Breathe 2 Project 3: Comprehensive Chronic Care

University of Wisconsin (UW)

Status: Completed

Conditions: Smoking Abstinence; Smoking Cessation

Treatments: Other: Standard Care; Other: Comprehensive Chronic Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05382221

2022-0124

A534253 (Other Identifier)

Protocol Version 10/12/2023 (Other Identifier)

2P01CA180945-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 979 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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979 participants in 2 patient groups

Comprehensive Chronic Care

Experimental group

Description:

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

Treatment:

Other: Comprehensive Chronic Care

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care