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Connect to Quit for Smoking (CTQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01299896
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : February 24, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Other: Coordinated Care Other: Usual Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
Study Start Date : March 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
Other Names:
  • Smoking, Tobacco
  • Tobacco Smoking
  • Smoking Cessation
  • Tobacco, Intervention
  • Nicotine Replacement
  • Buproprion, Wellbutrin
  • Chantix, Varenicline
  • Behavorial therapy
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.
Other Names:
  • Smoking, Tobacco
  • Tobacco Smoking
  • Smoking Cessation
  • Tobacco, Intervention
  • Nicotine Replacement
  • Buproprion, Wellbutrin
  • Chantix, Varenicline
  • Behavorial therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299896


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hilary A. Tindle, MD, MPH Vanderbilt University
More Information
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01299896    
Other Study ID Numbers: 02936
R01CA141596 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2011    Key Record Dates
Results First Posted: February 24, 2016
Last Update Posted: March 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Pittsburgh:
Cigarette Smoking
Smoking, Tobacco
Tobacco Smoking
Smoking Cessation
Tobacco Dependence
Additional relevant MeSH terms:
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Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors