Combining Default Choices and a Decision Aid to Improve Tobacco Cessation at 6 Months in Primary Care Patients: a Pragmatic, Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 试验地点
- 3
- 主要终点
- Smoking cessation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The smoking cessation experts administering the trainings will not be blinded. GPs will be not be blinded. GPs in the control group will likely realize their training is shorter, and GPs in the intervention group will realize their training is different from traditional teachings. Patients will be told that the study compares two training programs. To the extent possible, outcome assessors will be blinded to study arm when performing follow-up. The statistician performing the primary outcome analyses will be blinded to group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Smoking cessation
时间窗: 6 months follow-up after the baseline visit with a General Practitioner
Self-reported, 7-day point-prevalence smoking abstinence
次要结局
- Quit attempts - patient(6 month follow-up)
- Patient participation - patient(3 weeks follow-up)
- Exhaled Carbon monoxide - patient(6 month follow-up)
- Use of quit aids - patient(6 month follow-up)
- Smoking cessation - patient(3 weeks and 3 months follow-up)
- Continuous abstinence - patient(6 month follow-up)