Breathe 2 Project 3: Comprehensive Chronic Care

NCT05382221 | Completed

• 4 other identifiers: 2022-0124Protocol Version 10/12/2023A5342532P01CA180945-06
• Study Type: interventional
• Target: 979
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Smoking Cessation; Smoking Abstinence

Keywords

Chronic Care Tobacco Treatment; Standard of Care; Reduction Treatment; Motivation Phase Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  6 months

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

  12 months

• Group differences in Cessation Treatment

  Up to 18 months

• Total Cost of Intervention

  Up to 18 months

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

  Up to 18 months

Study Arms (2)

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

Other: Comprehensive Chronic Care

Standard Care

ACTIVE COMPARATOR

involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually

Other: Standard Care

Interventions

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.

Comprehensive Chronic Care

Standard Care OTHER

one offer of cessation treatment annually

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UW Health

Madison, Wisconsin, 53792, United States

Location

Advocate Aurora

Milwaukee, Wisconsin, 53204, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jessica Cook, PhD

  UW Center of Tobacco Research and Intervention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: August 8, 2022
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)