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Completed

NCT Number: NCT04868474

Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maison de santé Mermoz, Lyon, France

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training program and decision aid

Behavioral
  • 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 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.

Primary outcomes

  1. Smoking cessation

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

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

Secondary outcomes

  1. Exhaled Carbon monoxide - patient

    Time frame: 6 month follow-up

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

  2. Continuous abstinence - patient

    Time frame: 6 month follow-up

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

  3. Smoking cessation - patient

    Time frame: 3 weeks and 3 months follow-up

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

  4. Quit attempts - patient

    Time frame: 6 month follow-up

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

  5. Use of quit aids - patient

    Time frame: 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

  6. Patient participation - patient

    Time frame: 3 weeks follow-up

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

Other outcomes

  1. Prescribing quit aids - general practitioner

    Time frame: 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

  2. Default choice approach - general practitioner

    Time frame: 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

  3. Use of decision aid - general practitioner

    Time frame: 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)

  4. Discontinuation rate - GP implementation outcome

    Time frame: 12 months after training

    Number of GPs who recruit at least 20 patients / number of GPs randomized

  5. Recruitment rate - patient implementation outcome

    Time frame: 12 months after training

    Number of patients who sign consent / number of patients provided information about the trial

  6. Discontinuation rate - patient implementation outcome

    Time frame: 12 months after training

    Number of patients who complete 6-month follow-up / number of patients who sign consent

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Swiss Medical Association (FMH)
  • Tobacco Control Fund Switzerland

Registry information

Official study title

Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial

Acronym: FIRST

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 3, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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