A Data Management System Integrating Web-based Training and Randomized Trials: Requirements, Experiences and...

Area of Science:

• Health Services Research
• Medical Informatics
• Behavioral Science

Background:

• Substance abuse counselors require effective training in therapeutic methods like cognitive behavioral therapy (CBT).
• Web-based training offers a scalable solution for professional development, but requires robust management systems.
• Large-scale randomized trials necessitate integrated systems for both intervention delivery and data management.

Purpose of the Study:

• To describe a data management system (DMS) designed for a large-scale randomized trial of a web-based CBT training course for substance abuse counselors.
• To evaluate the effectiveness of a customized DMS in managing both web-course delivery and randomized trial protocols simultaneously.
• To highlight requirements for DMS supporting integrated web-based training and clinical trial management.

Main Methods:

• A proprietary data management system (Advanced Data Entry and Protocol Tracking - ADEPT) was customized and coupled with a web-based CBT course.
• The system supported all aspects of a randomized trial comparing web-course-trained counselors to those trained with a printed manual.
• Existing systems were reviewed, revealing limitations in simultaneously managing web-based training and randomized trials.

Main Results:

• The customized ADEPT system successfully managed the integrated needs of the web-course and the randomized trial.
• The system demonstrated the feasibility of coordinating web-based intervention delivery with rigorous trial management.
• The study confirmed the need for specialized DMS solutions at the intersection of e-learning and clinical trial management.

Conclusions:

• A customized, integrated DMS is crucial for efficiently managing complex research involving web-based training and randomized trials.
• The ADEPT system, tailored for this study, met the requirements for simultaneous management of course and trial components.
• Recommendations are provided for institutions planning similar research endeavors requiring integrated DMS solutions.