Acta Scientific Medical Sciences (ASMS)(ISSN: 2582-0931)

Research Article Volume 9 Issue 12

Implementing e-Bilingual Informed-Consent with e-Signature in EHR at Johns-Hopkins Aramco-Healthcare, Saudi Arabia: Quality-Improvement Initiative

Huda Al Sayed Ahmed*1, Osama Omari2, Ameerah Talib3, Anolynne Eastman4and Basmah AlDossary5

1Department of Quality and Patient Safety/ Enterprise Quality Compliance Unit, Johns Hopkins Aramco Healthcare Dhahran, Saudi Arabia
2Surgery Department/General Surgery Division, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia, OSAMA.OMARI@JHAH.com
3Clinical Applications Support Department, EHR Ancillary Applications, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia, ameerah.talib@JHAH.com
4Department of Quality and Patient Safety, Process Improvement, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia, ANOLYNNE.EASTMAN@JHAH.com
5Department of Quality and Patient Safety, Enterprise Quality Compliance Unit, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia, basmah.aldossary@JHAH.com

*Corresponding Author: Huda Al Sayed Ahmed, PhD, CPHQ, CHAP, CHTOT, H(ASCP), SCYM(ASCP), Department of Quality and Patient Safety/ Enterprise Quality Compliance Unit, Johns Hopkins Aramco Healthcare Dhahran, Saudi Arabia. huda.alsayedahmed@jhah.com

Received: November 03, 2025; Published: November 30, 2025

Abstract

Background: Patient involvement in healthcare decisions is essential, with informed consent (IC) being a legal requirement before any admission, surgery, or high-risk treatment. In Saudi Arabia, the local Saudi central board for accreditation of healthcare institutions (CBAHI) and the MOH mandate the use of IC forms in both English and Arabic to support the 2030 Vision.

Objective: To implement a bilingual electronic informed consent (e-IC) with e-signature functionality in the EHR, Epic, aiming to comply with accreditation and MOH requirements and achieve patient satisfaction ≥90% and staff satisfaction ≥75% within two years post-implementation.

Methods: This quality improvement initiative employed an implementation-focused design. All manual, paper-based IC forms were translated into Arabic, and bilingual ICs were integrated into the EHR. Retrospective data were collected to assess baseline practices, while prospective data were collected to measure improvements using several metrics, including patient satisfaction and staff satisfaction, after implementation. Data analysis was performed using SPSS v.30, with a statistical significance level set at p ≤ 0.05.

Results: Between January 2023 and December 2024, manual IC forms significantly decreased to 4.7% (p < 0.001), while e-IC usage rose to 95.2% (p < 0.001). Documentation deficiencies revealed a statistically significant 98.5% reduction (p < 0.001). Additionally, assessed patient satisfaction reached 92.5% while staff satisfaction reached 75.5%, exceeding the set targets.

Conclusions: Implementation of an e-bilingual IC with e-signatures streamlined the consent process, minimized documentation deficiencies, and enhanced patient and staff satisfaction. Healthcare institutions can adopt a standardized approach that supports accreditation compliance, promotes efficient, patient-centered care, and provides a sustainable model for healthcare institutions seeking prompt, measurable improvements in quality and safety.

 Keywords: Bilingual Informed Consent; e-Informed Consent; e-Signature; Electronic Health Record (EHR)

References

  1. Krvavac A., et al. “Improving Consent Documentation in the Medical Intensive Care Unit”. Cureus 11.11 (2019): e6174.
  2. Varkey B. “Principles of Clinical Ethics and Their Application to Practice”. Medical Principles and Practice: International Journal of the Kuwait University, Health Science Centre 30.1 (2021): 17-28.
  3. Arellano L., et al. “Ethical considerations in informed consent”. IntechOpen (2023).
  4. “Joint Commission International Accreditation Standards for Hospitals, 8th Edition” (2024).
  5. “Saudi Central Board for Accreditation of Healthcare Institutions, 3rd Edition” (2016).
  6. “Saudi Guidelines for Informed Consent, MOH, 1st Edition” (2019).
  7. Grady C., et al. “Informed Consent”. The New England Journal of Medicine 376.9 (2017): 856-867.
  8. De Sutter E., et al. “Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review”. Journal of Medical Internet Research 22.10 (2020): e19129.
  9. Reeves J J., et al. “Association of Electronic Surgical Consent Forms With Entry Error Rates”. JAMA Surgery 155.8 (2020): 777-778.
  10. Attafuah P Y A., et al. “Satisfied or not satisfied? Electronic health records system implementation in Ghana: Health leaders' perspective’. BMC Medical Informatics and Decision Making 22.1 (2022): 249.
  11. Verreydt S., et al. “Security and privacy requirements for electronic consent: a systematic literature review”. ACM Transactions on Computing for Healthcare 2.2 (2021): 1-24.
  12. Chimonas S., et al. “Electronic consent in clinical care: an international scoping review”. BMJ Health and Care Informatics 30.1 (2023): e100726.
  13. Tubaishat A. “The effect of electronic health records on patient safety: a qualitative exploratory study”. Inform Health Soc Care 44.1 (2019): 79-91.
  14. Kraus S., et al. “Digital transformation in healthcare: Analyzing the current state-of-research”. Journal of Business Research 123 (2021): 557-567.
  15. Mazzochi A T., et al. “Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks-a systematic review of studies within randomized controlled trials”. Trials 24.1 (2023): 127.
  16. De Sutter E., et al. “Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?”. Digital Health 10 (2024): 20552076231222361.
  17. Abujarad F., et al. “Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial”. JMIR Formative Research 5.10 (2021): e20458.
  18. Deepl Translator (2017).
  19. Felisberto M., et al. “Digital signatures in electronic health records: a scoping review”. Health and Technology 14.13 (2024): 1083-1096.
  20. Chen C., et al. “Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review. AMIA Joint Summits on Translational Science proceedings”. AMIA Joint Summits on Translational Science (2020): 80-88.
  21. Chimonas S., et al. “Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities”. JCO Clinical Cancer Informatics 7 (2023): e2200122.
  22. Williams H., et al. “Dynamic consent: a possible solution to improve patient confidence and trust in how electronic patient records are used in medical research”. JMIR Medical Informatics3.1 (2015): e3.
  23. St John E., et al. “Digital procedure-specific consent forms (OpInform) compared to handwritten surgical consent forms in breast surgery”. European Journal of Surgical Oncology 43.5 (2017): S5.
  24. Dyke R., et al. “Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department”. The surgeon: journal of the Royal Colleges of Surgeons of Edinburgh and Ireland 21.4 (2023): 235-241.
  25. St John E R., et al. “Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms. The surgeon: journal of the Royal Colleges of Surgeons of Edinburgh and Ireland 15.4 (2017): 190-195.
  26. St John E R., et al. “Assessment of the introduction of semi-digital consent into surgical practice”. The British Journal of Surgery 108.4 (2021): 342-345.
  27. Nguyen M., et al. “A Review of Patient and Provider Satisfaction with Telemedicine”. Current Allergy and Asthma Reports 20.11 (2020): 72.
  28. Buckley MT., et al. “Electronic research consents for complex early-phase I-II clinical trials integrated with telemedicine visits compared with in-person encounters. Journal of Clinical Oncology 40.16 (2020): 1514.
  29. Buckley M T., et al. “The Memorial Sloan Kettering (MSK) electronic informed consent (eIC) platform for clinical trials: An operational model and suite of tools for obtaining informed consent, and managing consent documents. Journal of Clinical Oncology 36.15 (2018): suppl.e18577.

Citation

Citation: Huda Al Sayed Ahmed., et al. “Implementing e-Bilingual Informed-Consent with e-Signature in EHR at Johns-Hopkins Aramco-Healthcare, Saudi Arabia: Quality-Improvement Initiative”.Acta Scientific Medical Sciences 9.12 (2025): 72-81.

Copyright

Copyright: © 2025 Huda Al Sayed Ahmed., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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