Combining Default Choices and a Decision Aid to Improve Tobacco Cessation

Smoking Cessation Clinical Trial

— FIRST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868474
• Other study ID #: FIRST
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Smoking Cessation

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

External Links

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