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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
810
Receive usual care
Ancillary studies
Receive referred to counseling session
Receive phone counseling
Undergo training
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Acceptability of intervention - delivery of AAC
This provider-level outcome includes self-reported changes in the delivery of the Ask, Advise, and Connect (AAC).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days
Floating abstinence
Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients.
Time frame: Up to 7 days
Prolonged abstinence
Defined as no smoking after a two-week grace period from the quit date. Self-reported by patients.
Time frame: At each follow-up visit over the span of the intervention (1 year)
Provider satisfaction
Measured via provider surveys
Time frame: Mid-points of each provider arm during the intervention year (1 year)
Staff satisfaction
Measured via staff surveys
Time frame: Mid-points of each provider arm during the intervention year (1 year)
Smoker satisfaction with Break Free counseling
Measured via patient surveys
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-training (1 day), 1 year
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