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 and dental 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 healthcare provider’s advice and achieved a better outcome. A better 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 condition using terms that are readily understandable. Discuss the available treatment options along with the associated benefits, risks, anticipated costs, and short-term and extended prognoses. Finally, outline the consequences of failing to undertake any treatment. Provide the opportunity for patient questions to be asked and answered.
The healthcare provider ordinarily 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. The statutes governing advanced practice clinicians are currently being revised in many states. In the event that an independent advanced practice clinician is involved in the treatment, it is recommended that you consult with the law in your jurisdiction regarding how the applicable statutes may affect the consent process.
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 discussion in advance decreases potential misunderstandings, disappointment, surprise, or even anger if an undesirable result occurs. For a more detailed discussion of informed consent, see our article “Informed Consent: Substance and Signature.”
Informed Refusal Process
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 factors that can be resolved, such as the patient’s treatment options, what the treatment entails, costs, or payment methods. Partner with the patient to overcome treatment barriers when possible.
The healthcare provider should assess and document the patient’s capacity to understand the information and to make a reasoned decision based on the facts presented. The provider’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, or personal issues (such as substance abuse).
If the result of the assessment is that the patient may not be competent to give an informed refusal, the provider should consider involving the facility risk manager (if applicable) for further guidance or contacting a member of the patient’s family to ask if an advanced directive or a healthcare power of attorney has previously been executed. Document all conversations with the patient, facility risk manager, and family members (including the reason for believing that the patient may not be competent).
In the event of litigation, the patient record is one of the most important components of the defense. Regardless of the 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 record:
- Information the provider gave to the patient concerning the patient’s 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, if appropriate.
- The provider’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 providers the strongest protection against subsequent claims alleging a lack of informed consent.
The paternalistic approach to providing 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. (See our article “Best Practices in Patient-Centered Care and Shared Decision Making.”) Increased communication, enhanced patient understanding of treatment options and the risks of refusal, and improved documentation may all help to reduce the risk of professional liability claims when the patient declines to follow recommendations.
For guidance and assistance in addressing any patient safety or risk management concerns, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.