Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: smoking treatment reach (use of cessation treatment) and abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
The investigators will evaluate these interventions using a 2-arm randomized controlled trial. Veterans who smoke daily, but who are not willing to enter smoking cessation treatment, will be eligible to participate, with no obligation to quit smoking. Participants (N=500) will be randomized to one of the following treatments: 1) Enhanced Chronic Care (n=250) or 2) Standard Care (n=250). These intervention conditions will last 2 years to permit analysis of their cumulative impact on abstinence and treatment use
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705-2254
- William S. Middleton Memorial Veterans Hospital, Madison, WI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not willing to set a quit date in the next 30 days
- Report smoking an average of 4 or more cigarettes daily for at least six months
- Read, write, and speak English
- Be medically eligible to use nicotine replacement therapy
- If female, use an approved method of birth control if they use nicotine replacement therapy
- Agree to participate in the study
- Be at least 18 years old
- Be a Veteran
Exclusion Criteria:
- Unable to give informed, voluntary consent to participate
- Current use of any pharmacotherapy for smoking cessation not provided by the researchers during tobacco treatment
- Use of non-cigarette tobacco products as a primary form of tobacco use
- Incarceration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Enhanced Chronic Care
Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.
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Enhanced Chronic Care involves four chronic care calls per year.
Enhanced Chronic Care is designed to help participants explore their goals and concerns with regard to smoking, engage in a nondirective, supportive, motivational interventions, and provide information about evidence-based smoking treatment available to them and ways to initiate treatment (i.e., warm hand-off from a clinical provider).
|
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Active Comparator: Standard Care
Standard Care provides phone-based brief advice to quit once per year.
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Standard Care involves one call per year.
During the Standard Care call, participants will be encouraged to quit smoking, reminded of the cessation treatment available to them, and provided with a number to call should they become interested in treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
7-Day Point-Prevalence Abstinence
Time Frame: 2 years
|
Participants who self-report no smoking for the past 7 days at the assessment endpoint (2-year follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who report any smoking in the past 7 days (at the 2 year follow-up) will be considered to be relapsed (smoking). Participants who self-report no smoking for the past 7 days at 2-year follow-up were mailed a self-administered saliva sample collection kit. A saliva cotinine level of 10 ng/mL was used as the cutoff to determine smoking abstinence. |
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Initiating at Least 1 Cessation Treatment Call
Time Frame: 2 years
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Cessation treatment use will be defined as making at least one treatment contact (initiating at least 1 cessation treatment call with reach coded as a binary outcome: use vs. no use).
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jessica Megan Cook, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NURA-009-18F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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