Agile monitoring dashboard for clinical research studies.

Abstract

Background: Clinical trial success hinges on efficient participant recruitment and retention. However, slow accrual and attrition frequently hinder progress. To address these challenges, a novel dashboard tool with control charts has been developed to provide investigators on the multi-site study of Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE study) with timely information to improve trial recruitment.

Methods: A quality monitoring Excel dashboard with control chart functionality developed by the principal investigator's (PI) group and implemented in a department of a large hospital was re-engineered for research study recruitment purposes. The dashboard provides the PIs and other stakeholders with timely, actionable, and unbiased information on the count of participants who have completed each stage or action within the process, the rates of completion and trends, both for the current week and cumulatively.

Results: The DANE dashboard was prototyped using Microsoft Excel for accessibility and rapid development. The tool integrates with a REDCap database, simplifying data import and analysis. By facilitating informed decision-making throughout the recruitment process, the DANE dashboard has significantly enhanced clinical trial efficiency and led to changes in the eligibility criteria and improvements in the approach and consent processes.

Conclusions: The DANE dashboard for monitoring participant recruitment and attrition in research studies represents a significant step towards enhancing study management and decision-making processes. It can be adapted to other clinical studies and other staged processes with attrition. The generic version, currently under development, holds promise for evolving into a valuable simulator by incorporating a spreadsheet for generating random data and accounting for resource constraints. This enhancement could further be augmented by integrating forecasting capabilities into the control charts.

Trial registration: The Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE) study (NCT05373017, 1R01AG076489-01) is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate 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. The DANE study received approval from the University of Wisconsin-Madison/University of Wisconsin Hospitals and Clinics Institutional Review Board (IRB, no. 2022-0545, approval date September 14, 2022), and Indiana University agreed to cede IRB review to University of Wisconsin-Madison/University of Wisconsin Hospital and Clinics (September 29, 2022).