Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation resources in Veterans. The hypotheses are 1) patients included in the TeaM OUT group will have higher accession of cessation services, such as counseling and medication therapies, compared to patients in enhanced usual care and 2) more patients in the TeaM OUT group will have quit smoking at one year after the intervention. Veterans with a recently diagnosed lung nodule who currently smoke will receive the TeaM OUT intervention or Enhanced Usual Care. The TeaM OUT intervention has 2 parts: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit Line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources. The enhanced usual care group will receive a letter that provides information about how to contact the IVR Quit Line. The IVR system will track referrals to cessation services. Additional information about smoking status and use of cessation resources will be collected from the electronic health record and surveys. .

Official Title
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Teachable Moment to Opt-out of Tobacco (TeaM OUT): A Stepped Wedge Cluster Randomized Intervention

Conditions
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Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Tobacco Use

Intervention / Treatment
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* Behavioral: TeaM OUT Intervention
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed pulmonary nodule with plan for surveillance Active smoker Receiving care at the Portland VA Health Care System, the Minneapolis VA Health Care System, or the Ralph H. Johnson Medical Center (Charleston, SC VA) Exclusion Criteria: -No exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The investigators will use a stepped wedge cluster design to randomize at the clinic level (including both community-based outpatient clinics and the main medical center) at each of the 3 sites. The investigators will first institute Enhanced Usual Care for 6 months at each CBOC/medical center. Using a random number generator, the investigators will divide the CBOCs/medical center in the 3 facilities in 4 steps. The investigators will randomize one CBOC at each site to the intervention (interactive voice response quit line) in the first step. For steps 2-4, the investigators will randomize one third of the remaining CBOCs at each facility per step every 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TeaM OUT Intervention<br>The TeaM OUT Intervention has 2 elements: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources. | Behavioral: TeaM OUT Intervention<br>* The TeaM OUT Intervention has 2 elements: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources.<br>|
| Other: Enhanced Usual Care<br>The Enhanced Usual Care arm also has two elements: 1) a letter that a) describes the nodule without linking it to smoking cessation (i.e. no teachable moment) with b) wording to contact an Optional IVR Quit line if desired and 2) the Optional IVR Quit line which a) offers smoking cessation resources and b) helps connect the patient to those resources. | Behavioral: Enhanced Usual Care<br>* The Enhanced Usual Care arm also has two elements: 1) a letter that a) describes the nodule without linking it to smoking cessation (i.e. no teachable moment) with b) wording to contact an Optional IVR Quit line if desired and 2) the Optional IVR Quit line which a) offers smoking cessation resources and b) helps connect the patient to those resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVR connection to smoking cessation service | A positive (yes) response is a completed call to a patient who then indicates (by pressing the number keypad) to be connected to one or more smoking cessation resources. In the control group, if the patient calls the Optional IVR Quitline and then requests to be connected to smoking cessation resources it is counted as a positive response. Each patient will be categorized as a yes after her/his first positive response to the system, regardless of how many times he/she actually engages with the system. | 56 weeks after nodule identification | 
| 7-day point prevalence nicotine abstinence | Aim 2: Participants will be considered to have quit smoking (including non-combustible) if they respond no to the question, Have you smoked a cigarette (regular or e-cigarette), even a puff, in the past 7 days? | 56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of cessation resources | Aim 1: Utilization includes new prescriptions and refills for nicotine-replacement therapies, anti-smoking medications, referrals to smoking cessation counseling, and attendance of smoking cessation counseling session, as recorded in the electronic health record. | 72 weeks after nodule identification | 
| Incremental Behavior Change Toward Smoking Cessation (IBC-S) | Aim 2: Measure is the summed score of the Incremental Behavior Change toward Smoking cessation (IBC-S) scale. | 56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco use cessation, smoking, evaluation study