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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04574518
Collaborator
Minneapolis Veterans Affairs Medical Center (U.S. Fed), Ralph H. Johnson VA Medical Center (U.S. Fed)
2,400
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2
27.6
800
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Study Details

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

  1. 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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Condition or Disease Intervention/Treatment Phase
  • Behavioral: TeaM OUT Intervention
  • Behavioral: Enhanced Usual Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention 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.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.
Primary Purpose:
Health Services Research
Official Title:
Teachable Moment to Opt-out of Tobacco (TeaM OUT): A Stepped Wedge Cluster Randomized Intervention
Actual Study Start Date :
Aug 12, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Other: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Other Outcome Measures

  1. Qualitative analysis of IVR intervention [Patients--56 weeks after exposure to TeaM OUT Intervention or Enhanced Usual Care; Clinical Stakeholders--at least 6 months after clinic randomization]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417
2 VA Portland Health Care System, Portland, OR Portland Oregon United States 97239
3 Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina United States 29401-5799

Sponsors and Collaborators

  • VA Office of Research and Development
  • Minneapolis Veterans Affairs Medical Center
  • Ralph H. Johnson VA Medical Center

Investigators

  • Principal Investigator: Christopher G. Slatore, MD MS, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04574518
Other Study ID Numbers:
  • IIR 19-425
First Posted:
Oct 5, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022