A model for increasing patient safety in the intensive care unit: increasing the implementation rates of proven safety measures.

BACKGROUND: Few published data exist with respect to current implementation of interventions that increase patient safety in intensive care units (ICUs) Furthermore, even less published data exist that address implementation of outcome-related methodologies of patient safety interventions in ICUs. OBJECTIVE: The purpose of this study was threefold: (1) to increase implementation rates of known, evidence-based interventions in the Dartmouth Hitchcock Medical Center (DHMC) ICU that have been demonstrated to reduce morbidity and mortality in critically ill patients; (2) to develop a durable and reproducible intervention model that can be applied not only to various aspects of ICU medicine but to any healthcare microsystem that is process oriented; and (3) to design an "ICU-specific" value compass. DESIGN: Using a before/after study design, the interventions involved: (1) establishing a systematic approach to integrate the delivery of proven ICU safety measures; (2) using the design of the various tools to develop a method for team communication and team building; (3) incorporating prompts into a ICU progress note for the healthcare team to address three evidence-based measures on a daily basis; and (4) using a data wall to demonstrate progress and to provide "real-time" feedback for error correction. SETTING AND PARTICIPANTS: In the before and after study, two groups of 40 consecutive patients admitted to DHMC's Intensive Care Unit were evaluated. The first group of patients was admitted between April and May of 2003. The second group of 40 patients was admitted between May and June of 2004. To ensure process stability, control data were also collected on patients at an interval time point between these two groups. MAIN OUTCOME MEASURES: Three evidence-based interventions were identified that reduce the likelihood of adverse events resulting simply from an ICU stay: (1) prophylaxis against venous thrombo-embolic disease (venous thromboembolism or deep vein thrombosis); (2) prophylaxis against ventilator-associated pneumonia (VAP); and (3) prophylaxis against stress-ulcers (SU). Two data points were obtained per patient per day corresponding to the work shift schedule in the ICU. The unit of measure was patient-shift observation. A limited data set was collected before implementing the change package to ensure system stability. RESULTS: Both traditional statistical analysis and statistical process control (SPC) were used to evaluate the results. For each metric, it was possible to demonstrate an increase in the measure of the mean, reduced point-to-point variation as well as a substantial narrowing of the control limits indicating improved process control. LIMITATIONS: By virtue of the involvement of the researcher in the data collection for the control group, the potential existed for methodological bias by acting on the information collected. There was also the lack of a cohesive data structure from which to collect information (ie, the hospital computer speaks one language, the ventilator a second and the monitoring systems a third). CONCLUSIONS: A model for changing the ICU microsystem at DHMC was created that enabled successful implementation of evidence-based measures by maximising the natural flow of work and fostering a team-based culture to improve patient safety. Unique to this method and unlike currently available methods that define only the delivery of the appropriate intervention as success, system success was defined in terms of both true positives, namely delivering care when it is indicated, as well as true negatives, not delivering care when there is none indicated, to offer a more comprehensive system review. Additionally, the method of data collection allowed simplified defect analysis, thereby eliminating a resource-consuming audit of data after the fact. This approach, therefore, provides a basis for adapting and redesigning the PDSA cycle so as to specifically apply this type of "disciplinary" work.

Anemia in the critically ill: the role of erythropoietin.

Anemia is a common clinical problem in critically ill patients and is associated with substantial red blood cell (RBC) transfusion requirements. However, RBC transfusion has significant risks, including adverse effects on the immune system. Although a low hemoglobin concentration may be tolerable, it may not be optimal for the critically ill patient. Thus, alternative therapies that can increase hemoglobin and avoid complications of RBC transfusion are desirable. Critically ill patients appear to have anemia identical to the anemia of chronic inflammatory disease with blunted erythropoietin production. Results of a recent randomized controlled trial in critically ill patients demonstrated that recombinant human erythropoietin (r-HuEPO, epoetin alfa) significantly reduced (by approximately 50%) the number of RBC units transfused (P <.002) and significantly increased hematocrit (P <.01) compared with placebo. There was no increase in mortality or adverse clinical events with therapy. Epoetin alfa may be an effective therapeutic approach to anemia in critically ill patients, decreasing the need for transfusion and achieving higher hemoglobin concentrations than generally attained with transfusion.

Acute renal failure and dialysis in the chronically critically ill patient.

Acute renal failure is a common clinical problem in the intensive care unit (ICU) and is associated with significant morbidity and mortality. There is no "magic bullet" to prevent acute renal failure or to modify the clinical course of established renal failure. The approach to therapy is directed to the early initiation of dialysis therapy. Continuous dialysis therapy is becoming the preferred form of dialysis in the ICU.

Survival of patients transferred to tertiary intensive care from rural community hospitals.

BACKGROUND: Accessibility to tertiary intensive care resources differs among hospitals within a rural region. Determining whether accessibility is associated with outcome is important for understanding the role of regionalization when providing critical care to a rural population. METHODS: In a prospective design, we identified and recorded the mortality ratio, percentage of unanticipated deaths, length of stay in the intensive care unit (ICU), and survival time of 147 patients transferred directly from other hospitals and 178 transferred from the wards within a rural tertiary-care hospital. RESULTS: The two groups did not differ significantly in the characteristics measured. Differences in access to tertiary critical care in this rural region did not affect survival or length of stay after admission to this tertiary ICU. The odds ratio (1.14; 95% confidence interval 0.72-1.83) for mortality associated with transfer from a rural community hospital was not statistically significant. CONCLUSIONS: Patients at community hospitals in this area who develop need for tertiary critical care are just as likely to survive as patients who develop ICU needs on the wards of this rural tertiary-care hospital, despite different accessibility to tertiary intensive-care services.

Nutritional deficiencies and blunted erythropoietin response as causes of the anemia of critical illness.

PURPOSE: The purpose of this article was to determine the prevalence of iron, vitamin B12, and folate deficiency and to evaluate the erythropoietin (EPO) response to anemia in a cohort of long-term intensive care unit (ICU) patients. MATERIALS AND METHODS: All patients admitted to three academic medical center multidisciplinary ICUs were screened for eligibility into a randomized trial of EPO for the treatment of ICU anemia. On their second or third ICU day, patients enrolled in this trial had EPO levels drawn and were screened for iron, B12, and folate deficiency. Weekly EPO levels were obtained throughout patients' ICU stay. RESULTS: A total of 184 patients were screened for iron, B12, and folate deficiency. Sixteen patients (9%) were iron deficient by study criteria, 4 (2%) were B12 deficient, and 4 (2%) were folate deficient. Mean hemoglobin and reticulocyte percents of the remaining 160 patients were 10.3 +/- 1.2 g/dL and 1.66 +/- 1.09%, respectively. In most patients, serum iron and total iron binding capacity levels were very low, whereas ferritin levels were very high. Mean and median day 2 EPO levels were 35.2 +/- 35.6 mIU/mL and 22.7 mIU/mL, respectively (normal = 4.2-27.8). Serial EPO levels in most persistently anemic patients remained within the normal range. CONCLUSIONS: In this cohort, screening for iron, B12, and folate deficiency identified potentially correctable abnormalities in more than 13% of patients and should be considered in those who are anticipated to have long ICU stays. Even at an early point of critical illness, most patients had iron studies consistent with anemia of chronic disease (ACD), as well as a blunted EPO response that may contribute to this ACD-like anemia of critical illness.

Efficacy of recombinant human erythropoietin in the critically ill patient: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required. DESIGN: A prospective, randomized, double-blind, placebo-controlled, multicenter trial. SETTING: ICUs at three academic tertiary care medical centers. PATIENTS: A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group). INTERVENTIONS: Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of >38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay >2 wks) up to a total of 6 wks (42 days) postrandomization. MEASUREMENTS AND MAIN RESULTS: The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p<.002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1+/-5.6 vs. 31.6+/-4.1; p<.01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events. CONCLUSIONS: The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require.

Renal failure associated with hepatitis C virus infection. Improvement in renal function after treatment with interferon-alpha.

Hepatitis C virus infection can result in mixed cryoglobulinemia and associated clinical syndromes including membranoproliferative glomerulonephritis. Reports regarding the efficacy of interferon-alpha (IFN-alpha) in the treatment of patients with membranoproliferative glomerulonephritis and chronic hepatitis C infection have been inconclusive regarding improvement of renal function. We describe two patients with chronic hepatitis secondary to hepatitis C virus complicated by mixed cryoglobulinemia and membranoproliferative glomerulonephritis who developed severe renal failure which resolved after treatment with standard doses of IFN-alpha 2b.

RBC transfusion in the ICU. Is there a reason?

OBJECTIVE: To evaluate RBC transfusion practice in the ICU. DESIGN: Retrospective chart review. SETTING: Multidisciplinary ICU in a tertiary care center. PATIENTS: All patients admitted to the ICU with a length of stay of greater than 1 week. RESULTS: A total of 23% of all patients admitted to the ICU had a length of stay of greater than 1 week (19.6 +/- 1.6 days). Of these patients, 85% received blood transfusions (9.5 +/- 0.8 U per patient). These transfusions were not solely a function of acute blood loss. Patients were transfused a constant 2 to 3 U/wk. Patients receiving blood transfusions were phlebotomized on average 61 to 70 mL per day. Phlebotomy accounted for 49% of the variation in amount of RBCs transfused. No indication for blood transfusion was identified for 29% of transfusion events. A low hematocrit (< 25%) was the only identifiable indication in an additional 19% of events. Almost one third of all RBCs transfused were without a clear transfusion indication. CONCLUSION: The long-term ICU population receive a large number of blood transfusions. Phlebotomy contributes significantly to these transfusions. There is no clear indication for a large number of the blood transfusions given. Many blood transfusions appear to be administered because of an arbitrary "transfusion trigger" rather than a physiologic need for blood. Blood conservation and adherence to transfusion guidelines could significantly reduce RBC transfusion in the ICU.

Progression and remission of renal disease in the Lupus Nephritis Collaborative Study. Results of treatment with prednisone and short-term oral cyclophosphamide.

OBJECTIVE: To describe the clinical course of severe lupus nephritis and to identify the risk factors for progression to renal failure among patients treated with prednisone and short-term courses of low-dose oral cyclophosphamide. DESIGN: Ancillary analyses of data from the Lupus Nephritis Collaborative Study (LNCS). SETTING: University hospital medical centers (14). PATIENTS: The 86 patients who participated in the LNCS (mean follow-up, 136 weeks [2.6 years]) and a subgroup of 63 patients with follow-up of more than 48 weeks (mean follow-up, 160 weeks [3.1 years]). MEASUREMENTS: Initial clinical and pathologic features, response to therapy within 48 weeks, and subsequent clinical events, including development of renal failure. MAIN RESULTS: Renal failure developed in 18 patients (21%). An observed elevation in serum creatinine concentration was the only initial feature predictive of subsequent renal failure. Mean (+/- SD) initial serum creatinine levels were higher in patients who subsequently developed renal failure (244 +/- 134 mumol/L [2.76 +/- 1.52 mg/dL] compared with 163 +/- 103 mumol/L [1.85 +/- 1.17 mg/dL]; P = 0.007). The risk for renal failure was higher among patients with initial serum creatinine levels greater than 106 mumol/L (1.2 mg/dL) (29% compared with 6.5%; P = 0.014). Response to therapy (defined as resolution of initial serum creatinine elevations within 48 weeks) refined the prognosis based on initial serum creatinine determinations. The risk for subsequent renal failure was higher among patients who failed to respond to therapy within 48 weeks (30% compared with 0%; P = 0.015). By comparison, 9% of patients with normal initial serum creatinine levels progressed to renal failure after 48 weeks. CONCLUSIONS: Initial serum creatinine levels and responses to initial therapy with prednisone and short-term cyclophosphamide, as used in the LNCS, can guide further therapy. Patients with normal initial serum creatinine levels or resolution of initial serum creatinine elevations within 48 weeks have a low risk for renal failure and may not require long-term treatment with cyclophosphamide.

Acute renal failure associated with cardiac operations. A case-control study.

We performed a case-control study to identify risk factors for the development of acute renal failure after cardiac operations. Forty-two cases of acute renal failure were identified in a total of 572 patients who underwent cardiac operations. They were matched with a control population of patients having cardiac operations without acute renal failure. Discriminant analysis performed with preoperative variables revealed preoperative serum creatinine values, concurrent valve and bypass surgery, and age to be significant variables for identifying patients at risk for acute renal failure. The use of these three variables in a discriminant model correctly classified 77% of patients. The addition of intraoperative variables did not significantly improve the ability of the model to correctly classify patients. Acute renal failure was associated with a significant increase in the number of postoperative complications, mortality, and length of hospitalization and intensive care unit stay.

The detection and interpretation of urinary eosinophils.

We determined the clinical diagnosis for 183 patients who had urine samples examined for the presence of eosinophils. Urine samples were examined with both Hansel's stain and Wright's stain. A total of 11% of these patients had eosinophils detected in the urine. A variety of clinical conditions were associated with eosinophiluria. Urinary tract infection and acute interstitial nephritis were most common, each accounting for 25% of the total patients with eosinophiluria. Eosinophiluria proved to be a good predictor of acute interstitial nephritis. Hansel's stain was superior to Wright's stain in detecting eosinophils in urine. In particular, Hansel's stain increased the sensitivity of eosinophiluria for acute interstitial nephritis (63% vs 25%) as well as its positive predictive value (50% vs 25%).

Lupus optic neuritis with negative serology.

A 56-year-old woman with a 12-year history of systemic lupus erythematosus presented with severe optic-disc swelling and blepharitis. At the same time, she developed acute pancreatitis and ultimately died of gram-negative sepsis. Although it appeared that the ocular and systemic disorders were manifestations of lupus, her serum antinuclear antibody and complement levels remained normal throughout her hospital course. Optic neuritis may be secondary to lupus, but the diagnosis is difficult to make when the serology is negative.

Relationship of aluminum to neurocognitive dysfunction in chronic dialysis patients.

Aluminum has been proposed as the causative agent in dialysis encephalopathy syndrome. We prospectively assessed whether other, less severe, neuropsychologic abnormalities were also associated with aluminum. A total of 16 patients receiving chronic dialytic therapy were studied. The deferoxamine infusion test (DIT) was used to assess total body aluminum burden. Neurologic function was evaluated by quantitative measures of asterixis, myoclonus, motor strength, and sensation. Cognitive function was assessed by measures of dementia, memory, language, and depression. There were four patients with a positive DIT (greater than 125 micrograms/L increment in serum aluminum) that was associated with an increase in the number of neurologic abnormalities observed, as well as an increase in severity of myoclonus, asterixis, and lower extremity weakness. Patients with a positive DIT also showed significant impairment in memory; however, no differences were noted on tests of dementia, depression, or language. There was no significant correlation between sex, age, presence of diabetes, mode of dialysis, years of chronic renal failure, years of dialysis or years of aluminum ingestion and any neurologic or neurobehavioral measurement, serum aluminum level, or DIT. These changes may represent early aluminum-associated neurologic dysfunction.