Connect to Quit for Smoking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Other: Coordinated Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>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. | Other: Usual Care<br>* Standard therapy to help participants with smoking cessation.<br>* Other names: Behavorial therapy;|
| Active Comparator: Coordinated Care<br>A CTQ Coordinator will coordinate the delivery of smoking related care. | Other: Coordinated Care<br>* 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.<br>* Other names: Behavorial therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two (2) year period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette Smoking, Smoking, Tobacco, Tobacco Smoking, Smoking Cessation, Tobacco Dependence