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Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

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Creating and Evaluating a Dynamic Study Randomization and Enrollment Tool within a Robust EHRs.

Nareesa A Mohammed-Rajput¹, Nyoman W Ribeka, Sylvester Kimaiyo

¹Regenstrief Institute, Inc., Indianapolis, IN;

AMIA ... Annual Symposium Proceedings. AMIA Symposium

|February 25, 2011

Summary

Implementing an automated Randomization and Enrollment Tool (RET) in electronic health records (EHRs) can streamline clinical trials. However, challenges with EHR data accuracy and clinic workflows must be addressed for optimal performance.

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Area of Science:

Health Informatics
Clinical Trials Methodology
Global Health

Background:

Randomized trials are challenging in resource-limited settings.
Electronic Health Records (EHRs) offer potential for improving trial efficiency.
Automated tools can support data collection and patient enrollment.

Purpose of the Study:

To assess the accuracy and adequacy of a novel Randomization and Enrollment Tool (RET).
To evaluate RET's performance in a real-world clinical setting for HIV decision support trials.
To identify limitations of EHR-based randomization tools.

Main Methods:

An observational assessment of the RET was conducted at three Kenyan HIV clinics.
The RET was integrated into live EHR systems to automate enrollment and randomization.
Manual reviews were performed to evaluate RET's enrollment accuracy and data integrity.

Main Results:

The RET enrolled 327 patients, but manual review found only 250 (76.5%) were eligible due to inaccurate EHR data.
An additional 23 eligible patients were missed due to reliance on EHR data.
5.5% of enrolled patients did not receive the intervention due to missed appointments.

Conclusions:

Automated randomization tools show promise for reducing costs in EHR-based randomized trials.
Data quality issues within EHRs pose a significant vulnerability for automated trial tools.
Workflow integration and data validation are critical for successful implementation of such tools.