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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 10/12/2023 | Other Identifier | UW Madison | |
| A534253 | Other Identifier | UW Madison | |
| 2P01CA180945-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.
This project is a 2-arm randomized controlled trial (RCT) designed to evaluate whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), increases smoking abstinence and treatment use in primary care patients who smoke. The aims are as follows:
Primary Aim
Secondary Aims
Comprehensive Chronic Care (CCC) provides ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt.
Standard Care (SC) involves one offer of cessation treatment per year (8 weeks of nicotine patch plus referral to the tobacco quit line).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Chronic Care | Experimental | ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt |
|
| Standard Care | Active Comparator | involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Chronic Care | Other | Those randomized to CCC will receive smoking treatment offers via the following routes: 1) Four Outreach Calls from a Health Counselor at 4, 8, 12, and 14 months post-study enrollment; 2) Four texts and/or mailings (depending on healthcare system preferences) over 14 months. These outreach contacts will offer cessation treatment or reduction treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months | Group differences in abstinence at 18 months will be evaluated using logistic regression. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with 7-day point-prevalence abstinence at 6 months | At 6 months, participants will be asked whether they have smoked in the past 7 days | 6 months |
| Number of Participants with 7-day point-prevalence abstinence at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Cook, PhD | UW Center of Tobacco Research and Intervention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health | Madison | Wisconsin | 53792 | United States | ||
| Advocate Aurora |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2023 | Dec 17, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Care | Other | one offer of cessation treatment annually |
|
At 12 months, participants will be asked whether they have smoked in the past 7 days
| 12 months |
| Group differences in Cessation Treatment | Group differences in cessation treatment use will be evaluated using logistic regression analysis. Initiating greater than 0 Cessation calls will be coded as binary (use vs. no use). | Up to 18 months |
| Total Cost of Intervention | Incremental resource costs related to the CCC intervention include Health Counselor/staff time, administration, staff training, recruitment, and medication. Methods recommended by the United States Panel on Cost-Effectiveness in Health and Medicine will be utilized. Costs will be measured from a societal perspective using direct observational data of health system resource use. Cost estimates will be converted to a common year. | Up to 18 months |
| Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER) | Cost per additional person who quits smoking, for the CCC vs. SC. The ICER is calculated as the difference in total costs between CCC and SC divided by the difference in 18-month quit rates. | Up to 18 months |
| Milwaukee |
| Wisconsin |
| 53204 |
| United States |