The addition of medication therapy management (MTM) to evidence-based tobacco longitudinal care (TLC) programs did not benefit promotion of smoking abstinence compared with TLC without MTM, according to new findings.¹

The finding that TLC was most useful for patients when conducted without the modification was the result of a new study assessing the addition of a referral to a TLC program for those being given a lung cancer screening (LCS) who were shown not to respond to earlier tobacco treatment.

A previous clinical trial showed that TLC that was delivered for a single year was shown to be efficacious, and the investigators of this new study sought to find data on how best to create an adaptive intervention for patients.² The research was authored by Steven S. Fu, MD, MSCE, from the Center for Care Delivery and Outcomes Research (CCDOR) at Minneapolis VA Health Care System.

“The primary aim was to assess the effect of adding referral to prescription medication therapy management (MTM) to TLC among participants who did not respond early to smoking cessation treatment (hereafter referred to as early treatment nonresponders, defined as any smoking, even a puff, in the last 7 days),” Fu and colleagues wrote.

Background and Findings

The investigators conducted their research with the goal of assessing the effects of integrating prescription MTM referrals into programs for TLC among those eligible for LCS who are known to be persistent smokers and show limited response to their early tobacco interventions. Also, the team worked to assess the results of intensity reduction of the TLC system for those who did show positive early responses to the beginning of treatment.

The research team used a randomized clinical trial design and conducted their research within the context of primary care centers and screening initiatives across 3 different major healthcare systems across the US. The recruitment of these individuals was initiated between October of 2016 and the 18-month follow-up meeting period which ended in April of 2021.

Those who were daily smokers and who qualified for LCS were assessed in the team’s research. The investigators used 3 distinct intervention methods:

• TLC, which involved rigorous telephone coaching as well as a mix of nicotine replacement therapy for participants during a single year with consistent monthly interaction;
• TLC integrated with MTM, involving a referral which was pharmacist-mediated and for prescription medications;
• Quarterly TLC, involving diminished frequency of TLC interaction to quarterly intervals.

The investigators based the allocation of the interventions upon the participants' first responses to their tobacco interventions, and they were decided at either the 4-week or 8-week point after treatment began. The team’s primary evaluation criteria was based upon patients’ self-reported 6-month abstinence which was sustained, and this was observed at their 18-month assessment time.

The idea of the trial's overall design and substantial time frame ensured a comprehensive assessment of the potential effects of MTM referral addition and TLC intensity adjustment on smoking cessation for the study’s population.

The investigators ended up with 636 total participants, 89.4% of which were White with a median age of 64.3 years. After initiation of their treatment, 80.2% of them continued smoking after either 4 or 8 weeks, categorized as ‘early treatment nonresponders,’ while 19.8% ended up successfully quitting and were labeled ‘early treatment responders.’

The research team found that the 18-month follow-up subsequent to this showed a response rate of 83.2%, and by this point, the overall 6-month prolonged abstinence rate overall intervention arms was found to be 24.4%. For the 416 individuals who did not respond positively to their early treatment, those given TLC with MTM were found to have gotten a 6-month prolonged abstinence rate of 17.8% versus 16.4% for participants with standard TLC (adjusted odds ratio [aOR] 1.13; 95% CI, 0.67 - 1.89).

The investigators also noted that 39% of the 254 individuals in the TLC with MTM arm of the study finished at least a single MTM visit. Among the 113 early treatment responders, the team reported a 6-month prolonged abstinence rate of about 43.6% for Quarterly TLC, while they reported 58.6% for TLC (aOR 0.54; 95% CI, 0.25 - 1.17).

“In this SMART clinical trial, offering a referral program to MTM along with TLC for patients continuing to smoke did not offer additional benefit,” they wrote. “This trial supports the feasibility and use of integrating longitudinal tobacco cessation care into the LCS setting.”

References

1. ^{Fu SS, Rothman AJ, Vock DM, et al. Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial. JAMA Netw Open. 2023;6(8):e2329903. doi:10.1001/jamanetworkopen.2023.29903.}
2. ^{Joseph AM, Fu SS, Lindgren B, et al. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. 2011;171(21):1894-1900. doi:10.1001/archinternmed.2011.500.}