Health Heritage© a web-based tool for the collection and assessment of family health history: initial user experience and analytic validity.

A detailed family health history is currently the most potentially useful tool for diagnosis and risk assessment in clinical genetics. We developed and evaluated the usability and analytic validity of a patient-driven web-based family health history collection and analysis tool. Health Heritage(©) guides users through the collection of their family health history by relative, generates a pedigree, completes risk assessment, stratification, and recommendations for 89 conditions. We compared the performance of Health Heritage to that of Usual Care using a nonrandomized cohort trial of 109 volunteers. We contrasted the completeness and sensitivity of family health history collection and risk assessments derived from Health Heritage and Usual Care to those obtained by genetic counselors and genetic assessment teams. Nearly half (42%) of the Health Heritage participants reported discovery of health risks; 63% found the information easy to understand and 56% indicated it would change their health behavior. Health Heritage consistently outperformed Usual Care in the completeness and accuracy of family health history collection, identifying 60% of the elevated risk conditions specified by the genetic team versus 24% identified by Usual Care. Health Heritage also had greater sensitivity than Usual Care when comparing the identification of risks. These results suggest a strong role for automated family health history collection and risk assessment and underscore the potential of these data to serve as the foundation for comprehensive, cost-effective personalized genomic medicine.

Intensive care unit length of stay: recent changes and future challenges.

OBJECTIVE: To compare case-mix adjusted intensive care unit (ICU) length of stay for critically ill patients with a variety of medical and surgical diagnoses during a 5-yr interval. DESIGN: Nonrandomized cohort study. SETTING: A total of 42 ICUs at 40 US hospitals during 1988-1990 and 285 ICUs at 161 US hospitals during 1993-1996. PATIENTS: A total of 17,105 consecutive ICU admissions during 1988-1990 and 38,888 consecutive ICU admissions during 1993-1996. MEASUREMENTS AND MAIN RESULTS: We used patient demographic and clinical characteristics to compare observed and predicted ICU length of stay and hospital mortality. Outcomes for patients studied during 1993-1996 were predicted using multivariable models that were developed and cross-validated using the 1988-1990 database. The mean observed hospital length of stay decreased by 3 days (from 14.8 days during 1988-1990 to 11.8 days during 1993-1996), but the mean observed ICU length of stay remained similar (4.70 vs. 4.53 days). After adjusting for patient and institutional differences, the mean predicted 1993-1996 ICU stay was 4.64 days. Thus, the mean-adjusted ICU stay decreased by 0.11 days during this 5-yr interval (T-statistic, 4.35; p < .001). The adjusted mean ICU length of stay was not changed for patients with 49 (75%) of the 65 ICU admission diagnoses. In contrast, the mean observed hospital length of stay was significantly shorter for 47 (72%) of the 65 admission diagnoses, and no ICU admission diagnosis was associated with a longer hospital stay. Aggregate risk-adjusted hospital mortality during 1993-1996 (12.35%) was not significantly different during 1988-1990 (12.27%, p = .54). CONCLUSIONS: For patients admitted to ICUs, the pressures associated with a decrease in hospital length of stay do not seem to have influenced the duration of ICU stay. Because of the high cost of intensive care, reduction in ICU stay may become a target for future cost-cutting efforts.

Initial development of a system-wide maternal-fetal outcomes assessment program.

OBJECTIVE: This study was undertaken to develop a comprehensive risk-assessment approach capable of evaluating maternal and fetal outcomes. STUDY DESIGN: Data from 10,984 women and 11,066 infants delivered at 79 military treatment facilities in the United States from 1995 to 1997 were used to develop two individual but complementary risk-adjustment models for maternal and, separately, fetal outcomes. A range of maternal and delivery-related risk variables and clinically important outcomes were identified by expert opinion and selected and weighted with ordinal logistic regression analysis. Receiver operating characteristic curves for the maternal and fetal models were determined. Variation across the facilities in risk-adjusted performance was also evaluated. RESULTS: Risk factors and poor outcomes were rare for both mothers and infants, with 96.9% of infants and 97.7% of mothers having good or excellent outcomes (0.7% mortality and 0.01% mortality, respectively). Despite the low frequency of poor outcomes both models performed well, with receiver operating characteristic curves of 0.75 for maternal outcomes and 0.78 for infant outcomes. When the models were applied to the military treatment facilities, there were significant differences among facilities in risk-adjusted outcomes. Twenty-four of the facilities in the study (30%) had outcomes odds ratios that were significantly >1 or significantly <1 (P <.05). There did not appear to be any relationship between the performance of a military treatment facility for maternal outcome and that for infant outcome. CONCLUSION: Complementary risk models for maternal and infant outcomes were developed that had satisfactory discriminatory power across a variety of facilities within a large health system. With further development and refinement this approach holds promise of being able to detect variations in risk-adjusted performance that could be used to identify best practices. The results might also be used to help coordinate and improve the quality of care for the entire conception-to-delivery process.

A predictive risk model for outcomes of ischemic stroke.

BACKGROUND AND PURPOSE: The great variability of outcome seen in stroke patients has led to an interest in identifying predictors of outcome. The combination of clinical and imaging variables as predictors of stroke outcome in a multivariable risk adjustment model may be more powerful than either alone. The purpose of this study was to determine the multivariable relationship between infarct volume, 6 clinical variables, and 3-month outcomes in ischemic stroke patients. METHODS: Included in the study were 256 eligible patients from the Randomized Trial of Tirilazad Mesylate in Acute Stroke (RANTTAS). Six clinical variables and 1-week infarct volume were the prespecified predictor variables. The National Institutes of Health Stroke Scale, Barthel Index, and Glasgow Outcome Scale were the outcomes. Multivariable logistic regression techniques were used to develop the model equations, and bootstrap techniques were used for internal validation. Predictive performance of the models was assessed for discrimination with receiver operator characteristic (ROC) curves and for calibration with calibration curves. RESULTS: The predictive models had areas under the ROC curve of 0.79 to 0.88 and demonstrated nearly ideal calibration curves. The areas under the ROC curves were statistically greater (P<0.001) with both clinical and imaging information combined than with either alone for predicting excellent recovery and death or severe disability. CONCLUSIONS: Combined clinical and imaging variables are predictive of 3-month outcome in ischemic stroke patients. Demonstration of this relationship with acute clinical variables and 1-week infarct information supports future attempts to predict 3-month outcome with all acute variables.

Older age, aggressiveness of care, and survival for seriously ill, hospitalized adults. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Older age is associated with less aggressive treatment and higher short-term mortality due to serious illness. It is not known whether less aggressive care contributes to this survival disadvantage in elderly persons. OBJECTIVE: To determine the effect of age on short-term survival, independent of baseline patient characteristics and aggressiveness of care. DESIGN: Secondary analysis of data from a prospective cohort study. SETTING: Five academic medical centers participating in SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). PATIENTS: 9105 adults hospitalized with one of nine serious illnesses associated with an average 6-month mortality rate of 50%. MEASUREMENTS: Survival through 180 days of follow-up. In Cox proportional hazards modeling, adjustment was made for patient sex; ethnicity; income; baseline physical function; severity of illness; intensity of hospital resource use; presence of do-not-resuscitate orders on study day 1; and presence and timing of decisions to withhold transfer to the intensive care unit, major surgery, dialysis, blood transfusion, vasopressors, and tube feeding. RESULTS: The mean (+/- SD) patient age was 63 +/- 16 years, 44% of patients were female, and 16% were black. Overall survival to 6 months was 53%. In analyses that adjusted for sex, ethnicity, income, baseline functional status, severity of illness, and aggressiveness of care, each additional year of age increased the hazard of death by 1.0% (hazard ratio, 1.010 [95% CI, 1.007 to 1.013]) for patients 18 to 70 years of age and by 2.0% (hazard ratio, 1.020 [CI, 1.013 to 1.026]) for patients older than 70 years of age. Adjusted estimates of age-specific 6-month mortality rates were 44% for 55-year-old patients, 48% for 65-year-old patients, 53% for 75-year-old patients, and 60% for 85-year-old patients. Similar results were obtained in analyses that did not adjust for aggressiveness of care. Acute physiology and diagnosis had much larger relative contributions to prognosis than age. CONCLUSIONS: We found a modest independent association between patient age and short-term survival of serious illness. This age effect was not explained by the current practice of providing less aggressive care to elderly patients.

Influence of patient preferences and local health system characteristics on the place of death. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Risks and Outcomes of Treatment.

OBJECTIVE: To examine the degree to which variation in place of death is explained by differences in the characteristics of patients, including preferences for dying at home, and by differences in the characteristics of local health systems. DESIGN: We drew on a clinically rich database to carry out a prospective study using data from the observational phase of the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT component). We used administrative databases for the Medicare program to carry out a national cross-sectional analysis of Medicare enrollees place of death (Medicare component). SETTING: Five teaching hospitals (SUPPORT); All U.S. Hospital Referral Regions (Medicare). STUDY POPULATIONS: Patients dying after the enrollment hospitalization in the observational phase of SUPPORT for whom place of death and preferences were known. Medicare beneficiaries who died in 1992 or 1993. MAIN OUTCOME MEASURES: Place of death (hospital vs non-hospital). RESULTS: In SUPPORT, most patients expressed a preference for dying at home, yet most died in the hospital. The percent of SUPPORT patients dying in-hospital varied by greater than 2-fold across the five SUPPORT sites (29 to 66%). For Medicare beneficiaries, the percent dying in-hospital varied from 23 to 54% across U.S. Hospital Referral Regions (HRRs). In SUPPORT, variations in place of death across site were not explained by sociodemographic or clinical characteristics or patient preferences. Patient level (SUPPORT) and national cross-sectional (Medicare) multivariate models gave consistent results. The risk of in-hospital death was increased for residents of regions with greater hospital bed availability and use; the risk of in-hospital death was decreased in regions with greater nursing home and hospice availability and use. Measures of hospital bed availability and use were the most powerful predictors of place of death across HRRs. CONCLUSIONS: Whether people die in the hospital or not is powerfully influenced by characteristics of the local health system but not by patient preferences or other patient characteristics. These findings may explain the failure of the SUPPORT intervention to alter care patterns for seriously ill and dying patients. Reforming the care of dying patients may require modification of local resource availability and provider routines.

Evaluation of acute physiology and chronic health evaluation III predictions of hospital mortality in an independent database.

OBJECTIVE: To assess the accuracy and validity of Acute Physiology and Chronic Health Evaluation (APACHE) III hospital mortality predictions in an independent sample of U.S. intensive care unit (ICU) admissions. DESIGN: Nonrandomized, observational, cohort study. SETTING: Two hundred eighty-five ICUs in 161 U.S. hospitals, including 65 members of the Council of Teaching Hospitals and 64 nonteaching hospitals. PATIENTS: A consecutive sample of 37,668 ICU admissions during 1993 to 1996; including 25,448 admissions at hospitals with >400 beds and 1,074 admissions at hospitals with <200 beds. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We used demographic, clinical, and physiologic information recorded during ICU day 1 and the APACHE III equation to predict the probability of hospital mortality for each patient. We compared observed and predicted mortality for all admissions and across patient subgroups and assessed predictive accuracy using tests of discrimination and calibration. Aggregate hospital death rate was 12.35% and predicted hospital death rate was 12.27% (p =.541). The model discriminated between survivors and nonsurvivors well (area under receiver operating curve = 0.89). A calibration curve showed that the observed number of hospital deaths was close to the number of deaths predicted by the model, but when tested across deciles of risk, goodness-of-fit (Hosmer-Lemeshow statistic, chi-square = 48.71, 8 degrees of freedom, p< .0001) was not perfect. Observed and predicted hospital mortality rates were not significantly (p < .01) different for 55 (84.6%) of APACHE III's 65 specific ICU admission diagnoses and for 11 (84.6%) of the 13 residual organ system-related categories. The most frequent diagnoses with significant (p < .01) differences between observed and predicted hospital mortality rates included acute myocardial infarction, drug overdose, nonoperative head trauma, and nonoperative multiple trauma. CONCLUSIONS: APACHE III accurately predicted aggregate hospital mortality in an independent sample of U.S. ICU admissions. Further improvements in calibration can be achieved by more precise disease labeling, improved acquisition and weighting of neurologic abnormalities, adjustments that reflect changes in treatment outcomes over time, and a larger national database.

Outcomes of acute exacerbation of severe congestive heart failure: quality of life, resource use, and survival. SUPPORT Investigators. The Study to Understand Prognosis and Preferences for Outcomes and Risks of Treatments.

BACKGROUND: Congestive heart failure (CHF) is a common disease with high health care costs and high mortality rates. Knowledge of the health-related quality of life outcomes of CHF may guide decision making and be useful in assessing new therapies for this population. METHODS: A prospective cohort study was conducted involving 1390 adult patients hospitalized with an acute exacerbation of severe CHF (New York Heart Association class III-IV). Demographic data and health-related quality of life were determined by interview; physiologic status and cost and intensity of care were determined from hospital charts. RESULTS: The median (25th, 75th percentiles) age of patients was 68.0 (58.2, 76.9) years; 61.7% were male. Survival was 93.4% at discharge from the index hospitalization, 72.9% at 180 days, and 61.5% at 1 year. Of patients interviewed at 180 days, the median health rating on a scale of 0 to 100 (0 indicates death; 100, excellent health) was 60 (interquartile range, 50-80), and 59.7% were independent in their activities of daily living. Overall quality of life was reported to be good, very good, or excellent in 58.2% at 180 days. Patients with worse functional capacity were more likely to die. Health perceptions among the patients with available interview data improved at 60 and 180 days after acute exacerbation of severe CHF. CONCLUSIONS: Patients hospitalized for acute exacerbation of severe CHF have a generally poor 6-month survival, but survivors retain relatively good functional status and have good health perceptions. Furthermore, health perceptions improve after the acute exacerbation.

Neurological intensive care admissions: identifying candidates for intermediate care and the services they receive.

OBJECTIVE: The high cost and scarcity of intensive care unit (ICU) beds has resulted in a need for improved utilization. This study describes the characteristics of patients who are admitted to the ICU for neurosurgical and neurological care, identifies patients who might receive all or most of their care in an intermediate care unit, and describes the services the patients would receive in an intermediate care unit. METHODS: We describe patients who received neurological care and who were part of a prospective study of 17,440 patients admitted to 42 ICUs at 40 United States hospitals. We identified patients who received only monitoring during ICU Day 1 and then used a previously validated equation to distinguish which patients were at low risk (< 10%) for subsequent active life-supporting therapy. We also describe the services these patients received during their ICU stay. RESULTS: Among 3000 patients admitted to the ICU for neurological care, 1350 received active therapy and 1650 (55%) underwent monitoring and received concentrated nursing care on ICU Day 1. After excluding those patients who received active therapy at admission, 1288 (78%) of the 1650 patients who underwent monitoring at admission were at low risk (< 10%) for subsequent active therapy; 95.8% received no active therapy. These patients who were at low risk for subsequent active therapy were significantly (P < 0.001) more often admitted postoperatively, were younger and less severely ill, and had lower ICU and hospital mortality rates (0.9 and 3.9%, respectively) than patients who received active treatment at admission. CONCLUSIONS: Patients receiving neurological care at an ICU who receive only monitoring during their 1st ICU day and have a less than 10% predicted risk of active treatment can be safely transferred to an intermediate care unit. Some of these patients may not require ICU admission. We suggest guidelines for equipping and staffing neurological intermediate care units based on the type and amount of therapy received by these patients.

ICU admission score for predicting morbidity and mortality risk after coronary artery bypass grafting.

BACKGROUND: This study was performed to develop an intensive care unit (ICU) admission risk score based on preoperative condition and intraoperative events. This score provides a tool with which to judge the effects of ICU quality of care on outcome. METHODS: Data were collected prospectively on 4,918 patients (study group n = 2,793 and a validation data set n = 2,125) undergoing coronary artery bypass grafting alone or combined with a valve or carotid procedure between January 1, 1993, and March 31, 1995. Data were analyzed by univariate and multiple logistic regression with the end points of hospital mortality and serious ICU morbidity (stroke, low cardiac output, myocardial infarction, prolonged ventilation, serious infection, renal failure, or death). RESULTS: Eight risk factors predicted hospital mortality at ICU admission, and these factors and five others predicted morbidity. A clinical score, weighted equally for morbidity and mortality, was developed. All models fit according to the Hosmer-Lemeshow goodness-of-fit test. This score applies equally well to patients undergoing isolated coronary artery bypass grafting. CONCLUSIONS: This model is complementary to our previously reported preoperative model, allowing the process of ICU care to be measured independent of the operative care. Sequential scoring also allows updated prognoses at different points in the continuum of care.

Evaluating laboratory usage in the intensive care unit: patient and institutional characteristics that influence frequency of blood sampling.

OBJECTIVES: To develop a predictive equation to estimate the frequency of blood drawing for intensive care unit (ICU) laboratory tests and to evaluate variations in ICU blood sampling practices after adjusting for patient and institutional factors. DESIGN: Prospective, inception, cohort study. SETTING: Forty-two ICUs in 40 hospitals, including 20 teaching and 17 nonteaching ICUs. PATIENTS: A consecutive sample of 17,440 ICU admissions, in which 14,043 blood samples were drawn for laboratory testing on ICU days 2 to 7. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patient demographic, physiologic, and treatment data were obtained on ICU day 1; the type and number of blood samples for laboratory testing were recorded on ICU days 1 to 7. In the 42 ICUs, a mean of 16.2 blood samples were drawn for tests on ICU days 2 to 7, but varied between 23 samples in the teaching ICUs and 9.9 samples in nonteaching ICUs. Using only ICU day 1 patient data, we predicted the subsequent number of samples drawn on ICU day 2 (R2 = .26 across individual patients) and on ICU days 2 to 7 (R2 = .26 across individual patients). The most important determinants of the number of blood samples drawn on ICU days 2 to 7 were the ICU day 1 Acute Physiology Score and admission diagnosis. After controlling for patient variables, hospital teaching status, number of beds, and location in the East and South were significantly (p < .05) associated with increased blood sampling on ICU day 2 and on ICU days 2 to 7. More frequent use of an arterial cannula and mechanical ventilation were also associated with increased blood sampling on subsequent days. CONCLUSIONS: The ability to adjust for patient and institutional variables and to predict the number of blood samples drawn for laboratory tests can allow ICUs to compare their practices with those of other units. When integrated into a continuous quality improvement process, this information can be used to identify and focus on opportunities for improving blood conservation and reducing excessive diagnostic testing.

Advance directives for seriously ill hospitalized patients: effectiveness with the patient self-determination act and the SUPPORT intervention. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

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. DESIGN: Observational cohort study conducted for 2 years before (PRE) and for 2 years after (POST) the PSDA, with a randomized, controlled trial of an additional intervention to improve decision-making after PSDA (POST+SUPPORT). SETTING: Five teaching hospitals in the United States. PATIENTS: A total of 9105 seriously ill patients treated in five teaching hospitals. INTERVENTIONS: The PSDA mandated patient education about ADs at hospital entry and documentation of ADs in the medical record. The SUPPORT intervention, in addition, provided a nurse to facilitate communication among patients, surrogates, and physicians about preferences for and outcomes of treatment alternatives and, when clinically appropriate, to encourage completion and utilization of ADs. MEASUREMENTS: Interviews were conducted with patients, surrogates, and attending physicians about awareness, completion, and impact of ADs. Medical records were reviewed for discussion about preferences concerning resuscitation, timing and writing of "Do Not Resuscitate" (DNR) orders, evidence of ADs, and the use or forgoing of resuscitation at the time of death. RESULTS: In the three cohorts, PRE, POST, and POST+SUPPORT, average age was 63. One-quarter of patients died during the initial hospitalization, one-half were dead within 6 months, and one-half were unconscious for their last 3 days. Before the PSDA (PRE), 62% were familiar with a living will, and 21% had an AD. These rates were similar for the POST and POST+SUPPORT cohorts. Just 36 (6%) of these directives were mentioned in the medical records for PRE, but a stable 35% were documented for POST, and POST+SUPPORT had an increasing rate averaging 78% (P < .001). As previously reported for PRE patients, the POST patients with and without ADs had no significant differences in the rates of medical record documentation of discussions about resuscitation (33% vs 38%, POST without AD vs POST with AD), DNR orders among those who wanted to forgo resuscitation (54% vs 58%), and attempted resuscitations at death (17% vs 9%). The POST+SUPPORT patients had similar results, with no evidence that the intervention enhanced the effect of ADs on these three measures of resuscitation decision-making. Patients with ADs more often reported that preferences about resuscitation were discussed with a physician (e.g., for POST patients, 30% for those with no AD and 43% for those with an AD, P < .05). Only 12% of patients with ADs had talked with a physician when completing the AD. Only 42% reported ever having discussed the AD with their physician. By the second study week, only one in four physicians was aware of patients' ADs. CONCLUSIONS: In these seriously ill patients, ADs did not substantially enhance physician-patient communication or decision-making about resuscitation. This lack of effect was not altered by the PSDA or by the enhanced efforts in SUPPORT, although these interventions each substantially increased documentation of existing ADs. Current practice patterns indicate that increasing the frequency of ADs is unlikely to be a substantial element in improving the care of seriously ill patients. Future work to improve decision-making should focus upon improving the current pattern of practice through better communication and more comprehensive advance care planning.

Do advance directives provide instructions that direct care? SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

OBJECTIVE: To evaluate whether the lack of effect of advance directives (ADs) on decision-making in SUPPORT might arise, in part, from the content of the actual documents. DESIGN: Advance directives placed in the medical records were abstracted for date of completion and content of additional written instructions. We examined directives with instructions to forgo life-sustaining treatment in the current state of health to determine whether care given was consistent with preferences noted in those directives. SETTINGS: Five teaching hospitals in the United States. PATIENTS: A total of 4804 patients with at least one of nine serious illnesses were admitted to five teaching hospitals in the 2 years following implementation of the Patient Self-Determination Act. Patients were part of a randomized controlled trial to improve decision-making and outcomes. RESULTS: From the medical records of 4804 patients, a total of 688 directives were collected from 569 patients. The majority of these directives (66%) were durable powers of attorney; in addition, 31% were standard living wills or other forms of written instructions (3%). Only 90 documents (13%) provided additional instructions for medical care beyond naming a proxy or stating the preferences of a standard living will. Only 36 contained specific instructions about the use of life-sustaining medical treatment, and only 22 of these directed forgoing life-sustaining treatment in the patient's current situation. For these, the treatment course was consistent with the instruction for nine patients. In two cases, patients may have changed an inconsistent directive after discussion with hospital staff. CONCLUSION: Advance directives placed in the medical records of seriously ill patients often did not guide medical decision-making beyond naming a healthcare proxy or documenting general preferences in a standard living will format. Even when specific instructions were present, care was potentially inconsistent in half of the cases.

The illusion of end-of-life resource savings with advance directives. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment.

OBJECTIVE: Would increasing the documentation of advance directives (ADs) lead to a reduction in resource utilization? We examined this question by conducting three secondary analyses: (1) we tested for a change in resource use among those who died in the hospital at a time before and after an intervention that increased the documentation of ADs in the medical record; (2) we replicated analyses of published studies that reported an association of chart documentation of ADs and hospital resource use; and (3) we examined whether a potential explanation of the observed association is biased documentation of ADs among patients who have completed an AD. DESIGN: Replication of analysis of previous published studies using data from a prospective cohort study and block-randomized controlled trial. SETTING: Five teaching hospitals in the United States. PATIENTS: A total of 9105 seriously ill patients were enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT), including 4301 patients in the 2 years (1989-91) before the Patient Self-Determination Act (PSDA) and 4804 in the 2 years (1992-94) after the PSDA implementation, with 2652 patients receiving the intervention and 2152 serving as controls. INTERVENTIONS: The SUPPORT intervention provided a nurse to facilitate communication among patients, surrogates, and physicians about preferences for and outcomes of treatments. Documenting existing advance directives was also one of this nurse's tasks. The Patient Self-Determination Act required that health care institutions inquire about and document existing advance directives at the time of hospital admission. MEASUREMENT: Hospital resource use was derived from the Therapeutic Intensity Scoring System and hospital length of stay, converted into 1994 dollars. RESULTS: Chart documentation of existing advance directives at the time of study admission increased with both the PSDA and the SUPPORT intervention. We found that intervention patients were more likely to have pre-existing ADs documented. Despite this increase, there was no corresponding change in hospital resource use for those who died during the enrollment hospitalization. Replication of analyses from published studies using data from the block randomized controlled trial found that ADs documented by the third day of serious illness were associated with a 23% reduction in hospital resource use among control patients ($21,284 with ADs documented compared with $26,127 without, 95% CI 1-48% reduction). However, this association was not observed among intervention patients, who had more pre-existing ADs documented in the medical record. Intervention patients with early documentation of ADs showed a trend toward greater cost ($28,017 compared with $24,178 among those without AD documentation, 95% CI 0-25% increase). The rate of documentation and characteristics of those with documentation differed between control and intervention patients. Intervention patients were more likely (as reported by patient or surrogate interview) to have ADs documented in the medical record by the third day (55% vs 32%, P < .001). In contrast to intervention patients, control patients who were older, less wealthy, less educated, more likely to prefer to forgo CPR, and more likely to want life-sustaining treatment limited had their ADs documented. These associations were not found among intervention patients when comparison was made between those with and those without an AD documented in the medical record. CONCLUSION: Increasing the documentation of pre-existing ADs was not associated with a reduction in hospital resource use. ADs documented without further intervention by the third day of a serious illness were associated with decreased hospital resource use. However, we did not find this association with an intervention that increased AD documentation. One potential explanation of these findings is that classification of those with an AD was based on cha

Treatment of severe systemic inflammatory response syndrome and sepsis with a novel bradykinin antagonist, deltibant (CP-0127). Results of a randomized, double-blind, placebo-controlled trial. CP-0127 SIRS and Sepsis Study Group.

OBJECTIVE: To test the effect of a novel bradykinin antagonist, deltibant (CP-0127), on survival, organ dysfunction, and other outcomes in patients with the systemic inflammatory response syndrome (SIRS) and presumed sepsis. DESIGN: Multicenter, randomized, placebo-controlled, double-blind, parallel, dose-ranging trial. Follow-up for 28 days or until death. SETTING: A total of 47 US referral hospitals. PATIENTS: A total of 504 patients with SIRS and documented evidence of infection plus either hypotension or dysfunction of 2 organ systems. INTERVENTIONS: Three-day continuous intravenous infusion of either placebo or 1 of 3 doses (0.3, 1.0, or 3.0 microg x kg(-1) x min(-1)) of deltibant. Concurrent therapy at the discretion of the treating physician. MAIN OUTCOME MEASURE: Risk-adjusted, 28-day, log-normal intent-to-treat survival analysis. Risk adjustment was performed using a study-specific risk model derived from the APACHE III database. RESULTS: Deltibant had no significant effect on risk-adjusted 28-day survival. In a posthoc analysis, risk-adjusted 7-day survival showed a nonsignificant trend toward improvement (P=.09). The 28-day risk-adjusted survival in the prospectively defined subset of patients with gram-negative infections showed a statistically significant improvement (P=.005). CONCLUSIONS: Deltibant may have some effect on survival in patients with SIRS and gram-negative sepsis; however, additional studies would be required to prove this.

Variations in the use of do-not-resuscitate orders in ICUS. Findings from a national study.

STUDY OBJECTIVES: To describe the variation in frequency of do-not-resuscitate (DNR) orders in 42 US ICUs and to examine the relationship between published guidelines and qualitative observations about terminal care in 9 ICUs. DESIGN: Prospective inception cohort. SETTING: Forty-two ICUs in 40 US hospitals with more than 200 beds: 26 randomly selected and 14 large tertiary-care volunteers. PARTICIPANTS: A consecutive sample of 17,440 ICU admissions during 1988 to 1990. MEASUREMENTS AND RESULTS: We used age, race, comorbid conditions, disease, functional status, and acute physiology score on ICU day 1 to predict the likelihood of a DNR order for each patient. A cross-validated model was then used to predict variations in the risk of an ICU DNR order from 0 to 45% (area under receiver operating characteristic curve = 0.9). The model was then used to compare aggregate observed with predicted frequency of ICU DNR orders. Finally, we compared observations of DNR practices by a team of clinical and organizational researchers at 9 of the 42 ICUs with published guidelines and risk-adjusted DNR frequency: 1,577 admissions (9%) had DNR orders written in the ICU (range, 1.5 to 22%). The ICU site was a significant (p < 0.0001) predictor of variance in the patient level model. DNR orders were written significantly (p < 0.05) less frequently than predicted in 5 and more frequently than predicted in 3 of 42 ICUs. Nonwhite patients had significantly (p = 0.0001) fewer DNR orders after adjustment. The research team's implicit judgments following on-site analysis failed to distinguish ICUs with more or less DNR orders than predicted. Site-visited ICUs exhibited practices to emulate and practice to avoid. CONCLUSIONS: The frequency of ICU DNR orders can be predicted based on individual risk factors for groups of ICU patients. After adjusting for differences in patient characteristics, there is significant variation in the frequency of DNR orders in a national sample of ICUs. These variations may be due to unmeasured differences in patient characteristics such as treatment preferences, religious affiliation, educational level, or physician practices. We found no relationship between risk-adjusted DNR order frequency and adherence to published guidelines.

Planning patient services for intermediate care units: insights based on care for intensive care unit low-risk monitor admissions.

OBJECTIVE: To describe the technology and nursing services that would be required to care for intensive care unit (ICU) low-risk monitor admissions in an intermediate unit. DESIGN: Prospective, multicenter, inception cohort analysis. SETTING: Forty U.S. hospitals with > 200 beds, including 26 hospitals that were randomly selected and 14 that volunteered for the study. PATIENTS: A sample of 8,040 ICU patients admitted to the ICU for monitoring, who received no active life-support treatment on ICU day 1. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Demographic, physiologic, and treatment information were obtained during ICU days 1 to 7. A previously validated multivariate equation was used to identify 6,180 monitor admissions at low (< 10%) risk for receiving active treatment during their entire ICU stay. We used daily Therapeutic intervention Scoring System (TISS) data to identify the equipment, type and amount of nursing care, and the types of active treatment that would have been used had these ICU patients been admitted to an intermediate care unit. Mean day-1 ICU TISS scores were as follows: 16.4 for all patients; 18.3 for surgical patients; and 13.5 for medical admissions. Concentrated nursing care accounted for 89% and technologic monitoring for 11% of day-1 TISS points. Surgical admissions had a 2.8-day mean ICU length of stay and received an average of 16.5 TISS points per patient per day. Medical admissions had a 2.7-day mean ICU length of stay and received an average of 12.3 TISS points per patient per day. Subsequent active life-support therapy was received by 4.4% of these ICU low-risk monitor admissions. CONCLUSIONS: The services received by ICU low-risk monitor admissions provide insight regarding the equipment and nursing care that might be required, and the kinds of emergencies that might occur, if these patients were cared for in medical and surgical intermediate care units. Our data suggest that if ICU low-risk monitor patients were admitted to an intermediate care unit, they would mainly require concentrated nursing care (nurse/patient ratio of 1:3 to 1:4) and limited technologic monitoring.

A comparison of risks and outcomes for patients with organ system failure: 1982-1990.

OBJECTIVES: To compare the outcomes for patients with one or more organ system failures treated in 1988 to 1990 with those outcomes from 1979 to 1982; to document risk factors for developing organ system failure; and investigate the relationship of these factors to hospital survival. DESIGN: Prospective, multicenter, inception cohort analysis. SETTING: Sixty intensive care units (ICUs) at 53 U.S. hospitals. PATIENTS: A total of 17,440 ICU admissions treated in 1988 to 1990 and 5,677 ICU admissions treated in 1979 to 1982. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: At the time of organ system failure, patients were classified by demographic, physiologic, and diagnostic information. The type and number of organ system failures and physiologic responses were recorded for < or = 7 days of ICU treatment, and all patients were followed for status at hospital discharge. Hospital survival and the prognostic value of assessing the number of organ system failures were compared with risk assessment, based on use of a prognostic scoring system that estimated the patient's probability of hospital mortality. The incidence of organ system failure (48%) among patients treated in 1988 to 1990 was similar (44%) to the occurrence rate in patients in 1979 to 1982; and an identical proportion (14%) developed multiple organ system failure. There was a significant (p < .0003) improvement in hospital mortality for patients with three or more organ system failures on day 4 or later of organ system failure. However, overall hospital mortality rates from multiple organ system failure were not different over this 8-yr period. The most important predictor of hospital mortality was the severity of physiologic disturbance on the initial day of failure. Discrimination of patients by risk of hospital mortality was better using the prognostic scoring system on day 1 of organ system failure (receiver operating characteristic curve = 0.88) than using a model based on the number of organ system failures (receiver operating characteristic curve = 0.68). CONCLUSIONS: Organ system failure remains a major contributor to death in patients in ICUs. The incidence and overall outcome have not significantly changed over the past 8 yrs, but there has been significant improvement in survival for patients with persistent severe organ system failure. A continuous measure of individual patient severity of illness is a more sensitive and accurate method for describing patients and estimating outcome than counting the number of organ system failures.

Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments)

In order to describe the outcomes of patients hospitalized with an acute exacerbation of severe chronic obstructive pulmonary disease (COPD) and determine the relationship between patient characteristics and length of survival, we studied a prospective cohort of 1,016 adult patients from five hospitals who were admitted with an exacerbation of COPD and a PaCO2 of 50 mm Hg or more. Patient characteristics and acute physiology were determined. Outcomes were evaluated over a 6 mo period. Although only 11% of the patients died during the index hospital stay, the 60-d, 180-d, 1-yr, and 2-yr mortality was high (20%, 33%, 43%, and 49%, respectively). The median cost of the index hospital stay was $7,100 ($4,100 to $16,000; interquartile range). The median length of the index hospital stay was 9 d (5 to 15 d). After discharge, 446 patients were readmitted 754 times in the next 6 mo. At 6 mo, only 26% of the cohort were both alive and able to report a good, very good, or excellent quality of life. Survival time was independently related to severity of illness, body mass index (BMI), age, prior functional status, PaO2/FI(O2), congestive heart failure, serum albumin, and the presence of cor pulmonale. Patients and caregivers should be aware of the likelihood of poor outcomes following hospitalization for exacerbation of COPD associated with hypercarbia.