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NCT Number: NCT05382221

Breathe 2 Project 3: Comprehensive Chronic Care

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Abstinence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Health, Madison, Wisconsin, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On smoking registry at a participating clinic OR report current smoking at a clinic visit
  • Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
  • Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
  • Able to speak and read English.

Exclusion criteria

  • Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.

Treatment and study plan

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.

Standard care

Other

one offer of cessation treatment annually

Primary outcomes

  1. Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months

    Time frame: up to 18 months

    Group differences in abstinence at 18 months will be evaluated using logistic regression.

Secondary outcomes

  1. Number of Participants with 7-day point-prevalence abstinence at 6 months

    Time frame: 6 months

    At 6 months, participants will be asked whether they have smoked in the past 7 days

  2. Number of Participants with 7-day point-prevalence abstinence at 12 months

    Time frame: 12 months

    At 12 months, participants will be asked whether they have smoked in the past 7 days

  3. Group differences in Cessation Treatment

    Time frame: Up to 18 months

    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).

  4. Total Cost of Intervention

    Time frame: Up to 18 months

    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.

  5. Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)

    Time frame: Up to 18 months

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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