An agile monitoring dashboard has been developed to enhance the management of clinical research studies, addressing recruitment and intervention challenges proactively. The dashboard, integrated with control charts, provides weekly updates on participant progress, completion rates, and trends, enabling immediate action if accrual goals are at risk.
Dashboard Concept and Design
The concept originated from a principal investigator (PI) with extensive experience in clinical research. Recognizing that early identification of recruitment challenges is crucial, the dashboard monitors counts, rates, and trends to ensure accrual targets are met. Rates can reveal incorrect assumptions, such as eligibility rates, prompting adjustments like adding sites or modifying eligibility criteria. Trends can also warn research teams if they are likely to fall behind or catch up on goals. Failure to reach accrual targets can lead to termination of clinical trial funding.
The dashboard was prototyped and tested in the Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE) study (NCT05373017), a multi-site, two-arm, single-blinded randomized controlled clinical trial. The DANE study evaluates the efficacy of the Emergency General Surgery (EGS) Delirium Recovery Model to improve the cognitive, physical, and psychological recovery of EGS delirium survivors over 65. Participants progress through stages involving actions initiated by study staff or the participants themselves, with potential attrition at various points.
The DANE dashboard re-engineered a successful quality monitoring Excel dashboard with control chart functionality. Data from the REDCap database was segmented by time and processed for use in the dashboard. A key feature is an update macro that allows the research coordinator to export data from REDCap, import it into Excel, and update the dashboard with a single click.
Development and Testing
The software underwent a 4-month development phase, followed by 1-month alpha testing and 3-month beta testing. The development involved weekly meetings between the in-house developer and the PI, as well as participation in project team meetings. Excel was chosen for its development speed and accessibility. REDCap reports were developed and formatted to load into the dashboard software.
Alpha testing assessed accuracy by comparing the dashboard against existing weekly reports extracted from the database using the REDCap API. Beta testing involved training the research coordinator to use the update macro and generate weekly reports. The research team evaluated the dashboard weekly for 3 months.
DANE Study Details
The DANE study aims to enroll 264 patients per group, with a total randomization target size of 528, assuming a 30% attrition rate. The study requires 185 study completers per group to yield a power of 80.6% to detect differences in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between the intervention and usual care groups with type I error rate at α = 0.05. The EGS Delirium Recovery Model includes a recovery care plan and a 12-month interaction period with a care coordinator.
Data Management and Security
Clinical data is entered into the University of Wisconsin School of Medicine and Public Health (SMPH) Research Electronic Data Capture (REDCap). The DANE dashboard improves security by limiting access to the full REDCap database, with only the research coordinator having access. This reduces the number of people involved and enhances data protection.
