Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

NCT ID: NCT04868474

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-02-29

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).

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Usual care training

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.

Group Type: ACTIVE_COMPARATOR

Refresher course

Intervention Type: 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.

Intervention training

The training course and decision aid aim to make treatment of tobacco use the default choice

Group Type: EXPERIMENTAL

Training program and decision aid

Intervention Type: 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.

Interventions

Training 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.

Intervention Type: BEHAVIORAL

Refresher 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tobacco Control Fund Switzerland

OTHER_GOV

Sponsor Role: collaborator

Swiss Medical Association (FMH)

OTHER_GOV

Sponsor Role: collaborator

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin J Selby, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Locations

Maison de santé Mermoz

Lyon, , France

Unisante

Lausanne, Canton of Vaud, Switzerland

Countries

France; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 28640564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36151529 (View on PubMed)

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. 2024 Oct 9. doi: 10.1007/s11606-024-09088-9. Online ahead of print.

Reference Type: DERIVED

PMID: 39384691 (View on PubMed)

Related Links

http://howtoquit.ch

Electronic decision aid used in trial

https://www.unisante.ch/sites/default/files/inline-files/UNI_tableau_stop_tabac-compressed.pdf

Paper decision aid used in trial

Other Identifiers

FIRST

Identifier Type: -

Identifier Source: org_study_id