Advance directives guide decisions for dementia
Patients' preferences could be more clear
(Note: In the May issue of Medical Ethics Advisor, the psychiatric advance directive (PAD) was examined as a means of permitting patients with mental illnesses to, when they are competent, direct the care they will receive when they are not competent. In this issue, research advance directives (RADs) are suggested as a solution to ethical issues present when dementia patients participate in research.)
When research calls for recruiting patients with Alzheimer's disease and other forms of dementia, it's often hard to know whether patients would want to participate had they been able to make the decision themselves.
Even proxies who have been chosen to make those decisions can be uncertain whether a particular type of research should be pursued.
Some experts in geriatric research have suggested research advance directives (RADs) as a possible solution to this problem.1
Like other types of advance directives, an RAD gives the patient an opportunity, while still cognitively capable, to make decisions about future care. In this case, the patient could detail not just whether he or she would want to participate in research, but the types of research or interventions he or she would permit.
"A person with diminished and failing cognitive capacity is different from other patients," says Carol B. Stocking, PhD, director of research at the MacLean Center for Clinical Medical Ethics at the University of Chicago.
"With other patients, as a decision needs to be made, you can talk with them then. When they become very ill, they become more analogous to people who can no longer carry on such discussions and make decisions."
In the early stages of dementia, patients are able to make enrollment decisions. As they lose decisional capacity, proxies or surrogates give consent and patients give assent for enrollment.
Stocking says the RADs would only provide guidance in the later decisions, which still would require consent from the proxy and assent from the patient.
While advance directives currently aren't used extensively in research, organizations such as the Alzheimer's Association (www.alz.org) have suggested them as a way to get the greatest possible input from subjects with dementia while they still have decisional capacity.
Constantine G. Lyketsos, MD, MHS, professor of psychiatry and director of the Memory and Alzheimer's Treatment Center at Johns Hopkins University and Hospital in Baltimore, says that RADs can be a useful tool for certain types of dementia research.
"Conceptually, I think it is a terrific idea," he says. "The time it really becomes useful is if the person is no longer able to make a decision. The real utility of a research advance directive is for research in advanced stages of the disease."
Both Lyketsos and Stocking say such directives wouldn't negate the need for a proxy or surrogate, but might give more direction as to the patient's intentions regarding research.
But they differ on the form the directive might take.
Stocking says that based on her experience, research advance directives should be very specific about the types of research a patient is considering. If possible, a patient could state willingness to be in a particular kind of study later in the progression of his or her disease.
"I would say it should be geared to the specific types of projects, and not be a general, broad consent to participate in future research," she says.
Lyketsos, on the other hand, sees greater utility in a more general research advance directive, particularly since the proxy's consent still would be obtained.
He says it's possible to outline the various types of research a person might be recruited for — genetic research, brain imaging research, etc. — but a proxy still would have to decide whether the study in question fits those general descriptions.
"There's still going to need to be someone at the time making some sort of decision," he says. "In a sense, a research advance directive is useful simply by saying that the person is generally inclined to be in research studies. That's the major utility for me.
"It says, 'I think research is important and I'm accepting of the fact that a surrogate might decide for me and these are the surrogates I would wish to appoint to make decisions,'" Lyketsos says. "That I actually think is very useful."
Planning ahead together
Stocking and her colleagues have researched a model of research advance directive that involved patients and their proxies being interviewed separately about whether to give consent for several hypothetical research projects, ranging from a low-risk blood draw to a very high-risk implantation of cells in the brain. The duos of patient and proxy then met together to discuss their choices and see where they differed.
"The patient might say, 'Yes, I would be in this research,' and the proxy might say, 'Oh, but I wouldn't have agreed to it,'" Stocking says. "And they would talk, and often one would persuade the other to their way of thinking.
"We thought of it not only as a model for an advance directive, but [also] as a way of getting them to talk about the future and future research so the proxy would know better how to guide the patient or if it ever came to that, to make decisions on behalf of the patient," she says.
During the process, half the patient-proxy duos created a Planning Ahead Together (PAT) document, which, while not legally binding, was an attempt to explain and document their choices. Copies were given to the duos and were placed in the patients' files.
Patients and proxies were interviewed immediately after patients were invited to participate in research projects, and again two years after the first interview.
Of the original 149 patients, 41 had been recruited during those two years — 23 who had completed a PAT, and 18 who hadn't.
Interestingly, those who had completed the PAT didn't report any differences from the non-PAT group in the relative ease of the decision or comfort with the decision-making process.
When asked whether the PAT document had been helpful, the majority of patients who answered the question said they weren't sure, but half the proxies who answered the question immediately after having been asked to enroll in a study said yes.
Overruling decisions?
Stocking says the overall number of patients recruited for research during that two-year window was much smaller than researchers had expected. And she notes that the research that was actually proposed to the subjects during that time was also significantly different from the hypothetical research described in the PAT. This may have contributed to the number of patients stating that they weren't sure the PAT had been helpful.
"We thought we were being very thoughtful about the kinds of research that [was] going on at the time we were designing the study, and it just happened that at the centers where we were doing our research, those kinds of studies were not engaged in during the research period," she says. "In fact, they were all very low-risk projects that people were invited into."
It's also possible, Stocking says, that the discussions between patients and proxies that occurred in the study — even among duos who didn't complete the Planning Ahead Together document — made the process easier for everyone and eliminated any contrast between the two groups.
In that case, might simply the act of discussing research ahead of time be as useful as an actual document? "It would be," she says.
Stocking says that much about the patient-proxy discussions surprised her.
"It was less conversational than I had imagined it would be," she says. "They said a little less, but they did talk. I remember one person said, 'I trust you. You can do whatever you want. You can make your best decisions when the time comes.'"
The research did find a small but significant minority of patients who expressed discomfort with their proxy's decision making and who would have preferred to limit the proxy's ability to overrule the choices they made in their PAT.
"Most patients in our study wanted proxies to make enrollment decisions when the time came, even if they had disagreed about enrollment in the hypothetical projects," Stocking says. "But a minority didn't and for them, a research advance directive might help proxies and researchers make the ethically appropriate decision."
Lyketsos says that it might be ethical for a proxy to override a binding research advance directive — say, if the proxy knows the patient no longer can tolerate a procedure he or she once agreed to. But he notes that in some states, advance directives for medical care can't legally be breached.
Reference
- Stocking CB, Hougham GW, Danner DD, et al. Empirical assessment of a research advance directive for persons with dementia and their proxies. J Am Geriatr Soc 2007;55:1,609-1,612.
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