BREATHE 2 Study

UW-CTRI is partnering with two health systems, Aurora Health Care and UW Health, to treat more than 4,000 clinic patients. BREATHE 2 has begun at St. Luke’s Medical Center, part of the Aurora system. Aurora doctors are excited about BREATHE 2’s promise.

BREATHE 2 Care Managers, who work for the participating health systems, are reaching out to patients listed as smokers in electronic health records at participating clinics.

The study uses opt-out recruitment, meaning everyone will hear about the study from the Care Managers unless the patient tells us they don’t want to hear about it. BREATHE 2 offers treatment to all smokers at participating clinics, and has now enrolled more than 190 participants.

What's YOUR reason to quit smoking?

The innovative experiment will be the first to experimentally compare the two most effective interventions available—varenicline (Chantix) vs. combination nicotine-replacement medications—and determine whether they are enhanced by type of counseling (in-person vs. phone), or by extra medication before quitting or after the standard treatment.

“About 25 million smokers in America make a primary care visit each year,” said Principal Investigator Dr. Tim Baker. “But only about five percent of smokers who try to quit use the cessation counseling and medication we know can help. In this study, we’ll reach out to them and offer these treatments.”

BREATHE 2 is led by Principal Investigators Dr. Tim Baker and Dr. Michael Fiore, research director and director of the UW-CTRI, and their staff, in conjunction with two Wisconsin health systems, Aurora Health Care and UW Health.
BREATHE 2 is led by Principal Investigators Dr. Tim Baker (right) and Dr. Michael Fiore (left), research director and director of the UW-CTRI, and their staff, in conjunction with two Wisconsin health systems, UW Health and Aurora Health Care.

This study will investigate how best to match treatments to smokers, given their readiness to quit.

“We know the majority of smokers who visit primary care clinics want to quit; most of them have already tried and are often discouraged,” Fiore said. “But smoking remains the leading preventable cause of death and disease in America. We will be offering something for everyone. For those not ready to quit, this includes incentives, tailored outreach and, if they decide to quit later, state of the art medication and quitline coaching.”

The clinic’s electronic medical record now lets all patients who attend a clinic visit or televisit know that someone will be calling in the next few days to talk about their smoking. For patients who don’t opt out, Aurora Tobacco Care Managers like Katherine Hudson call to tell them what their options are to get help with their smoking, including participating in BREATHE 2.

The BREATHE 2 team hopes to expand to additional Aurora clinics in January and February 2021.

BREATHE 2 has a contract with UW Health in the Madison area, and that system is hiring two tobacco care managers.

BREATHE 2 will develop a chronic care quit-smoking treatment using factorial designs to develop the best treatments for all smokers. It will use the “RE-AIM” research constructs to translate these results into real-world healthcare changes. Here’s how:

  • R: Increase Reach by using a more inclusive opt-out recruitment strategy to contact clinic patients and offer help.
  • E: Augment treatment Effectiveness by optimizing intervention components that work especially well together for smokers who are ready to quit and those who are not.
  • A: Bolster Adoption by developing the chronic-care program within two healthcare systems and using their patient populations, personnel, and resources (e.g., EHRs). Engineer the chronic-care program to produce benefits of great appeal to potential adopters (e.g., cost-effectiveness, little impact on clinic workflow).
  • I: Foster Implementation potential by evaluating all potential chronic-care program components to ensure they are feasible with regard to cost, staffing needs, training required, and resource requirements.
  • M: Finally, enhance Maintenance by developing treatments engineered to maintain patients’ behavior change and that are easy and inexpensive to continue by healthcare systems and staff.

It’s thanks to hard work by so many on the UW-CTRI staff and BREATHE 2 collaborators. Guided by Principal Investigators Dr. Tim Baker and Dr. Michael Fiore, BREATHE 2 has four main parts:

  1. Project 1, Cessation Optimization Trial, led by Dr. Megan Piper, will yield two optimized treatments for smokers ready to quit.
  2. Project 2, Reach Optimization Trial, led by Dr. Danielle McCarthy, will create an optimized treatment for those not ready to quit.
  3. Project 3, Evaluation Project, led by Dr. Jess Cook, will evaluate the optimized treatments from Projects 1 and 2 in a randomized control trial.
  4. Project 4, Implementation Project, led by Dr. Robin Mermelstein and Dr. Danielle McCarthy, will identify key strategies to translate these results into real-world clinical practices.

Dr. Marlon Mundt, UW-CTRI researcher and health economist, will work on cost-effectiveness calculations.

The innovative Cessation Study will be the first to identify the most effective strategies for taking the two most effective interventions available—varenicline (Chantix) vs. combination nicotine-replacement medications—and also determine whether they are enhanced by type of counseling (phone/video counseling vs. mentored mobile health access). For example, is it best to use the treatment for a month before quitting, or for an extended time after the quit date?

The inventive Reach Study will examine different ways to promote smoking cessation and use of evidence-based treatment among smokers not interested in quitting. These interventions include periodic contacts from Care Managers, incentives for engaging in cessation treatment, and targeted mailings.

If participants are interested in quitting, they are then screened for the Cessation Trial. Those not interested in quitting are screened for the Reach Trial.

BREATHE 2 Road Map

Ultimately, BREATHE 2 should greatly expand the reach and effectiveness of smoking treatment in healthcare systems, meaningfully reduce smoking prevalence in healthcare populations, and thereby reduce cancer morbidity and mortality.

BREATHE 2 Counselor Has Personal Connection to Tobacco Use