decision aid - general practitioner | After the training program (intention), at the end of patient recruitment, and at 12-months follow-up | Self-reported use of the decision aid (electronic or paper) |
| Discontinuation rate - GP implementation outcome | 12 months after training | Number of GPs who recruit at least 20 patients / number of GPs randomized |
| Recruitment rate - patient implementation outcome | 12 months after training | Number of patients who sign consent / number of patients provided information about the trial |
| Discontinuation rate - patient implementation outcome | 12 months after training | Number of patients who complete 6-month follow-up / number of patients who sign consent |
| Prescribing quit aids - general practitioner | After the training program (intention), at the end of patient recruitment, and at 12-months follow-up | The proportion of current smokers who are proposed a smoking cessation aid, as reported by GPs |
Countries
France, Switzerland
Outcome results
None listed