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AbstractObjectivesTo report lessons from integrating the methods and perspectives of clinical informatics (CI) and implementation science (IS) in the context of Improving the Management of symPtoms during and following Cancer Treatment (IMPACT) Consortium pragmatic trials.Materials and MethodsIMPACT informaticists, trialists, and implementation scientists met to identify challenges and solutions by examining robust case examples from 3 Research Centers that are deploying systematic symptom assessment and management interventions via electronic health records (EHRs). Investigators discussed data collection and CI challenges, implementation strategies, and lessons learned.ResultsCI implementation strategies and EHRs systems were utilized to collect and act upon symptoms and impairments in functioning via electronic patient-reported outcomes (ePRO) captured in ambulatory oncology settings. Limited EHR functionality and data collection capabilities constrained the ability to address IS questions. Collecting ePRO data required significant planning and organizational champions adept at navigating ambiguity.DiscussionBringing together CI and IS perspectives offers critical opportunities for monitoring and managing cancer symptoms via ePROs. Discussions between CI and IS researchers identified and addressed gaps between applied informatics implementation and theory-based IS trial and evaluation methods. The use of common terminology may foster shared mental models between CI and IS communities to enhance EHR design to more effectively facilitate ePRO implementation and clinical responses.ConclusionImplementation of ePROs in ambulatory oncology clinics benefits from common understanding of the concepts, lexicon, and incentives between CI implementers and IS researchers to facilitate and measure the results of implementation efforts.

PURPOSE The enhanced, electronic health record (EHR)–facilitated cancer symptom control (E2C2) trial is a cohort cluster-randomized, stepped-wedge, hybrid type II trial that leverages EHR systems to facilitate a collaborative care model (CCM) approach with the goal of improving cancer symptom management. Understanding factors that influence care team adoption of EHR systems remains a critical understudied area of research. This study examines how oncology care teams' perceptions regarding the feasibility, acceptability, and appropriateness of E2C2 EHR systems preimplementation were associated with adoption 3 months after implementation and characterizes differences in adoption by individual- and system-level factors. METHODS Care team members completed an electronic survey before and 3 months after implementation of E2C2 for their respective sequence. Adoption was defined as frequency of use to statements aligned with care team–directed EHR systems designed to facilitate CCM approaches. Chi-square tests assessed differences in adoption while logistic regression models estimated associations between baseline mean scores of acceptability, feasibility, and appropriateness on care team adoption at 3 months. RESULTS Results from 94 care team members (37.2% oncologists, 72.6% female, 55.3% in their role for 6+ years) found that adoption rates ranged from 48.9% to 71.7%, with significant differences observed by location (community-based health care systems v tertiary medical center) and professional role. Adjusting for professional role, care team members reporting higher levels of perceived acceptability and appropriateness at baseline had greater odds of adopting EHR systems at 3 months. CONCLUSION EHR systems perceived as acceptable and appropriate are more likely to be adopted by oncology care teams in our sample. Future implementation efforts should consider tailored strategies to facilitate adoption of EHR systems designed to promote CCM-based approaches to improve cancer symptom management.

Abstract Background This study examines patients’ understanding of health insurance terms and concepts and quantifies health insurance literacy (HIL) levels by key sociodemographic factors. Methods This study included 393 adult patients with cancer (>18 years old) receiving treatment in two ambulatory infusion centers: Mayo Clinic in Phoenix, Arizona and the University of Mississippi Medical Center in Jackson, Mississippi. Respondents’ perceptions of their HIL were assessed using the Health Insurance Literacy Measure (HILM), a validated 21‐item measure of a consumer's ability to select and use health insurance (HIL self‐efficacy). Respondents’ knowledge of health insurance concepts (HIL knowledge) was measured using 10 items created by the Kaiser Family Foundation. The number of correct answers was categorized into three levels: 0–4 (low knowledge), 5–6 (moderate knowledge), and 7–10 (high knowledge). Multivariable logistic regressions were used to compare correct answers to HIL knowledge questions by HIL self‐efficacy. Results Nearly three‐quarters of patients had high HIL self‐efficacy and high HIL knowledge (70.5%), understanding basic insurance terms, such as premiums and deductibles. Relatively low percentages of patients correctly answered questions about the meaning of provider networks, health insurance formularies, and calculating out‐of‐pocket spending in scenarios when insurers pay a portion of allowed charges. Lower HIL knowledge was more common among patients with less educational attainment (<college: 15.2%; ≥college: 4.7%), lower household income (<$4999: 11.8%; ≥$5000: 6.1%), and low HIL self‐efficacy scores (low: 24.8%; high: 5.2) (all p values <.05). Conclusions Efforts to improve HIL and navigation of health insurance plan features are required, especially for socioeconomically vulnerable patients.

12079 Background: Many troublesome symptoms experienced by men with prostate cancer are not specific to a particular disease state or treatment modality. As such, these issues' scope is neither fully appreciated nor characterized in the reporting of clinical trial data. A modern accounting of poorly controlled symptoms is needed to better inform survivorship and supportive care efforts. Methods: Data are drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) study, a cluster-randomized stepped wedge trial examining the effectiveness of routine symptom assessment and management on patient-centered outcomes and healthcare utilization (NCT03892967). This is a population-level study supporting patients with cancer, who are cared for in medical oncology clinics across the Midwest United States. The trial utilizes an automated symptom monitoring system with EHR-enabled algorithms for symptom triage and intervention. The current analysis focuses on pre-intervention surveys. The cohort includes E2C2 participants with prostate cancer (as determined by the Mayo Clinic Cancer Registry) receiving curative or palliative-intent therapies, along with prostate cancer survivors who previously completed their treatment. The prevalence of SPPADE symptoms (sleep disturbance, pain, impaired physical function, anxiety, depression, fatigue [low energy]) was assessed using 0 to 10 numerical rating scales (NRS), with scores of 4-6 indicating moderate symptoms and 7-10 indicating severe symptoms. Results: A total of 1,388 men with prostate cancer completed a pre-intervention survey between March 2019 and January 2023. The median age at completion of first survey was 74 years. The cohort includes patients living in diverse settings, including urban (n=718, 52%), micropolitan (n=250, 18%), small town (n=218, 16%), and rural (n=200, 14%) environments. The proportion of patients experiencing moderate-to-severe symptoms (NRS score ≥4) was 47% for fatigue, 40% for impaired physical function, 32% for sleep disturbance, 27% for pain, 22% for anxiety, and 20% for depression/emotional distress. The three domains with the highest prevalence of severe symptoms (NRS score ≥7) were fatigue (17%), impaired physical function (12%), and sleep disturbance (10%). Conclusions: Proactive symptom monitoring identifies a high overall burden of moderate-to-severe symptoms, particularly fatigue and impaired physical function, among prostate cancer patients and survivors. Collaborative care approaches and symptom control trials are needed to mitigate and manage these burdensome symptoms. Clinical trial information: NCT03892967 . [Table: see text]

12065 Background: Incidence of cancer, including colorectal, breast, pancreas, kidney, and uterine cancer, is increasing in younger populations. Adolescents and young adults (AYA, defined as age 15-39) with cancer face unique challenges. This study aimed to characterize how symptom burden differs between AYA and non-AYA (aged 40+) patients with cancer. Methods: We performed a subgroup analysis of the E2C2 study, a cluster-randomized, pragmatic trial examining the effectiveness of routine symptom assessment and guideline-based management on patient-centered and healthcare utilization metrics during and following cancer treatment. Six symptoms [Sleep disturbance, Pain, Physical function impairment, Anxiety, Depression, and Energy deficit/fatigue (SPPADE)] were evaluated using 11-point numerical rating scales (NRS). Symptom severity was classified as mild (0-3), moderate (4-6), or severe (7-10). We conducted a subgroup analysis of symptom burden among AYA patients (defined as age 18-39 in this study), using their first-reported NRS scores. Results: The E2C2 cohort included 2,598 AYA patients and 38,061 non-AYA patients who completed >1 SPPADE NRS on at least one survey. AYA patients were more likely than non-AYA patients to report severe anxiety ( p<0.0001) and depression ( p<0.0001) (Table). Non-AYA patients were more likely to report severe pain ( p=0.02179), fatigue ( p=0.0022), and physical function limitations ( p<0.0001). Sociodemographic differences were also noted. A higher proportion of AYA patients held a bachelor’s degree or higher (38% vs 28%), were employed (73% vs 37%), and lived in an urban setting (67% vs 56%), compared to non-AYA patients. Non-AYA patients were more likely to have government insurance (63% vs 21%) and to be married (72% vs 59%). Conclusions: AYA patients with cancer were more likely to report severe depression and anxiety compared to their counterparts age 40 and above, underscoring the need for targeted and tailored psycho-oncology care for this population. [Table: see text]

LBA12006 Background: Symptom burden and functional decline are prevalent, inconsistently treated, and associated with adverse health outcomes in patients with cancer. Symptom monitoring with electronic patient-reported outcome measures (ePROMs) has yielded mixed results due, in part, to care teams’ variable bandwidth and resourcing for symptom management. The collaborative care model (CCM) offers a validated means to address these issues and potentially improve clinical and health services outcomes. Capturing ePROMS through the electronic health record (EHR) for use in CCM delivery provides a potentially scalable approach to manage symptoms at the population level. Methods: E2C2 is a cluster-randomized, population-level, stepped wedge pragmatic trial that compares a bundled, EHR-facilitated, CCM-based intervention to improve control of SPPADE symptoms (Sleep interference, Pain, impaired Physical function, Anxiety, Depression, and Energy deficit/fatigue) with usual care. All patients, regardless of cancer type or stage, treated in the medical oncology clinics of a multi-state health system, were assigned to one of fifteen clusters. Control and intervention conditions monitored SPPADE symptoms with Epic EHR administered 11-point numerical rating scales (NRSs). Moderate and severe symptoms were defined as 4-6/10 and >7/10, respectively. The intervention added EHR clinician decision support; automated delivery of symptom self-management information; and options to address severe symptoms with a dedicated symptom care manager. The primary outcome was post-baseline SPPADE scores assessed using multivariate regression of six cluster-period mean SPPADE symptom scores against E2C2 exposure, fixed cluster and secular time effects. Results: From March 2019 to January 2023, 50,559 patients were assigned to E2C2 clusters and 40,295 completed at least one ePROM. At first assessment, participants’ mean age was 63.3 years; 58% were female; 26% were rural, and the prevalences of moderate or worse symptoms were fatigue 42%, impaired function 34%, sleep disturbance 34%, anxiety 27%, pain 26%, and depression 23%. The intervention significantly reduced mean composite SPPADE symptom scores, p <0.001, among all patients, as well as those with >1 moderate or worse symptom. All mean symptom scores were lower in the intervention group, with the largest effects detected among patients with fatigue -0.2 (-0.4, -0.07), anxiety -0.14 (-0.2, -0.03), and depression -0.1 (-0.2, -0.002). Conclusions: In this large cluster-randomized trial, an EHR-facilitated, bundled intervention that scaled CCM-based surveillance and management of SPPADE symptoms significantly reduced population-level symptom burden, particularly for fatigue, anxiety, and depression. This study provides real world evidence and the foundation for future national efforts aimed at controlling symptoms in patients with cancer. Clinical trial information: NCT03892967 .

11108 Background: Advances in cancer treatment have led to a growing population of patients living with metastatic cancer. Symptom burden for these patients is understudied. Our objective is to report the prevalence and severity of SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) in a large cohort of patients with metastatic cancer. Methods: These data are drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) stepped wedge pragmatic trial evaluating a symptom management intervention for cancer patients (NCT03892967). This analysis was limited to those identified with metastatic disease using ICD- codes and a natural language processing algorithm prior to or within 30 days of their baseline symptom survey. Symptom severity was measured on a 0-10 scale with scores of 1-3 categorized as “mild”, 4-6 as “moderate”, and ≥7 as “severe.” A SPPADE composite score was calculated by summing six individual symptom scores and is an indicator of total symptom burden. We report descriptive statistics for each symptom by severity category. We also test for differences in SPPADE composite score by race, disability status, employment status, education and cancer type using Kruskal-Wallis tests. Results: 12,824 patients with metastatic disease completed a survey between March 2019 and January 2023. Discretized score distributions for the SPPADE symptoms are reported in the Table. The SPPADE composite mean score for the cohort was 17.6 (SD +/- 12.0). Significant differences were found in total symptom burden by sociodemographic and clinical characteristics ( p<0.01): Higher total symptom burden (Mean [SD])was experienced by individuals who were American Indian/Alaska Native (AI/AN) (23.8[13.5]) or African American (AA) (20.5[14.7]), disabled (24.0[12.8]) or unemployed (21.1[13.0]), and had a high school education (20.0[13.3]) or less than high school education (18.5[12.4]). There were also statistically significant differences ( p<0.01) in symptom burden across cancer types, with patients with metastatic lung cancer reporting the highest symptom burden (20.0[12.2]) and those with metastatic melanoma reporting the lowest (14.7[11.4]). Conclusions: SPPADE symptoms are common in patients with metastatic cancer, especially fatigue, sleep disturbance, and physical function impairment. Symptom burden is especially high in AI/AN, AA, disabled/unemployed, and less educated patients. Further research is needed to tailor symptom interventions among those living with metastatic disease. [Table: see text]

Purpose: Lucid episodes (LEs: unexpected episodes of spontaneous, meaningful, and relevant communication or behavior) in Alzheimer disease and related dementias are a new area of scientific inquiry that lacks clinical consensus and require more conceptual attention. Methods: We aimed to measure consensus from an expert group on: (1) potential medical or clinical explanations for LEs; (2) necessary medical and clinical context to LEs; and (3) interpretation of LEs. Patients: We convened 13 experts from different disciplines (neurology, psychiatry, psychology, pharmacy, palliative care, hospice, nursing, social work, primary care, geriatrics, and professional home caregivers) to identify elements of LEs. Results: Experts provided a range of opinions on medical and clinical explanations and questions to understand LEs. Consensus on LEs when presented with clinical vignettes was not reached. Panelists highlighted key medical and contextual factors needed to make a definitive judgement about LEs. Conclusion: There is variability in how LEs are interpreted by clinical experts, which complicates the identification of LEs in Alzheimer disease and related dementias.

Abstract Background Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271.