An effective informed consent process helps both patients and clinicians

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The pressure on physicians to perform procedures is high. As they move from one patient to another, informed consent often becomes required paperwork rather than a real discussion that engages patients and empowers decision-making.

Here is one example of an all-too-common scenario: A nurse gets an informed consent document signed and tells the patient, “Please be sure to ask your doctor any questions you have.” Then, just before the procedure, the physician asks the patient, “Any questions?”

If the patient experiences a complication, this situation could lead to an informed consent lawsuit. Why? Because there is no evidence that the patient was aware of potential risks or alternatives.

An informed consent claim is based on the idea that a patient might not have undergone a procedure had they been aware of the risks involved. The patient’s attorney could argue that a competent physician would have disclosed the risks. Thus, if providers fail to reveal potential complications and adequately document the discussion, they have little hope of defending themselves.

Unsurprisingly, analysis of informed consent claims data since 2018 by Coverys reveals that 70% of the lawsuit allegations were related to procedures/surgeries. More notably, the data highlight that claims aren’t always triggered by extreme circumstances such as death or high-severity injury. Medium-severity injury—defined as a major temporary, minor permanent, or significant permanent injury—accounted for 66% of events and 68% of indemnity paid.

In many states, the limits on economic and punitive damages in such cases are high, reaching the $10 million-$20 million range depending on circumstances. However, with a robust informed consent process, health care providers and organizations gain greater medico-legal protection while simultaneously improving the patient experience.

Strategies to improve the informed consent process

A high-quality informed consent process both empowers patients and protects providers. By equipping patients with all the information they need to become truly informed decision-makers, informed consent conversations help patients fully engage with doctors in care. Consider this scenario:

A 65-year-old patient with a lingering cough six months after an episode of COVID-19 sees her primary care provider. She smoked for several years but quit 15 years ago. He suggests she undergo a chest x-ray. The x-ray shows a few areas of concern, and he orders a chest CT. In the outpatient department, the radiologist informs her of the risk of allergic reaction to the contrast solution, and she signs a consent. The procedure is completed without complications. At a follow-up visit, the provider informs her that four small pulmonary nodules were found on the CT scan.

Because of her smoking history, he encourages her to undergo a lung biopsy. He does not inform her that the incidence of false positives in chest CT are approximately 1:4 and does not give her the option to repeat the CT at the recommended interval of three to six months. She agrees to the biopsies.

After the procedure, she experiences a pneumothorax and is hospitalized. She develops pneumonia and does not survive. The pulmonary nodules were found to be benign. The husband hires an attorney, who argues that had the patient known about the incidence of false positives and the option to undergo follow-up scans, she would have chosen that instead of the biopsies. The jury renders a verdict in favor of the plaintiff and sets the indemnity payment from the physician at $250,000.

Among health systems that do an excellent job with informed consent, most:

• Educate providers about informed consent periodically—not just once.
• Build electronic medical record templates that trigger the informed consent discussion.
• Conduct internal audits for informed consent documentation as part of their physician peer review process.

Even small health care organizations with few risk management resources can take such steps. To incorporate informed consent into the peer review process, for example, medical practices and health systems can create an outline or checklist that prompts peer reviewers to examine whether documentation indicates that providers:

• Talked about the risks and benefits of treatment with the patient.
• Explained alternative treatment options to the patient—including what might happen without treatment.
• Gave the patient an opportunity to ask questions.

Likewise, health systems can coach providers not to pose consent questions in a way that patients can answer with a simple yes or no. For example, rather than ask, “Any questions?” providers should ask patients the open-ended query, “What are your questions about [name of the procedure]?”

Here are six additional ways to fortify the informed consent discussion:

1. Consider the timing — Whenever possible, have the informed consent discussion in the office before the day of a procedure. Having a genuine patient/physician conversation minutes before a procedure is much more difficult.
2. Use plain language — To ensure patients clearly understand their procedures, risks, and alternatives, ask them to explain their understanding of the procedures. Document the procedure’s name in medical and layperson terms on the informed consent form. Better yet, ask the patient to write down the procedure in their own words after talking it over with you.
3. Document the details — In the event of a malpractice claim, documentation that merely states, “risks and benefits discussed” will likely beg the question, “Which risks and benefits?” Although many organizations write common risks and benefits into consent forms, a better approach is for providers to document something like, “We discussed possible risks of [x, y, and z]. The patient expressed that she understood. We also discussed alternatives to treatment including [x, y, and z], and the patient chose to…”
4. Document informed refusal — In cases where patients refuse treatment, document “after discussion of risks, benefits, and alternatives, the patient made the choice to refuse treatment at this time.”
5. Be proactive — Clearly document if the procedure is one where it might become evident after starting that additional procedures are necessary. For example, the consent form for colonoscopy could state, “Additional procedures to include biopsy or polypectomy may be performed as necessary.”
6. Don’t forget anesthesia — If sedation or anesthesia is used, review a separate consent form with the patient that specifies the risks and benefits of the anesthesia that will be used during the procedure.

A win-win conversation

Would a reasonable patient in the plaintiff’s position have chosen not to undergo the procedure if informed of the risk? That’s what a plaintiff’s attorney must prove in an informed consent claim.

Informed consent is a pre-procedure legal and ethical obligation, but it’s also an opportunity to give patients control over their health care. Self-determination is key. By ensuring the informed consent process genuinely empowers patient choice, health systems may decrease legal risks even as they increase patients’ satisfaction.

Solveig Dittmann, RN, BA, BSN, CPHRM, CPPS, is a manager of risk management and analytics at Coverys, a medical liability insurance and risk management company.