Smoking Cessation
Conditions
Keywords
Veterans, Smoking cessation, Operation Enduring Freedom, Operation Iraqi Freedom
Brief summary
The overarching aim of the study is to evaluate in a randomized trial the impact of an internet intervention compared to a standard clinic-based control group to promote smoking cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.
Detailed description
Project Background: Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Intensive speciality clinic-based tobacco cessation programs have high efficacy, are more cost effective than less intensive approaches, and are employed by most VA medical centers. These programs, however, are infrequently attended by veterans, limiting the impact on prevalence, disease burden, and economic costs of smoking. An internet-based smoking cessation intervention could be an effective, low-cost method to implement evidence based smoking cessation principles. The internet could significantly increase the impact of smoking cessation efforts over current approaches by avoiding barriers that limit utilization of existing clinic-based services. Project Objectives: The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans. Accordingly, the specific aims and hypotheses are: AIM 1: To evaluate the impact of an internet-based smoking cessation intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 3 months and 12-month post-treatment follow-ups. Hypothesis 1: Abstinence rates will be significantly higher among veterans randomized to the web-based intervention than those randomized to VA specialty cessation care. AIM 2: To evaluate the impact of an internet-based smoking cessation intervention on reach of smoking cessation treatment. Hypothesis 2.1: Internet-based treatment will result in increased reach as measured by the proportion of patients who access care. Hypothesis 2.2: Internet-based treatment will result in engagement in treatment as measured by the proportion of patients that make at least one quit attempt. AIM 3: To evaluate the relative cost-effectiveness of the standard specialty care intervention to the web-based intervention. Project Methods: Proposed is a trial in which 410 OEF/OIF veteran smokers will be randomized to receive either an internet-based smoking cessation intervention and nicotine replacement therapy or referral to VA specialty smoking cessation care, which includes behavioral therapy, group counseling, telephone counseling, self-help materials, and choice of smoking cessation aid (pharmacotherapy). Participating patients will be surveyed at 3 months post-intervention and at 12 months. The primary outcome of the trial is a 7-day point prevalence abstinence at the 3-month post intervention follow-up, as measured by self-report and verified by cotinine assay.
Interventions
BEHAVIORALInternet-based
Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
BEHAVIORALStandard Clinic-Based
Veterans randomized to the control condition will have a consult placed to the Durham VA Medical Center (DVAMC) specialty Smoking Cessation Clinic placed on their behalf.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in DVAMC for ongoing care * Served during OEF/OIF * Current smokers willing to make a quit attempt in the next 30 days
Exclusion criteria
* Active diagnosis of psychosis in the medical record * Diagnosis of severe dementia in the medical record * Does not have access to a telephone * Severely impaired hearing or speech (veterans must be able to respond to phone calls) * Refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) | 3 months post treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. | 206 |
| Control Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf. | 207 |
| Total | 413 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 13.7 | 43.1 years STANDARD_DEVIATION 14 | 42.9 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 17 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 194 Participants | 393 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 162 Participants | 86 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 28 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 105 Participants | 209 Participants | 104 Participants |
| Region of Enrollment United States | 206 participants | 413 participants | 207 participants |
| Sex: Female, Male Female | 31 Participants | 64 Participants | 33 Participants |
| Sex: Female, Male Male | 175 Participants | 349 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 206 | 8 / 207 |
| serious Total, serious adverse events | 9 / 206 | 7 / 207 |
Outcome results
Primary
The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)
Time frame: 3 months post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) | 34.4 percentage of participants |
| Control | The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) | 24.7 percentage of participants |