Informed Refusal: An Underutilized Patient Safety and Risk Management Tool

By Eric Zacharias, MD

CASE STUDY

A 58-year-old woman saw her physician on a Friday morning with complaints of worsening, intermittent heartburn occurring over several months. The patient explained the symptoms felt like reflux and were occasionally improved using over-the-counter antacid tablets. She also stated the symptoms worsened

whenever she walked up the stairs in her home.

The physician was concerned that the patient might be experiencing unstable angina mimicking gastroesophageal reflux disease and advised her to go to the emergency department immediately for close monitoring and a cardiac workup.

The patient declined this plan, stating she had several items to do over the weekend, but that she would go to the emergency department on Monday if the symptoms failed to resolve with prescription medications for gastroesophageal reflux. While the physician documented this and his concerns, there was no documentation of his recommendation of seeking an immediate emergency department evaluation or the discussion regarding the risks of delay in evaluation.

The patient experienced a cardiac arrest at home over the weekend. She was resuscitated by EMS and transported to the nearest hospital in critical condition, but died two days after admission. The patient’s family sued the physician, alleging the risks of waiting until Monday were not clearly communicated to the patient, and that the patient would have undergone immediate evaluation had the physician made these risks more clear.

How an "Informed Refusal" Form Helps

This case illustrates a situation where the use of an informed refusal form might have protected the physician from allegations of negligent care and prevented a lawsuit. Though the physician was sure he had the conversation regarding risks around a delay in evaluation, including death, the lack of documentation of this discussion in the chart made the care very difficult to defend in front of a jury.

Using an informed refusal form offers the provider an efficient way to document real-time conversations and recommendations. It is particularly important to use when patients decline provider advice which might result in avoidable, severe outcomes.

Using a physical informed refusal form simplifies the process and demonstrates that the patient was aware of the gravity of the provider’s recommendations. While it’s possible to document the refusal in the medical record as “free text” in the assessment or plan area, a form underscores the provider’s concerns of not following the advised course of action. When a provider requests a patient to sign an informed refusal form, the request and the form may combine as a persuasive “nudge device,” and the patient may reconsider the recommended course of action and change their mind. Anecdotally, patients have stated that they changed their minds based on the physician's high level of concern over their treatment refusal.

Having a patient complete an informed refusal form is not a guarantee that a patient or their family won’t sue after an unexpected outcome resulting from failing to follow a provider's advice. However, informed refusal forms are a strong way to refute arguments that the patient wasn’t informed of the serious, adverse outcomes that could occur if advice wasn’t followed.

Eric Zacharias, MD, is with the COPIC Department of Patient Safety and Risk Management