Tobacco Dependence, Veterans
Conditions
Keywords
Tobacco dependence, Clinical Trial, Veterans
Brief summary
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: use of cessation treatment and smoking abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
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
Interventions
BEHAVIORALEnhanced Chronic Care
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).
BEHAVIORALStandard Care
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.
Sponsors
VA Office of Research and Development
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point-Prevalence Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiating at Least 1 Cessation Treatment Call | 2 years | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Megan Cook, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.55 Years STANDARD_DEVIATION 11.81 |
| Cigarettes per day | 16.82 Cigarettes smoked per day STANDARD_DEVIATION 9.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 246 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 85 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 198 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 231 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 19 / 249 | 23 / 253 |
| other Total, other adverse events | 4 / 158 | 3 / 30 |
| serious Total, serious adverse events | 0 / 249 | 0 / 253 |
Outcome results
None listed