By Sina Haeri, MD, MHSA
Chief Medical Officer, Confirmed Consent
Informed Consent is an essential component of patient care, and the clinician must ensure that the decision to proceed with the proposed intervention is truly an informed one. Although this is the ideal, for most, the reality is quite different.
The process of obtaining an informed consent is often overlooked, abbreviated, or delegated to assistants. Patients instill their trust in the clinician, and expect to have information presented to them without bias, and in detail. However, the reality is that many forms are filled with complex medical jargon, and patients often are not making the decision in a neutral environment and typically lack adequate time to process the information. This process requires time, patience, and specificity.
Informed Consent in the Ideal World
The informed consent process generally follows the discussion of the diagnosis. This process, if done properly, should include the following steps:
- Explaining the nature of the procedure in layman’s terms
- Discussing common risks associated with the procedure
- Reviewing benefits of the procedure, along with any potential treatment alternatives
- Consistency in the risks and benefits discussion for each patient
- Allowing adequate time for questions
- Informing the patient of their legal right to refuse (informed refusal)
- Providing a neutral environment for the decision – without coercion
- Documenting the above process, patient understanding of the information, and agreement to proceed
Unfortunately, there are a myriad of reasons why this is not always the case.
Informed Consent in Our World
The reality that many clinicians live in, is a world where they are under pressure to see more patients in less time and continue to provide high quality care. Unrelated urgent issues may demand the clinician’s time and attention, resulting in consent not being top of mind. There are ample distractions that can influence a clinician’s mental state when consenting a patient, whether that be work or personal life. In addition, the clinician may unintentionally and/or subliminally discriminate against patients in assessing their level of understanding, affecting their care.
Sometimes, this process may be delegated to a nurse or resident, and the clinician not be present for the actual consent. Perhaps there is some form of language barrier, and then communication must go through a third party and is mistranslated or diminished. That is not to say that all of these problems plague every single clinician, or that on any given day a clinician would definitively deal with even one of these. However, trends in the industry suggest that these are very real circumstances that do affect the consent process. These situations not only make for poor consent, but also increase the potential for medical errors, unhappy patients, and ultimately litigation. If you cannot be confident that every single consent you’re doing is of the highest quality and standard, there is a problem.
Worst case scenario for the patient, in terms of consent gone wrong, is that they experience an unknown complication that wasn’t addressed during the informed consent communication process with their clinician. This means they are in pain, unhappy, and frustrated with their clinician. Indeed, one-third of the 20,000-23,000 medical malpractice lawsuits filed annually allege poor communication and failure to adequately consent. When litigation is filed against a clinician, they are impacted mentally, financially, and worse, the stress of the litigation inherently impacts the clinician’s future performance and/or reputation.
How to Improve?
Fortunately, there are many adjustments that can be made to ensure you are providing every patient with the highest quality, standardized, unbiased informed consent process. We propose that each institution, irrespective of size, consider the following steps:
- Acknowledge that there is room for improvement in the consenting process and take the necessary steps to find the pain points in your organization that may be contributing to lower quality consenting.
- Be open to new opportunities that can help elevate your consenting process if necessary. In a new age of technology and innovation in medicine, there is no reason you can’t extend this same level of innovation to your consenting process.
- Leverage your invaluable feedback resource: the patients! Make sure to ask them about their informed consent.
Diligence is key in providing the best care and informed consent. Though it is easy to let drift to the back burner when there are seemingly more pressing matters, it is essential to always keep the informed consent process as a priority.
Sina Haeri, MD, MHSA, Chief Medical Officer, Confirmed Consent
Dr. Sina Haeri is a Maternal-Fetal Medicine specialist with over 15-years of leadership experience in healthcare including developing maternity programs to improve access to care for some of the nation’s largest healthcare entities including HCA and Access Physicians. He currently serves on the Society for Maternal-Fetal Medicine’s Healthcare Policy and Advocacy committee. He co-founded Confirmed Consent in 2017, where he is now the Chief Medical Officer.
About Confirmed Consent
Confirmed Consent is an interactive peri-operative consent platform that provides standardized and documented patient education and facilitates obtaining informed consent while confirming the patient’s competency and cognition.
Final Thoughts
Robert Broida, MD, FACEP
President, ED Quality Solutions
Informed Consent is a huge issue for many healthcare systems. Usually treated as a “necessary evil,” or “useless paperwork,” consents can be your best friend or your worst enemy in the event of an adverse outcome.
In the Emergency Department (ED), we have historically focused on patients leaving before treatment was completed or against medical advice (AMA). In fact, most hospitals’ paperwork is focused on AMA. A far more common issue is informed refusal of tests, procedures, examinations, etc. Patients have the right to be informed about their treatment options, risks and benefits (including non-treatment). With greater patient financial responsibility due to high deductibles, this takes on an ever greater place in our healthcare system.
Proper ED Informed Refusal should contain the following items:
- Informed Refusal of tests, procedures, exam, etc.
- Physician documentation of the patient’s decision-making capacity
- Physician discussion of risks and benefits with the patient and documentation of that discussion, including treatment alternatives and non-treatment (ideally in the context of Shared Decision-Making)
- Physician must offer (and document) an open invitation to return for care
- Nursing staff documentation of the patient’s understanding of the discussion, the various treatment alternatives and their willingness to accept the risks as part of their informed refusal.
It is important that several of the items be performed directly by the physician and not delegated. Equally important is to have a system to memorialize the discussion and the information conveyed. Consistency is important. This can be with a well-constructed form or via an electronic system. Flexibility is essential in the ED, due to the wide variety of conditions treated and the unique situations we encounter on a daily basis. As a best practice, hospital nursing staff should independently document patient understanding. Such corroborating notes are invaluable should there be any future litigation.
Healthcare systems should take a careful look at their consent/refusal process. While it is tempting to endorse a “one size fits all” approach to this issue, differences in clinical process must be considered. There MUST be a system in each department that actually works and provides the necessary protection. Informed Consent/Refusal should be a key focus of each hospital’s Legal and Risk Management Departments.
Resources:
https://www.thedoctors.com/articles/informed-consent-substance-and-signature/
https://www.thedoctors.com/Articles/Informed-Refusal
https://www.medpro.com/documents/10502/2820774/Article_Informed+Refusal_A+Review.pdf
https://www.reliasmedia.com/articles/64232-informed-refusal-just-as-important-as-informed-consent
https://physicians.dukehealth.org/articles/informed-refusal-what-you-need-know
https://www.capphysicians.com/articles/informed-refusal-defense