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

Not Applicable

• Conditions: Multiple Pulmonary Nodules; Tobacco Use; Solitary Pulmonary Nodule
• Interventions: Behavioral: Enhanced Usual Care; Behavioral: TeaM OUT Intervention

• Registration Number: NCT04574518
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Study Start: 2022-08-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2400

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)

Read More

Exclusion Criteria

-No exclusion criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care	Enhanced Usual Care	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.
TeaM OUT Intervention	TeaM OUT Intervention	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.

Primary Outcome Measures

Name	Time	Method
IVR connection to smoking cessation service	56 weeks after nodule identification	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.
7-day point prevalence nicotine abstinence	56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care	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?"

Secondary Outcome Measures

Name	Time	Method
Incremental Behavior Change Toward Smoking Cessation (IBC-S)	56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care	Aim 2: Measure is the summed score of the Incremental Behavior Change toward Smoking cessation (IBC-S) scale.
Utilization of cessation resources	72 weeks after nodule identification	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.

Trial Locations

Locations (3)

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

Ralph H. Johnson VA Medical Center, Charleston, SC; 🇺🇸 Charleston, South Carolina, United States