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Referral Approaches for Tobacco Use
N/A
Waitlist Available
Led By Steven S. Fu, MD MSCE
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-year intervention period
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether an opt-out or opt-in approach is more effective in referring smokers to treatment.
Who is the study for?
This trial is for current smokers who have been seen by a nursing assistant on the PACT team at the Manhattan or Brooklyn VA campus within the last year. It's also open to those nurses and administrative staff who smoke. Non-English speakers cannot participate.
What is being tested?
The study is comparing two methods of encouraging smoking cessation: an 'opt-out' where smokers are automatically referred to treatment unless they decline, and an 'opt-in' where smokers must actively choose to enroll in treatment programs.
What are the potential side effects?
Since this trial involves behavioral approaches like staff training rather than medication, there are no direct medical side effects. However, participants may experience stress or discomfort related to changing smoking habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-year intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-year intervention period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abstinence at the end of the 2-year intervention period
Proportion of smokers who accept referral to treatment (Quitline or text messaging)
Proportion of smokers who engage in treatment with the Quitline or text messaging service
Secondary study objectives
Cost-effectiveness of the two approaches (opt-out vs opt-in)
Use of smoking cessation medications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Opt-out tobacco treatmentExperimental Treatment1 Intervention
The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.
Group II: Opt-in clinical reminderExperimental Treatment1 Intervention
As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,764,423 Total Patients Enrolled
4 Trials studying Tobacco Use
3,785 Patients Enrolled for Tobacco Use
Steven S. Fu, MD MSCEPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
3 Previous Clinical Trials
10,714 Total Patients Enrolled
Scott E. Sherman, MD MPHPrincipal InvestigatorManhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 Previous Clinical Trials
220 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Opt-in clinical reminder
- Group 2: Opt-out tobacco treatment
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.
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