Combining Default Choices and a Decision Aid to Improve Tobacco Cessation (FIRST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Refresher course; Behavioral: Training program and decision aid

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).

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin J Selby, MD; Phone Number: +41795566756; Email: kevin.selby@unisante.ch
• Study Contact Backup: Name: Ines Habfast-Robertson, MD; Phone Number: +41795568113; Email: ines.habfast@unisante.ch

Study Locations

• France
  • Lyon, France
    • Maison de santé Mermoz
• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Unisanté

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care training; 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; 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.
Experimental: Intervention training; The training course and decision aid aim to make treatment of tobacco use the default choice	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	Self-reported, 7-day point-prevalence smoking abstinence	6 months follow-up after the baseline visit with a General Practitioner

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Carbon monoxide - patient	Chemical confirmation of abstinence among those who report 7-day smoking abstinence	6 month follow-up
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
Smoking cessation - patient	Self-reported, 7-day point-prevalence smoking abstinence	3 weeks and 3 months follow-up
Quit attempts - patient	Self-reported quit attempts (periods of abstinence to try to quit smoking) since the baseline visit	6 month follow-up
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
Patient participation - patient	Patient-reported participation in discussions about smoking cessation as measured by the CollaboRATE scale	3 weeks follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Discontinuation rate - GP implementation outcome	Number of GPs who recruit at least 20 patients / number of GPs randomized	12 months after training
Recruitment rate - patient implementation outcome	Number of patients who sign consent / number of patients provided information about the trial	12 months after training
Discontinuation rate - patient implementation outcome	Number of patients who complete 6-month follow-up / number of patients who sign consent	12 months after training

Collaborators and Investigators

• Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Collaborators: Tobacco Control Fund Switzerland; Swiss Medical Association (FMH)
• Investigators: Principal Investigator: Kevin J Selby, MD, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Publications and helpful links

General 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Primary care; Shared decision making; Behavioral economics; Default choice
• Other Study ID Numbers: FIRST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised data available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No