Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

NCT04868474 | Completed

• 1 other identifier: FIRST
• Study Type: interventional
• Target: 287
• Locations: 2 countries
• Sites: 2

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.

Conditions

Smoking Cessation

Keywords

Behavioral economics; Shared decision making; Default choice; Primary care

Outcome Measures

Primary Outcomes (1)

• Smoking cessation

  Self-reported, 7-day point-prevalence smoking abstinence

  6 months follow-up after the baseline visit with a General Practitioner

Secondary Outcomes (6)

• Exhaled Carbon monoxide - patient

  6 month follow-up

• Continuous abstinence - patient

  6 month follow-up

• Smoking cessation - patient

  3 weeks and 3 months follow-up

• Quit attempts - patient

  6 month follow-up

• Use of quit aids - patient

  6 month follow-up

Other Outcomes (6)

• Prescribing quit aids - general practitioner

  After the training program (intention), at the end of patient recruitment, and at 12-months follow-up

• Default choice approach - general practitioner

  After the training program (intention), at the end of patient recruitment, and at 12-months follow-up

• Use of decision aid - general practitioner

  After the training program (intention), at the end of patient recruitment, and at 12-months follow-up

Study Arms (2)

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.

Behavioral: Refresher course

Intervention training

EXPERIMENTAL

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

Behavioral: Training program and decision aid

Interventions

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.

Intervention training

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.

Usual care training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consider the GP they are seeing in consultation to be their primary care doctor
• Use tobacco daily (cigarettes, cigars, smokeless tobacco)

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Tobacco Control Fund Switzerland: collaborator
• Swiss Medical Association (FMH): collaborator

Study Sites (2)

Maison de santé Mermoz

Lyon, France

Location

Unisante

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 28640564 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.

  PMID: 36151529 BACKGROUND

• 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.

  PMID: 39384691 DERIVED

Related Links

• Electronic decision aid used in trial
• Paper decision aid used in trial

MeSH Terms

Conditions

Smoking Cessation

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kevin J Selby, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: May 3, 2021
• Study Start: June 15, 2021
• Primary Completion: November 30, 2023
• Study Completion: February 29, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CH (1)