Risk Management — Informed Consent

Thirty-five percent of the medical record errors involved absence of informed consent.

Simply stated, informed consent means that adult patients who are capable of rational communication must be provided with sufficient information about the risks, benefits, and alternatives associated with a proposed treatment or procedure to make a decision and expressly give permission. In most states, physicians have an affirmative duty to disclose such information. This means that you must volunteer the information and not wait for questions from your patients (although you should also encourage questions).

The informed consent for a treatment or procedure is not just a signed document; it is a process of managing the patient’s expectations. Patients who are informed about the purpose, benefits, risks, alternatives, and expected outcome are less apt to have unrealistic expectations. The informedconsent discussion implicitly shifts the responsibility for decision making from the physician alone to both the physician and patient and thus strengthens the physician-patient relationship.

When properly conducted, the process of obtaining informed consent can help establish a therapeutic alliance and launch or reinforce a positive doctor-patient relationship. If an unfavorable outcome occurs, that relationship can be crucial to maintaining patient trust. By focusing on how you say something as well as on what you say, you can transform a preoperative routine into an effective claims prevention mechanism.

To allay anxiety, you may seek to reassure your patients. In doing so, however, be wary of creating unwarranted expectations or implying a guarantee. Consider the different implications of these two statements:

“Don’t worry about a thing. I’ve taken care of hundreds of cases like yours. You’ll do just fine.”

“Barring any unforeseen problems, I see no reason why you shouldn’t do very well. I’ll certainly do everything I can to help you.”

The therapeutic objective of informed consent should be to replace some of the patient’s anxiety with a sense of control resulting from participation in the decision-making process. To be certain the patient understands your explanation, ask the patient to repeat back what you said. This strengthens the alliance between you and the patient. Instead of seeing each other as potential adversaries in the event of an unfavorable outcome, you are drawn closer by sharing acceptance of the uncertainty inherent in clinical practice.

Shared decision making certainly encompasses the informed consent discussion; however, it goes beyond that, by focusing on the collaborative process whereby treatment decisions are reached by both the physician and the patient.

While informed consent will not absolve you from responsibility if there is negligence, a well-drafted informed consent document is evidence that you tried to give the patient sufficient information

to make an intelligent decision. This document, supported by a handwritten note in the patient’s medical record, is often the key to a successful malpractice defense when the issue of consent to treatment arises.

The documentation (dictated or handwritten) usually does not need to be a laundry list of every possible complication. There is always the risk that in a long list, the very complication that occurred is not listed. However, follow your state’s statutory requirements governing informed consent. Some states, such as Texas, actually require a laundry list of risks to be disclosed for certain procedures.

Written and audiovisual materials for the patient to take home are a useful supplement to the informed consent discussion. These are helpful because many patients cannot remember or explain to their families what they were told by their doctors. Make sure you document that supplemental materials were provided and discussed with the patient.

If the patient is unable to communicate rationally, as in many emergency cases, there is a legally implied consent to treat. The implied consent in an emergency is assumed only for the duration of that emergency. However, when possible, it is safer to obtain the consent of the patient’s closest relative.

The treatment of minors carries the responsibility of obtaining consent from the parents or legal guardians. An exception in most states is the “emancipated” minor (those who are pregnant, married, serving in the military, or legally free and financially independent). However, in an emergency, you must not delay in treating a minor or an incompetent person if such a delay might adversely affect the outcome of the case. In such circumstances, anything less than prompt attention and treatment will increase your exposure to liability.

Informed Refusal

Doctors must also warn patients of the consequences of failing to heed medical advice by refusing treatment or diagnostic tests. It is essential to carefully document such refusals and their consequences in the medical record and to note that the patient understood those consequences. If a claim is filed and such a refusal is not written in the medical record, it is as though it never happened!

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

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