Connect to Quit for Smoking (CTQ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University of Pittsburgh
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01299896
First received: January 27, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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 Intervention
Smoking
Smoking Cessation
Other: Coordinated Care
Other: Usual Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 660
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)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299896

Contacts
Contact: Yvette Shipman, MA 412-954-5250 Yvette.Shipman@va.gov
Contact: Carol L. Mitchell, BSN, RN 412-954-5238 Carol.Mitchell2@va.gov

Locations
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         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Hilary A. Tindle, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01299896     History of Changes
Other Study ID Numbers: 02936, R01CA141596
Study First Received: January 27, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Cigarette Smoking
Smoking, Tobacco
Tobacco Smoking
Smoking Cessation
Tobacco Dependence

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014