Smoking, Smoking Cessation
Conditions
Keywords
Cigarette Smoking, Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco Dependence
Brief summary
The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care Connect to Quit (CTQ) is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.
Detailed description
Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.
Interventions
OTHERCoordinated Care
CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
OTHERUsual Care
Standard therapy to help participants with smoking cessation.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female 18 years or older * Veterans seen by a primary care physician within the VAPHS * Household income not more than $36,000 annually * Smoke at least 1 cigarette per day
Exclusion criteria
* Smokeless tobacco (snuff or chew) users * Non-cigarette (e.g., pipe) smokers * Non-English speaking patients * Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of CTQ vs UC | Two (2) year period | We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation. | 319 |
| Coordinated Care A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly. | 314 |
| Total | 633 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 7 |
Baseline characteristics
| Characteristic | Usual Care | Coordinated Care | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 11.5 | 55.7 years STANDARD_DEVIATION 8.7 | 55.2 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 319 participants | 314 participants | 633 participants |
| Sex: Female, Male Female | 28 Participants | 38 Participants | 66 Participants |
| Sex: Female, Male Male | 291 Participants | 276 Participants | 567 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 319 | 0 / 314 |
| serious Total, serious adverse events | 181 / 319 | 175 / 314 |
Outcome results
Primary
Effectiveness of CTQ vs UC
We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
Time frame: Two (2) year period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Effectiveness of CTQ vs UC | 7.5 percentage of participants per arm |
| Coordinated Care | Effectiveness of CTQ vs UC | 6.1 percentage of participants per arm |