Smoking Cessation Clinical Trial
— FIRSTOfficial title:
Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Maison de santé Mermoz | Lyon | |
Switzerland | Unisante | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Swiss Medical Association (FMH), Tobacco Control Fund Switzerland |
France, Switzerland,
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
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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