Consistent with the evolving trend of increased patient autonomy and patient participation in the decision-making process, individuals who have adequate mental capacity and are provided an appropriate disclosure of the options, risks, benefits, costs, and likely outcomes of care are legally entitled to exercise their freedom of choice. They may choose not to undergo any recommended course of treatment, despite potentially dire consequences.
Over the last decade, the concept of informed refusal has often created confusion for the medical community regarding its legal importance in the clinical setting. When a patient declines recommended treatment and an adverse event occurs—even though it may be the result of the natural course of the disease process—the patient may retain counsel and pursue a professional liability claim. In that setting, the plaintiff may contend that if a complete discussion had taken place about the consequences of failing to accept the recommended treatment, the patient would have taken the physician’s advice and achieved a better medical outcome. A better medical outcome might include increased longevity, an enhanced quality of life, no loss of earnings or earning capacity, and no out-of-pocket expenses.
Informed Consent Process
Before a patient can provide an informed refusal, the informed consent discussion must take place. Informed consent is an ongoing process, not simply executing a document that describes the proposed course of treatment with a laundry list of possible adverse consequences.
The informed consent conversation should be candid and include a clear discussion of the patient’s existing medical condition using terms that he or she can readily understand. Discuss the available treatment options along with their associated benefits, risks, anticipated costs, and short-term and extended prognoses. Finally, outline the consequences of failing to undertake any treatment.
The physician must always conduct the discussion directly and never delegate it to a staff member. Otherwise, critical communication may be obscured or inadvertently omitted and patient inquiries may be inaccurately addressed.
During the informed consent process, it is imperative to provide the patient with realistic expectations of what might be achieved by the treatment, therapy, or procedure. A clear preprocedure discussion decreases potential misunderstandings, disappointment, surprise, or even anger in the event that an undesirable result occurs. For a more detailed discussion of informed consent, see our article, “Informed Consent: Substance and Signature.”
Conduct the informed refusal dialogue with the same degree of specificity and care used in the informed consent discussion. If a patient indicates an unwillingness to undertake treatment—especially if failure to do so may result in death—attempt to determine the basis of the patient’s decision. It may simply be a misunderstanding about the treatment options, what the treatment entrails, its costs, methods of payment, or other factors that can be resolved.
The physician should assess and document the patient’s capacity to understand the medical information and to make a reasoned decision based on the facts presented. The physician’s assessment must recognize that a patient’s ability to comprehend may be impaired by factors that might include mental or emotional issues (such as dementia), cultural or language barriers, and personal issues (such as substance abuse).
If a physician concludes that a patient may not be competent to give an informed refusal based on the circumstances, he or she should consider involving the hospital risk manager for further guidance or contacting a family member to ask if an advanced directive or a healthcare power of attorney has previously been executed. In the chart, document all conversations with the patient (including the reason for believing that he or she may not be competent) and with the facility administrator or family members to minimize the potential for subsequent surprise, anger, or litigation.
In the event of litigation, the medical record is one of the most important components of the defense. Regardless of the medical record format, document the details of all informed consent or informed refusal discussions. The documentation should include when and where the discussion occurred; who participated or was physically present; the options, risks, benefits, costs, and possible outcomes addressed; and a notation that the patient’s questions were answered.
Documentation of a refusal should also include the following notations in the patient’s medical record:
- Information the physician gave to the patient concerning his or her condition and the proposed treatment or test. Reasons for the treatment or test should also be noted.
- The patient was advised of the possible risks and consequences of failing to undergo the treatment or test, including the loss of life or limb.
- The physician’s referral to a specialist, including the reasons for the referral and the possible risks of not seeing the specialist.
- The patient’s refusal of the treatment/testing plan or advice. In this circumstance, consider asking the patient to sign a specific refusal form. (See our sample form, “Refusal to Consent to Treatment, Medication, or Testing.”) Although a form is optional, it offers physicians the strongest protection against subsequent claims alleging a lack of informed consent.
The paternalistic approach to providing medical care has given way to a much more patient-centered environment in which patients enjoy greater autonomy and participation in the delivery of professional services. Increased communication, enhanced understanding of treatment options and the risks of refusal, and improved documentation may all help reduce the risk of professional liability claims when the patient declines to follow your recommendations.