Enrollment Rates Research Articles

Understanding uptake in demand-side broadband subsidy programs: The affordable connectivity program case

The Affordable Connectivity Program (ACP) represents a historic investment by the federal government to address the digital divide. Its goals are both to increase the rate of broadband adoption and make it easier for low-income households to sustain service. But what have been the drivers of ACP enrollment? We know a great deal about trends in adoption and the geography of enrollment among eligible households. But those metrics – especially a focus on enrollment rates among eligible households – are only so useful in explaining ACP sign-ups.This invites analysis that investigates the drivers of ACP enrollment in a comprehensive way, which this paper proposes to do. The paper hypothesizes that ACP enrollment decisions are not solely individual (i.e., that a household's enrollment decision is structured only by income level), but also influenced by community-wide considerations, such as housing costs, share of occupied houses, presence of anchor institutions such as public libraries, and population density (i.e., whether a place is urban or rural). The paper develops a regression model that predicts ACP enrollment rates among eligible households at the 5-digit zip code geography as a function of the variables discussed above, as well as others such as the racial and ethnic make-up of a zip code area. The analysis also controls for existing levels of broadband subscriptions and computer ownership in a given area. The difference between predicted and actual ACP enrollment rates at the 5-digit zip code level is proposed as a metric of ACP performance. These findings are supplemented with a geographically weighted regression (GWR) model that allows the relationship between each explanatory variable and ACP enrollment to vary by locality. This allows for analyzing and visualizing how these relationships vary across space.The empirical findings show that high levels of economic distress are a strong determinant of ACP enrollment in a given area, but social and community-wide indicators are important as well. The GWR results demonstrate that important differences in these relationships exist across geographies. Understanding spatial variations in ACP performance can help policymakers and other stakeholders better target resources to address the digital divide.

Feasibility and acceptability of a digital parent group chat intervention to prevent child and adolescent maltreatment in the Philippines.

This study examined the feasibility, acceptability, and preliminary outcomes of MaPaChat, a parent support intervention delivered using Viber group chat to caregivers in the Philippines during the COVID-19 pandemic. Forty caregivers of children aged 4-17 from predominantly low-income households participated in a culturally adapted version of the Parenting for Lifelong Health ParentChat programme. Feasibility was assessed by enrolment, attendance, and dropout rates. Semi-structured interviews with caregivers and programme facilitators explored programme acceptability. A single-group pre-post design was used to explore changes in child maltreatment, positive parenting, parenting stress, and other secondary outcomes. The mean attendance rate was 82% and the dropout rate was 10%. Caregivers and facilitators found the programme helpful in enhancing parenting knowledge and skills and were satisfied with the programme delivery using Viber group chat but also reported experiencing technological challenges. Pre-post comparisons suggested that the intervention has potential in reducing physical and emotional abuse and associated risk factors. The findings suggest that a parenting intervention delivered over digital group chat by trained community service providers may be a feasible and acceptable way to support caregivers in low-resource settings.

Molecular network characteristics and drug resistance analysis of 392 newly reported MSM HIV/AIDS cases in Chongqing, China.

To comprehensively investigate the molecular transmission patterns of HIV-1 genotypes among men who have sex with men (MSM) in Chongqing, we employed 392 pol sequences of MSM to construct a phylogenetic tree and gene transmission network. Among the viral subtypes, CRF07_BC accounted for 73.2% (287/392) and CRF01_AE accounted for 20.7% (81/392), emerging as the predominant subtypes in this investigation. Additionally, we observed the presence of CRF55_01B, subtype B, CRF08_BC and other circulating recombinant forms. The HIV-1 molecular network was constructed with a gene distance threshold of 1.5%, resulting in an entry rate of 61.4% (241/392). Within the network, we identified a total of 23 molecular clusters, with the largest cluster being the CRF07_BC molecular cluster comprising 148 node values. Transmitted drug-resistance (TDR) mutations were found in 4.34% of the cases, with 1.79% associated with protease inhibitors (PIs), 0.51% with nucleoside reverse transcriptase inhibitors (NRTIs), and 2.55% with non-nucleoside reverse transcriptase inhibitors (NNRTIs). Statistical analysis indicated a higher enrollment rate in the HIV-1 molecular network among infected individuals with the CRF07_BC subtype, those identifying with same-sex sexual roles as "vers," and individuals with higher education levels. This suggests the need for strengthened investigation and intervention in this population to prevent the formation of larger transmission clusters. Furthermore, continuous monitoring of the HIV-1 molecular dynamics network is necessary to promptly and accurately track changes in molecular epidemic characteristics.

Feasibility of continuous smart health monitoring in pregnant population: A mixed-method approach.

The utilization of smart monitoring technology offers potential for enhancing health outcomes, yet its feasibility and acceptance among Hispanic pregnant individuals remain uncertain. This is particularly crucial to investigate within the context of apparently healthy individuals identified as low risk, who still face a 10% likelihood of complications. Given their frequent underrepresentation in healthcare services and relative lack of attention, improving the feasibility of remote monitoring in this population could yield significant benefits. To address this gap, our study aimed to adapt and evaluate the practicality of a smart monitoring platform among healthy Hispanic pregnant women during the second and third trimesters of pregnancy, as well as one week following childbirth, a period when complications often arise. This longitudinal study followed n = 16 participants for an average of 17 weeks. Participants were instructed to wear the Oura ring for objective data collection, including activity, sleep, and heart rate, and to complete survey questions through REDcap to assess mental health and lifestyle factors. The study framework utilized the RE-AIM approach, with acceptability and adherence as key components of the feasibility evaluation. Our findings revealed that completion rates for biweekly and monthly surveys remained consistently high until after childbirth (approximately 80%), while daily question completion remained above 80% until 38th week of gestation, declining thereafter. The wearing rate of the Oura ring remained consistently above 80% until the 35th gestational week, decreasing to around 31% postpartum. Participants cited barriers to wearing the ring during the postpartum period, including difficulties managing the newborn, forgetfulness, and concerns about scratching the baby's skin. The enrollment rate was 71.42%, with an attrition rate of 6.25%. Thematic analysis of one-on-one interviews identified three main themes: personal desire for health improvement, social acceptability and support, and conditions influencing device/platform efficiency. In conclusion, while adherence varied based on gestational week and survey frequency, the study demonstrated strong acceptability of the smart monitoring platform among the study population, indicated by the high enrollment rate. Qualitative insights underscored the significance of personal motivation, social support, and device/platform efficiency in enhancing patient engagement with digital health monitoring during pregnancy, offering valuable considerations for future healthcare interventions in this domain.

Connected through movement: a feasibility study of online mindfulness-based dance/movement therapy for older adults with age-related cognitive decline during COVID-19

Objectives Social isolation and loneliness pose significant public health risks, especially among older adults experiencing age-related cognitive decline (ACD). This mixed methods feasibility study explored the potential of an online mindfulness-based dance/movement therapy (M-DMT) program to alleviate loneliness, enhance psychological well-being, and promote physical activity among older adults experiencing ACD during the COVID-19 pandemic. Method Sixteen participants engaged in a 12-week online group M-DMT program. Feasibility was assessed via enrollment and retention rates, attendance, adverse events, credibility/expectancy, participant perceptions, and satisfaction. Qualitative data were collected to capture participants’ perspectives on the intervention’s usefulness and perceived benefits. The intervention’s preliminary impact on loneliness, depression, positive affect, psychological well-being, and physical activity was also examined. Results The study met all feasibility criteria, with 65% reporting post-intervention improvement. Significant reductions in loneliness and depression, along with enhanced positive affect and psychological well-being, were observed. Though physical activity increased, statistical significance was not achieved. Qualitative feedback highlighted improved social connectedness, overall quality of life, body awareness, kinematic strategy, and satisfaction with the program. Conclusion Online M-DMT holds promise in addressing well-being and loneliness challenges in older adults experiencing ACD. Further research is necessary to validate and expand upon these promising findings.

Sex distribution in clinical trials of radiologic contrast agents: A 27-year review

PurposeClinical trials play a pivotal role in assessing the safety and efficacy of medical therapies. Addressing sex distribution among enrollees in clinical trials of radiologic contrast agents is essential for ensuring the generalizability of trial outcomes. Previous research has highlighted the influence of demographic factors, particularly sex, on treatment responses, emphasizing the need for equitable representation in clinical trials. Our study aim was to determine the sex distribution of enrollees in clinical trials of radiologic contrast agents. MethodsOur retrospective study included a total of 65 clinical trials conducted between 1990 and 2017 identified on clinicaltrials.gov after a comprehensive review including searching individually for all FDA approved contrast agents. Data collected included the year of FDA approval, the number of participants, sex distribution, trial location, trial phase, and study type. Inter-rater validation ensured data accuracy. ResultsOur analysis revealed fluctuations in sex distribution of trial enrollees. Enrollment of males exceeded females in most years, with a shift towards a more equitable representation in recent trials. Trials conducted in the United States had a higher rate of enrollment by females. Phase I trials had the most balanced representation, whereas Phase IV trials had the highest sex disparity. ConclusionAcross all trials, females made up 47.3 % of enrollees [3316 out of 7016 total enrollees]. Enrollment of males exceeded females in 44 of the 65 trials studied, females outnumbered males in 19 trials, and enrollment was equal between the sexes in 2 trials. While the sex distribution observed across all trials represents an equitable representation of enrollees, the wide variance of sex distribution at the level of individual trials has the potential to limit the generalizability of results.

Healthcare disparities are associated with eligibility and enrollment in clinical trials in Louisiana.

e13728 Background: Clinical trials offer an opportunity to evaluate novel therapeutic strategies and modalities of care. Overall enrollment is low for clinical trials, but previous literature has highlighted lower rates of enrollment among underrepresented populations. A disproportionately low accrual of minority or other populations will result in reducing the ability of such clinical trials to prove general benefit to the overall population. This study aims to evaluate the population of those able or unable to qualify for and enroll in the Gulf South Clinical Trials network, a minority/underserved NCORP community site. Methods: Patient data was collected through interviews using a screening tool developed by the National Cancer Institute’s Community Oncology and Prevention Trials Research Group and active enrollment of ongoing clinical trials. Patients were interviewed regarding demographic data and tumor staging. Reason for ineligibility or non-enrollment was documented by the clinical staff. Clinical trials were categorized between Cancer-Control and Cancer Care Delivery Research (CC-CCDR) Trials and Cancer Treatment Trials from 2017 and 2023. Rates of eligibility and enrollment were compared via Fisher’s Exact tests. Results: CC-CCDR Trials had 363 participants while Cancer Treatment had 550 participants. CC-CCDR Trials resulted in 19% (n=69) of patients being ineligible with 81% (n=294) being eligible with a higher proportion of Whites (p<.001), non-rural (p = .021), low income (p=.007), private insurance (p=<.001), stage 1 tumors (p<.001), and having a genetic predisposition (p<.001) being ineligible. From the patients that were eligible, 13% (n= 39) of patients were not enrolled with 87% (n=255) of patients enrolled. Cancer Treatment Trials resulted in 23% (n=129) of ineligible patients and 76.5% (n=421) of eligible patients, with a higher proportion of low income (p=.002), private insurance (p=.035), and those not having genetic predispositions (p=.022) being ineligible. From the participants that were eligible, 20% (n=85) of patients were not enrolled with 80% (n=336) of patients enrolled, with a higher proportion of female (p= .002) patients not enrolled. Conclusions: Disparities in socioeconomic factors and female gender are associated with lower rates of eligibility and enrollment in clinical trials in community oncology settings. Future research identifying modifiable underlying factors can assist in developing strategies to improve enrollment in underserved populations.

Patterns of breast cancer trial enrollment in a prospective patient database at a comprehensive cancer center.

e23026 Background: Clinical trials (CTs) play a crucial role in expanding the landscape of breast cancer (BC) treatment, improving patient’s (pts) outcome and quality of life. Success of CTs relies heavily on pt recruitment. Understanding barriers for CT non-enrollment (NE) despite opportunities to enroll in real world diverse populations can provide valuable insight into barriers to and facilitators of CT participation. Methods: Coordinators registered pts offered BC trial opportunities at the O’Neal Comprehensive Cancer Center at UAB (University of Alabama at Birmingham) from 12/2020 to 12/2023. Identifiers, ethnicity, race, NE reasons and dates (referral, consent, enrollment, and NE) were recorded. CTs were grouped as Pharmaceutical versus Academic based on sponsorship. Descriptive analysis, Fisher’s exact and Mann Whitney U were calculated using Python. Results: A total of 559 pts were offered a CT with a median age of 55 years. There were 145 pts (27%) enrolled (Gp1), 65 (12%) signed consent with NE (Gp2), and 334 (61%) were NE prior to signed consent (Gp3). Most common NE reason in Gp2 and Gp3 was not meeting protocol eligibility (66% & 43%). Gp3 NE reasons included lack of interest or confidence, insurance and logistics, concern over adverse events, delayed therapy start and change to Standard of Care. In terms of ethnicity and race, most pts were Non-Hispanic White (NHW 312, 56%) followed by Black (NHB 165, 30%). Gp1, Gp2 and Gp3 were 28% vs 15%, 59% vs 56%, 11% vs 15% respectively. NHW pts had higher enrollment to CTs compared to NHB (OR 1.135, p 0.73). For Gp2 and Gp3, patterns of NE were similar among NHW and NHB pts such as lack of interest or confidence (11% in Gp3). In Gp2, More NHB pts had NE due to not meeting protocol eligibility (58% vs 75%). In Gp3, NHW pts had higher NE due to insurance and logistics (8% vs 4%). Median Gp1 consent to enrollment and Gp2 consent to NE were 14 and 11 days. Academic CTs (467, 84%), when compared to Pharmaceutical CTs (92, 16%), had higher enrollment (Gp1 28% vs 16%. OR 2.07, p 0.01). NE reasons did not change significantly between CT types in Gp2 and Gp3. Pharmaceutical CTs had longer median time from referral to enrollment (27 vs 13 days, p 0.001). Of those who signed consent (Gp1 and Gp2), enrollment rate was 69%, with more NHW than NHB pts participating (73% vs 63%, OR 1.56, p 0.19) and more participation to Academic than Pharmaceutical CTs (71% vs 58%, OR 1.77, p 0.18). Conclusions: UAB exceeded the national average of BC CT enrollment (27% vs 9%). Only 50% of NE was related to not meeting protocol eligibility criteria. Issues such as lack of confidence in CTs, concern over adverse events, delayed therapy start date and logistics remain active barriers. NHW and NHB pts had similar enrollment rates, consistent with prior data. NHB pts had higher protocol ineligibility due to more Denovo Stage 4 diagnoses. Academic CTs had better enrollment rate and shorter time to enrollment. Further studies are needed to overcome barriers to enrollment on clinical trials.

Impact of the COVID-19 pandemic mitigation strategies on cancer treatment trials: A meta-analysis of industry and NCI studies.

11021 Background: ASCO and Friends of Cancer Research established a task force to evaluate trial mitigation strategies allowed by US regulators during the COVID-19 pandemic, including the use of telemedicine and remote monitoring. We report the results of a meta-analysis quantifying the impact of these strategies on quality metrics and the recovery time to pre-COVID levels. Methods: We invited 41 sponsors with active US cancer treatment trials from January 2015-May 2022 to contribute deidentified trial-level aggregate data on major protocol deviations (PDs), dropouts, severe or worse toxicity (CTCAE Grade 3-5), and enrollment. We examined outcomes as proportions of participants at-risk during the pre-COVID, initial wave (IW), initial recovery (IR), and secondary recovery (SR) assessment times (Table). Multi-level beta-regression analyses were adjusted for trial phase (“early”, phases I, II, or I/II, vs. “late”, phase III) with study and sponsor as random effects. Indicator variables were used for post-COVID time periods with pre-COVID as the reference. Results: Ten sponsors (9 industry and 1 NCI Cooperative Group) contributed 82 evaluable studies: 63 early and 19 late phase trials. Among the 15,679 participants, enrollment odds decreased 64% in the IW and 45% in the IR but recovered to approximately pre-COVID levels by the SR (Table). Major PDs, dropouts, and severe or worse toxicity all had lower incidence in the IW compared to pre-COVID; these outcomes were also less frequent in IR (p<.05 for each), but not in the SR (p>.05 for each) compared to pre-COVID. Conclusions: Large declines in enrollment rates during the IW rebounded to pre-COVID levels by 2021-2022. We found steep reductions in the rates of reported occurrence of major PDs, dropouts, and severe or worse toxicity during the initial outbreak, which also recovered to pre-COVID levels by 2021-2022. Findings suggest pandemic-related procedural flexibility did not lead to increased reporting of PDs or dropouts and highlight how use of mitigation strategies likely corresponded with the temporary disruption to trial conduct during the pandemic’s peak. Sponsors could consider broader adaptation of trial flexibilities moving forward. [Table: see text]

Geriatric enrollment patterns in clinical trials at a National Cancer Institute.

e13762 Background: Despite the majority of new cancer diagnoses occurring within the geriatric population, there is a disproportionate rate of clinical trial enrollment within this population. Previous data has estimated enrollment rate to be 18.9% in treatment trials among all adult cancer patients at designated National Cancer Institute Cancer Centers. The objective of this study is to assess geriatric cancer patient clinical trial enrollment rates in a single National Cancer Institute and highlight inequities within cancer care delivery. Methods: We performed a retrospective review of the electronic health record and included patients with cancer ≥ 65 years of age who died at our institution between January 2020 and July 2022. We examined the relationship between cancer type, patient race/ethnic identity, and age and analyzed enrollment in clinical trials. Analyses were conducted using descriptive statistics. Results: Of 117 decedent records analyzed, 11 (9%) were enrolled in treatment clinical trials of which 5 (4.3%) identified as White, 4 (3.4%) Other, and 2 (1.7%) Hispanic. Among the 117 geriatric patient records reviewed, there were 21 Black patients (17.9%) of which 0 (0%) Black patients were enrolled in clinical trials. In comparing enrollment by malignancy type, 5 patients had a hematologic malignancy (leukemia, lymphoma, or multiple myeloma), 3 patients had a genitourinary malignancy, 1 patient had a pancreatic malignancy, 1 patient had an endometrial malignancy, and 1 patient had a breast malignancy. Among all patients analyzed, 37 patients (31.6%) had a hematologic malignancy and 80 patients (68.4%) had a solid tumor malignancy. The average age of enrolled patients was 73, consistent with the average age of all patients analyzed (73.78). Conclusions: Geriatric patients with cancer are disproportionately underrepresented in treatment clinical trials. The inequity is exacerbated when analyzing enrollment among minoritized patients. There was a greater proportion of clinical trial enrollment in patients with hematologic malignancies than solid tumor malignancies, however analysis in larger population samples is necessary. Additional research to identify barriers to clinical trials and methods of increasing geriatric enrollment, including the use of geriatric specific performance scales, is necessary to ensure equitable access and representation in clinical trials. While these results may be skewed in the setting of the COVID-19 pandemic and selection of a decedent population, further research into geriatric accessibility in clinical trials is paramount.

Real-world implementation of an EHR-integrated, SMS text remote patient monitoring platform at an academic cancer center.

e13669 Background: Remote monitoring studies in oncology have shown improved quality of life, decreased healthcare utilization, and even improved overall survival in an oncologic population, however applications in a real-world setting have been limited. Barriers to successful deployment include low patient engagement rates with smartphone apps, lack of integration with the EHR and burdensome clinical workflows for staff. Methods: We sought to assess the feasibility of an EHR-integrated, SMS text conversational AI agent to automate the collection of ePRO data as well as the assessment and triage of common patient symptoms for patients with GI and GU tumors receiving anti-cancer therapy. This program was developed collaboratively by a health system digital health team, nursing informatics, IT support resources, oncology nurses, medical oncologists, and representatives from Memora Health. Core components included 1) weekly ePRO collection based on the NIH’s CTCAE, 2) NLP activated symptom triage for 16 common symptoms and toxicities 3) weekly symptom check-in 4) weekly medication adherence assessment for patients on oral therapy. Patients received all messages through SMS on their phones, and all data collected were routed into the EHR. In-EHR visualizations allowed nurse coordinators to track ePRO symptoms over time and symptoms that met pre-specified criteria triggered EHR-based alerts. Results: Of 99 patients ordered into this SMS program, 83 enrolled (84% enrollment rate), with 55 Uro Onc patients; 44 GI Onc patients. A total of 2,583 surveys were sent to patients. 98% of patients completed at least 1 survey. Overall patient survey completion rate was 62%. Medication adherence surveys had the highest completion rate at 81%. ePRO completion rates were higher for GU (65%) vs GI (39%) patients (p<0.01). 71% of ePRO surveys generated a symptom alert to the nursing staff. Patient satisfaction was high with 93% rating this SMS program as “excellent” or “good” (n=78). Care team surveys found that 3 of the 6 Oncologists believe ePRO collection is valuable and 3 of 6 used ePRO data to adjust a care plan. Nurse coordinators had a mixed view of the program with a majority reporting that there were too many symptom alerts. Conclusions: We successfully deployed an EHR-integrated SMS program to collect ePRO data, track patient symptoms, and monitor adherence to oral therapy. We believe having a physician champion influenced patient engagement in the GU patient population. Patients had a favorable impression of this program and survey completion rates demonstrated ease of use for patients. Clinical staff, particularly nurses, felt that there were too many alerts. Additional workflow changes may reduce alert burden and better incorporate ePRO learnings into clinical practice.

Breaking barriers for cancer clinical trials: A multi-tiered interventional approach to boost racial and ethnic minority participation in early-phase studies.

TPS1639 Background: Racial and ethnic minority populations are underrepresented in cancer clinical trials. The USC Norris Comprehensive Cancer Center (USC NCCC) has multiple clinical trial recruitment sites, including the Los Angeles General Medical Center (LAG), the largest safety-net hospital in the western USA. LAG partners with USC to provide cancer care to the underserved minority population of LAC, including clinical trials. As a result, between 2015-2022 a total of 120 LAG patients were accrued to phase I clinical trials; enrolled subjects were 66% Hispanic, 21% Asian, 4% Black, and 9% other. An interventional study was designed to further enhance the referral and participation of racial and ethnic minority patients from other Los Angeles County (LAC) safety-net facilities. The study is funded by the Stand up to Cancer Diversity in Early Development Clinical Trials Research Grants Program. Methods: This interventional study has 3 specific aims. First, to identify barriers to referral for minority and underserved patients: Qualitative interviews will be conducted with key stakeholders in the LAC safety net system which will uncover barriers to referring minority and underserved patients. A screening tool developed by the NCI to characterize barriers will be used. Second, to implement a multi-component program to enhance the referral of patients to early-phase clinical trials. The intervention addresses system-level, provider-level, and patient-level factors to improve the process, with a demonstration site compared to a non-demonstration site. Key features include a streamlined referral process for healthcare professionals with a singular centrally operated email managed by a specialized facilitator, weekly meetings to assign trials to prospective patients, and facilitation of approval and scheduling for referrals. We will educate providers regarding trials and exchange feedback on the referral process. We will extend resources to patients to assist with financial and transportation limitations. We will compare change in referral and enrollment rates at baseline and after the intervention for both the demonstration site and non-demonstration site. Third, to explore the impact of remotely conducted clinical trials: A clinical trial (NCT05340309) administers study drug subcutaneously and uses telemedicine visits, wearable sensors, and a smartphone app for monitoring. This pilot trial will be analyzed to determine the model’s impact on barriers to enrollment. The above interventions may provide a model that can be adapted in other healthcare delivery settings to optimize referral and enrollment of racial and ethnic minorities.

Barriers to enrollment in clinical trials in gynecologic oncology.

e13511 Background: While clinical trials improve survival in gynecologic oncology, racial and ethnic minorities remain underrepresented. Our objective was to evaluate factors associated with enrollment among patients considered for trials at a tertiary care center to inform future participant recruitment. Methods: We conducted a retrospective cohort study at the University of Pennsylvania Health System from 1/1/2022-12/31/2022. Our primary objective was the referral rate to clinical trials of patients discussed at a weekly multi-disciplinary tumor board. Patients could be discussed more than once and referred for screening for multiple trials. Each contact was classified as ‘referred/not referred’ for trial(s) screening and ‘enrolled/not-enrolled’ on trial(s). We collected socio-demographic, cancer, trial screening, and enrollment data, including reasons for ineligibility or non-enrollment, from electronic health records. We compared patient factors across 3 subgroups: 1) not-referred, 2) referred not-enrolled, 3) referred and enrolled. We performed descriptive analyses to characterize patient cohorts. Results: In a one-year period, 264 patients—194 unique—were discussed at tumor board. Referral rate for trial screening was 57%, representing 135 trial referrals for 111 unique patients. Patients were referred to screening for 2.2 trials on average. The median age of patients discussed was 65 years (IQR 58-73 years). 65.0% self-identified as White, 24.7% Black, and 10.3% other race. 96% identified English as their preferred language. The majority had Medicare insurance (51.0%), followed by private insurance (32.5%), and Medicaid (14.4%). Of 111 patients referred for trial screening, 12 patients enrolled in a trial for a referral-to-enrollment rate of 10.8% (12/111) and an overall enrollment rate of 6.2%. The majority of enrolled patients were white (10/12) and had Medicare (66%) or private insurance (25%). Cancer type varied by referral status, with most referrals for ovarian (n=87, 64%) and uterine cancer (n=37, 27.4%) and 5 for cervical cancer (3.7%). The non-referred cohort had lower rates of ovarian cancer (49.6%) and higher rates of cervical (12.4%) and other cancers (14.0%). Of patients referred to trial, but not enrolled, only 33.7% had a documented reason for non-enrollment. Documentation for incomplete screening or ineligibility cited the patient opting out of screening (26), medical comorbidity (22), and pursuit of other trial (16). Conclusions: While 57% of tumor board patients were referred for screening for at least one clinical trial, only 10.8% of referred patients and 6.2% of patients overall were enrolled in a trial. Disparities by race and insurance type were apparent between patients enrolled and not enrolled on trial. Improving documentation, educating patients about trials early in their disease course, and less restrictive trial criteria may help improve minority enrollment rates in clinical trials.

Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials.

e13586 Background: A major limitation of clinical trials is limited generalizability due to low enrollment of underrepresented minorities (URM). The percentage of patients who are non-English speaking (NES) is higher in URM and language barriers may discourage providers to offer participation in clinical trials. We have developed an artificial intelligence-based system to identify patients eligible for clinical trials, Clinical Trials Patient Matching (CTPM). This platform offers an ideal opportunity to explore bias in enrolling patients on clinical trials (CT). Among patients identified by CTPM as eligible for CT we assessed the impact of NES on trial enrollment. Methods: Individual algorithms were constructed within CTPM to identify patients potentially eligible for two trials open at Yale Cancer Center, DARE (NCT04567420) and EMBER-4 (NCT05514054). Eligibility was confirmed by Clinical Trials Office staff and notification of eligibility was communicated to the treating provider. Retrospectively, we evaluated the impact of NES status on clinical trial enrollment. This analysis occurred between 9/1/2022 and 11/30/2023 and all study-related activities were approved by the Yale IRB. Results: Out of the 13,466 unique patients presenting to the Yale Cancer Center and Smilow Cancer Network breast program within the period of study, 5.1% were NES and 94.9% were English speaking (ES). Of the patients identified by CTPM as eligible for the 2 clinical trials 7.9% were NES and 92.14% were ES. However, out of patients enrolled, only 1.59% were NES and 98.41% were ES. For the DARE trial, enrollment rate was 38.3% for ES vs 0% for NES (p=0.0081). For the EMBER4 trial, enrollment was 13.4% for ES vs 14.3% for NES (p=1.0). The aggregate data for both trials revealed an enrollment rate of 29.4% for ES vs 5.6% for NES (p=0.0285). Conclusions: We found that patients who identify as NES were less likely to be enrolled in cancer clinical trials. CTPM appears to be an effective tool to prospectively identify underrepresented populations in clinical trials and serve as a platform for developing interventions to address disparities in trial participation, including language. [Table: see text]

Effect of a novel artificial intelligence (AI) –enabled multi-trial matching system on patient matching using real-world data.

e13501 Background: Currently clinical research teams at sites are manually matching patients to clinical trials, where each trial in our experience takes at least 25 minutes using highly trained dedicated resources. This limits cancer patients’ clinical trial options and enrollment rates. Moreover, the lack of NGS testing results may also negatively impact matching to clinical trials in targeted therapies. PCC, a consortium of 7 of the Top 20 Pharmaceutical companies, collaborated with Massive Bio to demonstrate how cancer patients’ matching rates can be increased if patients are prescreened to multiple trials simultaneously (i.e. multi-trial matching) instead of a single trial and NGS testing results are integrated into the matching process. Methods: Massive Bio has developed a first-in-class AI-enabled matching system to extract 180 structured clinical data from medical records using computer vision and natural language processing and a recommendation system for matching patients to parameterized inclusion/exclusion (I/E) criteria from over 14,000 actively recruiting interventional clinical trials.Our analysis included a sample of 5,707 cancer patients from the Massive Bio Synergy AI real-world database, corresponding to tumor types in 23 selected trials. We developed a decision-tree algorithm for retrospective matching analysis using modeled I/E criteria and compared these results to the theoretical matching rate (TMR) for each trial based on tumor type and biomarker prevalence, extent of disease at diagnosis and prior treatment history. Results: 690 patients matched to at least one trial were matched to 1.82 times more trials in multi-trial matching; 2.10 times more potential matches were obtained with hypothetical 100% NGS testing; and 99.9% matching time was reduced with AI enabled system; key findings are summarized (Table). Conclusions: This study confirms the underutilization of NGS technology and substantial benefits of AI and NGS in cancer trial matching. Their use resulted in a nearly two-fold increase in potential patient eligibility for trials, and an unprecedented reduction in manual effort, underscoring a significant advancement in the efficiency of the clinical trial matching process. A prospective country-wide analysis is under consideration. [Table: see text]

Implementation and preliminary efficacy of a risk stratification system +/- patient-reported outcomes monitoring for patients with hospital-diagnosed advanced lung cancer.

11095 Background: Risk stratification systems may improve quality of care for patients with advanced lung cancer (ALC) by identifying those at high risk of rehospitalization and directing them to supportive care. The purpose of this study was to evaluate the implementation and preliminary efficacy of a risk-based system, with/without electronic patient-reported outcome (ePRO) symptom monitoring, to trigger supportive care for patients with hospital-diagnosed ALC. Methods: In this single-site, non-randomized, pragmatic study, patients in an academic center with hospital-diagnosed ALC were stratified to low or high risk using an established tool. High-risk patients were referred to two-pronged supportive care: patient navigation and outpatient palliative care. Eligible patients were recruited for 3 months of ePRO symptom monitoring coupled with provider alerts. Healthcare utilization was assessed at 90 days post-discharge. Program feasibility and acceptability were assessed using percent of eligible supportive care referrals made and completed, enrollment rates in ePROs, ePRO completion, and notifications to providers of concerning symptoms. Preliminary efficacy was defined as percentage of concerning ePRO symptoms resulting in new clinical action and 90-day readmissions. Results: At the time of interim analysis, 49 patients had been assessed with 48/49 (98%) identified as high risk. Patients had a mean age of 66 years, and were non-Hispanic, 51% male, and 22% Black. Patient navigation referral (92%) and completion (88%) was high. Palliative care referral (89%) and completion (45%) was lower. 14/39 (36%) of eligible patients enrolled in ePRO symptom monitoring, with competing priorities or feeling overwhelmed as the primary reasons for non-participation. Patient-level ePRO completion ranged from 0-100% (mean 53%). Nearly all (97%) concerning symptoms were reported to the clinical team; 27% of these resulted in new clinical action. By 90 days, 16/37 (43%) had hospital readmissions. Conclusions: Patient navigation was feasible and acceptable in patients with hospital-diagnosed ALC. However, there are ongoing barriers to implementation of post-hospitalization ePRO symptom monitoring and palliative care. Additional evaluation is needed to understand the barriers and facilitators and to measure the impact of navigation on patient outcomes. Since nearly all patients met high-risk criteria, future programs will eliminate risk stratification and target all patients with hospital-diagnosed ALC. Clinical trial information: NCT05722847 . [Table: see text]

Enhancing the patient journey to clinical trial enrollment with navigation to optimize accrual: A pilot study for a pragmatic multicentre, stepped wedge, cluster randomized controlled trial (The CTN Pilot Trial).

11093 Background: Clinical trials are essential to the advancement of clinical therapies, yet accrual rates remain disappointing. Multiple challenges lead to less than 5% of cancer patients enrolled onto clinical trials. The Clinical Trials Navigator (CTN) program was established to assist patients and health care professionals identify appropriate clinical trials for patients. Methods: Between March 2019 to January 2024, a novel navigator-assisted clinical trials search program was offered to Canadian patients. Three non-medical navigators were trained to receive referrals, review medical information, and search five different clinical trial search engines. Eligibility criteria was scrutinized. A second review of the clinical trial list was conducted by two physicians. The final curated list of clinical trials was provided to patients and their oncologist. Results: A total of 373 patients were referred to the CTN program during the study period. A unique clinical trial search was performed for each patient yielding a median of only one potentially eligible trial per patient. Clinical trial enrolment occurred in 3.2% of patients in our database which translates to a 19% rate of successful enrolment of those referred to a trial by the CTN. Most patients (78%) were referred to clinical trial sites that conducted more than 100 clinical trials at any time. Compared to the Canadian cancer statistics, lung, lymphoma, pancreatic and brain cancers were overrepresented in referrals to the CTN program while prostate cancer was underrepresented. Type of cancer played a significant role in the likelihood of a successful referral (p < 0.01). Lung cancer was the most frequently reported cancer that resulted in referrals and breast cancer showed a lower frequency of referrals. The cancer type, stage and number of lines of prior therapy were not significantly associated with the patient enrollment onto a clinical trial. An increase in survival of referred patients from last analysis from 3.0 months to 5.3 months. Conclusions: The CTN program is a successful tool to identify clinical trials for cancer patients and can improve clinical trial accrual, as almost one fifth of patients (19%) who were referred to a clinical trial were enrolled. Ongoing iterative changes to the program to improve these metrics are underway and efforts to improve implementation of the CTN program across Canada are ongoing.

Establishing a protocol to increase racial/ethnic minority enrollment on an active radiation oncology randomized clinical trial.

TPS1638 Background: In the United States (US), underrepresented racial/ethnic groups lack ample enrollment in clinical trials, yielding ungeneralizable trial results. Barriers to increasing minority enrollment include decreased awareness of clinical trials, lack of access, financial burden and toxicity, medical system mistrust, and discordant physician-patient demographics. The ongoing Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) clinical trial (NCT05617716) has a study design to actively accrue minority patients. We present our protocol addressing key targets to increase minority enrollment on this randomized, phase II clinical trial. Methods: Adults with evidence of symptomatic spine metastases are eligible. Baseline demographics (including race/ethnicity) are reported for statistical analysis. Our protocol seeks to minimize barriers to minority enrollment and targets four key areas. Access to care: SPORTSMEN involves institutions located in zip codes with diverse ethnic populations, presently located in regions 46% and 70% African American. Clinical trial design: SPORTSMEN has a prespecified goal of accruing patients to mirror US census representation. The rate of minority enrollment will be reviewed periodically at the discretion of the Data Safety and Monitoring Board. Community outreach and engagement: The trial team will engage with local health care systems to create an alliance within different oncology specialties to provide the basis and benefit for SPORTSMEN and patient-centered education on eligibility criteria, rationale, and intended outcomes. Our principal focus will be providers in prostate, breast, and lung cancers as minorities with these primary site malignancies have a higher propensity to be trial-eligible. Furthermore, we understand the historical mistrust of minorities for the medical community. Therefore, we will engage local grassroot organizations such as churches, community outreach centers, and social clubs to increase awareness of clinical trials and to help foster trust. Financial burden and toxicity: SPORTSMEN does not have direct enrollment costs. A short-course treatment regimen is used to minimize the number of treatment visits required allowing for decreased resources for travel, time lost at work, and additional childcare or eldercare needs. Financial toxicity will be objectively quantified using the validated COST-Functional Assessment of Chronic Illness Therapy survey. Increasing clinical trial diversity is a challenge that must be addressed with meaningful intent to present robust Level 1 data that broadens the understanding of treatment response in all demographics. Our protocol takes a patient-centered approach to achieve the objective of concordant racial/ethnic representation in a randomized clinical trial. Clinical trial information: NCT05617716 .

Higher Education Policy Narratives during COVID-19: How are Budget Requests Justified to State Legislatures?

During economic recessions, state funding for higher education contracts (Delaney & Doyle, 2011; Hovey, 1999; SHEEO, 2022). Despite this reality, public higher education officials need to offer insights and explanations to state legislators about the current status of their institutions and their needs when discussing their budget requests. We use a multiple case-study design, framed by the narrative policy framework, to examine how campus officials in California and Texas justify their budget requests to the state legislature during the COVID-19 pandemic. Drawing on 131 h of transcribed legislative budget meetings and 62 documents, our findings suggest that higher education leaders emphasize the economic functions of higher education and center their ability to successfully manage during these uncertain and difficult times by highlighting improved or stable accountability measures such as enrollment, persistence, graduation, and job placement rates. During these budget requests, there are commonalities between the states regarding the structure, justifications, and narrative strategies used. However, higher education leaders evoked different narrative objects depending on the perceived values, beliefs, and norms of their state legislators.

Interventions to Increase Affordable Care Act Marketplace Enrollment: A Systematic Review and Meta-Analysis.

Over 10 million uninsured individuals are eligible for subsidized health insurance coverage through the Affordable Care Act (ACA) marketplaces, and millions more were projected to become eligible with the end of the federal COVID-19 Public Health Emergency in 2023. Individual studies on behaviorally informed interventions designed to encourage enrollment suggest that some are more effective than others. This study summarizes evidence on the efficacy of these interventions and suggests which administrative burdens might be most relevant for potential enrollees. Published and unpublished studies were identified through a systematic review of studies assessing the impact of behaviorally informed interventions on ACA marketplace enrollment from 2014 to 2022. Thirty-four studies comprising over 18 million participants were included (32 randomized controlled trials and 2 quasiexperimental studies). At the time of data extraction, 8 were published. Twenty-seven of the studies qualified for inclusion in a meta-analysis, which found that the average rate of enrollment was about 1 percentage point higher for those who received an intervention (0.009, P < 0.001), a 24% increase relative to control households; for every 1000 people who receive an intervention, that would correspond to about 9 additional enrollees. When stratifying by intervention intensity, support-based interventions increased enrollment by 2 percentage points (0.020, P = 0.004), while information-based interventions increased enrollment by 0.6 percentage points (0.006, P < 0.001). The meta-analysis found that behaviorally informed interventions can increase ACA marketplace enrollment. Interventions aimed at alleviating compliance costs by providing enrollment support were about three times as effective as information alone.