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End-of-Life Care

The Costs Of Nonbeneficial Treatment In The Intensive Care Setting

PROLOGUE: In early 2005 Americans were riveted to the case of Terri Schiavo, a Florida woman who had lain in a persistent vegetative state for more than a decade. A legal and political battle raged over whether her husband would be allowed to follow her wish to end her life by withholding food and hydration. The Schiavo matter brought important issues to the forefront of discourse, including the need for written expression of a patient’s preferences and the involvement of family members and caregivers in making critical end-of-life decisions.

In this paper Todd Gilmer and his colleagues report on a study of ethics consultations in intensive care settings. These consultations are sought when there is conflict regarding treatment for people who are not likely to survive their hospital stay, in an attempt to reduce the use of "nonbeneficial" services and thus the cost of end-of-life care. Consultations were associated with reduced hospital stays and treatment costs and were deemed effective in resolving conflicts that were blocking the way of more appropriate comfort care.

Gilmer (tgilmer{at}ucsd.edu) is an assistant professor in the Department of Family and Preventive Medicine at the University of California, San Diego. Lawrence Schneiderman is a professor in that department; Holly Teetzel is a research associate there. Jeffrey Blustein is a professor of bioethics in the Department of Epidemiology and Social Medicine, Montefiore Medical Center, the Bronx. Kathleen Briggs is a supervisor in the Social Services Department, Hennepin County Medical Center, in Minneapolis. Felicia Cohn is director of medical ethics education in the Department of Medicine, College of Medicine, University of California, Irvine. Ronald Cranford is assistant chief in neurology in the Hennepin Center’s Department of Neurology. Daniel Dugan is a health care ethics consultant at Swedish Covenant Hospital, in Chicago. Glen Komatsu is director of neonatology and bioethics at Little Company of Mary Hospital in Torrance, California. Ernlé Young is an emeritus codirector and cofounder of the Stanford University Center for Biomedical Ethics and a professor at Stanford’s medical school.

Abstract

 
Ethics consultations have been shown to reduce the use of "nonbeneficial treatments," defined as life-sustaining treatments delivered to patients who ultimately did not survive to hospital discharge, when treatment conflicts occurred in the adult intensive care unit (ICU). In this paper we estimated the costs of nonbeneficial treatment using the results from a randomized trial of ethics consultations. We found that ethics consultations were associated with reductions in hospital days and treatment costs among patients who did not survive to hospital discharge. We conclude that consultations resolved conflicts that would have inappropriately prolonged nonbeneficial or unwanted treatments in the ICU instead of focusing on more appropriate comfort care.

Although these interventions illuminate valuable improvements in the provision of critical care, they fail to address the primary consideration of whether to pursue aggressive life-sustaining measures or to forgo them in favor of comfort care. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) showed in a large sample of severely ill hospitalized patients that physicians were largely unaware of patients’ preferences regarding end-of-life care.³ Patients, their family members and surrogates, and other caregivers were often dissatisfied with the health care provided to dying patients, who often experienced severe pain, dysphoria, and fatigue and who underwent life-sustaining treatments while expressing a preference for a treatment plan focused on comfort care.⁴ The SUPPORT intervention—to provide better estimates of survival and to improve communication between patients and providers—was surprisingly ineffective. Despite the apparent cooperation of physicians in "virtually all cases," simply having a nurse provide information to physicians did not improve patient care outcomes over those in the control group in which no intervention occurred.⁵ One reason for this lack of success might have been the failure to address a common obstacle: conflicts within the family, among providers, or between providers and the family that delay decisions regarding the treatment plan and extend the use of life-sustaining treatment, even when there is little hope for independent survival. Also, the nurse was given the difficult task of acting without important knowledge-based and institutional support. In the ethics consultations described here, all of the interventions were provided by a trained, experienced medical ethics consultation service, not only skilled in facilitating communication but also knowledgeable in ethics and the law and officially backed by an institutional ethics committee.

Ethics consultations have been introduced into the practice of medicine during the past several decades as a way to help health care professionals, patients, and surrogates come to a decision about medical treatment where value-laden conflicts are involved. According to the consensus statement:

Ethics consultation is a service provided by an individual consultant, team, or committee to address the ethical issues involved in a specific clinical case. Its central purpose is to improve the process and outcomes of patient care by helping to identify, analyze, and resolve ethical problems.⁶

Ethics consultations should also ensure that the process of decision making is inclusive, educational, respectful of cultural values, and supportive of institutional efforts at quality improvement and appropriate resource utilization.

We have studied ethics consultations provided to patients in the ICU in whom value-based treatment conflicts arose during the course of treatment in two randomized (one single site and one multicenter) controlled trials.⁷ These studies demonstrate that ethics consultations can positively affect end-of-life care by reducing the burden of what we define as nonbeneficial treatment: ICU days, hospital days, and life-sustaining treatments for patients who fail to survive to hospital discharge, which results from conflicts among family members or the patient care team. They also show that providing an ethics consultation is helpful in identifying, analyzing, and resolving ethical issues; educating patients and providers with respect to ethical issues; and presenting alternative views.

In this paper we report the results of an analysis of the financial impact of ethics consultations based on data collected during the multicenter trial of ethics consultations mentioned above, conducted November 2000 through December 2002. Our goal was to examine the resources involved in provision of nonbeneficial treatment and to analyze the sustainability of ethics consultation practices in hospitals. The hospitals were selected to represent a broad spectrum of characteristics and include community, religious, managed care, and academic institutions with diverse populations. Six hospitals were able to provide detailed cost data. All have busy ICUs and active consultation services.⁸

Study Data And Methods

Top Study Data And Methods Study Results Discussion NOTES

 
Study organization. At each hospital, nurses who made regular ICU rounds were assigned to identify adult patients in whom value-laden treatment conflicts were imminent or manifest that could lead to incompatible courses of action. Criteria for such conflicts included conflicts within the health care team about whether to pursue aggressive life-sustaining treatments or comfort care; conflicts within the health care team about which treatments are in the patient’s best interests in the absence of a qualified decisionmaker; conflicts over treatments regarded as futile by one or more members of the health care team; conflicts among family/friends as to who should serve as surrogate decisionmaker in the case of disagreement; conflicts between the health care team and family/friends about whether to pursue aggressive life-sustaining treatments or comfort care; and conflicts between the health care team and family/friends over treatments regarded by one or more members of the health care team as futile.

Patients were randomized to either the intervention (ethics consultation offered) or usual care (ethics consultation not offered) group. All data analyses were based on this time of study entry and this original intent-to-treat basis. Any ethics consultations requested for usual-care patients after this assignment did not alter this original assignment. Similarly, intervention patients who refused ethics consultation remained in the treatment group for the purposes of analysis.

If the patient was assigned to usual care, the hospital’s principal investigator did not initiate contact with the health care team, although reassurance was provided to all that anyone was free to request an ethics consultation at any time. If the patient was entered into the intervention arm of the trial, the principal investigator contacted the responsible physician and sought verbal consent to arrange an ethics consultation. The consultation was made available within twenty-four hours and conducted in a timely manner, depending on the circumstances.⁹

Ethics consultation. Although there was no standardized protocol, each site followed a general process model of ethics consultation, which involved the following steps: (1) Medical review: the medical record was reviewed, and those involved in the patient’s care who bore upon the issues under consideration were interviewed. (2) Ethical diagnosis: the ethics consultant(s) framed the issues in easily understood ethical terms with the parties involved, drawing upon relevant supporting material, including hospital policy, published ethical consensus statements, statutes, and case law. (3) Recommendations of the next steps, including measures for further meetings to improve communication (sharing information, dealing with emotional discomfort and grieving, correcting misunderstandings) ranging from team-only meetings with selected participants to a formal conference involving the full ethics committee. At a minimum, the consultant(s) saw to it that the following areas of importance were addressed: relevant medical factors, the patient’s known or inferred values and preferences, quality-of-life considerations, and other contextual factors of importance. The consultant(s) helped articulate consensus or disagreement and either facilitated implementing the consensus or facilitated ways to address and resolve the disagreement.

(4) Documentation of the consultation in the patient’s medical record, identifying the person requesting the consultation, activities occurring prior to the consultation, the reason for the ethics consultation, the ethical issues identified in the case, the steps taken to address those issues, the options and ethical rationales considered, the outcome, and the future plan. (5) Follow-up by the ethics consultant(s) to provide ongoing support to the process.

Data collection. At each participating hospital, a research assistant obtained demographic and medical data from patients’ medical records. These data included age, sex, ethnicity, payer, and major diagnosis at time of entry into the study. Life-sustaining interventions studied here consisted of days in the hospital and days in the ICU before and after entry into the study. Categories of hospitalization outcomes consisted of death or discharge to hospice, skilled nursing facility, or home.

Costs were estimated by adjusting inpatient charges using cost-to-charge ratios (CCRs) from Medicare cost reports. Detailed line-item inpatient charge data were collected for 499 of 551 study patients (81 percent) at six of the seven study sites (data were unavailable for seven patients across six sites, and one site with forty patients was unable to provide any inpatient data). These data included an individual identifier and admission and discharge dates as well as a service description and charge amount for each service provided during the inpatient stay. Services were generally identified with a more aggregate service category. Services without an aggregate identifier were assigned a service category based on the service description.

Medicare cost reports were obtained from the finance departments of the study hospitals. The cost centers listed in these reports and their accompanying CCRs were mapped to the more detailed service categories in the line-item charge data. Service cost was calculated by multiplying the service charge by the CCR for that service category. The cost reports also provided average per diem costs for room and board for adult inpatient and ICU days. Total inpatient stay costs were calculated as total service costs plus daily acute inpatient and ICU room-and-board costs. Costs were then aggregated to the level of the person for the hospital stay.

Outcome measures. The primary outcomes were hospital days and inpatient costs among patients who failed to survive to hospital discharge. Because of the failure to achieve a fundamental goal of medicine, we chose to call this "nonbeneficial treatment." We hypothesized that ethics consultation would serve to reduce hospital days and costs among patients in whom value-based treatment conflicts arose during the course of treatment and who would not have survived to hospital discharge. We also hypothesized that ethics consultation would have no effect on those who did survive.¹⁰ Intensive life-sustaining efforts are ethically justified when survival is a realistic possibility.

Analytic methods. Analyses of data were carried out according to the intention-to-treat principle. Several hospitals were unable to provide accurate information on service dates: Their electronic data included date of data entry, rather than actual date of service. Because we did not have accurate information on service dates, and thus were unable to delineate services provided before and after randomization, we used regression analysis to allocate costs to ICU and non-ICU hospital days before and after study entry.

Although the distributions of days in the hospital and inpatient costs were greatly skewed, inpatient costs were related to inpatient days in a linear fashion. We employed the entire sample on which we had cost data (N = 499) and regressed total cost for the inpatient stay on a constant term and four covariates: non-ICU hospital days prior to study entry, ICU days prior to study entry, ICU days after study entry, and non-ICU hospital days after study entry, using a covariance estimator that is consistent under heteroskedasticity and corrects for sampling by site (the study was not powered to detect site-specific effects).¹¹ We then set to zero non-ICU days and ICU days prior to study entry, and we calculated hospital costs after study entry as the predicted total costs as determined by ICU and non-ICU hospital days after study entry. Standard errors for the means of inpatient days and costs and their differences across intervention and control arms were calculated using the nonparametric bootstrap, while p values were calculated using nonparametric permutation.¹²

We estimated the net cost of an ethics consultation practice to a hospital using a combination of sources. The annual cost of the practice itself was priced at $150,000, which we estimate to be the approximate cost for a one-half full-time-equivalent (FTE) physician (with benefits) and a full-time administrative assistant plus office space in a hospital, including overhead.¹³ Costs were calculated as the estimated incremental per person cost savings of the intervention multiplied by the number of consultations expected in a given year, less the practice cost.

Study Results

Top Study Data And Methods Study Results Discussion NOTES

 
The study enrolled 551 people, 499 of whom were included in the cost analysis (Exhibit 1). The mean age was sixty-eight (standard deviation = 17), and 46 percent were female. The population was diverse in ethnicity and major diagnosis. Among the sample, 60 percent failed to survive to hospital discharge. There were no significant differences in age, sex, ethnicity, major diagnosis, or survival between intervention and control groups (p > .20). Daily hospital costs were the same in intervention and control groups ($2,839 versus $2,773, p > .20).

We conducted an additional analysis of the distribution of hospital days (in three-day intervals) among intervention and control groups (Exhibit 4). The proportion of patients with hospital stays of one to three days was approximately equal between the two groups. However, compared with the control group, the intervention group saw a greater proportion of patients with stays of four to nine days and fewer patients with stays of ten days or longer. These data suggest that ethics consultations are most effective in reducing lengths-of-stay among those who would otherwise remain in the hospital for ten days or more after identified as being in a conflict situation.

Discussion

Top Study Data And Methods Study Results Discussion NOTES

 
A spectrum of financial and organizational barriers deter the provision of high-quality end-of-life care. These include a health care system that is focused on acute and curative care, the accompanying scarcity of institutional palliative services, and a lack of specific reimbursement mechanisms for palliative care.¹⁴ Efforts to improve end-of-life care are not necessarily cost saving. High-quality palliative care—including medication and therapy for pain relief and assistance with activities of daily living—requires additional skilled (and costly) caregiver support.¹⁵ It is important to note that an ethics consultation may not always result in the decision to withdraw futile life-sustaining treatment. Under special circumstances, an ethics consultation may result in granting a temporary compassionate exception to allow a distant relative time to arrive and pay last respects or to facilitate coping and grieving by family members.¹⁶

Our study shows that ethics consultations reduced hospital spending and hastened death among those who ultimately die in hospital after a prolonged stay. In follow-up interviews of providers and patients/surrogates who received an ethics consultation, more than 90 percent of nurses and physicians and 80 percent of patients/surrogates agreed or strongly agreed that they would seek ethics consultations again and recommend them to others. Thus, we believe that the process of the ethics consultation makes it likely that the few days of life lost were preferable—to the patient, to the family, and to the provider—to using those few days to pursue aggressive yet futile measures to prolong life.

These data alone do not provide a complete picture of the quality of care or any improvement that might have resulted from the ethics consultation. Discontinuing aggressive life-sustaining treatment at the end of life is insufficient without its replacement by an equally dedicated effort at comfort care. Toward this end, skilled and experienced ethics consultants attempt to engage all of the relevant participants and clarify the facts and values that are helpful in making the very difficult and emotionally laden decisions for critically ill patients. By making the decision-making process inclusive, educational, and respectful of the cultural values of patients and family members as well as supporting physicians and nurses in their efforts to provide the most appropriate care, these interventions play an important role in the intensive care setting. The high degree of satisfaction reported by all of the participants is a measure of the success of these efforts.

One important role of ethics consultants is to help redirect the focus of treatment from aggressive and futile efforts at prolonging life to permitting a comfortable, dignified death. In this respect, a "good death," as described by Peter Pronovost and Derek Angus, has value that is not adequately captured either in lengths-of-stay or cost of services.¹⁷ Economic evaluations that fail to consider the value of improvements in the quality of death—as experienced by patients as well as their family/surrogates and health care providers—will underestimate the value of improving end-of-life care. It is our hope, however, that by demonstrating the value and cost savings involved with ethics consultations, this study will provide evidence to justify the institutional investment to maintain the financial sustainability of hospital-based ethics consultation practices.

Editor's Notes

 
This study was supported by the Agency for Healthcare Research and Quality (Grant no. 1 R01 H510251).

NOTES

Top Study Data And Methods Study Results Discussion NOTES

 

1. P. Jacobs and T.W. Noseworthy, "National Estimates of Intensive Care Utilization and Costs: Canada and the United States," Critical Care Medicine 18, no. 11 (1990): 1282–1286.[ISI][Medline]
2. See S.M. Burns et al., "Implementation of an Institutional Program to Improve Clinical and Financial Outcomes of Mechanically Ventilated Patients: One-Year Outcomes and Lessons Learned," Critical Care Medicine 31, no. 12 (2003): 2752–2763[CrossRef][ISI][Medline]; N.A. Smyrnios et al., "Effects of a Multifaceted, Multidisciplinary, Hospital-Wide Quality Improvement Program on Weaning from Mechanical Ventilation," Critical Care Medicine 30, no. 6 (2002): 1224–1230[CrossRef][ISI][Medline]; J.E. Zack et al., "Effect of an Education Program Aimed at Reducing the Occurrence of Ventilator-associated Pneumonia," Critical Care Medicine 30, no. 11 (2002): 2407–2412[CrossRef][ISI][Medline]; C.M. Coopersmith et al., "The Impact of Bedside Behavior on Catheter-related Bacteremia in the Intensive Care Unit," Archives of Surgery 139, no. 2 (2004): 131–136[Abstract/Free Full Text]; and M.I. Krupicka et al., "Impact of a Pediatric Clinical Pharmacist in the Pediatric Intensive Care Unit," Critical Care Medicine 30, no. 4 (2002): 919–921.[CrossRef][ISI][Medline]
3. SUPPORT Principal Investigators, "A Controlled Trial to Improve Care for Seriously Ill Hospitalized Patients: The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT)," Journal of the American Medical Association 274, no. 20 (1995): 1591–1598.[Abstract]
4. J. Lynn et al., "Rethinking Fundamental Assumptions: SUPPORT’s Implications for Future Reform, Study to Understand Prognoses and Preferences and Risks of Treatment," Journal of the American Geriatrics Society 48, no. 5 Supp. (2000): S214–S221.[ISI][Medline]
5. S.A. Schroeder, "The Legacy of SUPPORT: Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment," Annals of Internal Medicine 131, no. 10 (1999): 780–782.[Free Full Text]
6. J.C. Fletcher and M. Siegler, "What Are the Goals of Ethics Consultation? A Consensus Statement," Journal of Clinical Ethics 7, no. 2 (1996): 122–126.[ISI][Medline]
7. A single-site pilot study is described in L.J. Schneiderman, T. Gilmer, and H.D. Teetzel, "Impact of Ethics Consultations in the Intensive Care Setting: A Randomized, Controlled Trial," Critical Care Medicine 28, no. 12 (2000): 3920–3924[CrossRef][ISI][Medline]. The subsequent multisite trial is described in L.J. Schneiderman et al., "Effect of Ethics Consultations on Nonbeneficial Life-Sustaining Treatments in the Intensive Care Setting: A Randomized Controlled Trial," Journal of the American Medical Association 290, no. 9 (2003): 1166–1172.[Abstract/Free Full Text]
8. The participating hospitals were Montefiore Medical Center/Weiler Division in New York City (a teaching hospital for Albert Einstein Medical School); Hennepin County Medical Center in Minneapolis (a public teaching hospital affiliated with the University of Minnesota Medical School); Swedish Covenant Hospital in Chicago (a community hospital owned by the Evangelical Covenant Church); Little Company of Mary Hospital, in Torrance, California (a general acute care community hospital under the auspices of the Catholic church); Stanford Medical Center, in Stanford, California (the major teaching hospital for Stanford University School of Medicine); University of California, Irvine, Medical Center (the major teaching hospital for the University of California, Irvine, School of Medicine); and Southern California Permanente Medical Group, San Diego (a major hospital in the Kaiser health maintenance organization). Ethics consultations were provided by single consultants or teams; by people equipped with medical, doctoral, or law degrees; by social workers and theologians; by those formally schooled in ethics and philosophy; and by those who had acquired their expertise one way or another during the course of their professional career. Across institutions, the proportion of white patients ranged from 36 percent to 67 percent; African American, 4–30 percent; Hispanic, 7–23 percent; and Asian, 1–13 percent. The number of ICU beds ranged from 14 to 100, and the annual inpatient census, from 11,300 to 24,000.
9. During the course of the study, ethics consultations were not considered the standard care. Thus, we did not seek informed consent from usual-care patients. Any effort to seek informed consent from this group would have compromised and perhaps even invalidated the study by dividing the patients into those who were predisposed to accepting the intervention and those who were not. The Institutional Review Boards at the participating medical centers agreed that archival medical record data could be analyzed for the purpose of this research.
10. Analyses of survivors are not presented here but are available from the authors; send e-mail to Todd Gilmer, tgilmer{at}ucsd.edu.
11. H. White, "A Heteroskedasticity-Consistent Covariance Matrix Estimator and a Direct Test for Heteroskedasticity," Econometrica 48, no. 4 (1980): 817–838.[CrossRef][ISI]
12. B. Efron and R. Tibshirani, An Introduction to the Bootstrap: Monographs on Statistics and Applied Probability, vol. 57 (New York: Chapman and Hall, 1993); and V.W. Berger, "Pros and Cons of Permutation Tests in Clinical Trials," Statistics in Medicine 19, no. 10 (2000): 1319–1328.[CrossRef][ISI][Medline]
13. The cost estimate was provided by the UCSD business office. We requested a budget that included a one-half-FTE physician at a senior-level salary, an administrative assistant, rent for office space, and standard amounts for equipment and expenses.
14. H.A. Huskamp et al., "Providing Care at the End of Life: Do Medicare Rules Impede Good Care?" Health Affairs 20, no. 3 (2001): 204–211[Free Full Text]; M.B. Buntin and H. Huskamp, "What Is Known about the Economics of End-of-Life Care for Medicare Beneficiaries?" Gerontologist 42, no. S3 (2002): 40–48[Abstract/Free Full Text]; M.B. Buntin et al., "The Costs of Decedents in the Medicare Program: Implications for Payments to Medicare+Choice Plans," Health Services Research 39, no. 1 (2004): 111–130[CrossRef][ISI][Medline]; and S.Z. Pantilat and J.A. Billings, "Prevalence and Structure of Palliative Care Services in California Hospitals," Archives of Internal Medicine 163, no. 9 (2003): 1084–1088.[Abstract/Free Full Text]
15. E.J. Emanuel and L.L. Emanuel, "The Economics of Dying: The Illusion of Cost Savings at the End of Life," New England Journal of Medicine 330, no. 8 (1994): 540–544.[Free Full Text]
16. L.J. Schneiderman, N.S. Jecker, and A.R. Jonsen, "Medical Futility: Its Meaning and Ethical Implications," Annals of Internal Medicine 112, no. 12 (1990): 949–954.
17. P. Pronovost and D.C. Angus, "Economics of End-of-Life Care in the Intensive Care Unit," Critical Care Medicine 29, no. 2 Supp. (2001): N46–N51.[CrossRef][ISI][Medline]

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