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Patient Safety Tip of the Week
November 26,
2024
eConsent: Friend
or Foe?
We read with both interest and concerns a recent publication
about electronic surgical consent delivery via patient portal. Trang et al. (Trang
2024) recently undertook a study to evaluate the association of eConsent
delivery via the patient portal (PP) with operational efficiency and patient
engagement.
At UCSF (University of California, San Francisco) procedural
consent forms transitioned from paper to digital in February 2023 for all adult
patients undergoing procedures in a main operating room at their 3 main
hospitals. Their eConsent surgical consent process is as follows: The surgeon
discusses informed consent with the patient. After this discussion and
submitting the electronic case request via the EHR, the eConsent form can be generated
by the surgeon or their designee (resident, fellow, or advanced practice
provider). The attending primary surgeon must review and sign the eConsent form.
It is then automatically sent to the patient via PP if the patient has an
active account and the surgeon selects this option. Patients without PP accounts
or who do not sign via PP then sign on a hospital tablet (iPad; Apple Inc) on
the day of surgery.
In their study, 8478 surgical eConsents were generated for
7672 unique patients, of which 5318 (62.7%) were signed on hospital tablets and
3160 (37.3%) through the patient portal. Patients who signed eConsents via the
PP were younger than those who did not, more commonly White, and more commonly spoke
English as a preferred language. Signing the eConsent on a hospital tablet
rather than via the PP was more common in those cases with more than 1 primary
surgeon or with a higher postoperative level of care, or when the eConsents
that were sent to the PP on the same day of surgery rather than before. The median
time patients waited to sign an eConsent on the PP was 105 (range 178-528)
minutes but once they clicked onto the document it was signed in a median of 2
minutes. Patients had somewhat mixed views of the eConsent process but all
participants viewed the informed consent discussion with the surgeon as the
most important part of the consent process. Many reported either skimming the
paperwork or scrolling to the bottom and signing, relying on the relationship
and trust they had with their surgeon and hospital.
Compared with patients who signed an eConsent 1 day or more before
surgery, patients who signed on the same day had significantly higher odds of
having a delayed first case (OR 1.72). This association remained when the model
adjusted for age, sex, race and ethnicity, limited English proficiency, case
classification, and surgical service (OR 1.59). The authors noted that surgical
case delays are frustrating to staff and patients and are associated with
financial costs as well as worse patient outcomes.
They note additional benefits of eConsent via the PP include
reduced need for nursing staff to collect signatures and potentially obviated need
for a signature witness (due to the authentication and security features of the
PP).
Yes, the improved OR efficiency is nice, but the study
reaffirms that the discussion and relationship between surgeon and patient
remain central to the informed consent process.
In our Patient
Safety Tips of the Week for September 10, 2013 Informed Consent and Wrong-Site Surgery and September 10, 2024 Scheduling and Informed
Consent Contribute to Wrong-Site Surgery we discussed the important
role informed consent plays in promoting or preventing wrong-site surgery. Having
a signed eConsent and the surgical case request form available in the EHR means
all parties in the OR should have access to them during the pre-op huddle or surgical
timeout. And good electronic case scheduling forms and eConsent forms can help
avoid handwriting errors and inappropriate use of abbreviations that contribute
to wrong-site surgery.
Reeves et al. (Reeves
2020) made a case that eConsent could actually avoid many of the errors we
often see with paper-based consent forms. They note that handwritten,
paper-based forms can have error rates as high as 50%, and that those errors
can affect patient experience, patient understanding, and clinic and operating
room efficiency and can result in litigation. They reported on a pilot study at
UCSD (University of California, San Diego). They found an error rate of 1 of
100 (1%) for eConsents and 32 of 100 (32%) for paper-based forms. 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%).
The authors further note that 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.
Our main concern about eConsents is that they do not ensure
that the most important part of the consent process, the discussion with the
surgeon or person performing the procedure, has been adequate. That was echoed
by the editorialists (Hwang
2024) who reviewed the Trang study. They point out that the cursory nature
of the eConsent review, coupled with feedback from the qualitative interviews, raises
concerns that patients may not sufficiently review the eConsent to provide a
truly informed consent. We also think that it may be too easy to simply click
on a link that sends the eConsent form to the patient portal without verifying
that the truly informed part of the discussion has taken place.
Some of our prior columns related to wrong-site surgery:
September 23, 2008 Checklists
and Wrong Site Surgery
June 5, 2007 Patient
Safety in Ambulatory Surgery
July 2007 Pennsylvania
PSA: Preventing Wrong-Site Surgery
March 11, 2008 Lessons
from Ophthalmology
July 1, 2008 WHOs
New Surgical Safety Checklist
January 20, 2009 The
WHO Surgical Safety Checklist Delivers the Outcomes
September 14, 2010 Wrong-Site
Craniotomy: Lessons Learned
November 25, 2008 Wrong-Site
Neurosurgery
January 19, 2010 Timeouts
and Safe Surgery
June 8, 2010 Surgical
Safety Checklist for Cataract Surgery
December 6, 2010 More
Tips to Prevent Wrong-Site Surgery
June 6, 2011 Timeouts
Outside the OR
August 2011 New Wrong-Site Surgery Resources
December 2011 Novel Technique to Prevent Wrong Level Spine
Surgery
October 30, 2012 Surgical Scheduling Errors
January 2013 How Frequent are Surgical Never Events?
January 1, 2013 Dont Throw Away Those View Boxes Yet
August 27, 2013 Lessons on Wrong-Site Surgery
September 10, 2013 Informed Consent and Wrong-Site Surgery
July 2014 Wrong-Sided Thoracenteses
March 15, 2016 Dental
Patient Safety
May 17, 2016 Patient
Safety Issues in Cataract Surgery
July 19, 2016 Infants
and Wrong Site Surgery
September 13, 2016 Vanderbilts
Electronic Procedural Timeout
May 2017 Another
Success for the Safe Surgery Checklist
May 2, 2017 Anatomy
of a Wrong Procedure
June 2017 Another
Way to Verify Checklist Compliance
March 26, 2019 Patient
Misidentification
May 14, 2019 Wrong-Site Surgery and
Difficult-to-Mark Sites
May 2020 Poor
Timeout Compliance: Ring a Bell?
September 14, 2021 Wrong Eye Injections
October 5, 2021 Wrong Side Again
November 9, 2021 Ensuring Safe Site Surgery
February 15, 2022 Wrong-Side Chest Tubes
May 2022 PPSA:
Updated Wrong-Site Surgery Recommendations
June 13, 2023 Preventing Wrong-Site
Surgery
November 2023 Importance
of Timeouts Outside the OR
January 30, 2024 Is Your Surgical Safety
Checklist Working?
September 10, 2024 Scheduling and Informed
Consent Contribute to Wrong-Site Surgery
References:
Trang K, Decker HC, Gonzalez A, et al. Electronic Surgical
Consent Delivery Via Patient Portal to Improve Perioperative Efficiency. JAMA
Surg 2024; 159(11): 1300-1306
https://jamanetwork.com/journals/jamasurgery/article-abstract/2823530
Reeves JJ, Mekeel KL, Waterman RS, et al. Association of
Electronic Surgical Consent Forms with Entry Error Rates. JAMA Surg 2020; 155(8):
777-778
https://jamanetwork.com/journals/jamasurgery/fullarticle/2765980
Hwang ES, Kent M. Electronic Surgical Consent Delivery via
Patient Portal. JAMA Surg 2024; 159(11): 1307
https://jamanetwork.com/journals/jamasurgery/article-abstract/2823535
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