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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active smoker
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uppatients--56 weeks after exposure to team out intervention or enhanced usual care; clinical stakeholders--at least 6 months after clinic randomization
Awards & highlights
No Placebo-Only Group
TeaMOUT Trial Summary
This trial will evaluate the effectiveness of a smoking cessation outreach intervention on increasing use of smoking cessation resources in Veterans.
Eligible Conditions
- Tobacco Use
- Solitary Pulmonary Nodule
- Pulmonary Nodules
TeaMOUT Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are currently smoking cigarettes.
TeaMOUT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks after exposure to team out intervention or enhanced usual care
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks after exposure to team out intervention or enhanced usual care
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-day point prevalence nicotine abstinence
Smoke
Secondary outcome measures
Incremental Behavior Change Toward Smoking Cessation (IBC-S)
Utilization of cessation resources
Other outcome measures
Interventional procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
TeaMOUT Trial Design
2Treatment groups
Experimental Treatment
Group I: TeaM OUT InterventionExperimental Treatment1 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.
Group II: Enhanced Usual CareExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Usual Care
2010
Completed Phase 3
~7780
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,583 Previous Clinical Trials
2,895,275 Total Patients Enrolled
4 Trials studying Tobacco Use
2,634 Patients Enrolled for Tobacco Use
Minneapolis Veterans Affairs Medical CenterFED
69 Previous Clinical Trials
12,269 Total Patients Enrolled
Ralph H. Johnson VA Medical CenterFED
18 Previous Clinical Trials
3,188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently smoking cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: TeaM OUT Intervention
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots in this experiment for participants?
"Clinicaltrials.gov displays that this medical research is not currently seeking participants, despite having been posted on August 12th 2022 and last edited a week later. Nevertheless, at present there are 76 other trials searching for prospective candidates."
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