Smoking Reduction: Testing a Novel Approach to Cessation in Primary Care Practice Settings: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Feasibility of Providing the Intervention Measured by the Consult Completion Rate
研究概览
简要总结
Traditional models of smoking cessation focus on delivering advice and counseling to quit and providing assistance to patients ready to quit smoking, but do not actively intervene with patients who are not ready to quit (NRTQ). This abrupt cessation approach is often not an appealing option to those not ready to quit, however, a reduction approach can seem more attainable and engaging. In response to this need, this smoking cessation intervention has been developed.
This research is part of a pilot study to assess the feasibility of introducing a NRTQ intervention in a primary care setting. This study will also assess the effectiveness of increasing the number of smoking reduction interventions delivered, provider confidence and satisfaction, relative to control practice. Outcomes will be assessed by a pre-survey and a three-month follow-up survey, administered to all study participants. All study participants will also be asked to fill out brief NRTQ consult forms for each NRTQ patient they encounter for a two-week period. Additionally, participants randomized to the intervention arm will receive training, and access to tools and resources.
详细描述
3.0 HYPOTHESIS TO BE TESTED The intervention program will be feasible to introduce into primary care practices. The intervention program will also be effective in increasing the number of smoking reduction interventions delivered and provider confidence, relative to control practice. Providers in the intervention condition will be satisfied with the intervention and tools provided.
4.0 RELEVANCE TO THE ADVANCEMENT OF THE TREATMENT OF NICOTINE DEPENDENCE The Ministry of Health and Long Term care recently published an updated action plan on smoking cessation in Ontario (24). This action plan focuses on smoking prevention and cessation rather than harm reduction in smokers not ready to quit, which accounts for the majority of smokers in Ontario (24). Previous studies have demonstrated that smoking reduction strategies employing NRT can lead to smoking cessation in smokers not yet ready to quit (12). This pilot study aims to determine the feasibility of introducing a multi-component intervention program for primary care providers to target the unmotivated to quit smoker. If successful it will inform a larger trial throughout the OMSC platform to further evaluate the effectiveness of the smoking cessation through reduction approach. This might result in a shift in smoking cessation culture in Canada to include harm reduction as an approach to engage the smoker who is not ready to quit.
5.0 METHODS TO BE USED 5.1 Design A two-armed, cluster randomized controlled pilot study will be conducted. Primary care practices will be randomized to one of two study arms: the 'control' group or the 'intervention' group. Ten primary care practices will be randomly assigned to one of the two arms (5 practices per arm).
The study design schema and timeline for the collection of outcome data and intervention activities is presented in Appendix A -- Study Flow Diagram and Timeline.
5.2 Setting and Participants Ten primary care practices (5 per study arm) from the existing Ottawa Model for Smoking Cessation (OMSC) primary care network will be recruited from within the province of Ontario, over a 3-month recruitment period. We will recruit ≥ 40 Medical Doctors (MD), Nurse Practitioners (NP), Registered Nurses (RN), and pharmacists for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary care practice from the existing OMSC network
- •Primary care practice is staffed by ≥ 4 MDs/NPs/RNs/Pharmacists
- •A minimum of four clinicians within the practice are willing to participate
排除标准
- •Actively using a Reduce to Quit protocol in practice
结局指标
主要结局
Feasibility of Providing the Intervention Measured by the Consult Completion Rate
时间窗: 1 year
The feasibility of introducing a not ready to quit (NRTQ) intervention in a primary care setting by measuring the NRTQ consult completion rate. The number of NRTQ consults completed per physician in the intervention group and the control group will be evaluated and compared.
Feasibility of Providing the Intervention Measured by the Participation Rate
时间窗: 1 year
The feasibility of introducing a not ready to quit (NRTQ) intervention in a primary care setting by measuring the participation rate (i.e. Practitioner recruitment). The study will evaluate the number of providers who agree to participate divided by the total number of providers who are sent an invitation letter.
次要结局
- Increasing the number of reduction interventions provided by providers(3 months)
- Increasing provider confidence in addressing tobacco use among patients NRTQ(3 months)
- Assessing provider satisfaction with the smoking reduction intervention program: post-intervention survey(3 months)