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Introduction <p>Accurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a persistent challenge. This quality improvement project aimed to reduce VS-related protocol deviations through the implementation of monitor integration (MI) technology on an inpatient clinical research unit at an urban academic medical center.</p> Materials and Methods <p>Guided by Lewin’s Change Management Model, the intervention included structured educational sessions for 31 clinical research nurses (CRNs), emphasizing protocol adherence, the use of MI to reduce documentation errors, and hands-on MI training. Peer support champions were designated to provide bedside guidance. A two-week audit compared VS-related protocol deviation rates from 451 pre-intervention and 682 post-intervention research visits.</p> Results <p>Following implementation, VS-related protocol deviations decreased significantly from 2.7% to 0.3% (<i>p</i> &lt; 0.001). Nurse adoption of MI improved through targeted education and peer support, promoting alignment with Good Clinical Practice (GCP) guidelines and enhancing workflow efficiency.</p> Discussion <p>The combination of MI technology, training, and peer mentorship successfully reduced documentation errors and improved data quality. Despite initial resistance, CRNs adopted a new process, demonstrating the value of integrating technology into clinical workflows. Limitations include a short intervention period and the study’s single institution setting.</p> Conclusion <p>MI technology, when paired with education and peer support, can reduce VS-related protocol deviations and strengthen research compliance. These findings support broader adoption of MI in clinical research settings and underscore the importance of continued investment in CRN education and health technology integration.</p>

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Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project

  • 期刊论文

  • 发表日期：

    2026年3月21日

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  • Kathryn E. Hall,
  • Jean M. Bernhardt

摘要

Introduction

Accurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a persistent challenge. This quality improvement project aimed to reduce VS-related protocol deviations through the implementation of monitor integration (MI) technology on an inpatient clinical research unit at an urban academic medical center.

Materials and Methods

Guided by Lewin’s Change Management Model, the intervention included structured educational sessions for 31 clinical research nurses (CRNs), emphasizing protocol adherence, the use of MI to reduce documentation errors, and hands-on MI training. Peer support champions were designated to provide bedside guidance. A two-week audit compared VS-related protocol deviation rates from 451 pre-intervention and 682 post-intervention research visits.

Results

Following implementation, VS-related protocol deviations decreased significantly from 2.7% to 0.3% (p < 0.001). Nurse adoption of MI improved through targeted education and peer support, promoting alignment with Good Clinical Practice (GCP) guidelines and enhancing workflow efficiency.

Discussion

The combination of MI technology, training, and peer mentorship successfully reduced documentation errors and improved data quality. Despite initial resistance, CRNs adopted a new process, demonstrating the value of integrating technology into clinical workflows. Limitations include a short intervention period and the study’s single institution setting.

Conclusion

MI technology, when paired with education and peer support, can reduce VS-related protocol deviations and strengthen research compliance. These findings support broader adoption of MI in clinical research settings and underscore the importance of continued investment in CRN education and health technology integration.