Connect to Quit for Smoking

University of Pittsburgh633 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

633

Conditions

Smoking Smoking Cessation

Interventions

Coordinated CareOTHER

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 CareOTHER

Standard therapy to help participants with smoking cessation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Two (2) year period

Data from ClinicalTrials.gov

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