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Smoking CessationFIRSTNCT04868474

Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

A study testing Training program and decision aid and Refresher course in people with Smoking Cessation, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Training program and decision aid and Refresher course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
287 participants
Where
2 sitesin 2 countries
Study dates
15 Jun 2021to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Maison de santé Mermoz

    Lyon

Other trials in France

Switzerland1 site

  • Unisante

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

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

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.

Read the 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).

Being tested
Training program and decision aid, Refresher course
Keywords
Behavioral economics, Shared decision making, Default choice, Primary care
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training program and decision aidBehavioural

    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.

  • Refresher courseBehavioural

    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.

Study groups in NCT04868474
Study groupRoleWhat they receive
Usual care trainingActive comparatorA 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.
Receives: Behavioral: Refresher course
Intervention trainingExperimentalThe training course and decision aid aim to make treatment of tobacco use the default choice
Receives: Behavioral: Training program and decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking cessation

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

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

Secondary outcomes (6)

  1. Exhaled Carbon monoxide - patient

    Chemical confirmation of abstinence among those who report 7-day smoking abstinence

    Measured: 6 month follow-up

  2. Continuous abstinence - patient

    Self-reported continuous abstinence from the patient's quit date among those who report 7-day smoking abstinence

    Measured: 6 month follow-up

  3. Smoking cessation - patient

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

    Measured: 3 weeks and 3 months follow-up

  4. Quit attempts - patient

    Self-reported quit attempts (periods of abstinence to try to quit smoking) since the baseline visit

    Measured: 6 month follow-up

  5. 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

    Measured: 6 month follow-up

  6. Patient participation - patient

    Patient-reported participation in discussions about smoking cessation as measured by the CollaboRATE scale

    Measured: 3 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start15 Jun 2021
  3. Primary completion30 Nov 2023
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial
Masking
Single blind
Who is masked
Participant
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868474
Sponsor's protocol ID
FIRST
Acronym
FIRST
Status last verified
May 2024
First submitted
3 Mar 2021
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymised data available upon request

Publications

  • 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.

    PubMed 28640564

  • 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.

    PubMed 36151529

  • 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.

    PubMed 39384691

Questions about this trial

What is this clinical trial studying?

A study testing Training program and decision aid and Refresher course in people with Smoking Cessation, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking cessation (time frame: 6 months follow-up after the baseline visit with a General Practitioner). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868474, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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