Obtaining informed consent is a vital aspect of surgical care. The consent form is a medicolegal document that conveys important information to the patient, clinicians, schedulers, nursing and operating room (OR) staff, and in some cases the court of law.1 Handwritten, paper-based forms can have error rates as high as 50%, which can affect patient experience, patient understanding, and clinic and operating room efficiency and can result in litigation.2-4
Electronic-based consent forms (eConsents) have potential to improve the quality and consistency of documentation, eliminate illegible or misplaced forms, and enhance patient safety.2-5 This article describes a feasibility trial at a large academic medical center to implement eConsents for invasive procedures.
The University of California, San Diego Medical Center is a large, regional academic medical center with 2 hospital-based operating suites and an outpatient surgery center, which was chosen for the trial. The University of California, San Diego uses a commercially available, electronic health record, Epic, which has developed functionality to sign consents electronically. A team that included surgeons, anesthesiologists, nurses, and technology analysts designed the pilot trial, which was conducted over a 6-month period. Clinicians had the ability to use either eConsents or paper-based consent forms. The University of California, San Diego institutional review board reviewed the study protocol and waived the requirement for informed consent. An internal audit of 100 eConsents and 100 paper-based consent forms was performed to assess for completeness, accuracy, and legibility.
A total of 882 eConsents were successfully completed by 19 clinicians; 2 completed consents in both groups. Error rate was 1 of 100 (1%) for eConsents and 32 of 100 (32%) for paper-based forms (Table). One eConsent was missing a surgeon signature. Incomplete items in paper forms included date/time (18 of 100), signature (8 of 100), discussion of risks (6 of 100), procedure name (2 of 100), and name of the operating surgeon (2 of 100). The illegibility rate was 8 of 100 (8%). Several technical and workflow limitations were identified and optimized during the period to enhance the success of the eConsent tool.
This study demonstrates the feasibility of surgical eConsents in a large, regional academic medical center. Clinicians successfully completed eConsents in busy ambulatory clinics and a same-day procedure center. Using simple technology, the error rate decreased from 32% to 1%. eConsents are environmentally friendly and eliminate the need to fax, scan, copy, or file, allowing support staff to focus on direct patient care. An eConsent is permanently present in the electronic health record and cannot be lost. The documentation of surgical risks was required; however, similar to handwritten forms, documentation appeared to be of variable quality using universal eConsents. Thus, capturing the full potential of the eConsent construct, with development of standardized, procedure-specific risks, is an important enhancement to consider. Ultimately, accurate documentation can decrease medicolegal risks for surgeons and institutions.
At our institution, missing or incomplete consent is the most common reason for first case delay (17 minutes per delay; range, 1-75 minutes). Operating room delays affect patient experience and staff satisfaction and have significant financial consequences. This trial demonstrates the potential to eliminate this cause for delay and to improve overall OR efficiency.
Health care systems have leveraged technology to facilitate safe automation, improve speed and accuracy, and enable robust monitoring and analysis of clinical processes.6 The process of obtaining informed consent can benefit from the same transition. In 2017, Chhin et al5 reported successful implementation of eConsents within a radiation medicine program. This study shows that eConsents can be implemented across a range of surgical specialties and clinical settings.
Limitations to this study include a small sample size, minimal surgeon overlap between groups, and lack of objective data on the clinical effect of improved consent documentation. Challenges to implementing eConsent included software build, decreased flexibility in clinician workflow, and need for considerable clinician and staff education. However, there is enough evidence to support the use of eConsents across our institution. Further research is required to evaluate the effect on efficiency, patient and clinician experience/satisfaction, and medicolegal risk. In conclusion, compared with paper-based consent forms, eConsents were associated with decreased error rates and offer the potential to improve clinical efficiency.
Accepted for Publication: March 12, 2020.
Corresponding Author: J. Jeffery Reeves, MD, University of California, San Diego, 9300 Campus Point Dr, MC7400, La Jolla, CA, 92037-7400 (email@example.com).
Published Online: May 20, 2020. doi:10.1001/jamasurg.2020.1014
Author Contributions: Dr Reeves had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Reeves, Mekeel, Waterman, Rhodes, Clay, Longhurst.
Acquisition, analysis, or interpretation of data: Reeves, Mekeel, Rhodes, Clary, Longhurst.
Drafting of the manuscript: Reeves, Longhurst.
Critical revision of the manuscript for important intellectual content: All authors.
Obtained funding: Rhodes, Clay, Clary.
Administrative, technical, or material support: Reeves, Waterman, Rhodes, Clay, Clary, Longhurst.
Supervision: Mekeel, Waterman, Rhodes, Clay, Clary, Longhurst.
Conflict of Interest Disclosures: None reported.
Additional Contributions: We thank Douglas Chang, MD, PhD, and David Dalstrom, MD, Department of Orthopedics and Andrew Kader, MD, PhD, Department of Urology, for feedback on software design, development of clinical workflow, and early use. Douglas Chang, MD, PhD, also assisted with review of the literature and ongoing optimization of the workflow following the initial go-live. We thank Andrew Graham, RN, BSN, Department of Information Services, and Roman Martinez, RN, Department of Peri-operative Services, for technical design, support and data collection. All of these persons are associated with the University of California, San Diego, and received no financial compensation for their contributions to the manuscript.
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