Clinical trial NCT05382221: Breathe 2 Project 3: Comprehensive Chronic Care
Official title: Breathe 2 Project 3: Comprehensive Chronic Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Smoking Abstinence
Keywords: Chronic Care Tobacco Treatment
Standard of Care
Reduction Treatment
Motivation Phase Treatment
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-19
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
timeFrame: up to 18 months
Secondary outcomes:
measure: Number of Participants with 7-day point-prevalence abstinence at 6 months
timeFrame: 6 months
measure: Number of Participants with 7-day point-prevalence abstinence at 12 months
timeFrame: 12 months
measure: Group differences in Cessation Treatment
timeFrame: Up to 18 months
measure: Total Cost of Intervention
timeFrame: Up to 18 months
measure: Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Advocate Aurora
state: Wisconsin
Study officials:
affiliation: UW Center of Tobacco Research and Intervention
name: Jessica Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: