Universal consent forms raise questions of ethics

Using a universal consent form for multiple procedures anticipated for a patient can nearly double the consent rate for most of the invasive procedures performed in an intensive care unit (ICU), according to researchers in Chicago. But observers say the tactic may violate the spirit of the informed consent process.

The suggestion for such a consent form arose in one of the first detailed studies of the informed consent process in an ICU. In that study, the researchers found that the rapid, unpredictable pace of critical illness combined with the inability of very sick patients to make decisions took a serious toll on patient autonomy. When caregivers relied on standard practice, patients or their proxies had the opportunity to consent to or refuse invasive procedures recommended by their doctors only 53% of the time.1 A large fraction of procedures were performed with implied consent because they were deemed necessary by caregivers.

After the authors devised a universal consent form that explained the risks and benefits for the eight most common ICU procedures and presented the options to patients and families as soon as they were admitted to the ICU, they were able to raise the consent rate to 90%, says Jesse Hall, MD, professor of medicine and chief of pulmonary and critical care at the University of Chicago.

"Precise, widely accepted guidelines for obtaining consent in the ICU environment do not exist," Hall says. "Physicians can’t even agree on which procedures require consent. Our goal was to begin to standardize the process and to find ways to make it more effective."

The study was performed in a 16-bed ICU at a university hospital. For two months, from Nov. 1 to Dec. 31, 2001, the researchers charted the consent rate for invasive procedures. They found that only 53.1% of the time (155 out of 292 procedures) did patients have the opportunity to consent to or refuse treatment. ICU physicians attributed their inability to get consent to the emergent nature of the procedure and the lack of an available proxy when needed.

Consent rates higher with universal form

In the intervention period, March 1 to April 30, 2002, a universal consent form that explained the risks and benefits of each procedure was presented to patients and families soon after they came to the unit. For this period, the consent rate increased to 90.5%, with consent secured in advance for 308 out of 340 procedures. "This is a far more acceptable level of patient participation," Hall says. "It enabled us to be more responsive to family wishes and also allowed patients themselves to make more decisions."

Before the universal consent form was introduced, patients made their own decisions in only 28.4% of cases. Proxies made the rest. Using the comprehensive form allowed the patient to make the call in 34.4% of cases. Comprehension by both patients and proxy decision makers was high and did not differ between the two periods. "We have shown that education of clinicians, patients, and proxies regarding the process of informed consent can improve this process in critically ill patients," the authors conclude.

Eight common procedures

The universal consent form described eight commonly performed procedures: placement of an arterial catheter, a central venous catheter, a pulmonary artery catheter, or a peripherally inserted central catheter, lumbar puncture, thoracentesis (surgical puncture through the chest wall with drainage of fluid from the thoracic cavity), paracentesis (surgical puncture through the abdominal wall with drainage or aspiration of fluid from the abdominal cavity), and intubation/mechanical ventilation.

Form may be practical, but at what expense?

Another researcher who has studied consent forms extensively says the University of Chicago proposal may be well intended but it seems to violate the spirit of the informed consent process. Melissa Bottrell, MPH, project manager at the National Center for Ethics in Healthcare at the Veterans Administration Puget Sound Health Care System in Seattle. Bottrell says the universal consent form may solve a practical problem for clinicians but does not benefit the patient.

"It seems like they’re trying to put a solution on the problem without realizing what the real problem is," she says. "They’re saying they don’t get documentation of consent, so that’s in essence a legal problem, a lack of consent. So trying to solve that with this form, but I worry that the real effect is that they get a piece of paper without going through a true process of informed consent."

Bottrell points out that the situation may change significantly after the universal consent form is signed. The patient’s condition may worsen or improve, for instance, or relatives may simply change their minds about what should be done for the patient.

Though the University of Chicago researchers say they urge clinicians to consider such a change in circumstances and repeat the informed consent process if necessary, but Bottrell says she doesn’t think that would happen much in a real world environment. Once the consent is obtained, she says, clinicians are unlikely to consider whether it is still valid. "Informed consent is about shared decision making," she says, "but having this form signed before there might be a change in the patient’s decision-making status, or a change in the patient’s condition that would affect that decision, essentially allows the clinician to opt out of that shared decision-making process because they already have documented consent."

"There is coercive power with the clinician in the ICU saying we might need to do these eight procedures and want you to sign off on them now," Bottrell continues. "It puts the patient in a situation in which it seems shared decision making will be less likely to happen rather than more likely, which is not the goal of a consent form in the first place. It solves some of the practical problems with obtaining consent but it doesn’t fulfill the sprit of obtaining informed consent."

Bottrell notes that the proposed universal consent form differs in one important way from consent forms used up front for multiple procedures such as weekly dialysis treatment. In those situations, the patient’s condition is unlikely to change significantly during the period covered by the consent form, she says.

Other consent forms also can be faulty

Even the standard consent forms used more commonly in all health care settings might not be as good as you think. Bottrell’s previous research suggested that many of them amount to nothing more than a waste of time and may actually create more of a litigation problem than they could ever prevent. She and her colleagues were amazed at how poorly most informed consent forms achieve their goals. Bottrell says most of the forms are "a waste of paper. They’re worthless."

Risk managers may have to take some responsibility for that, she says. In an effort to protect the provider, most consent documents are written so much from the hospital’s perspective that they do not even make a good-faith effort at informing the patient, Bottrell says. They are written so clearly with the hospital’s interest in mind that they often become a complicated legal document no typical patient could possibly understand, she says. When that happens, the document becomes nothing more than a legal formality, and Bottrell says she is surprised that courts do not reject them more often than they do.

When the document reaches that level of legal complexity and one-sidedness, it achieves nothing, she says. At that point, it does not even achieve protection for the hospital and may backfire in that regard. "When it is so clearly written from the hospital’s perspective, the form becomes worthless. It just doesn’t function as intended," she says. "All they do is create more paperwork and lead the patient to believe that you’re only out to protect the hospital rather than inform the patient. That can lead to some real animosity if things go wrong later."

Unfortunately, Bottrell is not talking about just some informed consent forms. She’s talking about nearly all the forms currently used by hospitals. In her recent study, Bottrell and her colleagues analyzed 540 informed consent forms from 157 hospitals nationwide, and they found that "most forms did not meet accepted standards of informed consent or patient physician interactions."2

They examined the forms to see if they included the basic elements of informed consent — nature of the procedure, risks, benefits, and alternatives — as well as features that might enhance physician-patient interactions and encourage shared decision making. They found that only 26% of the forms included all four basic elements of informed consent, 35% had three, 23% had two, 14% had only one, and 2% had none of the elements. Ninety-six percent of the forms indicated the nature of the procedure. Seventy-five percent of the forms authorized treatment, and 59% appeared to protect the hospitals and caregivers from liability, but only 40% clarified information about the procedures and only 14% aided patients in the decision making.

State laws can prompt better consent forms

Bottrell found that forms from the states that actually require all four informed consent elements in the form were no more likely to have them. The researchers noted that many of the forms included phrases such as "I certify that no guarantee or assurance has been made as to the results that may be obtained," making the tone of the form more like a waiver to get the hospital off the hook. "Such a construction may even reduce the likelihood of a quality informed consent process by increasing the perception of physician or institutional self-protection over patient care, and causing patient anxiety an annoyance from having to sign another piece of paper," the researchers concluded.

The irony, they say, is that trying to use the forms that way does not actually provide much legal protection for the hospital but it most definitely thwarts any effort at informing the patient.

Bottrell acknowledges that the informed consent document often does not represent the entire informed consent process in a health care setting. Ideally, the doctor and the patient have had a careful, meaningful conversation before signing the form, which some risk managers would argue is only an administrative record of the actual informed consent process. That may be the case sometimes, she says, but a faulty informed consent document can unravel much of the work done by the doctor by making it seem that the hospital wants a free ride if anything goes wrong.

A worksheet for patient and doctor

Bottrell and her colleagues recommend a wholesale revamping of the informed consent process so that it revolves around a worksheet that the patient and doctor can work through together.

Rather than anything resembling a legal document, the worksheet should be a form that they can use to facilitate a personal discussion about the medical treatment, with plenty of questions prompting the patient to respond. Questions could include phrasing such as "This is a reasonable decision for me because . . . ." with the patient filling in the rest as a demonstration that he or she has been adequately informed.

She also suggests that the same list of eight common procedures used in the University of Chicago universal consent form could be used as a checklist to prompt clinicians during the informed consent process in the ICU. That would be a better solution than asking for universal consent up front, she says.

"The problem is they’re trying to solve the problem of obtaining consent in emergency situations by just showing proof of documentation," she says. "You could just as easily have the same conversation without necessarily having the form signed. If it’s true that the physician does anticipate a number of procedures, you can have that conversation and use the checklist to remember to check them off and talk about them. It can be good to address these issues up front all at once, but not obtain consent."

References

1. Davis N, Pohlman A, Gehlbach B, et al. Improving the process of informed consent in the critically ill. JAMA 2003; 289:1,963-1,968.

2. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: Facilitating quality patient interaction. Arch Surg 2000; 135:26-33.