Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities

Study Overview
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Brief Summary
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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.

Detailed Description
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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. ARM I (EARLY ARM): Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 13-24. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist. ARM II (DELAYED ARM): Female smokers receive usual care during months 13-24. Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 25-36. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.

Official Title
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Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities

Conditions
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Tobacco-Related Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Survey Administration
* Other: Tobacco Cessation Counseling
* Other: Tobacco Cessation Counseling
* Other: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HEALTH SYSTEM/CLINIC Based in one of the Appalachian regions included in this program project Provides care to female smokers PROVIDER Practicing in one of the participating health systems Involved in patient care PATIENT Females 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (early arm)<br>Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 13-24. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist. | Other: Survey Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive referred to counseling session<br>Other: Tobacco Cessation Counseling<br>* Receive phone counseling<br>Other: Training<br>* Undergo training<br>* Other names: Training Programs;|
| Active Comparator: Arm II (delayed arm)<br>Female smokers receive usual care during months 13-24. Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 25-36. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Survey Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive referred to counseling session<br>Other: Tobacco Cessation Counseling<br>* Receive phone counseling<br>Other: Training<br>* Undergo training<br>* Other names: Training Programs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of intervention - delivery of AAC | This provider-level outcome includes self-reported changes in the delivery of the Ask, Advise, and Connect (AAC). | Up to 6 months | 
| Acceptability of intervention - referral rate | This provider-level outcome includes the rate of referrals to the in-clinic smoking cessation counselor. | Up to 6 months | 
| Fidelity to the intervention: counseling calls | Measured by asking 10% of randomly selected women questions about content of the phone counseling. | Day after phone counseling during the span of the intervention (one year) | 
| Fidelity to the intervention: provider visits | 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. | At time of in person visit for a one week span, every other month during the span of the intervention (one year) | 
| Sustainability of the intervention: clinic continuation of Break Free | Measured by self-reported continuation of cessation counseling by clinic staff | During the span of the final phase of study (2 years) | 
| Sustainability of the intervention: counseling sessions | Measured by the number of counseling sessions billed for overall | During the span of the final phase of study (2 years) | 
| Sustainability of the intervention: counseling sessions per smoker | Measured by the number of counseling sessions billed for each individual smoker who has at least one session | During the span of the final phase of study (2 years) | 
| Sustainability of the intervention: EHR documentation | Measured by electronic health record documentation of tobacco use | During the span of the final phase of study (2 years) | 
| Cost-effectiveness of intervention | 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. | Up to 6 months | 
| Effectiveness of intervention at increasing brief cessation counseling: Change over time | Will be assessed using patient post-visit surveys and see if they increase over time. | 3 months, 6 months, 12 months | 
| Point prevalence | 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. | Up to 7 days | 
| Floating abstinence | Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients. | Up to 7 days | 
| Prolonged abstinence | Defined as no smoking after a two-week grace period from the quit date. Self-reported by patients. | At each follow-up visit over the span of the intervention (1 year) | 
| Provider satisfaction | Measured via provider surveys | Mid-points of each provider arm during the intervention year (1 year) | 
| Staff satisfaction | Measured via staff surveys | Mid-points of each provider arm during the intervention year (1 year) | 
| Smoker satisfaction with Break Free counseling | Measured via patient surveys | At the end of each Break Free counseling sessions during the intervention year (year 1) | 
| Smoker satisfaction during Break Free counseling | Measured via patient surveys | At the end of each Break Free counseling sessions during the intervention year (year 1) | 
| Smoker satisfaction after Break Free program | Measured via patient surveys | At 6 months after completion of Break Free counseling | 
| Change in provider knowledge | Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider knowledge will be assessed. | Baseline, post-training (same day), 1 year | 
| Change in provider attitudes | Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider attitudes will be assessed. | Baseline, post-training (1 day), 1 year | 
| Change in provider's normative beliefs | Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's normative beliefs will be assessed. | Baseline, post-training (1 day), 1 year | 
| Change in provider's perceived behavioral control | Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's perceived behavioral control will be assessed. | Baseline, post-training (1 day), 1 year | 
| Effectiveness of intervention of Improved provider knowledge and attitude | Using the Theory of Planned Behavior (TPB) model, attitudes, normative beliefs, and perceived behavioral control will be assessed. | Baseline, post-training (1 day), 1 year |