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 * Aim 1: To determine whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment. * Secondary Aims * Aim 2: To determine the effects of CCC relative to SC on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment. * Aim 3: To compare CCC with SC on cessation treatment use over 18 months of treatment access. 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
979
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.
one offer of cessation treatment annually
UW Health
Madison, Wisconsin, United States
Advocate Aurora
Milwaukee, Wisconsin, United States
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.
Time frame: up to 18 months
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
Time frame: 6 months
Number of Participants with 7-day point-prevalence abstinence at 12 months
At 12 months, participants will be asked whether they have smoked in the past 7 days
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: Up to 18 months