A large percentage of the health care world tends to associate malpractice lawsuits with disastrous clinical outcomes. In other words, something terrible happens in the emergency department, and, as a result, the practice gets sued.
In fact, there is little correlation between the severity of treatment-related adverse events and incidence of malpractice lawsuits. According to risk management experts, patients who sue tend to be more dissatisfied with the interpersonal relationship with their physicians rather than the quality of their care. Studies have found that one of the most common reasons for legal action is patients’ perception that providers are withholding explanations or information. Thus, it is vital that health care providers make certain that patients understand the details and nuances of their diagnosis and care, including the decisions they make as treatment progresses. The common legal term for this is informed consent.
To enhance a practice’s legal protection, risk managers suggest supplementing informed consent with what is known as shared decision making (SDM).
SDM is a bidirectional doctor-patient interaction meant to achieve a more legally and clinically robust decision than informed consent alone. The language must be simplified to about a sixth to eighth grade reading level. Options are discussed, not just read in a document. Risks, benefits, side effects, and alternative therapies are described. What really differentiates SDM from informed consent is that it assesses patients’ values and preferences and uses decision aids.
Decision aids are tools such as videos or flash cards that translate the complex legal language of informed consent documents into concepts that can be easily understood by patients with limited educational backgrounds or verbal skills.
Applicability and Physician Buy-In
Patient decision making has always played a large role in health care. In fact, it is estimated that about one-third of all medical care can be deemed what risk managers call “preference sensitive,” according to Benjamin Moulton, JD, of Informed Consulting, LLC, in Boston, who has spent decades studying these issues as a lawyer and researcher. This encompasses fields and procedures in which patients have multiple options, such as breast cancer, coronary artery disease, prostate-specific antigen testing, spinal surgery, and total joint hip and knee replacement surgeries.
Although surgeons tend to have a greater risk for lawsuits than office-based physicians, informed consent issues do extend outside the surgical setting. “Currently, the largest use of SDM is in primary care and the choice of referral to a specialist for treatment,” says Karen B. Domino, MD, MPH, professor and vice chair for clinical research at the Department of Anesthesiology and Pain Medicine at the University of Washington in Seattle.
The average SDM session does not take long, according to Domino—only about 5 to 10 minutes, as long as the patient has already reviewed the decision aid material. But many physicians see no need for it, she adds. “Health care provider buy-in is key and a significant issue in the broad implementation of SDM, as many physicians resist it. They often erroneously believe they already provide adequate informed consent.”
Implications of Widespread Adoption
Perhaps because adoption of SDM protocols by the medical field is uncommon, there have been occasional attempts to codify it into law. For example, in 2007, the state of Washington passed legislation that designated proof of SDM as prima facie (rebuttable) evidence of informed consent during a lawsuit. Although other states studied the issue, none followed suit.
More recently, Medicare has begun to require SDM as a condition of coverage. In August 2018, implantable cardioverter defibrillators (ICDs) became the third procedure since 2015 to require SDM with the patient.
Theoretically, SDM has the potential to garner bipartisan political, legislative, and regulatory support. In addition to some evidence suggesting that SDM might improve outcomes by making patients more knowledgeable about their conditions, it might also provide a means of curtailing costs.
There is also the matter of full disclosure of co-pays, which, in a world of high fees and drug prices, can themselves be financially devastating. “There are studies that suggest that many cancer patients have been forced to declare bankruptcy even when they are fully insured,” says Moulton.
“In the end, we are all patients,” he concludes. “And we should all strive to go through life fully informed about our medical treatment options.”
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