Connect to Quit for Smoking

Not Applicable

Completed

• Conditions: Smoking Cessation; Smoking
• Interventions: Other: Usual Care; Other: Coordinated Care

• Registration Number: NCT01299896
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Study Start: 2011-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-01-21
• Results First Submitted QC: 2016-01-26
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Results First Posted: 2016-02-24
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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.
Coordinated Care	Coordinated Care	A CTQ Coordinator will coordinate the delivery of smoking related care.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States