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What Makes an Effective Informed Consent Document?


The informed consent process can reduce malpractice risk through the use of digital informed consent documents in Taylor’s iMedConsent solution

According to the 2021 Medscape Malpractice Report, 51% of all physicians have been named in a malpractice lawsuit – including a staggering 83% of both plastic and general surgeons. Likewise, the Journal of Evaluation in Clinical Practice finds that 21% of patients have experienced medical errors.

Legal experts agree that informed consent documents can prevent medical malpractice claims if they are properly executed. In many cases, however, procedural errors render the informed consent process ineffective.

In this article, we will explore the elements of an effective informed consent document. Along the way, we will look at the basic procedural errors that so often render informed consent documents ineffective as well as some communication best practices that benefit physicians, patients and healthcare organizations alike.

The Hallmarks of an Effective Informed Consent Document

Bernard C. McDonnell, DO, is a surveyor with the Healthcare Facilities Accreditation Program, or HFAP. The HFAP is a nonprofit organization that strives to help healthcare organizations enhance the quality of patient care and comply with regulations pertaining to the healthcare environment.

In an article published by Relias Media, McDonnell noted that an effective informed consent document should, at a minimum, incorporate all of the following:

  1. The name of the facility at which care is being provided.
  2. The name of the specific procedure or treatment for which consent is being given.
  3. The name of the responsible practitioner, such as the physician performing the procedure.
  4. A description of the benefits, risks and alternative therapies available.
  5. The patient’s (or guardian’s) signature with date and time witnessed.

Where Informed Consent Documents Go Wrong

Unfortunately, one or more of these five elements is often missing from informed consent documents. HFAP’s quality study noted the following common informed consent document

Error #1: Informed consent documents are missing

An informed consent document does nothing to mitigate malpractice risk if it cannot be found. Paper forms are the bane of the informed consent process and are frequently lost, destroyed or misfiled. Indeed, one study at Johns Hopkins found that consent forms were missing for 66% of surgical patients.

Error #2: Incomplete informed consent documentation or processes

The informed consent process is only effective if it is consistent and complete. It’s critical that standardized consent forms be used for each procedure, that all pages of the consent form are reviewed and signed, and that the physician use the form to engage the patient in a detailed conversation about the procedure or treatment.

Error #3: Informed consent documents lack the date or time of key

A seemingly insignificant detail, noting the date and time of the patient’s and physician’s signature is of paramount importance. Doing so documents that consent was obtained before any medications were administered that might have affected the patient’s judgment.

How To Do Informed Consent Documents Right

Dr. Mikkael A. Sekeres and Dr. Timothy D. Gilligan of the Cleveland Clinic have been outspoken in their efforts to improve the informed consent process. “The secret is that informed consent in healthcare is commonly not-so-well informed,” they maintain.

Looking beyond the three procedural errors noted above, Sekeres and Gilligan say that the physician’s communication style itself directly affects the patient’s understanding of the procedure or treatment. Together, they suggest five ways that physicians can ensure that the patient is informed.

Guideline #1: Use plain language 

Sekeres and Gilligan advocate for the use of common words and terms, not medical jargon. McDonnell of the HFAP wholeheartedly agrees, recommending that a fourth-grade language comprehension level be assumed. For example, “cholecystectomy” could be written as “gallbladder removal” or even “removal of a sac containing fluid that assists in the internal processing of food and nutrition.”

Guideline #2: Ask the patient to summarize

After explaining a procedure and its inherent risks, Sekeres and Gilligan recommend that the doctor ask the patient to repeat back what they’ve heard. If the patient is not “tracking” what has been discussed, the physician can then alter their communication style as needed.

Guideline #3: Accommodate different styles of learning

A conversation is not enough for all patients and some procedures are vastly more complex than others. Sekeres and Gilligan suggest that physicians and healthcare organizations strive to accommodate other styles of learning. For example, consider providing written materials, illustrations or videos that the patient can study at home in advance of their consent decision.

Guideline #4: Describe all scenarios

Simply describing what is typical for a procedure or course of treatment is not sufficient. The physician should use the informed consent process as an opportunity to describe the best-case, worst-case and most likely scenarios for the patient. Only then can a patient make a truly informed decision to move forward.

Guideline #5: Discuss the alternatives

Physicians would be wise to avoid over-emphasizing any one course of action. Sekeres and Gilligan recommend that patients always be informed of their alternative treatment options as well as the advantages and disadvantages of each.

Taylor Healthcare: A Leader In Informed Consent

Taylor Healthcare provides innovative document automation and patient engagement solutions that are specifically engineered to increase patient safety, enhance operational efficiency and eliminate malpractice risk for healthcare organizations. As just one example, we are a recognized leader in digital informed consent technologies.

Our iMedConsent™ solution provides easy-to-understand consent forms in a digital format for more than 4,400 treatments in 37 clinical specialties. The iMedConsent library includes pre- and post-procedure instructions, anatomical images and prescription drug and OTC medication monographs in both English and Spanish.

Paper forms are eliminated from the informed consent process with iMedConsent. Patient/guardian signatures are captured on a tablet computer, a digital signature pad or – thanks to Taylor Healthcare’s proprietary Mobile Signature Capture technology – the patient’s own smart phone. Completed digital consent forms are then automatically stored in the EHR, patient portal and/or document management system.

Whether it’s scanning costs, operating room delays due to lost consent forms, or the professional liability noted in the blog post above, our iMedConsent solution is an integral component of a healthcare organization’s efforts to improve operational efficiency and minimize malpractice risk.

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