UW-CTRI researchers have published a new study in the journal Nicotine & Tobacco Research that identifies some promising ways to improve smoking treatment trial recruitment in primary care settings.
Using electronic health records (EHR) at clinics to prompt staff to make the referral is one way to help. Another is to relax inclusion criteria that disproportionately exclude people from underrepresented groups who want to quit smoking and want to participate in research.
This work was part of the first BREATHE study at UW-CTRI.
“Engaging all communities that use tobacco in smoking treatment clinical trials is critically important in the effort to identify treatments that work well across populations,” said UW-CTRI Director of Research Dr. Danielle McCarthy. “Many clinical trials struggle to reach their recruitment goals, and to engage people from historically underrepresented groups in trials. This slows progress in smoking treatment research.”
A Better Way Forward
UW-CTRI partnered with two health systems, Dean Health Care and Aurora Health Care, to offer smoking treatment to thousands of patients who smoked at 18 clinics.
All patients age 18 or older whose EHR indicated they currently smoked cigarettes were eligible for the EHR alert and e-referral to the research team.
“This study indicated that proactive EHR-facilitated outreach can engage nearly one in every four adult primary care patients who smoke in research,” said McCarthy.
“E-referral reach was particularly strong among some historically underserved groups—like Black patients and those with Medicaid or Medicare, but less so among others like Hispanic and uninsured patients.”
McCarthy noted that finding ways to reach people from minoritized groups and those with socioeconomic disadvantages is important, as this is a gap in prior studies. A systematic review of 78 tobacco-related clinical trials showed that people from minoritized groups were markedly under-represented in these studies.
The results of the recent study suggest that proactively reaching out to all adult primary care patients who smoke may help to close some of these gaps. More work, such as developing culturally specific Spanish-language outreach materials, may be needed, as well.
Three out of every 10 e-referred patients later passed eligibility screening and enrolled in BREATHE, bringing the overall rate of treatment enrollment among all eligible patients who smoked to seven percent. This rate of engagement is greater than the reach of quitline e-referral in previous studies.
Removing Barriers to Enrollment
Results pointed to more ways to enhance representation in future trials, as some exclusion criteria disproportionately affected particular groups of people.
For example, requiring people to smoke at least five cigarettes per day to enter a smoking treatment study excludes more Black people than White people and people in less advantaged neighborhoods.
McCarthy suggested “Relaxing inclusion criteria that are not essential for patient safety may enhance representation of communities hard hit by tobacco in our smoking treatment trials.”
To watch a video about how BREATHE helped one patient, Gary, to quit smoking, click here.
UW-CTRI thanks Dean Health Care, Aurora Health Care, the National Cancer Institute, and Epic Systems for their support of this research.
Kim N, Kirsch J, Millevolte R, Oguss MK, Fraser DL, Kobinsky K, Piper ME, Cook JW, Schlam TR, Baker TB, Fiore MC, Kathuria H, McCarthy DE. (2025) Representativeness of Electronic Referral to Smoking Treatment Trials in Adult Primary Care. Nicotine & Tobacco Research. Online February 22, 2025.