ABSTRACT
Introduction: Efficient and comprehensive trial oversight and data management ensures valid, robust outcomes necessary to inform health policy and improve patient outcomes. This is particularly challenging in the context of multicenter trials. The format of this session will include four introductory presentations (15 min each), followed by 30-min panel discussion/Q&A focusing on recent experiences and innovative approaches utilized within the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB). Since 2017, WF has managed 15 studies with approximately 3000 patient and 1000 provider/stakeholder accruals across 1000 potential participating community oncology practices within the United States and Puerto Rico. These practices often operate differently from academic medical centers, with varying patient capacity, provider number and level of engagement, use of advanced practice providers, and services offered. In addition, practices within this network have heterogeneous utility of electronic health records (EHRs) and display a wide range of clinical research staffing models. The COVID-19 pandemic has highlighted the need for streamlining research visits and maximizing telehealth technologies when applicable, particularly for intervention non-therapeutic clinical trials. As such, research expectations must be standardized to ensure quality trial conduct and data collection across diverse practices. Recently, the WF NCORP RB has taken many steps to improve efficiency and data quality across our studies. This session will discuss a comprehensive approach to data quality and management across the lifespan of a trial. This starts with consent/ recruitment strategies and general oversight/ monitoring of our portfolio of trials. WF RB now utilizes REDCap for all data capture, as this allows direct data entry for site personnel and participant entered patient-reported outcomes using surveys. In addition, REDCap facilitates data monitoring, query, and auditing strategies. We will also introduce a team-based approach to adjudicate complex outcomes. Talk 1 (15 min): Specifically, Karen Craver, our RB administrator, will discuss approaches to obtain robust data as a result of strong screening and recruitment. She will provide an overview on how we survey practice research staff within the Landscape assessment and brief, pre-trial interest surveys to identify optimal target populations during the planning stage. We utilize our internal EHR to create custom screening reports to identify potential participants and generalize these for other practices to customize and use as a screening tool within their clinic. The RB has integrated remote consenting in part due to the pandemic, but we realize the need to continue offering flexibility in consent modality moving forward. Talk 2 (15 min): Emily Dressler, lead Biostatistician, will discuss oversight of the RB portfolio using dynamic reports within Tableau. These reports update daily and provide a comprehensive assessment of all ongoing and completed studies. RB personnel can filter reports to create custom results subset by timeframe, practice or set of practices, trial type, and/or other demographic characteristics. This has greatly reduced the request for study-specific accrual reports and has standardized our reporting across studies. She will also discuss the rationale for transitioning to REDCap, including strengths and weaknesses for integrating in multicenter studies. Talk 3 (15 min): Bill Stanfield, lead data manager, will demonstrate our utilization of the REDCap Data Resolution Workflow and Data Quality modules to efficiently manage data collection, data quality, and audits. He will show how REDCap can be used to seamlessly communicate with research staff to obtain missing or late data, verify out of range values, and then validate and lock responses for analysis. Talk 4 (15 min): Glenn Lesser, WF NCORP multiple principal investigator (mPI), will discuss a team approach to adjudicating cancer treatment information that often consists of combination of surgery, radiation, chemotherapy, or immunotherapy/targeted agents. This remains a particularly challenging problem in large trials enrolling patients with multiple types of cancer who may be treated with a wide spectrum of standard therapeutic regimens. This diversity limits both the effectiveness of automated reviews of remote data entries and the study-specific training of data management staff at sites. Data are pulled in real time from multiple forms within REDCap and collated into participant-level summaries of treatment, starting with the time of baseline assessment and sorted sequentially for each drug administration or event. A multidisciplinary team of data managers, biostatisticians, and clinicians meet to adjudicate each participant as data collection completes. Particularly for trials with multiple cancer types or treatment regimens, our experience with this approach has shown it identifies significant data gaps in treatment, with at least 75% of entries requiring clarification from research staff prior to finalizing and locking data. This process highlighted the challenge of real-time adjudication of treatment data in patients receiving multiple anti-cancer agents, given at varying doses and schedules, and in multiple combinations and/or phases over an individual patient's course of therapy. Panel (30 min): We will conclude with a panel discussion and Q&A. The panel will contribute additional perspective on implications of these strategies in the conduct of multilevel cancer care delivery research studies. We will also incorporate perspectives from NCORP community sites implementing these strategies. Panelists will discuss the broad applicability of these strategies for diverse trials, with attention to size/ complexity, database vendor, and patient population.
ABSTRACT
Background: Patient portals support patient access, engagement, and care coordination, yet could also widen the digital divide and exacerbate disparities among vulnerable populations. There is emerging evidence that racial/ethnic minority patients are less likely to use portals, yet prior research has not examined potential rural differences. We identified sociodemographic factors associated with portal enrollment and use among a racially and geographically diverse population of cancer patients. Methods: We retrospectively examined portal enrollment and use at an NCI-designated comprehensive cancer center from January 2015 until February 2022 among patients 18+ years old with a neoplastic disease diagnosis (ICD-10-CM C00-D49). Potential predictors included gender, race/ethnicity, marital status, age, rural (Rural-Urban Continuum Codes [RUCC] 4-9) vs nonrural (RUCC 1-3) residence, residential distance from the cancer center, and time since diagnosis. We used multivariable logistic regression to generate odds ratios (ORs) for portal enrollment and having ever sent a portal message, and Poisson regression to determine incidence rate ratios (IRRs) for number of logins and number of healthcare team interactions (portal messages or appointment requests), controlling for ICD-10 diagnosis (SAS 9.4). Results: We identified 11,333 patients (average age 67 years, 59% female, 24% rural, 10% Non-Hispanic Black, 1% Hispanic, 20% non-melanoma skin cancer, 14% breast cancer, 9% lung cancer). 36% of patients had enrolled in the portal, and of these, 80% had sent at least one message. Patients logged in a median of 203.5 times and had a median of 19 portal interactions. Rural residents were less likely to enroll in the portal than urban patients (28% vs 38%, p < 0.0001). Non-Hispanic Black patients and Hispanic/Latinx patients were less likely to enroll in the portal compared with non-Hispanic White patients (22% and 27%, respectively, vs 38.5%, p < 0.0001). Women, younger patients, more recently diagnosed cancer patients, and patients who were married/ partnered were significantly more likely to enroll. In multivariable analysis controlling for cancer type, rural patients were half as likely to enroll in the portal (OR: 0.48 [0.43-0.54]). Among those enrolled, rural residents were 25% less likely to have ever sent a portal message (OR: 0.75 [(0.62-0.92]), and had nearly half the login and interaction rates (IRR: 0.66 [0.66-0.67];IRR: 0.58 [0.58-0.59], respectively). Patients who were Non-Hispanic Black, Hispanic, or unmarried were also significantly less likely to enroll or engage in the portal. Conclusions: Patient portals remain underutilized among cancer patients, despite an increased reliance on virtual communications in the COVID era. Interventions to support portal engagement among rural residents and racial/ethnic minority patients are needed to avoid potentially exacerbating health disparities.