Connect to Quit for Smoking

NCT ID: NCT01299896

Last Updated: 2016-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Standard therapy to help participants with smoking cessation.

Coordinated Care

A CTQ Coordinator will coordinate the delivery of smoking related care.

Group Type ACTIVE_COMPARATOR

Coordinated Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Usual Care

Standard therapy to help participants with smoking cessation.

Intervention Type OTHER

Other Intervention Names

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Smoking, Tobacco Tobacco Smoking Smoking Cessation Tobacco, Intervention Nicotine Replacement Buproprion, Wellbutrin Chantix, Varenicline Behavorial therapy Smoking, Tobacco Tobacco Smoking Smoking Cessation Tobacco, Intervention Nicotine Replacement Buproprion, Wellbutrin Chantix, Varenicline Behavorial therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hilary A. Tindle, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA141596

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02936

Identifier Type: -

Identifier Source: org_study_id

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