Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 633
- Locations
- 2
- Primary Endpoint
- Effectiveness of CTQ vs UC
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Effectiveness of CTQ vs UC
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported