DR. NICHOLS is the vice president for medical services of the Cabrini Eldercare Consortium in New York City, which includes two skilled nursing facilities, three home care agencies, two adult day care programs, and a senior housing complex. He invites your questions for possible discussion in this column.
Dear Dr. Jeff:
I was approached yesterday by a respected neurologist at our local hospital. He is participating in an institutional review board–approved, multicenter trial of a new medication for the treatment of Alzheimer's disease. He proposed that residents of our nursing home be enrolled in the study and that I join as a coinvestigator. The study is being sponsored by the pharmaceutical manufacturer, and the nursing home would receive an appropriate reimbursement for the associated costs. We have never done research before, although we have occasionally cooperated with an ongoing study when a participant became one of our residents. What should I say?
Dr. Jeff responds: Physicians who care for the frail elderly have complained for years that the medicines we use in treatment have never been tested in our patient population. The vast majority of drug trials enroll healthy patients or patients with no comorbid conditions, in anticipation of approval by the Food and Drug Administration. If the FDA cooperates, it will authorize the drug's use in all patients, including frail seniors who have multiple medical problems and are taking many other prescription and nonprescription medications.
Certainly the neurologist is to be commended for even considering testing this medication on the population that might ultimately use it.
The AMDA Foundation created a Long Term Care Research Network in 1999 to encourage clinicians to participate in research. The network has helped practitioners like you to develop the skills required to initiate studies in their facilities and to prepare scientific publications. It also has linked long-term care practitioners with established geriatrics researchers.
These efforts have yielded several significant publications, but physicians who practice in long-term care remain starved for data to support the care they provide. Multiple barriers to nursing home research persist, as you'll probably see if you decide to proceed with this research proposal.
The simplest studies involve retrospective data analysis, such as reviews of charts and minimum data set records: Do most falls occur during the late afternoon? What is the prevalence of rheumatoid arthritis among residents in skilled nursing facilities? Do dementia residents with agitation decline more rapidly than those with depression? What is the average life expectancy of a nursing home resident with newly diagnosed pancreatic cancer? These are all questions that might be answered by existing data from multiple facilities.
One barrier to performing such studies is that nursing home records are massive aggregations of paper scattered with relevant information. In addition, studying multiple facilities, which is often necessary to achieve statistically significant results, complicates the work further.
Many quality-improvement studies are really small research projects whose goal is to identify variables that affect resident outcomes: Does one shift, or one unit, have more falls? What makes that shift or unit different? Can the frequent fallers be identified by diagnosis? Do falls predominate among new admissions unfamiliar with a new environment or among long-stay residents who are becoming frailer?
Data are collected and analyzed. Typically, the facility attempts an intervention (perhaps an in-service or a new form) based on the data, and then monitors the outcome. If an intervention is begun on one unit or one shift, the others essentially represent a control group. Unfortunately, many facilities would be horrified to be told that they were doing interventional research. The AMDA Foundation/Pfizer Quality Improvement Awards were established to encourage the development of these studies and their dissemination.
It Won't Be Easy
The culture of long-term care has often been unfriendly to research. The appropriate concentration on the needs of each resident sometimes appears to run contrary to the scientific needs of the community at large. Staff may resist what they perceive as “their” residents being used as “guinea pigs” by academics. Staff may resent the extra testing often involved in a well-designed research project, even if it is no more than routine laboratory tests.
Obviously, the support of the administrator is an absolute necessity for any research project, particularly if the study has any financial or regulatory implications. The director of nursing and social work staff also should be involved. It is rarely if ever advisable to proceed without these professionals' endorsements. Further, the entire interdisciplinary team should be consulted about the project in advance and given an opportunity to provide input on potential risks and benefits for any particular patient to participate in the study and any implications for individuals' care plans. The team should not be broadsided.
Researchers in the United States have experienced significant difficulty enrolling participants for a wide variety of potential research studies. A recent front-page article in the New York Times referenced cancer researchers who had obtained federal funding for clinical research but then couldn't secure enough study subjects. Families or guardians of elderly residents may oppose participation because an individual is “too old” or “too sick.”
Studies designed for general populations often include exclusions that make participation by nursing home residents virtually impossible. My facility was approached to participate in a very worthy study concerning renal function in the elderly. Study exclusions included any history of cognitive impairment, psychiatric illness, or use of a nonsteroidal analgesic or ACE inhibitor. In a 240-bed facility, this left one potential participant. He declined to even read the study materials.
A Special Population
Another barrier to nursing home research is the vulnerable nature of our resident population. Because of their multiple needs, nursing home residents are dependent on the facility and staff for assistance with vital activities. Residents and their designated representatives may be anxious that a refusal to participate might lead to retribution.
Even though institutional review boards approve studies and informed consent procedures, these bodies are generally not familiar with the special conditions in long-term care. The medical director is responsible for ensuring that necessary protections are in place, with both verbal and written communication, so that the informed consent process reflects genuine consent.
The particular study proposed to you represents some special issues that should be considered prior to any decision to participate. First, it is sponsored by a pharmaceutical company. Although drug manufacturers are no worse than other for-profit corporations, the nature of their business may at times interfere with high-quality scientific research. It is important to identify exactly what benefit this proposed medication might have over drugs already on the market.
The history of drug development suggests that many new medications are minor modifications of old drugs. These “me too” drugs are ostensibly being introduced because they have longer or shorter half-lives, different delivery systems, or perhaps different allergy profiles. But above all, they are an opportunity for a manufacturer to cash in on an existing market. In a capitalist economy, this profit motivation is considered legitimate, but it may not represent an appropriate use of your valuable time and skills.
Second, the study involves research with dementia patients. Most nursing home residents with diagnosed cognitive impairment would have insufficient capacity to give consent to participate in a research study. Such consent would require knowledge of each person's medical condition and some insight into his or her impairments, as well as an ability to evaluate the risks and benefits of participation.
There is no consensus regarding the standards for obtaining consent for research on dementia patients. Few patients have advance directives that address this issue. Although a health care proxy might have legal authority to sign consent for a medication or testing, many ethicists question the process by which one person gives consent for another. Many would argue that a proxy should not give consent unless the research offers a reasonable potential benefit to that particular patient. Thus, a proxy could consent to this study if the medication might dramatically help a dementia patient with the condition, but not consent if the medication is for a condition the patient doesn't have.
Thorny Issues
Some scientists and ethicists say that the nature of “substituted judgment” that underlies proxy decision making can never apply to research. Others would argue that such restrictions deny dementia patients one of their basic human rights, the right to help others. Clearly, the facility and all those involved in the research project need to be in agreement as to the standard that will be used.
The participation of nursing homes in drug research raises thorny questions with no right answers. It is easy to say no, but then how will potentially helpful medications ever be developed or tested? How can the care of frail seniors be improved if interventions aren't tried and evaluated? Although this particular study may not prove ideal for your facility, going forward in some way is clearly necessary. It is important to be fully aware of the issues and to arrive at a decision consistent with the values of your nursing home and the community you serve.
FULL TEXT