Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 810
- 试验地点
- 8
- 主要终点
- Smoker satisfaction after Break Free program
研究概览
简要总结
This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the effectiveness of a core component of an integrated cervical cancer prevention program designed to help female smokers quit by standardizing clinical practice supports and protocols. (Service outcomes) II. Determine satisfaction with the multilevel intervention. (Client outcomes) III. Test the sustainability of the multilevel intervention via training of providers and staff on counseling and billing for evidence-based smoking cessation services. (Implementation outcomes)
OUTLINE:
IMPLEMENTATION OF TOBACCO-USER IDENTIFICATION SYSTEM: Clinics and systems develop and implement minimally required electronic tracking and reporting systems for identification of smokers during months 1-12.
GROUP RANDOMIZED TRIAL: Providers and participants are randomized to 1 of 2 arms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HEALTH SYSTEM/CLINIC
- •Based in one of the Appalachian regions included in this program project
- •Provides care to female smokers
- •Practicing in one of the participating health systems
- •Involved in patient care
- •Age 18 to 64
- •Smokers who consume at least 5 cigarettes per day (less than the minimum in most cessation studies, yet still enough to show signs of nicotine dependence)
- •Ready to quit smoking in the next 6 months
- •English-speaking
- •Able to participate in counseling
- •Willing to try smoking cessation pharmacotherapy
- •Not pregnant
排除标准
- 未提供
结局指标
主要结局
Smoker satisfaction after Break Free program
时间窗: At 6 months after completion of Break Free counseling
Measured via patient surveys
Acceptability of intervention - referral rate
时间窗: Up to 6 months
This provider-level outcome includes the rate of referrals to the in-clinic smoking cessation counselor.
Fidelity to the intervention: counseling calls
时间窗: Day after phone counseling during the span of the intervention (one year)
Measured by asking 10% of randomly selected women questions about content of the phone counseling.
Effectiveness of intervention at increasing brief cessation counseling: Change over time
时间窗: 3 months, 6 months, 12 months
Will be assessed using patient post-visit surveys and see if they increase over time.
Fidelity to the intervention: provider visits
时间窗: At time of in person visit for a one week span, every other month during the span of the intervention (one year)
Measured by self-administered, anonymous, post-provider visit surveys every other month by patients who were in the clinic for a visit during a one-week period. Patients will be asking whether the provider asked about tobacco use, if a smoker, advised the patient to quit, discussed cessation, and connected the smoker to counseling.
Sustainability of the intervention: clinic continuation of Break Free
时间窗: During the span of the final phase of study (2 years)
Measured by self-reported continuation of cessation counseling by clinic staff
Sustainability of the intervention: counseling sessions
时间窗: During the span of the final phase of study (2 years)
Measured by the number of counseling sessions billed for overall
Sustainability of the intervention: counseling sessions per smoker
时间窗: During the span of the final phase of study (2 years)
Measured by the number of counseling sessions billed for each individual smoker who has at least one session
Cost-effectiveness of intervention
时间窗: Up to 6 months
Will be assessed using standard costs by considering costs of each component including pharmacotherapy, clinic counselor time and training, smoking cessation counselor time and training, telephone and material costs, and other administrative costs.
Floating abstinence
时间窗: Up to 7 days
Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients.
Staff satisfaction
时间窗: Mid-points of each provider arm during the intervention year (1 year)
Measured via staff surveys
Smoker satisfaction with Break Free counseling
时间窗: At the end of each Break Free counseling sessions during the intervention year (year 1)
Measured via patient surveys
Prolonged abstinence
时间窗: At each follow-up visit over the span of the intervention (1 year)
Defined as no smoking after a two-week grace period from the quit date. Self-reported by patients.
Smoker satisfaction during Break Free counseling
时间窗: At the end of each Break Free counseling sessions during the intervention year (year 1)
Measured via patient surveys
Acceptability of intervention - delivery of AAC
时间窗: Up to 6 months
This provider-level outcome includes self-reported changes in the delivery of the Ask, Advise, and Connect (AAC).
Sustainability of the intervention: EHR documentation
时间窗: During the span of the final phase of study (2 years)
Measured by electronic health record documentation of tobacco use
Point prevalence
时间窗: Up to 7 days
Measured using self-report of any tobacco use. Abstainers will be classified as those participants who self-report no use of tobacco during the past week.
Provider satisfaction
时间窗: Mid-points of each provider arm during the intervention year (1 year)
Measured via provider surveys
Change in provider knowledge
时间窗: Baseline, post-training (same day), 1 year
Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider knowledge will be assessed.
Change in provider attitudes
时间窗: Baseline, post-training (1 day), 1 year
Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider attitudes will be assessed.
Change in provider's normative beliefs
时间窗: Baseline, post-training (1 day), 1 year
Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's normative beliefs will be assessed.
Change in provider's perceived behavioral control
时间窗: Baseline, post-training (1 day), 1 year
Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's perceived behavioral control will be assessed.
Effectiveness of intervention of Improved provider knowledge and attitude
时间窗: Baseline, post-training (1 day), 1 year
Using the Theory of Planned Behavior (TPB) model, attitudes, normative beliefs, and perceived behavioral control will be assessed.
次要结局
未报告次要终点
研究者
Amy Ferketich
Principal Investigator
Ohio State University Comprehensive Cancer Center