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Statement on Improving Care at the End of Life: Research Issues by Patricia A. Grady, Ph.D.
Director, National Institute of Nursing Research
National Institutes of Health
U.S. Department of Health and Human Services

Good afternoon, Mr. Chairman and members of the Committee. It is a pleasure to be here today as Director of the National Institute of Nursing Research (NINR) to discuss a topic of importance to all of us – how to ensure that the end of our lives is as free of pain and other symptoms as possible; that this final phase is one of comfort and dignity; and that our choices of the type and extent of care are respected and implemented.

I am here today before this Committee because the National Institute of Nursing Research (NINR) is the lead Institute within the National Institutes of Health (NIH) responsible for coordinating research on palliative care at the end of life. Whether palliative care research involves conventional or complementary approaches, its purpose is to add scientifically verified evidence to our base of knowledge about appropriate and compassionate health care. Research on end of life focuses on clinical management of physical and psychological symptoms, communication, ethics and clinical decisionmaking, support of caregivers, and delivery of care. These scientific investigators come from many disciplines rather than any one discipline and often work in teams. The collaborative goal of this research is to discover how best to promote quality of life leading to a peaceful death.

Today I will discuss how end of life issues are receiving increased research and public policy attention. Recent trends and NIH research responses to these trends will be summarized, including complementary therapies. And finally, I will identify future opportunities and challenges.

End-of-life concerns were highlighted in a 1997 report by the Institute of Medicine (IOM), "Approaching Death: Improving Care at the End of Life." This report recommended a change of focus when a patient is considered to be in the final phase of life -- from very aggressive conventional care to one of palliative care, which stresses comfort and quality of life acceptable to the patient and family members. In addition, the Robert Wood Johnson Foundation funded the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) which also identified some disquieting facts. Serious pain, common in most terminally ill patients, was undertreated; discrepancies existed between patient desires and actual treatment; and almost half of physicians studied were unaware that their patients’ preferences were "do not resuscitate." Furthermore, there were many reports from experts that the public was generally not satisfied with care at the end of life. The IOM stated that while technological advances in health care "continue to increase life expectancy, attention to the quality of life and to the inevitable experience of dying has not kept pace."

National trends point to the need for research in the end-of-life area. The aging and growth of the population predict an increase in the prevalence of chronic illnesses. More than 2 million Americans died in 1998, most from chronic illness that they had endured for a long period of time. More than 70% of deaths occur in those over 65 years of age. Furthermore, a shift is taking place from patient care in the hospital to family care in the home, which presents a special challenge for family or friend caregivers. Such caregivers need help with learning health care delivery skills, problem solving, and use of community-based services.

The IOM and SUPPORT study results provide a basis for the research being undertaken by NINR and other researchers. For example, families report that clinicians underestimate pain levels and other symptoms of patient distress. Families also report distress that some clinicians view the death of their family member as a failure. Patients report distress caused by abrupt changes in settings, such as when they are discharged from the hospital to a nursing home. Patients without health insurance are likely to use expensive hospitalization for symptoms that could be managed by hospice or home health nurses.

Soon after the IOM report was published, NINR convened a research workshop to address symptom management and other issues of terminal illness. The meeting, "Symptoms in Terminal Illness: A Research Workshop," was cosponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute of Drug Abuse (NIDA), and the then Office of Alternative Medicine (OAM). Palliative care experts and basic and clinical scientists involved in end of life issues were convened to assess the state of the science in this area and make recommendations for research. The workshop focus was on major symptoms of distress, including pain, dyspnea (difficulty breathing), cognitive disturbances, and cachexia (muscle wasting and weight loss). The report emphasized the importance of intervening appropriately in the dying process to maximize quality of life at the very end of life.

Because of NINR’s research experience and expertise in the key areas of end of life and its history of collaborative effort, NINR was designated as the lead to coordinate NIH research efforts. NINR issued a program announcement, in collaboration with NCI, NIAID, NIMH (National Institute of Mental Health), and OAM. The request was made to stimulate integrative, multidisciplinary research programs in basic and clinical areas to address the constellation of symptoms at the end of life across disease conditions.

Earlier this year NINR initiated a Request for Applications (RFA), which was cosponsored by seven other NIH components and the Agency for Health Care Policy and Research (AHCPR). The RFA was issued to generate scientific knowledge leading to improved care for those at the end of life. Twelve grants resulting from this RFA have just been funded -- the majority by the NINR. Let me briefly describe some of these new and ongoing studies.

In the behavioral area, NINR researchers are testing interventions for cancer pain, such as guided imagery, in which patients imagine, for example, their immune cells attacking a tumor; cognitive restructuring, where patients can put an unpleasant experience in a less stressful context; and relaxation techniques. Guided imagery is also being tested to reduce postoperative pain in children, in combination with analgesia, and to determine which patients with cancer pain will benefit from this technique. Certain patients may be more receptive than others.

Self care, increasingly important to the public in managing chronic illness, is also relevant at the end of life. In studying end of life patients with congestive heart failure and chronic obstructive pulmonary disorder (COPD), researchers are analyzing the use of acupuncture, massage therapy, vitamins, herbs, and nutritional supplements, in addition to conventional care.

Technology has both positive and negative effects on end of life. Research is underway to investigate the use of life support technology, especially mechanical ventilation, in older individuals. The research study is designed to learn which aspects of maintenance and withdrawal of life support technology are considered problematic and why. Also under investigation is how decisions about life-prolonging technologies are influenced by hospital routines. Another study addresses the positive effects of technology through a computer intervention called Tele-Care for caregiver spouses of patients at the end of life. This intervention will be evaluated to ascertain effects on depression, social support and personal growth of Caucasian and Hispanic caregivers. Information gained from these studies can help guide us in providing culturally sensitive end of life care.

Models of ethnic and culturally sensitive variations of interventions, such as the one just mentioned, are needed for health care at the end of life as much as they are at all other times of life. For example, investigators are studying ethnic differences in African American and Caucasian approaches to decisionmaking, treatment preferences, and family caregiver satisfaction with end of life care for their ill family members. The burden and health of caregivers, as well as their bereavement, are also under study. Decision making, particularly regarding enhancing quality of life by tailoring health care to patients’ wishes, and use of advance directives, is the focus of another newly funded study being carried out within a managed care environment.

In other ongoing research supported by the NINR, I would like to provide two promising examples. A study receiving national attention earlier this year was one in which a jaw relaxation technique and music therapy, separately or together, when combined with the usual pain medication, significantly reduced pain following major abdominal surgery. This study was published in the may issue of PAIN. The finding is encouraging because it is an example of a novel approach to acute pain management. Better management in both acute and chronic pain that effectively decreases the use of pharmacological agents has benefits at the end of life.

Distinguishing emotional triggers of dyspnea from physical ones is important in determining the best treatment for dyspnea at the end of life. NINR-supported research indicates that patients can differentiate dyspnea caused by distress and anxiety from dyspnea stemming from physical causes. This distinction will help in the selection of the most appropriate therapies.

Although NINR funds additional studies that involve either end of life or complementary therapies, the previous summary provides representative examples. Let me now turn to a discussion of research in other NIH institutes that addresses the central theme of this hearing.

The Warren Grant Magnuson Clinical Center

The Clinical Center is responsible for patients enrolled in approximately 900 active clinical research protocols and offers a wide range of support to meet critical patient needs. The Clinical Center will soon initiate a clinical program that will provide state of the art pain management, symptom control and palliative care to patients. The program is multidisciplinary and will have active patient and staff education and clinical research components. A fellowship training program will be developed as the program matures.

The Department of Rehabilitation Medicine of the Clinical Center provides support for patients with chronic pain – offering a variety of complementary pain alleviation techniques to reduce the impact of pain and increase functional independence. Examples include instruction in pain relief strategies, maintenance of a pain journal, and weekly classes and support group meetings focused on relief of pain. Nonpharmacological interventions for pain management include massage, exercise and immobilization, transcutaneous electrical nerve stimulation, imagery and biofeedback. Services also include acupuncture and acupressure, desensitization, guided imagery, aquatics, relaxation training and distraction-refocusing.

The Clinical Center also uses a multidisciplinary approach to address the difficult issues associated with the end of life. Continued participation of patients in research protocols must be balanced with the needs and wishes of the patient and family members or significant others. The Social Work Department provides counseling and works with other disciplines to perform a thorough assessment of the need for palliative care and/or hospice support. Bereavement counseling is also provided. The Spiritual Ministry Department establishes spiritually supportive relationships with seriously ill patients and their families to help them face end of life. Prayer, spiritual discussions and soothing music are provided, and memorial services are also available.

The Bioethics Department has a portfolio of research projects that address the end of life. One of these, a study recently published in the New England Journal of Medicine, reported the results of interviews with 988 terminally ill patients about such issues as symptoms, physician-patient communication, caregiving needs, and views on euthanasia. Another study is comparing costs of care at the end of life as they relate to issues such as managed care versus fee for service; people with different types of terminal illnesses; and the use or nonuse of hospice care.

The National Cancer Institute

The National Cancer Institute has a dedicated interest in current and planned research related to palliative, hospice, and end of life care for patients. Studies show that two-thirds of people with advanced cancer experience significant pain. NCI’s portfolio of pain research is wide-ranging and includes studies that test complementary strategies.

One example is an NCI-supported study that focuses on resiniferatoxin, an anti-pain substance isolated from a cactus-like plant, which may lead to the development of new pain relief drugs. There are also studies of behavioral interventions, such as distraction, relaxation, and imagery, that may offer care providers with non-pharmacological tools to help their patients handle pain.

In addition to participating in the program announcement and RFA on management of symptoms at the end of life, NCI participates in the trans-NIH biobehavioral pain research program announcement to conduct basic and clinical studies on pain. Some of the activities included in this announcement that have relevance to this hearing are: examining the role of the placebo effect in pain treatment; exploring the basic mechanisms of conscious perception of pain and affective responses; clarifying the relationship between depression and chronic pain; and determining the effectiveness of biobehavioral pain management in terminally ill and dying patients.

The National Institute of Neurological Disorders and Stroke

The NINDS supports a broad range of basic and clinical research on pain and is a participant in the end-of-life RFA. NINDS also shares the lead with NIDCR in the NIH Pain Research Consortium. Of interest to this Committee is NINDS’ basic research related to neurological symptoms that occur in many chronic and terminal disorders. These include pain, swallowing problems, memory loss, and nausea and vomiting. For example, two recent basic research findings are unraveling the mysteries of chronic pain states. They involve separating "good pain," that is, the normal protective sensation, from the "bad pain" of abnormal chronic pain states. Using animal models, one study selectively eliminated spinal cord nerve cells that respond to the chemical messenger substance P. In another study, mice were genetically engineered to omit a form of the enzyme protein kinase C that is involved in some types of pain signals. In both experiments, the "good pain" responses were intact, but "bad pain" was eliminated.

The National Institute on Aging

The National Institute on Aging research portfolio addresses the diverse array of end-of-life issues affecting the elderly population. Examples of studies include how staff, family, and residents manage end of life care in nursing homes, and how the stress of decision making can be reduced during the final phase of life. NIA is also one of the institute cosponsors of the end-of-life RFA. Through its Alzheimer’s Disease Centers program, the NIA-supported researchers at the Boston center have established a Dementia Study Unit as a clinical model for late-stage Alzheimer’s disease care, the first research group in the country to focus efforts on the difficult, emotionally charged, clinical issues in late-stage and terminal care of this patient population. Activities have expanded to include an outpatient program, a respite care program, and an adult day care program. As a result of research in the Dementia Unit, staff developed a hospice approach to the care of Alzheimer’s disease patients. This consists of assigning patients to one of the five levels of care, with progressive limitations on medical interventions. Treatment limitation decisions are discussed at a meeting of family members with the Interdisciplinary Treatment Team.

The National Institute of Dental and Craniofacial Research

The National Institute of Dental and Craniofacial Research supports studies that address key issues at the end of life – the prevention and relief of pain. Studies within the NIDCR portfolio are relevant to palliative, hospice and end of life care issues, particularly the research on pain. Sharing the lead with NINDS of the trans-NIH Pain Consortium, NIDCR also operates the Pain Research Clinic in the NIH Clinical Center. Programs within the clinic include developing better methods for assessing pain, understanding the mechanisms of acute and chronic pain, and developing new methods of pain control. Recent findings include an animal model of gene therapy for pain.

The oral complications of cancer therapy are also under study. Radiation treatment damage to salivary gland tissue and many drug therapies can result in lack of saliva, or xerostomia, which leads to difficulty in chewing, swallowing, and speaking, problems for many at the end of life. Research on salivary glands and saliva constitute a significant component of the NIDCR portfolio. Of note is the development of another animal model of gene therapy – this time to restore saliva production.

The Office of Behavioral and Social Sciences Research, Office of the Director, NIH

The Office of Behavioral and Social Sciences Research (OBSSR), the National Center for Complementary and Alternative Medicine, and several NIH Institutes, are co-sponsoring a workshop on October 26-27, 1999 on "Spirituality, Religion, and Health." An expert panel will review the state of the science in the area, and assist in developing a research agenda relevant to NIH. Numerous issues will be addressed, including linkages to morbidity and mortality, biobehavioral and psychosocial mechanisms, social and cultural influences, measurement issues, gaps in the literature, and scientific opportunities. A report summarizing the work of the invited panel will be disseminated following the workshop.

National Center for Complementary and Alternative Medicine

The National Center for Complementary and Alternative Medicine (NCCAM), a new entity, is the successor organization of the OAM, with enhanced statutory authority and function, and increased staffing levels. Many of NCCAM’s studies concern palliative care research, with a focus on increasing patient comfort, diminishing pain, and rendering disease symptoms less intense or severe. Although NCCAM does not have a specific focus on end of life, research results of many studies may be beneficial to patients at this final phase. Among these projects are an examination of the benefits of hatha yoga on the cognitive and behavioral changes associated with aging and neurological disorders; evaluation of the effects of acupuncture on persistent pain and inflammation; a clinical study of St. John’s Wort’s effects on major depression; the effect of acupuncture and moxibustion (heat applied at the acupuncture point), and, in collaboration with NIA, the efficacy of ginkgo biloba (a botanical product) in older individuals who are at risk for dementia, which may have pertinence to those at the end of life.

As is evident, the NIH institutes are actively pursuing many avenues of research, both conventional and complementary, of relevance to patients and families at the end of life. Trans-NIH Committees relevant to coordination of these efforts include the trans-NIH Pain Consortium, the trans-NIH Alzheimer’s Working Group, and other formal and informal Committees.

In conclusion, it is becoming increasingly clear that, as we look to the future, distressing symptoms considered inevitable at the end of life can be eased, and that more can be done to maintain a patient’s quality of life, sense of control, and dignity. A number of issues remain to be resolved, however, through research. Our aging population depends on the health care system and the evolution of how it manages end-of-life care. We need to know more about the appropriate course of treatment during the dying process. Despite the availability of pain medications for terminally ill patients, pain is still inadequately treated. We need improved assessment tools to help health care professionals accurately evaluate symptoms at the end of life. Patients’ comfort needs and their wishes for end of life care must be respected. Family caregivers’ needs must be addressed so that they become competent in providing pharmacological and other treatments, determining the changing nutritional needs of a dying person, and responding to changes in function and care required by those changes. Caregivers need assistance in coping with stress and maintaining their own health.