Results of a collaborative quality improvement program on outcomes and costs in a tertiary critical care unit.

OBJECTIVE: To demonstrate that by using the knowledge and skills of the primary care provider and by applying statistical and scientific principles of quality improvement, outcomes can be improved and costs significantly reduced. DESIGN: A before and after quasi-experimentally designed trial using historical controls plus an analysis of costs in areas not influenced by intensive care unit (ICU) practice to control for possible secular changes. SETTING: A tertiary ICU. PATIENTS: All patients admitted to the above-mentioned ICU from January 1, 1991, through December 31, 1995. INTERVENTIONS: a) A focused program that applied statistical and scientific quality improvement processes to the practice of intensive care. b) An organized effort to modify the culture, thinking, and behavior of the personnel who practice in the ICU. MEASUREMENTS: Severity of illness, ICU and hospital lengths of stay, ICU and hospital mortality rates, total hospital costs as analyzed by the cost center, and measures of improvement in specific areas of care. MAIN RESULTS: Significant improvement in glucose control, use of enteral feeding, antibiotic use, adult respiratory distress syndrome survival, laboratory use, blood gases use, radiograph use, and appropriate use of sedation. A severity adjusted total hospital cost reduction of $2,580,981 in 1991 dollars when comparing 1995 with the control year of 1991, with 87% of the reduction in those cost centers directly influenced by the intervention. CONCLUSIONS: A focused quality improvement program in the ICU can have a beneficial impact on care and simultaneously reduce costs.

Calf-thigh sequential pneumatic compression compared with plantar venous pneumatic compression to prevent deep-vein thrombosis after non-lower extremity trauma.

OBJECTIVE: To compare the effectiveness of calf-thigh sequential pneumatic compression devices with the effectiveness of plantar venous intermittent pneumatic compression devices in prevention of venous thrombosis after major trauma. SUBJECTS AND METHODS: We evaluated 181 consecutive patients after major trauma without lower extremity injuries that precluded the use of pneumatic compression devices. We randomly assigned 149 patients to either calf-thigh sequential pneumatic compression or plantar venous pneumatic compression. After blinding the observers to the method of prophylaxis against deep-vein thrombosis, we performed bilateral compression ultrasonography on or before day 8 after randomization. RESULTS: Among 149 randomized patients, 62 who received calf-thigh sequential pneumatic compression and 62 who received plantar venous intermittent pneumatic compression devices completed the trial. Thirteen patients randomized to plantar venous intermittent pneumatic compression (21.0%) and 4 patients randomized to calf-thigh sequential pneumatic compression (6.5%) had deep-vein thrombosis (p = 0.009). Seven of 13 patients with deep-vein thrombosis after prophylaxis with plantar venous intermittent pneumatic compression had bilateral deep-vein thromboses, whereas all 4 patients with deep-vein thrombosis after prophylaxis with calf-thigh sequential pneumatic compression had unilateral deep-vein thrombosis. CONCLUSION: Calf-thigh sequential pneumatic compression prevents deep-vein thrombosis more effectively than plantar venous intermittent pneumatic compression after major trauma without lower extremity injuries.

Evaluation of compliance with a computerized protocol: weaning from mechanical ventilator support using pressure support.

STUDY OBJECTIVES: To use a computerized consultation system to evaluate the feasibility of a mechanical ventilator weaning protocol which used the rapid shallow breathing index to guide adjustments in pressure support. A program to monitor user compliance and reasons for noncompliance was built into the computerized consultation system. METHODS: A total of nine critically ill patients (ten weaning episodes) were enrolled in the protocol. The respiratory therapists performed routine computer charting in the electronic database. They accepted or declined the explicit instructions generated by the computerized protocol and displayed on the bedside terminal. The consultation program monitored whether accepted instructions were implemented by the user. RESULTS: Patient's therapy was controlled by protocol for a total of 1075 h (mean 108 h, range 4 to 339 h) and 94.8% (1321/1394) of instructions were followed by the clinical staff. Of the 42 instructions clinical staff refused to follow, 23 (55%) were extubation instructions. There were 52 (3.7%) incorrect instructions generated with 24 software errors, 21 errors in underlying logic, and seven user misunderstanding errors. CONCLUSIONS: A high level of user compliance with this protocol was achieved. The methods described herein to monitor compliance and reasons for noncompliance within a protocol are reusable in the domain of mechanical ventilation and possibly in other domains.

Cooperation: the foundation of improvement.

Cooperation--working together to produce mutual benefit or attain a common purpose--is almost inseparable from the quest for improvement. Although the case for cooperation can be made on ethical grounds, neither the motivation for nor the effects of cooperation need to be interpreted solely in terms of altruism. Cooperation can be a shrewd and pragmatic strategy for accomplishing personal goals in an interdependent system. Earlier papers in this series have explored the conceptual roots of modern approaches to improvement, which lie in systems theory. To improve systems, we must usually attend first and foremost to interactions. Among humans, "better interaction" is almost synonymous with "better cooperation." Physicians have ample opportunities and, indeed, an obligation to cooperate with other physicians in the same or different specialties, with nurses and other clinical workers, with administrators, and with patients and families. Many intellectual disciplines have made cooperation an object of study. These include anthropology; social psychology; genetics; biology; mathematics; game theory; linguistics; operations research; economics; and, of course, moral and rational philosophy. Scientifically grounded methods to enhance cooperation include developing a shared purpose; creating an open, safe environment; including all who share a common purpose and encouraging diverse viewpoints; negotiating agreement; and insisting on fairness and equity in the application of rules. These methods apply at the organizational level and at the level of the individual physician. This paper describes the application of these methods at the organizational level and focuses on one especially successful example of system-level cooperation in a care delivery site where interactions matter a great deal: the modern intensive care unit.

Developing and gaining acceptance for patient care protocols.

The purpose of developing protocols and guidelines is greater than reducing variation in practice. The process also creates new paradigms and changes the culture in which health care is delivered. The protocol itself is designed to be transient. The new environment and perceptions of how to improve health care in the future, along with new relationships and processes to accomplish this, are the real power of learning to develop and implement protocols and guidelines. Framing the process of protocol development, therefore, is more important than the resulting document. In developing protocols, attention to changing the thinking and practice of the front-line practitioners, establishing new relationships, and devising new methods of delivering and improving care is key. The process of developing protocols should include all practitioners. They should remain in control of patient care using new methods that allow: a) the monitoring of process and outcomes, b) identification of problems, and c) the evaluation and validation of the effectiveness of implemented change. Evidence from the literature of strategies for protocol development and implementation which are effective in creating change are reviewed, and an example of a known effective method which improves practice is given.

A computer-assisted management program for antibiotics and other antiinfective agents.

BACKGROUND AND METHODS: Optimal decisions about the use of antibiotics and other antiinfective agents in critically ill patients require access to a large amount of complex information. We have developed a computerized decision-support program linked to computer-based patient records that can assist physicians in the use of antiinfective agents and improve the quality of care. This program presents epidemiologic information, along with detailed recommendations and warnings. The program recommends antiinfective regimens and courses of therapy for particular patients and provides immediate feedback. We prospectively studied the use of the computerized antiinfectives-management program for one year in a 12-bed intensive care unit. RESULTS: During the intervention period, all 545 patients admitted were cared for with the aid of the antiinfectives-management program. Measures of processes and outcomes were compared with those for the 1136 patients admitted to the same unit during the two years before the intervention period. The use of the program led to significant reductions in orders for drugs to which the patients had reported allergies (35, vs. 146 during the preintervention period; P<0.01), excess drug dosages (87 vs. 405, P<0.01), and antibiotic-susceptibility mismatches (12 vs. 206, P<0.01). There were also marked reductions in the mean number of days of excessive drug dosage (2.7 vs. 5.9, P<0.002) and in adverse events caused by antiinfective agents (4 vs. 28, P<0.02). In analyses of patients who received antiinfective agents, those treated during the intervention period who always received the regimens recommended by the computer program (n=203) had significant reductions, as compared with those who did not always receive the recommended regimens (n= 195) and those in the preintervention cohort (n = 766), in the cost of antiinfective agents (adjusted mean, $102 vs. $427 and $340, respectively; P<0.001), in total hospital costs (adjusted mean, $26,315 vs. $44,865 and $35,283; P<0.001), and in the length of the hospital stay days (adjusted mean, 10.0 vs. 16.7 and 12.9; P<0.001). CONCLUSIONS; A computerized antiinfectives-management program can improve the quality of patient care and reduce costs.

Increased mortality of older patients with acute respiratory distress syndrome.

OBJECTIVE: To examine the relationship between age and mortality in ARDS patients and evaluate the importance of factors that increase the mortality of older ARDS patients. DESIGN: Prospective inception cohort study. SETTING: Community-based referral hospital. PATIENTS: Two hundred fifty-six ARDS patients identified from May 1987 to December 1990. ARDS was defined by the following: (1) PaO2/PAO2 < or = 0.2; (2) pulmonary capillary wedge pressure < or = 15 mm Hg; (3) total static thoracic compliance < or = 50 mL/cm H2O; (4) bilateral infiltrates on chest radiograph; and (5) an appropriate clinical setting for ARDS. MAIN OUTCOME MEASURES: Comparison of organ failure, incidence of sepsis, patient demographics, arterial oxygenation, and level of support in those 55 years and younger and those older than 55 years of age. Withdrawal of support in patients who died. RESULTS: Seventy-two of 112 patients older than 55 years (64%) died vs 65 of 144 patients 55 years and younger (45%) (p = 0.002). Examination of patient groups using age identified older than 55 years as a "cutpoint" above which mortality was greater (p = 0.002). Older nonsurvivors did not differ from nonsurvivors 55 years or younger with respect to gender, smoking history, ARDS risk factors, ARDS identifying characteristics, APACHE II (acute physiology and chronic health evaluation), number of organ failures, or the incidence of sepsis. In the 48 h prior to death, nonsurvivors 55 years and younger had more organ failure (3.4 +/- 0.2 vs 2.8 +/- 0.2; p = 0.03), higher fraction of inspired oxygen (0.82 +/- 0.03 vs 0.68 +/- 0.03; p = 0.008), and higher positive end-expiratory pressure levels (13 +/- 1 vs 8 +/- 1; p = 0.001) than older nonsurvivors. Despite more severe expression of disease, only 32 (50%) nonsurvivors 55 years and younger had support withdrawn. Significantly more nonsurvivors older than 55 years (73%) had support withdrawn (p = 0.009). Even in the absence of chronic disease states, withdrawal was more likely for patients older than 55 years (21/51) than in those 55 years and younger (3/32; p < 0.001). CONCLUSIONS: Mortality is significantly higher for patients with ARDS older than 55 years. Decisions to withdraw support are made more often in ARDS patients older than 55 years. These data suggest that age bias may influence decisions to withdraw support.

Telemedicine protocols and standards: development and implementation.

Telemedicine is likely to adopt rather than create most of its protocols and standards as it becomes an integral part of medical practice. To optimize this process, it will be necessary to understand how to use existing protocols and standards, and influence the development, evaluation, and modification of new ones. We have identified key participants in standards setting activities under the titles of international government, United States government, professional certifying organizations, and independent institutes. We have reviewed their roles in establishing standards for identification of patients and providers, content and structure of patient records, terminology and codes of medical information and records, and transfer of messages and data. We have addressed requirements for storing and viewing images, the impact of image resolution on accuracy of clinical interpretation, the choice of communications protocols to satisfy transmission requirements, the need to link images and text data, and the evaluation of telemedicine systems.

The role of medical informatics in telemedicine.

The role of medical informatics in telemedicine is dependent on using the power of the computerized database to not only feed patient specific information to the health care providers, but to use the epidemiological and statistical information in the data base to improve decision making and ultimately care. The computer is also a powerful tool to facilitate standardizing and monitoring of care and when applied in continuous quality improvement methodology it can enhance the improvement process well beyond what can be done by hand. The coupling of medical informatics with telemedicine allows sophisticated medical informatics systems to be applied in low population density and remote areas.

Using statistical quality control techniques to monitor blood glucose levels.

Continuous Quality Improvement techniques developed in industry are increasingly being applied to the medical field. Statistical process control charts are a CQI technique aimed at monitoring a process and its variability. At our hospital, statistical quality control charts are being constructed from laboratory blood glucose measurements of patients receiving enteral or parenteral nutrition. The charts will be used to monitor glucose levels, reveal variations, and illustrate the effects of new protocols designed to manage glucose levels.

A decision support tool for antibiotic therapy.

We developed a decision support tool to assist physicians anticipating the need for antibiotic therapy. The initial screen alerts physicians of pertinent patient information, provides direct access to other essential medical information, and stimulates clinical judgment by suggesting an antibiotic regimen. The decision support tool also suggests the dose and interval for any ordered antibiotics selected by the physicians. During a 7-month pilot study, all antibiotics for patients admitted to the Shock/Trauma/Respiratory Intensive Care Unit (STRICU) were ordered using the decision support tool. Clinical data from the study period and a 12-month control period (the previous year) were collected and compared. The decision support tool was used to order antibiotics 588 times during the study period and the suggested antibiotics were used 218 (37%) times. The computer suggested dosages were used over 90% of the time. The mean cost of antibiotics was $87.00 (p < 0.04) less per patient during the study period as compared to the control period. Prospective assessment revealed only 3 antibiotic adverse drug events (ADEs) (0.9%) among 336 study patients as compared to 15 ADEs (2.4%) among 626 control patients (p = 0.164).

Nutrition support teams: role in the new health care environment.

Many hospitals have strong political leaders who question the need for a nutrition support service. In addition, the pressures of economic and health care reform are forcing administrators to cut unnecessary and unproven, albeit beneficial, services. The challenge for nutrition support services is clear-cut: in order to survive, nutrition support teams must understand the changes in health care and must learn how to adapt to them. This article clarifies the issues and assists nutrition support teams in establishing a new direction.

Effect of interferon gamma on infection-related death in patients with severe injuries. A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To assess the efficacy of interferon gamma in reducing infection and death in patients sustaining severe injury. DESIGN: Multicenter, randomized, double-blind, placebo-controlled trial with observation for 60 days and until discharge for patients with major infection on day 60. SETTING: Nine university-affiliated level 1 trauma centers. PATIENTS: Four hundred sixteen patients with severe injuries, assessed by Injury Severity Score and degree of contamination. INTERVENTION: Recombinant human interferon gamma, 100 micrograms, was administered subcutaneously once daily for 21 days (or until patient discharge if prior to 21 days) as an adjunct to standard antibiotic and supportive therapy. MAIN OUTCOME MEASURES: Incidence of major infection, death related to infection, and death. RESULTS: Infection rates were similar in both treatment groups; however, patients treated with interferon gamma experienced fewer deaths related to infection (seven [3%] vs 18 [9%]; P = .008) and fewer overall deaths (21 [10%] vs 30 [14%]; P = .17). While 12 early deaths (days 1 through 7) occurred in each treatment group, late death occurred in 18 placebo-treated patients and nine in interferon gamma-treated patients. The results were dominated by findings at one center, which had the highest enrollment and higher infection and death rates. Statistical analysis did not eliminate the possibility of an unidentified imbalance between arms as an explanation for the results. CONCLUSION: Further evaluation is required to determine the validity of the observed reduction in infection-related deaths in patients treated with interferon gamma.

Regionalization of critical care medicine: task force report of the American College of Critical Care Medicine.

OBJECTIVES: To review the existing literature and task force opinions on regionalization of critical care services, and to synthesize a judgement on possible costs, benefits, disadvantages, and strategies. DATA SOURCES: Pertinent literature in the English language. STUDY SELECTION: One hundred forty-six English language papers were studied to determine possible ramifications of regionalization of critical care or other similar services. DATA EXTRACTION: Information on possible influence on the care of the critically ill was sought and integrated with the opinions of task force members. Possible costs, benefits, as well as disadvantages to the patient, transferring and receiving institutions, and region as a whole were sought. DATA SYNTHESIS: Regionalization of critical care services was thought to be advantageous to the patient. The larger academic institutions tend to have more resources, better subspecialty availability, and expertise in the care of the critically ill. Efficiency and safety during transport need to be in place. Disadvantages of overutilization, possible costliness to both the referring institution as well as to the receiving institution were outlined. It was agreed that pediatric critical care medicine was a separate issue. CONCLUSIONS: Regionalization of critical care medicine probably is beneficial and the concept should be explored.

Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome.

The impact of a new therapy that includes pressure-controlled inverse ratio ventilation followed by extracorporeal CO2 removal on the survival of patients with severe ARDS was evaluated in a randomized controlled clinical trial. Computerized protocols generated around-the-clock instructions for management of arterial oxygenation to assure equivalent intensity of care for patients randomized to the new therapy limb and those randomized to the control, mechanical ventilation limb. We randomized 40 patients with severe ARDS who met the ECMO entry criteria. The main outcome measure was survival at 30 days after randomization. Survival was not significantly different in the 19 mechanical ventilation (42%) and 21 new therapy (extracorporeal) (33%) patients (p = 0.8). All deaths occurred within 30 days of randomization. Overall patient survival was 38% (15 of 40) and was about four times that expected from historical data (p = 0.0002). Extracorporeal treatment group survival was not significantly different from other published survival rates after extracorporeal CO2 removal. Mechanical ventilation patient group survival was significantly higher than the 12% derived from published data (p = 0.0001). Protocols controlled care 86% of the time. Average PaO2 was 59 mm Hg in both treatment groups. Intensity of care required to maintain arterial oxygenation was similar in both groups (2.6 and 2.6 PEEP changes/day; 4.3 and 5.0 FIO2 changes/day). We conclude that there was no significant difference in survival between the mechanical ventilation and the extracorporeal CO2 removal groups. We do not recommend extracorporeal support as a therapy for ARDS. Extracorporeal support for ARDS should be restricted to controlled clinical trials.

Representative charting of vital signs in an intensive care unit.

An automatic vital signs charting system had been operational in the intensive care units of our hospital for over 10 years, but the system was susceptible to non-representative transients in the data. A median selection rule was implemented to make the system less susceptible to transients. After implementation of the median rule, we examined (1) the agreement of the resulting medians and the values that would have been reported using the previous "real-time" system and (2) the frequency of occurrence of "out-of-range" values for each system. The median value system was found to improve the representativeness of the recorded data. Improved representativeness will enhance the usefulness of reports, but more importantly will enable us to use the resulting data as inputs to computerized practice protocols and other computerized decision support applications.