Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation

Despite efforts to enhance enrollment and the merger of national cooperative groups, < 5% of patients with cancer will enroll into a clinical trial. Additionally, clinical trials are affected by a lack of diversity inclusive of minority patients, rural residents, or low-income individuals. COVID-19 further exacerbated known barriers of reduced physician-patient interaction, physician availability, trial activation and enrollment, financial resources, and capacity for conducting research. Based on the cumulative insight of academic and community clinical researchers, we have created a white paper identifying existing challenges in clinical trial conduct and have provided specific recommendations of sustainable modifications to improve efficiency in the activation and conduct of clinical trials with an overarching goal of providing improved access and care to our patients with cancer.

Role of advanced practice providers (APP) in meeting rising demands on oncology practices.

e18372 Background: The role of advanced practice providers (APPs), nurse practitioners (NPs) and physician assistants (PAs), is expanding in oncology for myriad reasons including improving access to care by closing the gap between demand for services and physician availability. This is especially true in oncology, where the shortage of oncologists and increasingly cited physician burnout is creating challenges for many practices and communities. Methods: We surveyed US physicians to understand their practices’ use of APPs, their role in patient treatment and support as well as their impact on practice workflow. Data were collected using web-based instrument between Sep 2018 and Nov 2018. Responses have been summarized using descriptive statistics. Results: Among 163 oncologists and hematologists surveyed, 74.2% (n = 121) employed NPs, 39.9% (n = 65) employed PAs, and 19.0% (n = 31) did not employ any APPs in their practice. Amongst practices that employed ≥1 APP (n = 132; 81.0%), over 40% of physicians reported a 1:3 APP: physician ratio. Most (62.1%) physicians stated that APPs only evaluated and saw returning patients, whereas 35.6% physicians used APPs to evaluate and see both new and return patients. More than 60% of physicians stated that APPs enhanced their practice efficiency, enabled physicians to focus more on complex patient cases, and made their workload manageable. By employing APPs, 52.3% of physicians were able to increase their patient caseload. The majority (57.6%) of physicians reported that they would employ more APPs in the next 3 years if resources were available, and 41.7% of physicians reported that APPs would likely take on additional responsibility in the next 3 years. Conclusions: Most community oncology practices in the US are employing APPs and are finding significant value in the APP roles by delegating various aspects of patient care to them. Most community practices are considering increasing the number of employed APPs and to expand the breadth of their responsibility. Integrating APPs into oncology practices is likely to have a larger impact on quality of patient care and potential mitigation of physician burnout.

Experiences of patients living with inflammatory bowel disease in rural communities

Inflammatory bowel disease (IBD) is a chronic disease that often has fluctuating and painful symptoms. IBD patients must cope with a lifelong illness with relapses, remissions, and varied treatments that can affect their overall quality of life. Patients living in a rural setting are faced with further challenges such as access to healthcare, physician availability, and socioeconomic factors. For the current study, we interviewed adult patients in a clinic who were diagnosed with IBD for at least 3 years to better understand their experiences with the aim to inform intervention and educations for patients and physicians. Through a thematic analysis, we argue that five themes emerged from the data: i) IBD etiology, ii) ceding self-care, iii) environmental factors associated with disclosure, iv) stigma, and v) environmental obstacles to care. We suggest opportunities for research and collaboration among researchers and practitioners to help reduce stigma associated with IBD and promote health among rural communities.

Validation of a New Continuous Geographic Isolation Scale: A Tool for Rural Health Disparities Research

The purpose of this study was to develop and test a new continuous measure for rural health disparities research to characterize geographic areas according to a perspective of access to resources. We call the measure Isolation and anticipate it will be useful as an alternative to commonly used rural classification schemes (e.g., the Census Bureau's measure). Following the best known standards for measuring rurality, it captures the trade-off between access to resource-rich, high-population-density areas and the cost of travel to those areas; thus even intrinsically low-resource areas may have high access to nearby resources. Validity was tested with proxies such as nighttime outdoor lights, distance to hospitals, physician availability, and access to high quality food. The Isolation scale demonstrated good construct validity (i.e., both convergent and criterion validity). Fit statistics indicated that, compared to other commonly-used urban/rural definitions, the Isolation scale was the best overall measure when predicting several proxies for rurality, even when categorized. We also show that the measure does a substantially better job at explaining national health outcome data at the state level. This new continuous Isolation scale shows considerable promise for improving our conceptualization, theorization, and measurement of the features of rurality that are pertinent to rural health disparities research, and can also be useful to policy makers who may find value in using isolation thresholds that are most relevant to their policy planning needs.

Procedural Pediatric Sedation by Nurses: Available, Competent, and Safe

Sedation and/or analgesia are standard of care for pediatric patients during painful intervention or medical imaging requiring immobility. Physician availability is frequently insufficient to allow for all procedural sedation. A nurse-led sedation program was created at the Centre Hospitalier Universitaire de Sherbrooke (CHUS) to address this problem.Objective. To evaluate the effectiveness and the safety of our program.Methods. A retrospective study of all the procedural sedations done over one year was performed. Complications were separated in four categories: (1) major complications (call for help; unexpected admission, aspiration, and code); (2) reportable sedation events (oxygen saturation <90%, bradycardia (more than 2 SD below normal for the age of the child), and hypotension (more than 2 SD below normal for the age of the child); (3) difficult sedation (agitation, inadequate sedation, and failure to perform the procedure), (4) minor complications.Results. 448 patients, 249 boys and 199 girls; received sedation for 555 procedures. Overall, 78% (432) of interventions were successfully accomplished: 0% of major complications, 8% of reportable sedation events; 5% of difficult sedation; 9% of minor complications.Conclusion. Our nurse-led sedation program compares favorably to other similar systems.