Connect to Quit for Smoking (CTQ)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans|
- Effectiveness of CTQ vs UC [ Time Frame: Two (2) year period ] [ Designated as safety issue: No ]We will measure abstinence of CTQ smokers vs those in UC. We will biochemically-validate self reported abstinence (30 day point-prevalence) at the end of 2 years.
- Cost and Incremental Cost-effectiveness of CTQ vs. UC [ Time Frame: Two ( 2) year period ] [ Designated as safety issue: No ]Micro-costing techniques will be used to estimate direct and indirect costs, and will calculate the incremental cost per successful quit of CTQ vs. UC.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Other: Usual Care
Standard therapy to help participants with smoking cessation.
Active Comparator: Coordinated Care
A CTQ Coordinator will coordinate the delivery of smoking related care.
Other: 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.
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299896
|Contact: Yvette Shipman, MA||412-954-5250||Yvette.Shipman@va.gov|
|Contact: Carol L. Mitchell, BSN, RN||412-954-5238||Carol.Mitchell2@va.gov|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15206|
|Contact: Yvette Shipman, MA 412-954-5250 Yvette.Shipman@va.gov|
|Contact: Carol L. Mitchell, BSN, RN 412-954-5238 Carol.Mitchell2@va.gov|
|Principal Investigator: Hilary A. Tindle, MD, MPH|
|Sub-Investigator: Kevin L. Kraemer, MD, MSc|
|Sub-Investigator: Chester B. Good, MD, MPH|
|Sub-Investigator: Adam J. Gordon, MD, MPH, FACP, FASAM|
|Sub-Investigator: Edward S. Lee, MD|
|Principal Investigator:||Hilary A. Tindle, MD, MPH||University of Pittsburgh|