The informed consent process is intended to protect patients and physicians both.7 Legal doctrine, including hospital accreditation standards, ethical theories, and perspectives on the physician-patient relationship, emphasizes the importance of full patient comprehension regarding treatment. But many hospitals do not use forms that contribute to that objective. In a study by Bottrell and colleagues of 540 forms from 157 hospitals nationwide, 96% indicated the nature of the procedure for the patient; however, only 26% of forms included all four elements of informed consent: procedure, risks, benefits, and alternative treatment options. Thirty-five percent included three of four elements, 23% provided two of four elements, 14% listed only one element, and 2% contained none of the elements.
In general, the investigators concluded, the forms appear to be designed to authorize treatment or protect hospitals and caregivers from liability rather than to help patients clarify information or make decisions. Even hospitals in states that have statutes requiring institutions to include all four elements on their forms were no more likely to do so than those in other states. Fewer than 40% of forms were found to support models of shared decision making, the basis of patient autonomy and the overarching intention for informed consent.
“Generally … informed consent forms are seen as mere documentation vehicles, and perhaps as legal protection, regardless of whether the process of informed consent was successfully accomplished or of minimal quality,” this study’s authors wrote, and because patients are not blind to the intentions of these forms, this may add to their discomfort.7 Most forms, the authors concluded, are insufficient because the language used does not accommodate low health literacy or because there are no graphic features.
On the other hand, “informed consent can sometimes get very awkward and cumbersome,” says William Jacott, MD, special advisor for professional relations at the Joint Commission on Accreditation of Healthcare Organizations, St. Paul, Minn., for the past five years and liaison to SHM for the past two. Some institutions or organizations interpret Joint Commission and other legal standards excessively, he says, “and I’ve seen 10-page consent forms, which just overwhelms the patient, let alone the doctor. So an over-interpretation and overkill need to be avoided.”
Conclusion: Communication and Documentation
The ways in which hospitalists can avoid the pitfalls of faulty informed consent conversations include close communication with surgeons as well as other colleagues.
“We have a great tendency to communicate via the medical record,” says Dr. Jacott, and if a patient’s co-managers (the hospitalist and subspecialist) don’t communicate, “one might assume the other has already done [informed consent], and nobody does it.”
He has also seen instances in teaching hospitals in which both the surgeon and the hospitalist incorrectly assume that the house staff has acquired informed consent.
Nurses can also help hospitalists ensure that patients are comfortable with their treatment choices. “Nurses often have more firsthand information about when patients are confused or scared or dubious or are somehow being coerced or manipulated into consenting to something,” says Dr. Rich.
Hospitalists should also avoid making assumptions about the completeness of their colleagues’ discussions with patients and should look for clear documentation as well as record their own. “Some subspecialists play fast and loose with informed consent,” Dr. Rich says, “and [may] resent a medical staff colleague who takes it seriously and attempts to hold them accountable for really doing it right. And for the hospitalist, that’s where it is critical that their institution stand behind them.”
A hospitalist’s responsibilities with regard to informed consent also include ensuring that the patient’s consent is truly informed. Using the teach back method, allowing time for the patient to ask questions and voice concerns, and including all four elements of informed consent on the patient’s consent form are just some of the ways the hospitalist can play an essential role in the continuum that is informed consent.