Breathe 2 Project 3: Comprehensive Chronic Care

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Smoking Abstinence
• Intervention / Treatment: Other: Comprehensive Chronic Care; Other: Standard Care

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).

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Health
    • Milwaukee, Wisconsin, United States, 53204
      • Advocate Aurora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: Standard Care; involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually	Other: Standard Care; one offer of cessation treatment annually

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with 7-day point-prevalence abstinence at 6 months	At 6 months, participants will be asked whether they have smoked in the past 7 days	6 months
Number of Participants with 7-day point-prevalence abstinence at 12 months	At 12 months, participants will be asked whether they have smoked in the past 7 days	12 months
Group differences in Cessation Treatment	Group differences in cessation treatment use will be evaluated using logistic regression analysis. Initiating greater than 0 Cessation calls will be coded as binary (use vs. no use).	Up to 18 months
Total Cost of Intervention	Incremental resource costs related to the CCC intervention include Health Counselor/staff time, administration, staff training, recruitment, and medication. Methods recommended by the United States Panel on Cost-Effectiveness in Health and Medicine will be utilized. Costs will be measured from a societal perspective using direct observational data of health system resource use. Cost estimates will be converted to a common year.	Up to 18 months
Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)	Cost per additional person who quits smoking, for the CCC vs. SC. The ICER is calculated as the difference in total costs between CCC and SC divided by the difference in 18-month quit rates.	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jessica Cook, PhD, UW Center of Tobacco Research and Intervention

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Standard of Care; Chronic Care Tobacco Treatment; Reduction Treatment; Motivation Phase Treatment
• Other Study ID Numbers: 2022-0124; A534253 (Other Identifier: UW Madison); 2P01CA180945-06 (U.S. NIH Grant/Contract); Protocol Version 10/12/2023 (Other Identifier: UW - Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No