Clinical trial NCT04868474: Combining Default Choices and a Decision Aid to Improve Tobacco Cessation
Official title: Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Behavioral economics
Shared decision making
Default choice
Primary care
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Tobacco Control Fund Switzerland
name: Swiss Medical Association (FMH)
First posted: 2021-05-03
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: PREVENTION

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).

Eligibility 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 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

Primary outcomes:
measure: Smoking cessation
timeFrame: 6 months follow-up after the baseline visit with a General Practitioner
Secondary outcomes:
measure: Exhaled Carbon monoxide - patient
timeFrame: 6 month follow-up
measure: Continuous abstinence - patient
timeFrame: 6 month follow-up
measure: Smoking cessation - patient
timeFrame: 3 weeks and 3 months follow-up
measure: Quit attempts - patient
timeFrame: 6 month follow-up
measure: Use of quit aids - patient
timeFrame: 6 month follow-up
measure: Patient participation - patient
timeFrame: 3 weeks follow-up
Other outcomes:
measure: Prescribing quit aids - general practitioner
timeFrame: After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
measure: Default choice approach - general practitioner
timeFrame: After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
measure: Use of decision aid - general practitioner
timeFrame: After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
measure: Discontinuation rate - GP implementation outcome
timeFrame: 12 months after training
measure: Recruitment rate - patient implementation outcome
timeFrame: 12 months after training
measure: Discontinuation rate - patient implementation outcome
timeFrame: 12 months after training
Locations:
city: Lyon
country: France
facility: Maison de santé Mermoz
city: Lausanne
country: Switzerland
facility: Unisante
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Kevin J Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.