Center for Health Innovation and Implementation Science, School of Medicine, Indiana University, Indianapolis, IN, USA.
School of Medicine, Indiana University, Indiana University, Indianapolis, IN, USA.
Trials. 2024 Nov 29;25(1):802. doi: 10.1186/s13063-024-08646-0.
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.
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.
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.
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.
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).
临床试验的成功取决于参与者招募和保留的效率。然而，入组速度缓慢和脱落率高经常会阻碍研究进展。为了解决这些挑战，开发了一种带有控制图的新型仪表盘工具，为多中心急诊普通外科幸存者的谵妄和神经心理恢复研究（DANE 研究）的研究者提供了及时的信息，以改善试验招募。
由主要研究者（PI）小组开发并在一家大型医院的一个部门实施的质量监测 Excel 仪表盘，经过重新设计，用于研究招募目的。该仪表盘为 PI 和其他利益相关者提供了有关参与者完成过程中每个阶段或操作的人数、完成率和趋势的及时、可操作和无偏见的信息，包括当前周和累计的信息。
DANE 仪表盘使用 Microsoft Excel 进行原型设计，以实现可访问性和快速开发。该工具与 REDCap 数据库集成，简化了数据导入和分析。通过在整个招募过程中促进知情决策，DANE 仪表盘显著提高了临床试验的效率，并导致了入选标准的改变，以及方法和知情同意过程的改进。
用于监测研究中参与者招募和脱落的 DANE 仪表盘代表了朝着增强研究管理和决策过程迈出的重要一步。它可以适用于其他临床研究和其他具有脱落率的分阶段过程。目前正在开发的通用版本有望通过纳入用于生成随机数据和考虑资源限制的电子表格，发展成为一个有价值的模拟器。通过将预测能力集成到控制图中，可以进一步增强这一功能。
Delirium 和 Emergency General Surgery Survivors 中的神经心理恢复（DANE）研究（NCT05373017，1R01AG076489-01）是一项多中心、两臂、单盲随机对照临床试验，旨在评估 Emergency General Surgery（EGS）Delirium Recovery Model 改善 65 岁以上 EGS 谵妄幸存者的认知、身体和心理恢复的疗效。DANE 研究获得了威斯康星大学麦迪逊分校/威斯康星大学医院和诊所机构审查委员会（IRB，编号 2022-0545，批准日期 2022 年 9 月 14 日）的批准，印第安纳大学同意将 IRB 审查权让渡给威斯康星大学麦迪逊分校/威斯康星大学医院和诊所（2022 年 9 月 29 日）。
