Clinical trial participation and end-of-life care among older adults: A multi-center longitudinal observational cohort analysis of 121,717 patients with cancer.
Authors: Subbiah Ishwaria M. , Indurlal Puneeth , Deepak Divya , Sharma Gunjan , Garey Jody S. , Mills Lydia , Wilfong Lalan S. 
Published: June 2024

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Background: Patients’ access to clinical trials remains significantly disparate across the US & world. Complex drivers, some rooted in evidence while others in perceptions, impact shared decision making about trial participation esp in older adults (65y+). To that end, we investigated clinical trial participation (CTP) and unplanned healthcare utilization & hospice use in patients w cancer. Methods: We queried the prospective longitudinal observational cohort of all patients with cancer receiving care at any of the 323 practice locations of 14 multi-site community cancer centers across 11 US states, all within the US Oncology Network and participating in the Oncology Care Model (OCM), an alternative payment model pilot from CMS to promote quality cancer care while reducing costs. We extracted data from OCM episode claims, medical records from 7/1/17-6/30/22 and used propensity score matching by time period, age, gender, date of death, cancer type to identify matched episodes for further stratification by CTP, to compare hospice care & unplanned ER utilization by non-trial usual care vs CTP. Results: Overall, 121,717 pts received cancer care across 282,604 OCM care episodes in the community during this 5-yr period. Most (94%) were older adults aged 65y+ with breast, lung, multiple myeloma being the most common cancers. Of 121,717 pts, 4800 (3.9%) participated in a cancer treatment clinical trial in at least one care episode. Analysis of the 13,260 propensity score-matched episodes (6630 usual care vs 6630 CTP) shows: 1. ER/Observation visits: Patients on clinical trials did nothave any more ER/Obs visits vs usual care (ER/Obs episodes: CTP 23.4%, usual care 22.3%, p0.11). 2. Hospitalizations: The proportion of care episodes with hospitalization was higher in CTP vs usual care (25.9% vs 21.9%, p<0.001). 3. Hospice enrollment: Patients on clinical trials were no less likely to enroll in hospice >3 days prior to death, compared to non-trial usual care cohort (CTP 56.8%, usual care 52.6%, OR 1.18, p 0.13). Furthermore, median duration of hospice in patients on trials was not different from usual care (CTP 8 days, usual care 9 days, p 0.16). Conclusions: Our findings show that while more hospitalizations were observed, clinical trials participation is not associated with suboptimal end of life care outcomes pertaining to hospice enrollment & duration as well as unplanned ER/healthcare utilization. Further efforts to integrate access to clinical trials and evidence-based supportive/palliative care in a scalable sustainable model of goal-concordant, patient-center cancer care are ongoing. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document.