Connect to Quit for Smoking

Smoking Cessation Clinical Trial

— CTQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299896
• Other study ID #: 02936
• Secondary ID: R01CA141596
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 26, 2016
• Start date: March 2011
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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.
• Usual Care
Standard therapy to help participants with smoking cessation.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of CTQ vs UC	We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate self reported abstinence (30 day point-prevalence) at the end of 2 years.	Two (2) year period	No