Breathe 2 Project 3: Comprehensive Chronic Care

NCT ID: NCT05382221

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 979 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2025-09-25

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.

Detailed 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).

Conditions

Smoking Cessation; Smoking Abstinence

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Comprehensive Chronic Care

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

Group Type: EXPERIMENTAL

Comprehensive Chronic Care

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

one offer of cessation treatment annually

Interventions

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.

Intervention Type: OTHER

Standard Care

one offer of cessation treatment annually

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

UW Center of Tobacco Research and Intervention

Locations

UW Health

Madison, Wisconsin, United States

Advocate Aurora

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Protocol Version 10/12/2023

Identifier Type: OTHER

Identifier Source: secondary_id

A534253

Identifier Type: OTHER

Identifier Source: secondary_id

2P01CA180945-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-0124

Identifier Type: -

Identifier Source: org_study_id