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Clinical Trials/NCT04574518
NCT04574518
Active, not recruiting
Not Applicable

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

VA Office of Research and Development6 sites in 1 country223 target enrollmentAugust 12, 2022

Overview

Phase
Not Applicable
Intervention
TeaM OUT Intervention
Conditions
Solitary Pulmonary Nodule
Sponsor
VA Office of Research and Development
Enrollment
223
Locations
6
Primary Endpoint
IVR connection to smoking cessation service
Status
Active, not recruiting
Last Updated
3 months ago

Overview

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.

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Registry
clinicaltrials.gov
Start Date
August 12, 2022
End Date
March 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: TeaM OUT Intervention

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.

Intervention: Enhanced Usual Care

Outcomes

Primary Outcomes

IVR connection to smoking cessation service

Time Frame: 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

Time Frame: 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 Outcomes

  • Incremental Behavior Change Toward Smoking Cessation (IBC-S)(56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care)
  • Utilization of cessation resources(72 weeks after nodule identification)

Study Sites (6)

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