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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA141596 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | 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. |
|
| Coordinated Care | Active Comparator | A CTQ Coordinator will coordinate the delivery of smoking related care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coordinated Care | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two (2) year period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary A. Tindle, MD, MPH | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (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. Usual Care: Standard therapy to help participants with smoking cessation. |
| FG001 | Coordinated Care | A CTQ Coordinator will coordinate the delivery of smoking related care. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Usual Care: Standard therapy to help participants with smoking cessation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants per arm | Two (2) year period |
|
Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Usual Care: Standard therapy to help participants with smoking cessation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilary A. Tindle | Vanderbilt University | 615-875-9726 | hilary.tindle@vanderbilt.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D062789 | Tobacco Products |
| D008722 | Methods |
| D000095488 | Nicotine Replacement Therapy |
| D016642 | Bupropion |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
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|
| Usual Care | Other | Standard therapy to help participants with smoking cessation. |
|
|
| BG001 |
| Coordinated Care |
A CTQ Coordinator will coordinate the delivery of smoking related care. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A CTQ Coordinator will coordinate the delivery of smoking related care.
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.
|
|
| 181 |
| 319 |
| 0 |
| 319 |
| EG001 | Coordinated Care | A CTQ Coordinator will coordinate the delivery of smoking related care. 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. | 175 | 314 | 0 | 314 |
| Death | General disorders | Systematic Assessment |
|
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D013812 | Therapeutics |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |