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

Tobacco Use Clinical Trial

— TeaMOUT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04574518
• Other study ID #: IIR 19-425
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2400
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule
• Tobacco Use

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Minneapolis Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Braithwaite D, Karanth SD, Slatore CG, Zhang D, Bian J, Meza R, Jeon J, Tammemagi M, Schabath M, Wheeler M, Guo Y, Hochhegger B, Kaye FJ, Silvestri GA, Gould MK. Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chroni — View Citation

Gershengorn HB, Vranas KC, Ouyang D, Cheng S, Rogers AJ, Schweiger L, Cooke CR, Slatore CG. Influence of the COVID-19 Pandemic on Author Sex and Manuscript Acceptance Rates among Pulmonary and Critical Care Journals. Ann Am Thorac Soc. 2023 Feb;20(2):215- — View Citation

Lewis JA, Samuels LR, Denton J, Matheny ME, Maiga A, Slatore CG, Grogan E, Kim J, Sherrier RH, Dittus RS, Massion PP, Keohane L, Roumie CL, Nikpay S. The Association of Health Care System Resources With Lung Cancer Screening Implementation: A Cohort Study — View Citation

Lewis JA, Wiener RS, Slatore CG, Spalluto LB. Doing Versus Documenting Shared Decision-Making for Lung Cancer Screening-Are They the Same? J Am Coll Radiol. 2022 Aug;19(8):954-956. doi: 10.1016/j.jacr.2022.03.019. Epub 2022 May 18. No abstract available. — View Citation

Reinke LF, Sullivan DR, Slatore C, Dransfield MT, Ruedebusch S, Smith P, Rise PJ, Tartaglione EV, Vig EK, Au DH. A Randomized Trial of a Nurse-Led Palliative Care Intervention for Patients with Newly Diagnosed Lung Cancer. J Palliat Med. 2022 Nov;25(11):1 — View Citation

Slatore CG, Golden SE, Thomas T, Patzel M, Bumatay S, Shannon J, Davis M. Beliefs and Practices of Primary Care Providers Regarding Performing Low-Dose CT Studies for Lung Cancer Screening. Chest. 2022 Mar;161(3):853-859. doi: 10.1016/j.chest.2021.08.062. — View Citation

Wang Q, Stone K, Kern JA, Slatore CG, Swanson S, Blackstock W Jr, Khan RS, Smith CB, Veluswamy RR, Chidel M, Wisnivesky JP. Adverse Events Following Limited Resection versus Stereotactic Body Radiation Therapy for Early Stage Lung Cancer. Ann Am Thorac So — View Citation

Wiener RS, Barker AM, Carter-Harris L, Caverly TJ, Crocker DA, Denietolis A, Doherty C, Fagerlin A, Gallagher-Seaman M, Gould MK, Han PKJ, Herbst AN, Ito Fukunaga M, McCullough MB, Miano DA, Quaife SL, Slatore CG, Fix GM. Stakeholder Research Priorities t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative analysis of IVR intervention	Aim 3: Interviews with patients and clinical stakeholders will collect feedback about the IVR intervention. Interview content will be analyzed using qualitative description. Interview transcripts will be reviewed and coded by the qualitative analysts. Development of the codes will occur in the context of the qualitative data. The analysts will discuss the codes, achieve consensus, resolve differences, and modify the codes if necessary.	Patients--56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care; Clinical Stakeholders--at least 6 months after clinic randomization
Primary	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
Primary	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	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
Secondary	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