This case study demonstrates the potential for technology to enhance efficiency and accuracy in clinical data management, ultimately improving patient care and research outcomes.

Challenge

Healthcare institutions frequently require clinicians to manually enter clinical research data into disease or patient-specific databases. This task is crucial for regulatory compliance, public reporting, research, and quality improvement. However, manual data entry is time-consuming, expensive, and prone to errors. Clinicians or research coordinators must search through medical records to populate database fields, diverting their attention from patient care. When performed by paid data abstractors, this process incurs significant labor and time costs, highlighting the need for a more efficient solution.

Solution

To address these challenges, a custom tool was developed to facilitate the direct transfer of subject data from the Electronic Health Record (EHR) to a proprietary, study-specific database. This case study examines the implementation of this technology using the Advanced Cardiac Therapies Improving Outcomes Learning Network (ACTION) database (https://www.actionlearningnetwork.org). The initiative was spearheaded by Dr. Robert A. Niebler from the Medical College of Wisconsin and Herma Heart Institute, Children’s Wisconsin.

The EHR system utilized by Children’s Wisconsin is rom Epic. The implementation involved several key steps:

1. Creation of Data Abstraction Forms: Within Epic, data abstraction forms were designed to replicate the data collection fields required by the ACTION database.

2.Secure Data Transmission: Data was securely transmitted from the local EHR system to the database manager, Simplified Clinical Data Systems. Existing data use agreements covered this electronic transfer, eliminating the need for direct access to the EHR by the database manager.

3. Automated Data Processing: Upon receipt, the secured data files were automatically processed by Simplified’s Universal Data Integration Gateway (UDIG) to populate the ACTION database.

Results

The project was completed in the summer of 2024, with the system operational by fall 2024. The implementation resulted in several significant benefits:

– Time Savings: Research Coordinator/Investigators save significant number of hours, allowing them to focus more on patient care.

– Data Accuracy: The data captured was a 100% accurate reflection of the EHR data in Epic.

– Scalability: The ACTION registry forms and fields can be easily adapted by any organization using Epic as their EHR vendor.

– Broader Applicability: The techniques and tools developed can be applied to any registry or research project currently relying on manual data abstraction.

WHAT SHOULD STUDY SPONSORS DO?

Any Healthcare institution can achieve these benefits with Simplified Clinical to successfully implement a similar system and overcome challenges.

Assess Current EHR System: Institutions should evaluate their existing EHR system to determine its capabilities for custom form creation and data extraction. While the case study focused on Epic, other EHR systems may offer similar functionalities. Simplified Clinical is capable of working with many other EHR systems.

Design Custom Data Abstraction Forms: Create data abstraction forms within the EHR that mirror the fields required by the target database or registry. This step is crucial for ensuring that the correct data is captured and transferred.

Establish Secure Data Transfer Protocols: Develop a secure method to transmit data from the EHR to the database platform (Microsoft Azure Cloud for Healthcare).

Automate Data Processing: Partner with Simplified Clinical and their Universal Data Integration Gateway (UDIG) to automatically process the received data files and populate the target database.

Apply to Other Research Efforts: The techniques and tools developed for this project can be applied to virtually any registry or clinical research project that currently relies on manual data abstraction. This scalability allows institutions to streamline data collection across multiple studies and databases.

Realize Benefits: By implementing the Simplified Clinical solution, healthcare institutions can expect to:

• Save significant hours of Research Coordinator/Investigator time
• Achieve 100% data accuracy in reflecting EHR data
• Improve efficiency in data collection and management
• Allocate more time to patient care