NCT05382221

Breathe 2 Project 3: Comprehensive Chronic Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 979 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
OTHER	Standard Care	one offer of cessation treatment annually

Timeline

• Start date: 2022-08-08
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2022-05-19
• Last updated: 2025-12-18

Locations

2 sites across 1 country: United States