A randomized study evaluating a patient decision aid (PDA) compared with standard educational material in the setting of lung cancer screening showed less decisional conflict in the former group compared with the latter. The findings from this study were reported in JAMA Network Open.
Lung cancer screening with low-dose computed tomography (LDCT) has been associated with a decreased risk of death in former and current smokers meeting screening criteria, although the procedure has associated risks, such as false-positive findings and radiation exposure. Hence, the Centers for Medicare & Medicaid Services (CMS) require prior participation in “patient counseling and [a] shared decision-making visit using PDAs” before referring a patient for lung cancer screening. However, few PDAs have been developed to help patients decide whether to participate in lung cancer screening.
In this randomized, open label clinical trial (ClinicalTrials.gov Identifier: NCT02286713), people who contacted a tobacco quit line and met age, smoking history, and other eligibility criteria for lung cancer screening using LDCT and agreed to participate in the study were assigned in a 1:1 ratio to receive a DVD containing a 9.5-minute decision-aid video (ie, PDA) or a 2-page educational booklet on lung cancer screening.
The PDA covered lung cancer screening eligibility and a calculation of tobacco pack-year smoking history; epidemiology of and risk factors for lung cancer; a video of a patient undergoing a CT scan; icon array graphics depicting mortality reduction, rate of false-positive results, and potential harms from invasive diagnostic procedures; and comparisons of radiation exposure from lung screening with that of other sources of radiation (eg, a screening mammogram). The educational booklet addressed
Screening eligibility criteria, harms and benefits of screening, what to expect when undergoing an LDCT scan, costs, how to interpret the LDCT results, the importance of smoking cessation, and where to find more information about lung cancer and screening.
The primary outcomes of the study involved assessments of preparation for screening decision-making and decisional conflict at 1 week follow-up using established measures. Secondary study outcomes included knowledge of, intention to undergo, and completion of lung cancer screening at 1-week, 3-months, and 6-months follow-up.
Of the 516 participants undergoing study randomization, nearly three-quarters were younger than 65 years, approximately one-quarter identified as black, slightly more than 60% were women, and the highest level of education was high school or less for 43.8%. The 1-week and 6-month assessments were completed by more than 90% and 80% of participants in the 2 study arms, respectively.
A key finding at 1-week follow-up was that rates of patients reporting preparedness to make decisions related to lung cancer screening were approximately 20% higher for those exposed to the PDA (67.4%) compared with those who received the standard educational materials (48.2%; odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P <.001). Conversely, the rates of those reporting high decisional conflict about decisions related to lung cancer screening were more than 20% lower for those in the former compared with the latter group at 1-week assessment following exposure to the educational tools (21.8% vs 44.2%; OR, 0.32; 95% CI, 0.21-0.49;P <.001).
Nevertheless, neither the rates of patients intending to be screened within the next year at 1-week follow-up (70.8% vs 65.1%; P =.29) nor the rates of those scheduling a healthcare visit to discuss lung cancer screening by 6-month follow-up (63.0% [PDA] vs 66.4% [standard]; P =.47) were significantly different when the 2 study arms were compared.
“These findings suggest that participants who received [the standard educational tool] were making decisions about lung cancer screening while feeling less prepared, being less clear about their values related to the harms and benefits, and having poorer knowledge of the harms and benefits than participants who received the PDA,” the study authors concluded.
Furthermore, at each of the follow-up assessments, those exposed to the PDA had a higher knowledge level about lung cancer screening compared with the group receiving the standard educational material.
Volk RJ, Lowenstein LM, Leal VB, et al. Effect of a patient decision aid on lung cancer screening decision-making by persons who smoke: A randomized clinical trial. JAMA Netw Open. 2020;3(1):e1920362.