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

Primary Purpose

Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Tobacco Use

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TeaM OUT Intervention
Enhanced Usual Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Solitary Pulmonary Nodule focused on measuring tobacco use cessation, smoking, evaluation study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MN
  • VA Portland Health Care System, Portland, OR
  • Ralph H. Johnson VA Medical Center, Charleston, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TeaM OUT Intervention

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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?"

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 3, 2020
Last Updated
August 17, 2023
Sponsor
VA Office of Research and Development
Collaborators
Minneapolis Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04574518
Brief Title
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Acronym
TeaMOUT
Official Title
Teachable Moment to Opt-out of Tobacco (TeaM OUT): A Stepped Wedge Cluster Randomized Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Minneapolis Veterans Affairs Medical Center, Ralph H. Johnson VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Tobacco Use
Keywords
tobacco use cessation, smoking, evaluation study

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Masking Description
Participants will not be informed that the intervention is being implemented in a randomized fashion, but they cannot be blinded to the interventions (letter and IVR) they will receive.
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TeaM OUT Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
TeaM OUT Intervention
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
IVR connection to smoking cessation service
Description
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.
Time Frame
56 weeks after nodule identification
Title
7-day point prevalence nicotine abstinence
Description
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?"
Time Frame
56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care
Secondary Outcome Measure Information:
Title
Utilization of cessation resources
Description
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.
Time Frame
72 weeks after nodule identification
Title
Incremental Behavior Change Toward Smoking Cessation (IBC-S)
Description
Aim 2: Measure is the summed score of the Incremental Behavior Change toward Smoking cessation (IBC-S) scale.
Time Frame
56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care
Other Pre-specified Outcome Measures:
Title
Qualitative analysis of IVR intervention
Description
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.
Time Frame
Patients--56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care; Clinical Stakeholders--at least 6 months after clinic randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G. Slatore, MD MS
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be saved in our IRB-approved Health Services Research Repository (Portland VA IRB #3535) at the conclusion of the study and requests for access can be submitted to the study team.
IPD Sharing Time Frame
Conclusion of the study, estimated to be November 2024
Citations:
PubMed Identifier
35649214
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):1668-1676. doi: 10.1089/jpm.2022.0008. Epub 2022 Jun 1.
Results Reference
result
PubMed Identifier
35289730
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 to Promote Implementation of Shared Decision-Making for Lung Cancer Screening: An American Thoracic Society and Veterans Affairs Health Services Research and Development Statement. Am J Respir Crit Care Med. 2022 Mar 15;205(6):619-630. doi: 10.1164/rccm.202201-0126ST.
Results Reference
result
PubMed Identifier
35594952
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.
Results Reference
result
PubMed Identifier
34480957
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. Epub 2021 Sep 1. No abstract available.
Results Reference
result
PubMed Identifier
35413280
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. Chest. 2022 Sep;162(3):701-711. doi: 10.1016/j.chest.2022.03.050. Epub 2022 Apr 9.
Results Reference
result
PubMed Identifier
35588358
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):215-225. doi: 10.1513/AnnalsATS.202203-277OC.
Results Reference
result
PubMed Identifier
35732383
Citation
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 chronic conditions to clinical practice and policy: protocol for a multicentre observational study. BMJ Open. 2022 Jun 22;12(6):e064142. doi: 10.1136/bmjopen-2022-064142.
Results Reference
result
PubMed Identifier
35816617
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 Soc. 2022 Dec;19(12):2053-2061. doi: 10.1513/AnnalsATS.202203-275OC.
Results Reference
result

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

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