William Fulkerson

Advance directives for seriously ill hospitalized patients: Effectiveness with the patient self-determination act and the SUPPORT intervention

OBJECTIVE: To assess the effectiveness of written advance directives (ADs) in the care of seriously ill, hospitalized patients. In particular, to conduct an assessment after ADs were promoted by the Patient Self‐Determination Act (PSDA) and enhanced by the effort to improve decision‐making in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT), focusing upon the impact of ADs on decision‐making about resuscitation.

Pain and satisfaction with pain control in seriously ill hospitalized adults: Findings from the SUPPORT research investigations

OBJECTIVES To evaluate the pain experience of seriously ill hospitalized patients and their satisfaction with control of pain during hospitalization. To understand the relationship of level of pain and dissatisfaction with pain control to demographic, psychological, and illness-related variables. DESIGN Prospective, cohort study. SETTING Five teaching hospitals. PATIENTS Patients for whom interviews were available about pain (n = 5,176) from a total of 9,105 patients in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Patients were interviewed after study enrollment about their experiences with pain. When patients could not be interviewed due to illness, we used surrogate (usually a family member) responses calibrated to patient responses (from the subset of interviews with both patient and surrogate responses). Ordinal logistic regression was used to study the association of variables with level of pain and satisfaction with its control. Nearly 50% of patients reported pain. Nearly 15% reported extremely severe pain or moderately severe pain occurring at least half of the time, and nearly 15% of those patients with pain were dissatisfied with its control. After adjustment for confounding variables, older and sicker patients reported less pain, while patients with more dependencies in activities of daily living, more comorbid conditions, more depression, more anxiety, and poor quality of life reported more pain. Patients with colon cancer reported more pain than patients in other disease categories. Levels of reported pain varied among the five hospitals and also by physician specialty. After adjustment for confounding variables, dissatisfaction with pain control was more likely among patients with more severe pain, greater anxiety, depression, and alteration of mental status, and lower reported income; dissatisfaction with pain control also varied among study hospitals and by physician specialty. CONCLUSIONS Pain is common among severely ill hospitalized patients. The most important variables associated with pain and satisfaction with pain control were patient demographics and those variables that reflected the acute illness. Pain and satisfaction with pain control varied significantly among study sites, even after adjustment for many potential confounders. Better pain management strategies are needed for patients with the serious and common illnesses studied in SUPPORT.

The impact of serious illness on patients' families. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

OBJECTIVE To examine the impact of illness on the families of seriously ill adults and to determine the correlates of adverse economic impact. DESIGN Data were collected during the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT), a prospective cohort study of outcomes, preferences, and decision making in seriously ill hospitalized adults and their families. SETTING Five tertiary care hospitals in the United States. PARTICIPANTS The 2661 seriously ill patients in nine diagnostic categories who survived their index hospitalization and were discharged home were eligible for this analysis. Surrogate and/or patient interviews about the impact of illness on the family were obtained for 2129 (80%) of these patients (mean age, 62 years; 43% women; 6-month survival, 75%). OUTCOME MEASURES Surrogates and patients were surveyed to determine the frequency of adverse caregiving and economic burdens. Multivariable analyses were performed to determine correlates of loss of family savings. RESULTS One third (34%) of patients required considerable caregiving assistance from a family member. In 20% of cases, a family member had to quit work or make another major life change to provide care for the patient. Loss of most or all of the family savings was reported by 31% of families, whereas 29% reported loss of the major source of income. Patient factors independently associated with loss of the familys savings on multivariable analysis included poor functional status (odds ratio [OR], 1.40; 95% confidence interval [CI], 1.10 to 1.78 for patients needing assistance with three or more activities of daily living), lower family income (OR, 1.74; 95% CI, 1.37 to 2.21 for those with annual incomes below

Effects of ibuprofen on the physiology and survival of hypothermic sepsis

25,000), and young age (OR, 2.85; 95% CI, 2.13 to 3.82 for those younger than 45 years compared with those 65 years or older). CONCLUSIONS Many families of seriously ill patients experience severe caregiving and financial burdens. Families of younger, poorer, and more functionally dependent patients are most likely to report loss of most or all of the familys savings.

Changing pattern of organ dysfunction in early human sepsis is related to mortality.

OBJECTIVES The objective was to compare the clinical and physiologic characteristics of febrile septic patients with hypothermic septic patients; and to examine plasma levels of cytokines tumor necrosis factor alpha (TNF-alpha and interleukin 6 (IL-6) and the lipid mediators thromboxane B2 (TxB2) and prostacyclin in hypothermic septic patients in comparison with febrile patients. Most importantly, we wanted to report the effect of ibuprofen treatment on vital signs, organ failure, and mortality in hypothermic sepsis. SETTING The study was performed in the intensive care units (ICUs) of seven clinical centers in the United States and Canada. PATIENTS Four hundred fifty-five patients admitted to the ICU who met defined criteria for severe sepsis and were suspected of having a serious infection. INTERVENTION Ibuprofen at a dose of 10 mg/kg (maximum 800 mg) was administered intravenously over 30 to 60 mins every 6 hrs for eight doses vs. placebo (glycine buffer vehicle). MEASUREMENTS AND MAIN RESULTS Forty-four (10%) septic patients met criteria for hypothermia and 409 were febrile. The mortality rate was significantly higher in hypothermic patients, 70% vs. 35% for febrile patients. At study entry, urinary metabolites of TxB2, prostacyclin, and serum levels of TNF-alpha and IL-6 were significantly elevated in hypothermic patients compared with febrile patients. In hypothermic patients treated with ibuprofen, there was a trend toward an increased number of days free of major organ system failures and a significant reduction in the 30-day mortality rate from 90% (18/20 placebo-treated patients) to 54% (13/24 ibuprofen-treated patients). CONCLUSIONS Hypothermic sepsis has an incidence of approximately 10% and an untreated mortality twice that of severe sepsis presenting with fever. When compared with febrile patients, the hypothermic group has an amplified response with respect to cytokines TNF-alpha and IL-6 and lipid mediators TxB2 and prostacyclin. Treatment with ibuprofen may decrease mortality in this select group of septic patients.

Patient empowerment and feedback did not decrease pain in seriously ill hospitalized adults

ObjectiveWe examined the pattern of organ system dysfunction, the evolution of this pattern over time, and the relationship of these features to mortality in patients who had sepsis syndrome. DesignProspective, multicenter, observational study. SettingIntensive care units in tertiary referral teaching hospitals. PatientsA total of 287 patients who had sepsis syndrome were prospectively identified in intensive care units. Materials and MeasurementsCardiovascular, pulmonary, neurologic, coagulation, renal, and hepatic dysfunction were assessed at onset and on day 3 of sepsis syndrome. Organ dysfunction was classified as normal, mild, moderate, severe, and extreme dysfunction. We calculated the occurrence rate and associated 30-day mortality rate of organ dysfunction at the onset of sepsis syndrome. We then measured the change in organ dysfunction from onset to day 3 of sepsis syndrome and determined, for individual organ systems, the associated 30-day mortality rate. ResultsAt the onset of sepsis syndrome, clinically significant pulmonary dysfunction was the most common organ failure, but was not related to 30-day mortality. Clinically significant cardiovascular, neurologic, coagulation, renal, and hepatic dysfunction were less common at the onset of sepsis syndrome but were significantly associated with the 30-day mortality rate. Worsening neurologic, coagulation, and renal dysfunction from onset to day 3 of sepsis syndrome were associated with significantly higher 30-day mortality than with improvement or no change in organ dysfunction. ConclusionsIncreased mortality rate in sepsis syndrome is associated with a pattern characterized by failure of nonpulmonary organ systems and, in particular, worsening neurologic, coagulation, and renal dysfunction over the first 3 days. Although initial pulmonary dysfunction is common in patients with sepsis syndrome, it is not associated with an increased mortality rate.

Overall and cause-specific mortality in a cohort of home-/bisexual men, injecting drug users, and female partners of HIV-infected men

&NA; We tested a nurse clinician‐mediated intervention to relieve pain in a group of seriously ill hospitalized adults using a randomized controlled trial at five tertiary care academic centers in the US. The study included 4804 patients admitted between January 1992 and January 1994 with one or more of nine high mortality diagnoses; 2652 were allocated to the intervention and 2152 to usual care. Specially‐trained nurse clinicians assessed patients’ pain, educated them and their families about pain control, empowered patients to expect pain relief, informed patients’ nurses and physicians about level of pain and suggested or used other pain management resources. Patients’ pain was determined from hospital interviews with patients and surrogates. Pain 2 and 6 months later or after death and satisfaction with its control at all time periods were also assessed. All analyses were adjusted for baseline risk of being in pain and propensity to be in the intervention group. Overall, 50.9% of patients reported some pain. After adjustment for other variables associated with pain, comparing the intervention to the control group, there was not a statistically significant difference in level of pain (OR for higher levels of pain 1.15; CI 1.00–1.32) or satisfaction with control of pain during the hospitalization (OR for higher levels of pain 1.12; CI 0.91–1.39), 2 or 6 months after discharge, or during the last 3 days of life. A multifaceted intervention using information, empowerment, advocacy, counseling and feedback was ineffective in ameliorating pain in seriously ill patients. Control of pain in these patients remains an important problem. More intensive pain treatment strategies addressing the needs of seriously ill hospitalized adults must be evaluated.

The effectiveness of right heart catheterization in the initial care of critically ill patients. SUPPORT Investigators.

OBJECTIVE To study the overall and cause-specific HIV-related mortality in a cohort of HIV-seropositive subjects according to transmission category, race/ethnicity, sex and severity of immunosuppression. DESIGN A cohort of 1129 HIV-seropositive homo-/bisexual men, injecting drug users, and female partners of HIV-infected men were enrolled at six centers in San Francisco, Los Angeles, Chicago, Newark, Detroit and New York between 1 November 1988 and 1 November 1989. Subjects were evaluated every 6 months at least until 31 March 1994. METHODS The analyses of overall mortality for the subgroups of interest were performed with Kaplan-Meier plots and Cox proportional hazards models. Cause-specific analyses were performed on the primary cause of death using rates per 100 person-years of exposure. RESULTS AND CONCLUSIONS Baseline severity of immunosuppression is the strongest predictor of mortality. There were no statistically significant differences in overall HIV-related mortality among transmission categories, race/ethnicity groups or sexes. There were differences, however, in cause-specific mortality among the different risk groups.