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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04868474
Other study ID # FIRST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date February 29, 2024

Study information

Verified date May 2024
Source Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 287
Est. completion date February 29, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
France Maison de santé Mermoz Lyon
Switzerland Unisante Lausanne Vaud

Sponsors (3)

Lead Sponsor Collaborator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland Swiss Medical Association (FMH), Tobacco Control Fund Switzerland

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Prescribing quit aids - general practitioner The proportion of current smokers who are proposed a smoking cessation aid, as reported by GPs After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
Other Default choice approach - general practitioner Self-reported use of the default choice approach for smoking cessation After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
Other Use of decision aid - general practitioner Self-reported use of the decision aid (electronic or paper) After the training program (intention), at the end of patient recruitment, and at 12-months follow-up
Other Discontinuation rate - GP implementation outcome Number of GPs who recruit at least 20 patients / number of GPs randomized 12 months after training
Other Recruitment rate - patient implementation outcome Number of patients who sign consent / number of patients provided information about the trial 12 months after training
Other Discontinuation rate - patient implementation outcome Number of patients who complete 6-month follow-up / number of patients who sign consent 12 months after training
Primary Smoking cessation Self-reported, 7-day point-prevalence smoking abstinence 6 months follow-up after the baseline visit with a General Practitioner
Secondary Exhaled Carbon monoxide - patient Chemical confirmation of abstinence among those who report 7-day smoking abstinence 6 month follow-up
Secondary Continuous abstinence - patient Self-reported continuous abstinence from the patient's quit date among those who report 7-day smoking abstinence 6 month follow-up
Secondary Smoking cessation - patient Self-reported, 7-day point-prevalence smoking abstinence 3 weeks and 3 months follow-up
Secondary Quit attempts - patient Self-reported quit attempts (periods of abstinence to try to quit smoking) since the baseline visit 6 month follow-up
Secondary 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 6 month follow-up
Secondary Patient participation - patient Patient-reported participation in discussions about smoking cessation as measured by the CollaboRATE scale 3 weeks follow-up
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