Breathe 2 Project 3: Comprehensive Chronic Care

Smoking Cessation Clinical Trial

Official title:

Breathe 2 Project 3: Comprehensive Chronic Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05382221
• Other study ID #: 2022-0124
• Secondary ID: Protocol Version
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Abstinence
• Smoking Cessation

Intervention

Other:
• Comprehensive Chronic Care
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
one offer of cessation treatment annually

Locations

Country	Name	City	State
United States	UW Health	Madison	Wisconsin
United States	Advocate Aurora	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	12 months
Secondary	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
Secondary	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
Secondary	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