Healthcare utilization among Medicare beneficiaries with lung cancer participating in cancer clinical trials.

130 Background: Cancer clinical trial participants often require frequent outpatient monitoring to evaluate the safety and efficacy of experimental therapies. Healthcare utilization among cancer clinical trial participants vs non-participants remains poorly characterized. Cancer clinical trial participation may lead to more frequent acute care visits and inpatient admissions for the management of treatment-related toxicities. In this analysis, we compared differences in acute care health utilization among newly diagnosed lung cancer patients (pts) who enrolled vs did not enroll in interventional cancer clinical trials. Methods: We used SEER-Medicare data to identify pts with a new diagnosis of lung cancer in 2016. Clinical trial participants were defined as pts with a Medicare claim that included a National Clinical Trial identifier corresponding to an interventional cancer clinical trial within 1 year of diagnosis. Frequency of emergency department (ED) visits and inpatient admissions were evaluated from diagnosis through 6 month follow-up. Clinical trial pts were matched with non-clinical trial pts based on month of diagnosis, age at diagnosis, marital status, race, median income, Charlson Comorbidity Index, and stage. Univariable negative binomial models were built to quantify associations of clinical trial status with ED visits and inpatient admissions. Standardized Mean Differences (SMD) between groups were calculated to determine balance post-matching. A p-value less than < 0.05 was considered statistically significant. Statistical analyses were conducted using R (version 4.4.1, R Core Development Team, Vienna, Austria) and SAS 9.4 (SAS Institute, Cary, NC). Results: 188 newly diagnosed lung cancer pts participating on interventional clinical trials were identified and matched with 450 non-clinical trial pts and the groups were adequately balanced. Most pts did not have any inpatient admissions (62% among clinical trial pts vs 60% non-clinical pts, p = 0.7). Mean inpatient visits were similar among clinical trial pts vs non-clinical trial pts [Mean = 0.61 (SD = 0.96) vs 0.67 (SD = 1.04); Incidence Rate Ratio (IRR) = 0.9, 95% CI (0.69, 1.19); p = 0.5]. Most pts did not have any ED visits (50% among clinical trial pts vs 53% non-clinical trial pts, p = 0.5). Mean ED visits were also similar among clinical trial pts v non-clinical trial pts [Mean = 0.80 (SD = 0.98) vs 0.81 (SD = 1.19); IRR = 0.98, 95% CI (0.78, 1.24); p = 0.9]. Conclusions: We found no difference in acute healthcare utilization among newly diagnosed lung cancer pts that participated vs did not participate in an interventional cancer clinical trial. Despite the risk of treatment-related toxicities and adverse events associated with experimental cancer therapeutics, our data suggests this does not result in a higher burden of ED visits or inpatient admissions.