If you wish to receive credit for this activity, which begins on the next page, please refer to the website: www.blackwellpublishing.com/cme.

Accreditation and Designation Statement

Blackwell Futura Media Services designates this educational activity for a 1 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Blackwell Futura Media Services is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Educational Objectives

Continuous participation in the Journal of Hospital Medicine CME program will enable learners to be better able to:

• Interpret clinical guidelines and their applications for higher quality and more efficient care for all hospitalized patients.

• Describe the standard of care for common illnesses and conditions treated in the hospital; such as pneumonia, COPD exacerbation, acute coronary syndrome, HF exacerbation, glycemic control, venous thromboembolic disease, stroke, etc.

• Discuss evidence‐based recommendations involving transitions of care, including the hospital discharge process.

• Gain insights into the roles of hospitalists as medical educators, researchers, medical ethicists, palliative care providers, and hospital‐based geriatricians.

• Incorporate best practices for hospitalist administration, including quality improvement, patient safety, practice management, leadership, and demonstrating hospitalist value.

• Identify evidence‐based best practices and trends for both adult and pediatric hospital medicine.

Instructions on Receiving Credit

For information on applicability and acceptance of continuing medical education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity during the valid credit period that is noted on the title page.

Follow these steps to earn credit:

• Log on to www.blackwellpublishing.com/cme.

• Read the target audience, learning objectives, and author disclosures.

• Read the article in print or online format.

• Reflect on the article.

• Access the CME Exam, and choose the best answer to each question.

• Complete the required evaluation component of the activity.

If you wish to receive credit for this activity, which begins on the next page, please refer to the website: www.blackwellpublishing.com/cme.

Accreditation and Designation Statement

Blackwell Futura Media Services designates this educational activity for a 1 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Blackwell Futura Media Services is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Educational Objectives

Continuous participation in the Journal of Hospital Medicine CME program will enable learners to be better able to:

• Interpret clinical guidelines and their applications for higher quality and more efficient care for all hospitalized patients.

• Describe the standard of care for common illnesses and conditions treated in the hospital; such as pneumonia, COPD exacerbation, acute coronary syndrome, HF exacerbation, glycemic control, venous thromboembolic disease, stroke, etc.

• Discuss evidence‐based recommendations involving transitions of care, including the hospital discharge process.

• Gain insights into the roles of hospitalists as medical educators, researchers, medical ethicists, palliative care providers, and hospital‐based geriatricians.

• Incorporate best practices for hospitalist administration, including quality improvement, patient safety, practice management, leadership, and demonstrating hospitalist value.

• Identify evidence‐based best practices and trends for both adult and pediatric hospital medicine.

Instructions on Receiving Credit

For information on applicability and acceptance of continuing medical education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity during the valid credit period that is noted on the title page.

Follow these steps to earn credit:

• Log on to www.blackwellpublishing.com/cme.

• Read the target audience, learning objectives, and author disclosures.

• Read the article in print or online format.

• Reflect on the article.

• Access the CME Exam, and choose the best answer to each question.

• Complete the required evaluation component of the activity.

If you wish to receive credit for this activity, which begins on the next page, please refer to the website: www.blackwellpublishing.com/cme.

Accreditation and Designation Statement

Blackwell Futura Media Services designates this educational activity for a 1 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Blackwell Futura Media Services is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Educational Objectives

Continuous participation in the Journal of Hospital Medicine CME program will enable learners to be better able to:

• Interpret clinical guidelines and their applications for higher quality and more efficient care for all hospitalized patients.

• Describe the standard of care for common illnesses and conditions treated in the hospital; such as pneumonia, COPD exacerbation, acute coronary syndrome, HF exacerbation, glycemic control, venous thromboembolic disease, stroke, etc.

• Discuss evidence‐based recommendations involving transitions of care, including the hospital discharge process.

• Gain insights into the roles of hospitalists as medical educators, researchers, medical ethicists, palliative care providers, and hospital‐based geriatricians.

• Incorporate best practices for hospitalist administration, including quality improvement, patient safety, practice management, leadership, and demonstrating hospitalist value.

• Identify evidence‐based best practices and trends for both adult and pediatric hospital medicine.

Instructions on Receiving Credit

For information on applicability and acceptance of continuing medical education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity during the valid credit period that is noted on the title page.

Follow these steps to earn credit:

• Log on to www.blackwellpublishing.com/cme.

• Read the target audience, learning objectives, and author disclosures.

• Read the article in print or online format.

• Reflect on the article.

• Access the CME Exam, and choose the best answer to each question.

• Complete the required evaluation component of the activity.

We thank Dr. Aldaja for the comments on our work. We agree that delays in laboratory diagnosis, and the inability to identify influenza viral subtype may further undermine the low rates of appropriate prescription of oseltamivir noted in our study. Additionally, we also suspect that improved diagnostic and treatment practices for patients with seasonal influenza are likely to benefit patients if an influenza pandemic were to arise.

We thank Dr. Aldaja for the comments on our work. We agree that delays in laboratory diagnosis, and the inability to identify influenza viral subtype may further undermine the low rates of appropriate prescription of oseltamivir noted in our study. Additionally, we also suspect that improved diagnostic and treatment practices for patients with seasonal influenza are likely to benefit patients if an influenza pandemic were to arise.

We thank Dr. Aldaja for the comments on our work. We agree that delays in laboratory diagnosis, and the inability to identify influenza viral subtype may further undermine the low rates of appropriate prescription of oseltamivir noted in our study. Additionally, we also suspect that improved diagnostic and treatment practices for patients with seasonal influenza are likely to benefit patients if an influenza pandemic were to arise.

Dysglycemia, defined as a random blood glucose value >180 mg/dL or <70 mg/dL, is present in 25% to 28% of hospitalized patients.1, 2 It is associated with poor clinical outcomes, such as increased hospital‐acquired infection rates, increased hospital length of stay, and higher mortality rates.25 Although optimal targets for glycemic control remain unknown for non‐criticallyill patients, adverse effects of hyperglycemia remain very clear.3, 5, 6 The American Diabetes Association and various medical societies have published recommendations and position statements urging better management of hyperglycemia even in stabilized patients on general medical floors.7 Effective options for managing inpatient dysglycemia are available,8 but still remain underutilized. Despite increasing questions about its clinical benefit, lone correctional insulin (LCI) therapy, commonly known as sliding scale insulin, remains a common approach for glycemic control.9, 10 Explanations for this clinical inertia to utilize best practices range from fears of causing hypoglycemia, to a shortage of glycemic control specialists.11

Along with LCI therapy, use of potentially inappropriate oral hypoglycemic medications (PIOHMs) during hospitalization remains common. Scotton et al.12 reports that up to 68% of hospitalized patients on metformin were continued on the drug despite contraindications to its use.1214 Surgical intervention, intravenous contrast use, and elevated creatinine accounted for the majority of contraindications.12 Unfortunately, an educational memo mailed to physicians as well as a computer alert regarding the contraindications to metformin use failed to decrease the inappropriate use of metformin on an inpatient basis.12 Notably, the computer alert appeared whenever metformin was prescribed but did not require the clinician to actively acknowledge the statement. One study has found that inpatient metformin use did not result in increased mortality or adverse events.

Research has shown that implementation of best practices increases with a team approach, or when specialist oversight follows educational efforts.15, 16 Elinav et al.15 describe the difficulty in maintaining specialist oversight, which was essential to provide enhanced glycemic control for inpatients. To capture the potential strengths of team‐based care and specialist oversight, we hypothesized that a glycemic control order set combined with a real‐time nursing intervention (RTNI) could improve best‐practice utilization for glycemic control among hospitalized patients. This intervention likely has the capability to be sustainable, as it is modeled to be incorporated into the frontline workflow. This pilot study depicts the effects of a comprehensive effort to improve glycemic control catalyzed by the RTNI.

Materials and Methods

This study was carried out in a new 110‐bed exurban community teaching hospital, where patients with dysglycemia are primarily treated by family medicine residents, academic hospitalists, private generalists, and bariatric surgeons. Several months prior to the beginning of the study, a glycemic control task force was formed and supported as part of the strategic plan for this new hospital. The interventions in this study were approved by the task force as part of a quality improvement program (QI). Institutional review board (IRB) approval for this study was obtained through Emory University.

A total of 653 patients qualified to participate in this study (Table 1). The analysis was retrospective, using the hospital's electronic health record. Patients were included based on the frequency of blood glucose values obtained. Consent was not required nor obtained for this analysis.

Prior to the RTNI, several educational programs were undertaken from mid‐September 2007 to early November 2007. The glycemic control task force conducted physician education through: 1‐on‐1 physician office visits; phone conferences for hospital‐based physicians; and mailed letters to physicians informing them of available protocols. All 40 physicians who manage dysglycemia at this hospital were contacted by the principal investigator (PI), with 2 exceptions, due to logistic difficulties. We posted clinical guidelines to treat dysglycemia and glucometric performance data in physician workstations. In addition, we developed and conducted a mandatory educational session for nurses. The session lasted 6 hours, and consisted of literature review, pathophysiology, hospital metrics, diabetic pharmacology, and dietary education. All nurses who work on the medical and surgical floors of our hospital were required to attend. Nurses hired after the live educational sessions were required to watch a videotape. Finally, we compiled, distributed, and publicized a paper‐based glycemic control order set for non‐critically‐ill patients. The glycemic control protocol (GCP) contained prompts to encourage key elements of best practices, such as basal insulin, use of prandial insulin for patients who were eating, automatic orders for nurses to address nutritional interruptions, and a hypoglycemic protocol (see Appendix A: Glycemic Control Protocol).

After these educational measures, the RTNI ran for 2 months (December 1, 2007 to January 31, 2008). The charge nurse of each floor identified patients with point of care (POC) glucose monitoring who had any glucose level >130mg/dL. When any such patient did not have a physician‐completed GCP, the charge nurse called the attending physician to remind them of the availability and likely appropriateness of initiating the GCP. The nurses offered to take verbal orders for the GCP and referred the physicians to the hospital pharmacist for any dosing questions. This information was recorded on log sheets and stored in a secure office by the charge nurses. After 2 months, the RTNI was removed as scheduled (Figure 1).

Figure 1

The hospital's electronic clinical information system was used to extract information on all noncritical and nonobstetric adult patients having 2 recorded blood glucose values per day for at least 2 days during the admission. Both serum glucose and POC glucose values were sufficient for inclusion. This level of glucose monitoring was the only qualifying criteria. Serum glucose testing was performed on the Siemens RXL MAX (Siemens, Deerfield, IL), and POC glucose values were obtained using the Roche Accuchek (Roche, Nutley, NJ).

One laboratory technician was trained to conduct this data extraction. This work was reviewed by the PI to assure data integrity. Our analysis included data on qualifying patients from the following time periods: (1) patients hospitalized during the 2‐month period prior to the initiation of educational programs (baseline); (2) patients hospitalized during the 2 months of education; (3) patients hospitalized during the RTNI; and (4) patients admitted for 2 months after the RTNI was removed (post‐RTNI). Between the RTNI and the post‐RTNI groups, 1 month's data were discarded as a washout period.

Five metrics were tracked for all patients. The first metric, the overall patient day‐weighted mean glucose (PDWMG; ie, mean glucose for each hospital day, averaged across all hospital days) value, was calculated using a method similar to a previously validated technique.17 We excluded all values <70 mg/dL, all values after day 10 of the hospitalization, and all values within 90 minutes of the previous value. Using the remaining values, the mean for each day was calculated. With each patient having 1 such value per patient‐day, we then calculated the individual PDWMG as the mean of all these patient‐days (1 value per qualifying patient per admission). The overall PDWMG was an average of the PDWMGs for all study patients in a particular time period.

The second metric was the percentage of qualifying patients with PDWMGs >180 mg/dL. The third metric was the percentage of patients who were administered PIOHMs (metformin or sulfonylureas). The fourth metric was the percentage of study patients who were administered correctional insulin without scheduled insulin. Fifth, we calculated the percentage of patients with severe recurrent hypoglycemia (glucose <50 mg/dL on more than 1 occasion separated by 30 minutes). We tracked patient data on a monthly basis and used 1‐way analysis of variance (ANOVA) to analyze the data (Figure 2).

Figure 2

Results

There were 1902 nonobstetric, noncritical, adult admissions to our facility during the entire study period. A total of 521 patients were admitted during the RTNI period. A total of 653 patients met inclusion criteria during the entire study. During the RTNI period, 183 patients met inclusion criteria. Forty‐nine patients met criteria for an RTNI call. The number of patients who had an RTNI call done was 25. The number of patients placed on the order set after an RTNI call was 12.

The study was designed to elucidate whether or not our RTNI was effective in improving best practices and glycemic control in a hospital that provided its staff with education to effectively treat dysglycemia. Compared to baseline, the use of LCIn regimens decreased from 48.2% to 31.3% (P < 0.01) during the RTNI period and the rate of PIOHM usage was reduced from 28.5% to 13.3% (P < 0.01).

We observed a decrease in PDWMG from 166 mg/dL to 156 mg/dL (P = 0.04) and found a trend toward a reduced rate of patients with PDWMG > 180 mg/dL, from 27.0% to 21.7% (P = 0.28). After removal of the intervention, all 4 glycemic control metrics trended back toward and were not significantly different from the baseline, with the exception of PIOHM use. The PIOHM remained significantly lower, from 28.5% in the baseline group, to 19.4% in the postintervention group (P = 0.039) (Table 2). The prevalence of severe recurrent hypoglycemia was not significantly different in 7 of the 8 months. The exception was in the first month of the RTNI, when we observed a spike to 10%. Figures 3 to 5 depict some of these findings using annotated statistical process control charts.

Figure 3

Figure 4

Figure 5

Discussion

Glucometrics are useful in monitoring changes during a glycemic control QI program.17 Our study was designed to explore the glucometric effect of a RTNI when preceded by staff education and a best‐practice glycemic control order set. In this study, after identifying patients with dysglycemia, charge nurses personally encouraged physicians to use a paper‐based best‐practice order set. During the 2 months of the RTNI, we observed a significant corresponding improvement in many metrics. This improvement largely disappeared following removal of the RTNI. We postulate that the RTNI triggered clinically important moments of awareness or accountability to overcome clinical inertia. The total number of calls was only a fraction of the total patients who met inclusion criteria. We postulate that the publicized RTNI program created a level of awareness for many providers, who came to anticipate phone call reminders regarding use of the GCP. Clinical inertia has been described as the failure of health care providers to initiate or intensify therapy when indicated,18 and thereby represents a plausible explanation for underutilizing best‐practice guidelines.

PIOHM usage decreased and stayed low after withdrawal of the intervention. The literature is not conclusive with regard to the inappropriateness of oral medication use in hospitals, but avoiding these oral medications is espoused by experts in the field.19

Because our RTNI did not include a focused insulin titration component we did not demonstrate a vast improvement in glycemic control itself, the metric with the greatest association with morbid events.3 We theorize that the addition of a focused titration component to an RTNI may address this issue.

There was a concerning rise in hypoglycemic events initially, which completely returned to pre‐RTNI levels in 1 month. Although the reason for the increased hypoglycemia is not clear, we speculate that the lack of physician familiarity with insulin dosing played a large role. Since this problem did not persist after the first RTNI month, despite the same study conditions, we speculate that the physicians responsible adapted by learning to make the appropriate dose adjustments. In these patients, no intensive care unit (ICU) transfers or seizures resulted from the hypoglycemia.

Hypoglycemia is a common problem encountered even in several studies on intensive glucose control in both an inpatient and outpatient setting. In medical ICU patients, the rate of hypoglycemia was shown be 18.7% in the intensive treatment group as compared with 3.1% in the control group.20 Hypoglycemia is also the reason one clinical trial on intensive insulin therapy in critically ill patients was stopped.21 However, one study of 302 ICU patients found no association between hypoglycemia and short‐term (within 5 days of the event) or late (hospital) mortality.22 The Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE‐SUGAR) study found a lower overall incidence of severe hypoglycemia in its study of critically ill patients, but the tight glycemic control group had a 2.6% higher mortality rate, and the number needed to harm was only 38.23

In February 2008, the outpatient glycemic control study of Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) was halted due to the finding of an increased rate of mortality in the intensive arm compared with the standard arm. In both study arms, participants with severe hypoglycemia had higher mortality than those without severe hypoglycemia. Controversy still remains secondary to the inability of the ACCORD, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE), and Veterans Administration Diabetes Trial (VADT) trials to demonstrate significant reduction of cardiovascular disease (CVD) with intensive glycemic control in outpatients and recently the American Diabetes Association (ADA) came out with a position statement,24 in which it concludes the evidence obtained from the ACCORD, ADVANCE, and VADT trials do not suggest the need for total abandonment of, or major changes in glycemic control targets. The statement stresses on individualization as the benefits of intensive glycemic control on microvascular and neuropathic complications are well established for both type 1 and type 2 diabetes. This controversy is all the more reason to properly address dysglycemia. LCI places patients at risk for both hyperglycemia from lack of basal insulin, and hypoglycemia from insulin stacking. A proactive strategy of appropriately dosed scheduled insulin via a defined protocol is therefore recommended.

Our study demonstrates that a relatively simple intervention can create the situational awareness to overcome clinical inertia in appropriately treating hyperglycemia. However, it clearly warns glycemic control QI leaders of the need to diligently monitor for hypoglycemia as improvement efforts begin. A system devised to formally check insulin dosing may be warranted. Healthcare providers new to practicing proactive glycemic control with basal/bolus insulin regimens may require close oversight, especially early in the Do phase of the Plan Do Study Act (PDSA) cycle. The Randomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes (RABBIT 2) trial randomized insulin naive diabetic patients to weight based scheduled insulin dosing and an adjustable LCI regimen, and found no difference in rates of hypoglycemia, while substantially reducing hyperglycemia with scheduled insulin.25 Our study included patients with advanced age and renal dysfunction who require decreased insulin dosing, the initial increase of hypoglycemia highlights the need for further research in this area.

Conclusions

An RTNI coupled with a GCP significantly improved best‐practices for hospitalized patients with dysglycemia and may have modestly improved glycemic control. The RTNI accommodates normal clinical workflow and therefore is likely to be sustainable. Additional study should gauge the effect of a focused insulin titration component and further investigation is needed to gauge sustainability, transferability across nursing units and hospitals, and scalability of the underlying concept to additional inpatient care metrics. Vigilant monitoring of hypoglycemia is necessary as glycemic control QI initiatives are undertaken.

Dysglycemia, defined as a random blood glucose value >180 mg/dL or <70 mg/dL, is present in 25% to 28% of hospitalized patients.1, 2 It is associated with poor clinical outcomes, such as increased hospital‐acquired infection rates, increased hospital length of stay, and higher mortality rates.25 Although optimal targets for glycemic control remain unknown for non‐criticallyill patients, adverse effects of hyperglycemia remain very clear.3, 5, 6 The American Diabetes Association and various medical societies have published recommendations and position statements urging better management of hyperglycemia even in stabilized patients on general medical floors.7 Effective options for managing inpatient dysglycemia are available,8 but still remain underutilized. Despite increasing questions about its clinical benefit, lone correctional insulin (LCI) therapy, commonly known as sliding scale insulin, remains a common approach for glycemic control.9, 10 Explanations for this clinical inertia to utilize best practices range from fears of causing hypoglycemia, to a shortage of glycemic control specialists.11

Along with LCI therapy, use of potentially inappropriate oral hypoglycemic medications (PIOHMs) during hospitalization remains common. Scotton et al.12 reports that up to 68% of hospitalized patients on metformin were continued on the drug despite contraindications to its use.1214 Surgical intervention, intravenous contrast use, and elevated creatinine accounted for the majority of contraindications.12 Unfortunately, an educational memo mailed to physicians as well as a computer alert regarding the contraindications to metformin use failed to decrease the inappropriate use of metformin on an inpatient basis.12 Notably, the computer alert appeared whenever metformin was prescribed but did not require the clinician to actively acknowledge the statement. One study has found that inpatient metformin use did not result in increased mortality or adverse events.

Research has shown that implementation of best practices increases with a team approach, or when specialist oversight follows educational efforts.15, 16 Elinav et al.15 describe the difficulty in maintaining specialist oversight, which was essential to provide enhanced glycemic control for inpatients. To capture the potential strengths of team‐based care and specialist oversight, we hypothesized that a glycemic control order set combined with a real‐time nursing intervention (RTNI) could improve best‐practice utilization for glycemic control among hospitalized patients. This intervention likely has the capability to be sustainable, as it is modeled to be incorporated into the frontline workflow. This pilot study depicts the effects of a comprehensive effort to improve glycemic control catalyzed by the RTNI.

Materials and Methods

This study was carried out in a new 110‐bed exurban community teaching hospital, where patients with dysglycemia are primarily treated by family medicine residents, academic hospitalists, private generalists, and bariatric surgeons. Several months prior to the beginning of the study, a glycemic control task force was formed and supported as part of the strategic plan for this new hospital. The interventions in this study were approved by the task force as part of a quality improvement program (QI). Institutional review board (IRB) approval for this study was obtained through Emory University.

A total of 653 patients qualified to participate in this study (Table 1). The analysis was retrospective, using the hospital's electronic health record. Patients were included based on the frequency of blood glucose values obtained. Consent was not required nor obtained for this analysis.

Prior to the RTNI, several educational programs were undertaken from mid‐September 2007 to early November 2007. The glycemic control task force conducted physician education through: 1‐on‐1 physician office visits; phone conferences for hospital‐based physicians; and mailed letters to physicians informing them of available protocols. All 40 physicians who manage dysglycemia at this hospital were contacted by the principal investigator (PI), with 2 exceptions, due to logistic difficulties. We posted clinical guidelines to treat dysglycemia and glucometric performance data in physician workstations. In addition, we developed and conducted a mandatory educational session for nurses. The session lasted 6 hours, and consisted of literature review, pathophysiology, hospital metrics, diabetic pharmacology, and dietary education. All nurses who work on the medical and surgical floors of our hospital were required to attend. Nurses hired after the live educational sessions were required to watch a videotape. Finally, we compiled, distributed, and publicized a paper‐based glycemic control order set for non‐critically‐ill patients. The glycemic control protocol (GCP) contained prompts to encourage key elements of best practices, such as basal insulin, use of prandial insulin for patients who were eating, automatic orders for nurses to address nutritional interruptions, and a hypoglycemic protocol (see Appendix A: Glycemic Control Protocol).

After these educational measures, the RTNI ran for 2 months (December 1, 2007 to January 31, 2008). The charge nurse of each floor identified patients with point of care (POC) glucose monitoring who had any glucose level >130mg/dL. When any such patient did not have a physician‐completed GCP, the charge nurse called the attending physician to remind them of the availability and likely appropriateness of initiating the GCP. The nurses offered to take verbal orders for the GCP and referred the physicians to the hospital pharmacist for any dosing questions. This information was recorded on log sheets and stored in a secure office by the charge nurses. After 2 months, the RTNI was removed as scheduled (Figure 1).

Figure 1

The hospital's electronic clinical information system was used to extract information on all noncritical and nonobstetric adult patients having 2 recorded blood glucose values per day for at least 2 days during the admission. Both serum glucose and POC glucose values were sufficient for inclusion. This level of glucose monitoring was the only qualifying criteria. Serum glucose testing was performed on the Siemens RXL MAX (Siemens, Deerfield, IL), and POC glucose values were obtained using the Roche Accuchek (Roche, Nutley, NJ).

One laboratory technician was trained to conduct this data extraction. This work was reviewed by the PI to assure data integrity. Our analysis included data on qualifying patients from the following time periods: (1) patients hospitalized during the 2‐month period prior to the initiation of educational programs (baseline); (2) patients hospitalized during the 2 months of education; (3) patients hospitalized during the RTNI; and (4) patients admitted for 2 months after the RTNI was removed (post‐RTNI). Between the RTNI and the post‐RTNI groups, 1 month's data were discarded as a washout period.

Five metrics were tracked for all patients. The first metric, the overall patient day‐weighted mean glucose (PDWMG; ie, mean glucose for each hospital day, averaged across all hospital days) value, was calculated using a method similar to a previously validated technique.17 We excluded all values <70 mg/dL, all values after day 10 of the hospitalization, and all values within 90 minutes of the previous value. Using the remaining values, the mean for each day was calculated. With each patient having 1 such value per patient‐day, we then calculated the individual PDWMG as the mean of all these patient‐days (1 value per qualifying patient per admission). The overall PDWMG was an average of the PDWMGs for all study patients in a particular time period.

The second metric was the percentage of qualifying patients with PDWMGs >180 mg/dL. The third metric was the percentage of patients who were administered PIOHMs (metformin or sulfonylureas). The fourth metric was the percentage of study patients who were administered correctional insulin without scheduled insulin. Fifth, we calculated the percentage of patients with severe recurrent hypoglycemia (glucose <50 mg/dL on more than 1 occasion separated by 30 minutes). We tracked patient data on a monthly basis and used 1‐way analysis of variance (ANOVA) to analyze the data (Figure 2).

Figure 2

Results

There were 1902 nonobstetric, noncritical, adult admissions to our facility during the entire study period. A total of 521 patients were admitted during the RTNI period. A total of 653 patients met inclusion criteria during the entire study. During the RTNI period, 183 patients met inclusion criteria. Forty‐nine patients met criteria for an RTNI call. The number of patients who had an RTNI call done was 25. The number of patients placed on the order set after an RTNI call was 12.

The study was designed to elucidate whether or not our RTNI was effective in improving best practices and glycemic control in a hospital that provided its staff with education to effectively treat dysglycemia. Compared to baseline, the use of LCIn regimens decreased from 48.2% to 31.3% (P < 0.01) during the RTNI period and the rate of PIOHM usage was reduced from 28.5% to 13.3% (P < 0.01).

We observed a decrease in PDWMG from 166 mg/dL to 156 mg/dL (P = 0.04) and found a trend toward a reduced rate of patients with PDWMG > 180 mg/dL, from 27.0% to 21.7% (P = 0.28). After removal of the intervention, all 4 glycemic control metrics trended back toward and were not significantly different from the baseline, with the exception of PIOHM use. The PIOHM remained significantly lower, from 28.5% in the baseline group, to 19.4% in the postintervention group (P = 0.039) (Table 2). The prevalence of severe recurrent hypoglycemia was not significantly different in 7 of the 8 months. The exception was in the first month of the RTNI, when we observed a spike to 10%. Figures 3 to 5 depict some of these findings using annotated statistical process control charts.

Figure 3

Figure 4

Figure 5

Discussion

Glucometrics are useful in monitoring changes during a glycemic control QI program.17 Our study was designed to explore the glucometric effect of a RTNI when preceded by staff education and a best‐practice glycemic control order set. In this study, after identifying patients with dysglycemia, charge nurses personally encouraged physicians to use a paper‐based best‐practice order set. During the 2 months of the RTNI, we observed a significant corresponding improvement in many metrics. This improvement largely disappeared following removal of the RTNI. We postulate that the RTNI triggered clinically important moments of awareness or accountability to overcome clinical inertia. The total number of calls was only a fraction of the total patients who met inclusion criteria. We postulate that the publicized RTNI program created a level of awareness for many providers, who came to anticipate phone call reminders regarding use of the GCP. Clinical inertia has been described as the failure of health care providers to initiate or intensify therapy when indicated,18 and thereby represents a plausible explanation for underutilizing best‐practice guidelines.

PIOHM usage decreased and stayed low after withdrawal of the intervention. The literature is not conclusive with regard to the inappropriateness of oral medication use in hospitals, but avoiding these oral medications is espoused by experts in the field.19

Because our RTNI did not include a focused insulin titration component we did not demonstrate a vast improvement in glycemic control itself, the metric with the greatest association with morbid events.3 We theorize that the addition of a focused titration component to an RTNI may address this issue.

There was a concerning rise in hypoglycemic events initially, which completely returned to pre‐RTNI levels in 1 month. Although the reason for the increased hypoglycemia is not clear, we speculate that the lack of physician familiarity with insulin dosing played a large role. Since this problem did not persist after the first RTNI month, despite the same study conditions, we speculate that the physicians responsible adapted by learning to make the appropriate dose adjustments. In these patients, no intensive care unit (ICU) transfers or seizures resulted from the hypoglycemia.

Hypoglycemia is a common problem encountered even in several studies on intensive glucose control in both an inpatient and outpatient setting. In medical ICU patients, the rate of hypoglycemia was shown be 18.7% in the intensive treatment group as compared with 3.1% in the control group.20 Hypoglycemia is also the reason one clinical trial on intensive insulin therapy in critically ill patients was stopped.21 However, one study of 302 ICU patients found no association between hypoglycemia and short‐term (within 5 days of the event) or late (hospital) mortality.22 The Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE‐SUGAR) study found a lower overall incidence of severe hypoglycemia in its study of critically ill patients, but the tight glycemic control group had a 2.6% higher mortality rate, and the number needed to harm was only 38.23

In February 2008, the outpatient glycemic control study of Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) was halted due to the finding of an increased rate of mortality in the intensive arm compared with the standard arm. In both study arms, participants with severe hypoglycemia had higher mortality than those without severe hypoglycemia. Controversy still remains secondary to the inability of the ACCORD, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE), and Veterans Administration Diabetes Trial (VADT) trials to demonstrate significant reduction of cardiovascular disease (CVD) with intensive glycemic control in outpatients and recently the American Diabetes Association (ADA) came out with a position statement,24 in which it concludes the evidence obtained from the ACCORD, ADVANCE, and VADT trials do not suggest the need for total abandonment of, or major changes in glycemic control targets. The statement stresses on individualization as the benefits of intensive glycemic control on microvascular and neuropathic complications are well established for both type 1 and type 2 diabetes. This controversy is all the more reason to properly address dysglycemia. LCI places patients at risk for both hyperglycemia from lack of basal insulin, and hypoglycemia from insulin stacking. A proactive strategy of appropriately dosed scheduled insulin via a defined protocol is therefore recommended.

Our study demonstrates that a relatively simple intervention can create the situational awareness to overcome clinical inertia in appropriately treating hyperglycemia. However, it clearly warns glycemic control QI leaders of the need to diligently monitor for hypoglycemia as improvement efforts begin. A system devised to formally check insulin dosing may be warranted. Healthcare providers new to practicing proactive glycemic control with basal/bolus insulin regimens may require close oversight, especially early in the Do phase of the Plan Do Study Act (PDSA) cycle. The Randomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes (RABBIT 2) trial randomized insulin naive diabetic patients to weight based scheduled insulin dosing and an adjustable LCI regimen, and found no difference in rates of hypoglycemia, while substantially reducing hyperglycemia with scheduled insulin.25 Our study included patients with advanced age and renal dysfunction who require decreased insulin dosing, the initial increase of hypoglycemia highlights the need for further research in this area.

Conclusions

An RTNI coupled with a GCP significantly improved best‐practices for hospitalized patients with dysglycemia and may have modestly improved glycemic control. The RTNI accommodates normal clinical workflow and therefore is likely to be sustainable. Additional study should gauge the effect of a focused insulin titration component and further investigation is needed to gauge sustainability, transferability across nursing units and hospitals, and scalability of the underlying concept to additional inpatient care metrics. Vigilant monitoring of hypoglycemia is necessary as glycemic control QI initiatives are undertaken.

Dysglycemia, defined as a random blood glucose value >180 mg/dL or <70 mg/dL, is present in 25% to 28% of hospitalized patients.1, 2 It is associated with poor clinical outcomes, such as increased hospital‐acquired infection rates, increased hospital length of stay, and higher mortality rates.25 Although optimal targets for glycemic control remain unknown for non‐criticallyill patients, adverse effects of hyperglycemia remain very clear.3, 5, 6 The American Diabetes Association and various medical societies have published recommendations and position statements urging better management of hyperglycemia even in stabilized patients on general medical floors.7 Effective options for managing inpatient dysglycemia are available,8 but still remain underutilized. Despite increasing questions about its clinical benefit, lone correctional insulin (LCI) therapy, commonly known as sliding scale insulin, remains a common approach for glycemic control.9, 10 Explanations for this clinical inertia to utilize best practices range from fears of causing hypoglycemia, to a shortage of glycemic control specialists.11

Along with LCI therapy, use of potentially inappropriate oral hypoglycemic medications (PIOHMs) during hospitalization remains common. Scotton et al.12 reports that up to 68% of hospitalized patients on metformin were continued on the drug despite contraindications to its use.1214 Surgical intervention, intravenous contrast use, and elevated creatinine accounted for the majority of contraindications.12 Unfortunately, an educational memo mailed to physicians as well as a computer alert regarding the contraindications to metformin use failed to decrease the inappropriate use of metformin on an inpatient basis.12 Notably, the computer alert appeared whenever metformin was prescribed but did not require the clinician to actively acknowledge the statement. One study has found that inpatient metformin use did not result in increased mortality or adverse events.

Research has shown that implementation of best practices increases with a team approach, or when specialist oversight follows educational efforts.15, 16 Elinav et al.15 describe the difficulty in maintaining specialist oversight, which was essential to provide enhanced glycemic control for inpatients. To capture the potential strengths of team‐based care and specialist oversight, we hypothesized that a glycemic control order set combined with a real‐time nursing intervention (RTNI) could improve best‐practice utilization for glycemic control among hospitalized patients. This intervention likely has the capability to be sustainable, as it is modeled to be incorporated into the frontline workflow. This pilot study depicts the effects of a comprehensive effort to improve glycemic control catalyzed by the RTNI.

Materials and Methods

This study was carried out in a new 110‐bed exurban community teaching hospital, where patients with dysglycemia are primarily treated by family medicine residents, academic hospitalists, private generalists, and bariatric surgeons. Several months prior to the beginning of the study, a glycemic control task force was formed and supported as part of the strategic plan for this new hospital. The interventions in this study were approved by the task force as part of a quality improvement program (QI). Institutional review board (IRB) approval for this study was obtained through Emory University.

A total of 653 patients qualified to participate in this study (Table 1). The analysis was retrospective, using the hospital's electronic health record. Patients were included based on the frequency of blood glucose values obtained. Consent was not required nor obtained for this analysis.

Prior to the RTNI, several educational programs were undertaken from mid‐September 2007 to early November 2007. The glycemic control task force conducted physician education through: 1‐on‐1 physician office visits; phone conferences for hospital‐based physicians; and mailed letters to physicians informing them of available protocols. All 40 physicians who manage dysglycemia at this hospital were contacted by the principal investigator (PI), with 2 exceptions, due to logistic difficulties. We posted clinical guidelines to treat dysglycemia and glucometric performance data in physician workstations. In addition, we developed and conducted a mandatory educational session for nurses. The session lasted 6 hours, and consisted of literature review, pathophysiology, hospital metrics, diabetic pharmacology, and dietary education. All nurses who work on the medical and surgical floors of our hospital were required to attend. Nurses hired after the live educational sessions were required to watch a videotape. Finally, we compiled, distributed, and publicized a paper‐based glycemic control order set for non‐critically‐ill patients. The glycemic control protocol (GCP) contained prompts to encourage key elements of best practices, such as basal insulin, use of prandial insulin for patients who were eating, automatic orders for nurses to address nutritional interruptions, and a hypoglycemic protocol (see Appendix A: Glycemic Control Protocol).

After these educational measures, the RTNI ran for 2 months (December 1, 2007 to January 31, 2008). The charge nurse of each floor identified patients with point of care (POC) glucose monitoring who had any glucose level >130mg/dL. When any such patient did not have a physician‐completed GCP, the charge nurse called the attending physician to remind them of the availability and likely appropriateness of initiating the GCP. The nurses offered to take verbal orders for the GCP and referred the physicians to the hospital pharmacist for any dosing questions. This information was recorded on log sheets and stored in a secure office by the charge nurses. After 2 months, the RTNI was removed as scheduled (Figure 1).

Figure 1

The hospital's electronic clinical information system was used to extract information on all noncritical and nonobstetric adult patients having 2 recorded blood glucose values per day for at least 2 days during the admission. Both serum glucose and POC glucose values were sufficient for inclusion. This level of glucose monitoring was the only qualifying criteria. Serum glucose testing was performed on the Siemens RXL MAX (Siemens, Deerfield, IL), and POC glucose values were obtained using the Roche Accuchek (Roche, Nutley, NJ).

One laboratory technician was trained to conduct this data extraction. This work was reviewed by the PI to assure data integrity. Our analysis included data on qualifying patients from the following time periods: (1) patients hospitalized during the 2‐month period prior to the initiation of educational programs (baseline); (2) patients hospitalized during the 2 months of education; (3) patients hospitalized during the RTNI; and (4) patients admitted for 2 months after the RTNI was removed (post‐RTNI). Between the RTNI and the post‐RTNI groups, 1 month's data were discarded as a washout period.

Five metrics were tracked for all patients. The first metric, the overall patient day‐weighted mean glucose (PDWMG; ie, mean glucose for each hospital day, averaged across all hospital days) value, was calculated using a method similar to a previously validated technique.17 We excluded all values <70 mg/dL, all values after day 10 of the hospitalization, and all values within 90 minutes of the previous value. Using the remaining values, the mean for each day was calculated. With each patient having 1 such value per patient‐day, we then calculated the individual PDWMG as the mean of all these patient‐days (1 value per qualifying patient per admission). The overall PDWMG was an average of the PDWMGs for all study patients in a particular time period.

The second metric was the percentage of qualifying patients with PDWMGs >180 mg/dL. The third metric was the percentage of patients who were administered PIOHMs (metformin or sulfonylureas). The fourth metric was the percentage of study patients who were administered correctional insulin without scheduled insulin. Fifth, we calculated the percentage of patients with severe recurrent hypoglycemia (glucose <50 mg/dL on more than 1 occasion separated by 30 minutes). We tracked patient data on a monthly basis and used 1‐way analysis of variance (ANOVA) to analyze the data (Figure 2).

Figure 2

Results

There were 1902 nonobstetric, noncritical, adult admissions to our facility during the entire study period. A total of 521 patients were admitted during the RTNI period. A total of 653 patients met inclusion criteria during the entire study. During the RTNI period, 183 patients met inclusion criteria. Forty‐nine patients met criteria for an RTNI call. The number of patients who had an RTNI call done was 25. The number of patients placed on the order set after an RTNI call was 12.

The study was designed to elucidate whether or not our RTNI was effective in improving best practices and glycemic control in a hospital that provided its staff with education to effectively treat dysglycemia. Compared to baseline, the use of LCIn regimens decreased from 48.2% to 31.3% (P < 0.01) during the RTNI period and the rate of PIOHM usage was reduced from 28.5% to 13.3% (P < 0.01).

We observed a decrease in PDWMG from 166 mg/dL to 156 mg/dL (P = 0.04) and found a trend toward a reduced rate of patients with PDWMG > 180 mg/dL, from 27.0% to 21.7% (P = 0.28). After removal of the intervention, all 4 glycemic control metrics trended back toward and were not significantly different from the baseline, with the exception of PIOHM use. The PIOHM remained significantly lower, from 28.5% in the baseline group, to 19.4% in the postintervention group (P = 0.039) (Table 2). The prevalence of severe recurrent hypoglycemia was not significantly different in 7 of the 8 months. The exception was in the first month of the RTNI, when we observed a spike to 10%. Figures 3 to 5 depict some of these findings using annotated statistical process control charts.

Figure 3

Figure 4

Figure 5

Discussion

Glucometrics are useful in monitoring changes during a glycemic control QI program.17 Our study was designed to explore the glucometric effect of a RTNI when preceded by staff education and a best‐practice glycemic control order set. In this study, after identifying patients with dysglycemia, charge nurses personally encouraged physicians to use a paper‐based best‐practice order set. During the 2 months of the RTNI, we observed a significant corresponding improvement in many metrics. This improvement largely disappeared following removal of the RTNI. We postulate that the RTNI triggered clinically important moments of awareness or accountability to overcome clinical inertia. The total number of calls was only a fraction of the total patients who met inclusion criteria. We postulate that the publicized RTNI program created a level of awareness for many providers, who came to anticipate phone call reminders regarding use of the GCP. Clinical inertia has been described as the failure of health care providers to initiate or intensify therapy when indicated,18 and thereby represents a plausible explanation for underutilizing best‐practice guidelines.

PIOHM usage decreased and stayed low after withdrawal of the intervention. The literature is not conclusive with regard to the inappropriateness of oral medication use in hospitals, but avoiding these oral medications is espoused by experts in the field.19

Because our RTNI did not include a focused insulin titration component we did not demonstrate a vast improvement in glycemic control itself, the metric with the greatest association with morbid events.3 We theorize that the addition of a focused titration component to an RTNI may address this issue.

There was a concerning rise in hypoglycemic events initially, which completely returned to pre‐RTNI levels in 1 month. Although the reason for the increased hypoglycemia is not clear, we speculate that the lack of physician familiarity with insulin dosing played a large role. Since this problem did not persist after the first RTNI month, despite the same study conditions, we speculate that the physicians responsible adapted by learning to make the appropriate dose adjustments. In these patients, no intensive care unit (ICU) transfers or seizures resulted from the hypoglycemia.

Hypoglycemia is a common problem encountered even in several studies on intensive glucose control in both an inpatient and outpatient setting. In medical ICU patients, the rate of hypoglycemia was shown be 18.7% in the intensive treatment group as compared with 3.1% in the control group.20 Hypoglycemia is also the reason one clinical trial on intensive insulin therapy in critically ill patients was stopped.21 However, one study of 302 ICU patients found no association between hypoglycemia and short‐term (within 5 days of the event) or late (hospital) mortality.22 The Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE‐SUGAR) study found a lower overall incidence of severe hypoglycemia in its study of critically ill patients, but the tight glycemic control group had a 2.6% higher mortality rate, and the number needed to harm was only 38.23

In February 2008, the outpatient glycemic control study of Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) was halted due to the finding of an increased rate of mortality in the intensive arm compared with the standard arm. In both study arms, participants with severe hypoglycemia had higher mortality than those without severe hypoglycemia. Controversy still remains secondary to the inability of the ACCORD, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE), and Veterans Administration Diabetes Trial (VADT) trials to demonstrate significant reduction of cardiovascular disease (CVD) with intensive glycemic control in outpatients and recently the American Diabetes Association (ADA) came out with a position statement,24 in which it concludes the evidence obtained from the ACCORD, ADVANCE, and VADT trials do not suggest the need for total abandonment of, or major changes in glycemic control targets. The statement stresses on individualization as the benefits of intensive glycemic control on microvascular and neuropathic complications are well established for both type 1 and type 2 diabetes. This controversy is all the more reason to properly address dysglycemia. LCI places patients at risk for both hyperglycemia from lack of basal insulin, and hypoglycemia from insulin stacking. A proactive strategy of appropriately dosed scheduled insulin via a defined protocol is therefore recommended.

Our study demonstrates that a relatively simple intervention can create the situational awareness to overcome clinical inertia in appropriately treating hyperglycemia. However, it clearly warns glycemic control QI leaders of the need to diligently monitor for hypoglycemia as improvement efforts begin. A system devised to formally check insulin dosing may be warranted. Healthcare providers new to practicing proactive glycemic control with basal/bolus insulin regimens may require close oversight, especially early in the Do phase of the Plan Do Study Act (PDSA) cycle. The Randomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes (RABBIT 2) trial randomized insulin naive diabetic patients to weight based scheduled insulin dosing and an adjustable LCI regimen, and found no difference in rates of hypoglycemia, while substantially reducing hyperglycemia with scheduled insulin.25 Our study included patients with advanced age and renal dysfunction who require decreased insulin dosing, the initial increase of hypoglycemia highlights the need for further research in this area.

Conclusions

An RTNI coupled with a GCP significantly improved best‐practices for hospitalized patients with dysglycemia and may have modestly improved glycemic control. The RTNI accommodates normal clinical workflow and therefore is likely to be sustainable. Additional study should gauge the effect of a focused insulin titration component and further investigation is needed to gauge sustainability, transferability across nursing units and hospitals, and scalability of the underlying concept to additional inpatient care metrics. Vigilant monitoring of hypoglycemia is necessary as glycemic control QI initiatives are undertaken.

Organization of physician services in intensive care units (ICUs) varies widely and influences mortality, morbidity, and costs of care. Intensive care provided by intensivists in a high‐intensity physician staffing model, in which intensivists are the sole attending physicians or consult on all patients, has been associated with desirable outcomes such as decreased length of stay, resource utilization, and mortality.1‐4 As a result, higher intensity ICU models have been recommended by various healthcare agencies, including the National Quality Forum and the Leapfrog Group.5‐7

One national survey indicated that 47% of ICUs surveyed had some intensivist coverage and only 4% of intensive care units met Leapfrog high‐intensity model standards.8 However, only one‐third of ICUs responded to this survey, smaller ICUs were overrepresented, and the survey may not have reflected the influence of newer policy initiatives because it was conducted in 1997. Though the attributes by which intensivists improve patient outcomes is unknown, researchers have suggested it is by having a knowledgeable physician present in the ICU, having a physician communicate with other clinicians and families, and by having a physician who manages the ICU by writing policies and procedures and administrative activities.9

Results have been conflicting as patients managed by intensivists have also been found to have an increased mortality, particularly when managed on an elective consultation basis in an open ICU, where patient orders are written by several physician specialties.10, 11 Alternative ICU staffing models, such as the use of hospitalists, have been utilized to compensate for the intensivist workforce shortage. Hospitalists often provide ICU care, although they are seldom board‐certified in critical care. Hospitalist care has been shown to provide clinical and efficiency benefits such as decreased length of hospital stay.12‐14

Understanding the manner in which critical care is currently delivered, particularly the utilization of intensivist and nonintensivist care providers, can provide insights into subsequent allocation of a limited intensivist workforce as nonintensivist care providers such as hospitalists become more available. To understand how intensivists and other practitioners, such as hospitalists, deliver critical care in Michigan, we performed a cross‐sectional survey of Michigan hospitals participating in the Keystone ICU project, a statewide quality‐improvement initiative.

Methods

The hospitals involved and the methods of Keystone ICU have been published previously.15 The Keystone ICU project is a collaborative quality improvement initiative first organized in October 2003 by the Michigan Health and Hospitals Association (MHA) Keystone Center for Patient Safety and Quality. At its inception, 103 ICUs voluntarily agreed to participate in Keystone ICU and reported data representing 85% of ICU beds in Michigan. Nonparticipating hospitals (n = 37) were smaller, 79% having fewer than 100 beds, many of which did not have ICUs. All ICUs from the 72 hospitals participating in the Keystone ICU project as of July 2005 were asked to complete surveys as part of ongoing data collection.

Keystone ICU sought to improve safety culture, increase adherence to evidence‐based practices among patients receiving mechanical ventilation, and reduce central lineassociated bloodstream infections and ventilator‐associated pneumonia through a number of interventions. Keystone also encouraged teams to standardize their physician staffing, and presented teams with evidence regarding the benefits of ICU physician staffing. Because many of the ICUs were small and believed it was not practical to staff their ICUs with intensivists, Keystone encouraged ICUs to create as many of the attributes of intensivist staffing as possible: having someone present who is knowledgeable, able to manage at the unit level, and who communicates well with clinicians and families.9 As part of this project, we developed a survey to describe the physician staffing in Michigan ICUs. Additional elements of the survey sought to ascertain how medical decision‐making occurred, which decisions were made by what types of clinicians, and who performed various procedures in the ICU.

Results

Discussion

As all Keystone ICU participating sites responded to the questionnaire, we believe these results to be representative of critical care practice in the state of Michigan at the present time. Michigan ICU staffing structures are variable. Only a minority (25%) of Michigan Keystone ICU sites operated in an environment where intensivists are the only attending physicians of record. Although intensivists rounded in 60% of sites not utilizing a closed model, 75% of sites had nonintensivist attending physicians, with primary care physicians and hospitalists commonly providing ICU services. The utilization of hospitalists to provide critical care services was found in the absence of intensivists, regardless of hospital or ICU size.

Closed ICUs were seen in larger hospitals and in larger ICUs. This finding is similar to data obtained on a national level.8‐16 A high‐intensity model of care was also uncommon, although decision‐making was at least shared between intensivists and nonintensivists at two‐thirds of sites. These findings are in keeping with the observation that intensivist‐directed care advocated by the Leapfrog Group has not been widely implemented,17 including in Michigan, a regional rollout leader for the Leapfrog Group.

Fewer ICUs reported utilizing a nonintensivist model than was reported in the survey by Angus et al.,8 where approximately one‐half of ICUs delivered care in this manner. This survey was performed in 1997, prior to the launch of the Leapfrog Group effort, and may have reflected a relative over representation of smaller, general ICUs. Our study is the first statewide analysis of critical care practices in the postLeapfrog Group era. Our finding that an array of approaches to critical care delivery existed in Michigan, even when intensivists rounded on patients, is similar to that found among Leapfrog‐compliant hospitals sampled from several regions of the United States.18

Other than intensivists, surgeons, primary care, and hospitalist physicians provided care in Michigan ICUs. The hospitalist movement is relatively new.19 However, in our survey 37.5% of sites had hospitalists serving as attending physicians. Although the closed ICU model was more prevalent in larger ICUs and hospitals, the use of a hospitalist model to staff ICUs was not related to hospital size, but was instead a function of whether or not intensivists were present in a given setting. In lieu of a projected shortage of intensivists, we believe this confirms the crucial role that hospitalists will play in the provision of critical care services in the future.

The attributes of intensivist care that led to improved outcomes in previous studies1‐4 are unknown. To the extent that the involvement of intensivists on an elective rather than mandatory consultative basis may explain the higher mortality found in 1 recent study,1011 we hypothesize that having a knowledgeable physician present who communicates with clinicians and families and manages at the unit level is an important factor leading to improved outcomes. While hospitalists can have these attributes, their knowledge of specific critical care therapies and technologies may vary with the extent of their ICU training and experience. Further research should seek to quantify the attributes by which intensivists are associated with improved outcomes and seek ways to foster those attributes among hospitalists who participate in critical care delivery. Central to this will be ensuring that training programs ensure competency in critical care therapies and technologies among hospitalists and other non‐ICU physicians.

We recognize several limitations in this study. First, the validity of the survey may introduce misclassification of ICU staffing. However, the survey instrument was informed by previously‐validated instruments and experts in ICU physician staffing and hospitalist care. Second, we did not link variation in staffing to outcomes. While such analysis is important, it is beyond the scope of this survey. Third, our study was conducted in 1 state and the results may not be generalizable across the United States. Nevertheless, Michigan is a large state with a diverse array of hospitals, and as our study sample broadly represented this diversity, we believe our results are likely to be generalizable.

In conclusion, few ICUs in Michigan are closed and many utilize nonintensivist critical‐care providers such as hospitalists, primary care providers, and physician extenders to deliver clinical care. Our findings have significant implications for future efforts at a national level that involve the training of hospitalists and their acceptance as critical care practitioners. We suggest future research involving intensive care delivery focus on the feasibility of training sufficient hospitalists to satisfy a growing need for critical care that cannot be filled by intensivists, along with strategic planning to insure the model of care provided is commensurate with the complexity of illness. Although this approach appears to be occurring in Michigan on an ad hoc basis, we believe coordination between larger, intensivist‐run ICUs and smaller, nonintensivist‐run ICUs should be formalized in order to optimize the delivery of intensive care.²⁵

Organization of physician services in intensive care units (ICUs) varies widely and influences mortality, morbidity, and costs of care. Intensive care provided by intensivists in a high‐intensity physician staffing model, in which intensivists are the sole attending physicians or consult on all patients, has been associated with desirable outcomes such as decreased length of stay, resource utilization, and mortality.1‐4 As a result, higher intensity ICU models have been recommended by various healthcare agencies, including the National Quality Forum and the Leapfrog Group.5‐7

One national survey indicated that 47% of ICUs surveyed had some intensivist coverage and only 4% of intensive care units met Leapfrog high‐intensity model standards.8 However, only one‐third of ICUs responded to this survey, smaller ICUs were overrepresented, and the survey may not have reflected the influence of newer policy initiatives because it was conducted in 1997. Though the attributes by which intensivists improve patient outcomes is unknown, researchers have suggested it is by having a knowledgeable physician present in the ICU, having a physician communicate with other clinicians and families, and by having a physician who manages the ICU by writing policies and procedures and administrative activities.9

Results have been conflicting as patients managed by intensivists have also been found to have an increased mortality, particularly when managed on an elective consultation basis in an open ICU, where patient orders are written by several physician specialties.10, 11 Alternative ICU staffing models, such as the use of hospitalists, have been utilized to compensate for the intensivist workforce shortage. Hospitalists often provide ICU care, although they are seldom board‐certified in critical care. Hospitalist care has been shown to provide clinical and efficiency benefits such as decreased length of hospital stay.12‐14

Understanding the manner in which critical care is currently delivered, particularly the utilization of intensivist and nonintensivist care providers, can provide insights into subsequent allocation of a limited intensivist workforce as nonintensivist care providers such as hospitalists become more available. To understand how intensivists and other practitioners, such as hospitalists, deliver critical care in Michigan, we performed a cross‐sectional survey of Michigan hospitals participating in the Keystone ICU project, a statewide quality‐improvement initiative.

Methods

The hospitals involved and the methods of Keystone ICU have been published previously.15 The Keystone ICU project is a collaborative quality improvement initiative first organized in October 2003 by the Michigan Health and Hospitals Association (MHA) Keystone Center for Patient Safety and Quality. At its inception, 103 ICUs voluntarily agreed to participate in Keystone ICU and reported data representing 85% of ICU beds in Michigan. Nonparticipating hospitals (n = 37) were smaller, 79% having fewer than 100 beds, many of which did not have ICUs. All ICUs from the 72 hospitals participating in the Keystone ICU project as of July 2005 were asked to complete surveys as part of ongoing data collection.

Keystone ICU sought to improve safety culture, increase adherence to evidence‐based practices among patients receiving mechanical ventilation, and reduce central lineassociated bloodstream infections and ventilator‐associated pneumonia through a number of interventions. Keystone also encouraged teams to standardize their physician staffing, and presented teams with evidence regarding the benefits of ICU physician staffing. Because many of the ICUs were small and believed it was not practical to staff their ICUs with intensivists, Keystone encouraged ICUs to create as many of the attributes of intensivist staffing as possible: having someone present who is knowledgeable, able to manage at the unit level, and who communicates well with clinicians and families.9 As part of this project, we developed a survey to describe the physician staffing in Michigan ICUs. Additional elements of the survey sought to ascertain how medical decision‐making occurred, which decisions were made by what types of clinicians, and who performed various procedures in the ICU.

Results

Discussion

As all Keystone ICU participating sites responded to the questionnaire, we believe these results to be representative of critical care practice in the state of Michigan at the present time. Michigan ICU staffing structures are variable. Only a minority (25%) of Michigan Keystone ICU sites operated in an environment where intensivists are the only attending physicians of record. Although intensivists rounded in 60% of sites not utilizing a closed model, 75% of sites had nonintensivist attending physicians, with primary care physicians and hospitalists commonly providing ICU services. The utilization of hospitalists to provide critical care services was found in the absence of intensivists, regardless of hospital or ICU size.

Closed ICUs were seen in larger hospitals and in larger ICUs. This finding is similar to data obtained on a national level.8‐16 A high‐intensity model of care was also uncommon, although decision‐making was at least shared between intensivists and nonintensivists at two‐thirds of sites. These findings are in keeping with the observation that intensivist‐directed care advocated by the Leapfrog Group has not been widely implemented,17 including in Michigan, a regional rollout leader for the Leapfrog Group.

Fewer ICUs reported utilizing a nonintensivist model than was reported in the survey by Angus et al.,8 where approximately one‐half of ICUs delivered care in this manner. This survey was performed in 1997, prior to the launch of the Leapfrog Group effort, and may have reflected a relative over representation of smaller, general ICUs. Our study is the first statewide analysis of critical care practices in the postLeapfrog Group era. Our finding that an array of approaches to critical care delivery existed in Michigan, even when intensivists rounded on patients, is similar to that found among Leapfrog‐compliant hospitals sampled from several regions of the United States.18

Other than intensivists, surgeons, primary care, and hospitalist physicians provided care in Michigan ICUs. The hospitalist movement is relatively new.19 However, in our survey 37.5% of sites had hospitalists serving as attending physicians. Although the closed ICU model was more prevalent in larger ICUs and hospitals, the use of a hospitalist model to staff ICUs was not related to hospital size, but was instead a function of whether or not intensivists were present in a given setting. In lieu of a projected shortage of intensivists, we believe this confirms the crucial role that hospitalists will play in the provision of critical care services in the future.

The attributes of intensivist care that led to improved outcomes in previous studies1‐4 are unknown. To the extent that the involvement of intensivists on an elective rather than mandatory consultative basis may explain the higher mortality found in 1 recent study,1011 we hypothesize that having a knowledgeable physician present who communicates with clinicians and families and manages at the unit level is an important factor leading to improved outcomes. While hospitalists can have these attributes, their knowledge of specific critical care therapies and technologies may vary with the extent of their ICU training and experience. Further research should seek to quantify the attributes by which intensivists are associated with improved outcomes and seek ways to foster those attributes among hospitalists who participate in critical care delivery. Central to this will be ensuring that training programs ensure competency in critical care therapies and technologies among hospitalists and other non‐ICU physicians.

We recognize several limitations in this study. First, the validity of the survey may introduce misclassification of ICU staffing. However, the survey instrument was informed by previously‐validated instruments and experts in ICU physician staffing and hospitalist care. Second, we did not link variation in staffing to outcomes. While such analysis is important, it is beyond the scope of this survey. Third, our study was conducted in 1 state and the results may not be generalizable across the United States. Nevertheless, Michigan is a large state with a diverse array of hospitals, and as our study sample broadly represented this diversity, we believe our results are likely to be generalizable.

In conclusion, few ICUs in Michigan are closed and many utilize nonintensivist critical‐care providers such as hospitalists, primary care providers, and physician extenders to deliver clinical care. Our findings have significant implications for future efforts at a national level that involve the training of hospitalists and their acceptance as critical care practitioners. We suggest future research involving intensive care delivery focus on the feasibility of training sufficient hospitalists to satisfy a growing need for critical care that cannot be filled by intensivists, along with strategic planning to insure the model of care provided is commensurate with the complexity of illness. Although this approach appears to be occurring in Michigan on an ad hoc basis, we believe coordination between larger, intensivist‐run ICUs and smaller, nonintensivist‐run ICUs should be formalized in order to optimize the delivery of intensive care.²⁵

Organization of physician services in intensive care units (ICUs) varies widely and influences mortality, morbidity, and costs of care. Intensive care provided by intensivists in a high‐intensity physician staffing model, in which intensivists are the sole attending physicians or consult on all patients, has been associated with desirable outcomes such as decreased length of stay, resource utilization, and mortality.1‐4 As a result, higher intensity ICU models have been recommended by various healthcare agencies, including the National Quality Forum and the Leapfrog Group.5‐7

One national survey indicated that 47% of ICUs surveyed had some intensivist coverage and only 4% of intensive care units met Leapfrog high‐intensity model standards.8 However, only one‐third of ICUs responded to this survey, smaller ICUs were overrepresented, and the survey may not have reflected the influence of newer policy initiatives because it was conducted in 1997. Though the attributes by which intensivists improve patient outcomes is unknown, researchers have suggested it is by having a knowledgeable physician present in the ICU, having a physician communicate with other clinicians and families, and by having a physician who manages the ICU by writing policies and procedures and administrative activities.9

Results have been conflicting as patients managed by intensivists have also been found to have an increased mortality, particularly when managed on an elective consultation basis in an open ICU, where patient orders are written by several physician specialties.10, 11 Alternative ICU staffing models, such as the use of hospitalists, have been utilized to compensate for the intensivist workforce shortage. Hospitalists often provide ICU care, although they are seldom board‐certified in critical care. Hospitalist care has been shown to provide clinical and efficiency benefits such as decreased length of hospital stay.12‐14

Understanding the manner in which critical care is currently delivered, particularly the utilization of intensivist and nonintensivist care providers, can provide insights into subsequent allocation of a limited intensivist workforce as nonintensivist care providers such as hospitalists become more available. To understand how intensivists and other practitioners, such as hospitalists, deliver critical care in Michigan, we performed a cross‐sectional survey of Michigan hospitals participating in the Keystone ICU project, a statewide quality‐improvement initiative.

Methods

The hospitals involved and the methods of Keystone ICU have been published previously.15 The Keystone ICU project is a collaborative quality improvement initiative first organized in October 2003 by the Michigan Health and Hospitals Association (MHA) Keystone Center for Patient Safety and Quality. At its inception, 103 ICUs voluntarily agreed to participate in Keystone ICU and reported data representing 85% of ICU beds in Michigan. Nonparticipating hospitals (n = 37) were smaller, 79% having fewer than 100 beds, many of which did not have ICUs. All ICUs from the 72 hospitals participating in the Keystone ICU project as of July 2005 were asked to complete surveys as part of ongoing data collection.

Keystone ICU sought to improve safety culture, increase adherence to evidence‐based practices among patients receiving mechanical ventilation, and reduce central lineassociated bloodstream infections and ventilator‐associated pneumonia through a number of interventions. Keystone also encouraged teams to standardize their physician staffing, and presented teams with evidence regarding the benefits of ICU physician staffing. Because many of the ICUs were small and believed it was not practical to staff their ICUs with intensivists, Keystone encouraged ICUs to create as many of the attributes of intensivist staffing as possible: having someone present who is knowledgeable, able to manage at the unit level, and who communicates well with clinicians and families.9 As part of this project, we developed a survey to describe the physician staffing in Michigan ICUs. Additional elements of the survey sought to ascertain how medical decision‐making occurred, which decisions were made by what types of clinicians, and who performed various procedures in the ICU.

Results

Discussion

As all Keystone ICU participating sites responded to the questionnaire, we believe these results to be representative of critical care practice in the state of Michigan at the present time. Michigan ICU staffing structures are variable. Only a minority (25%) of Michigan Keystone ICU sites operated in an environment where intensivists are the only attending physicians of record. Although intensivists rounded in 60% of sites not utilizing a closed model, 75% of sites had nonintensivist attending physicians, with primary care physicians and hospitalists commonly providing ICU services. The utilization of hospitalists to provide critical care services was found in the absence of intensivists, regardless of hospital or ICU size.

Closed ICUs were seen in larger hospitals and in larger ICUs. This finding is similar to data obtained on a national level.8‐16 A high‐intensity model of care was also uncommon, although decision‐making was at least shared between intensivists and nonintensivists at two‐thirds of sites. These findings are in keeping with the observation that intensivist‐directed care advocated by the Leapfrog Group has not been widely implemented,17 including in Michigan, a regional rollout leader for the Leapfrog Group.

Fewer ICUs reported utilizing a nonintensivist model than was reported in the survey by Angus et al.,8 where approximately one‐half of ICUs delivered care in this manner. This survey was performed in 1997, prior to the launch of the Leapfrog Group effort, and may have reflected a relative over representation of smaller, general ICUs. Our study is the first statewide analysis of critical care practices in the postLeapfrog Group era. Our finding that an array of approaches to critical care delivery existed in Michigan, even when intensivists rounded on patients, is similar to that found among Leapfrog‐compliant hospitals sampled from several regions of the United States.18

Other than intensivists, surgeons, primary care, and hospitalist physicians provided care in Michigan ICUs. The hospitalist movement is relatively new.19 However, in our survey 37.5% of sites had hospitalists serving as attending physicians. Although the closed ICU model was more prevalent in larger ICUs and hospitals, the use of a hospitalist model to staff ICUs was not related to hospital size, but was instead a function of whether or not intensivists were present in a given setting. In lieu of a projected shortage of intensivists, we believe this confirms the crucial role that hospitalists will play in the provision of critical care services in the future.

The attributes of intensivist care that led to improved outcomes in previous studies1‐4 are unknown. To the extent that the involvement of intensivists on an elective rather than mandatory consultative basis may explain the higher mortality found in 1 recent study,1011 we hypothesize that having a knowledgeable physician present who communicates with clinicians and families and manages at the unit level is an important factor leading to improved outcomes. While hospitalists can have these attributes, their knowledge of specific critical care therapies and technologies may vary with the extent of their ICU training and experience. Further research should seek to quantify the attributes by which intensivists are associated with improved outcomes and seek ways to foster those attributes among hospitalists who participate in critical care delivery. Central to this will be ensuring that training programs ensure competency in critical care therapies and technologies among hospitalists and other non‐ICU physicians.

We recognize several limitations in this study. First, the validity of the survey may introduce misclassification of ICU staffing. However, the survey instrument was informed by previously‐validated instruments and experts in ICU physician staffing and hospitalist care. Second, we did not link variation in staffing to outcomes. While such analysis is important, it is beyond the scope of this survey. Third, our study was conducted in 1 state and the results may not be generalizable across the United States. Nevertheless, Michigan is a large state with a diverse array of hospitals, and as our study sample broadly represented this diversity, we believe our results are likely to be generalizable.

In conclusion, few ICUs in Michigan are closed and many utilize nonintensivist critical‐care providers such as hospitalists, primary care providers, and physician extenders to deliver clinical care. Our findings have significant implications for future efforts at a national level that involve the training of hospitalists and their acceptance as critical care practitioners. We suggest future research involving intensive care delivery focus on the feasibility of training sufficient hospitalists to satisfy a growing need for critical care that cannot be filled by intensivists, along with strategic planning to insure the model of care provided is commensurate with the complexity of illness. Although this approach appears to be occurring in Michigan on an ad hoc basis, we believe coordination between larger, intensivist‐run ICUs and smaller, nonintensivist‐run ICUs should be formalized in order to optimize the delivery of intensive care.²⁵

In‐hospital administration of antimicrobials is often subject to controls and policies designed to limit the indiscriminant use of antimicrobials in situations where they are not warranted, to control costs, and to reduce the potential for the development of resistant microorganismsa major public health threat and patient safety concern. These controls and policies may include strategies such as limiting the choices of antimicrobials on formulary, rotational schedules of available antimicrobials, and antimicrobial approval processes.16 Antimicrobial approval processes commonly require that the bedside clinician obtain permission from a secondary source to administer a particular antimicrobial. This approval process may take the form of submitting written justification forms and/or direct telephone/fax requests to an Infectious Disease specialist, Clinical Pharmacist, or other surrogate prior to release of the antibiotic from the pharmacy. While these approval processes and other strategies have been shown to reduce the development of resistance,7, 8 improve outcomes,8 and provide education and revision of antimicrobial choice that may be more appropriate for the patient and suspected infection,9 they have the potential to delay the administration of the necessary antimicrobial by adding additional steps to the sequence of ordering, obtaining, and administering the medication. While it is certainly desirable to control the indiscriminant use of these medications, delays in antimicrobial administration may, in turn, worsen outcomes, thus counteracting the beneficial effects of control policies. The early and timely administration of appropriate broad spectrum antimicrobials chosen to cover the most expected organisms has been consistently shown to improve outcomes1027 and has been cited as an essential element of the Surviving Sepsis Campaign (http://www.survivingsepsis.org/emmplement/resources/guidelines), for which the rapid administration of broad‐spectrum coverage within 1 hour of making the diagnosis of possible or probable sepsis is a best‐practices goal. While not all orders for antimicrobials are stat or have severe sepsis or septic shock as an indication, most infections in hospitalized patients confer the risk of progressing to serious morbidity. When a clinician orders a medication, treatment or test stat, it is assumed that the clinician believes that timely execution of the order is important.

At our institution, the antimicrobial approval process requires written justification forms and/or a call or fax to an Infectious Disease specialist or Clinical Pharmacist prior to the antimicrobial being released from the pharmacy. We hypothesized that this process is associated with significant delays in patients receiving their prescribed antimicrobials when a restricted drug was chosen. The antibiotic approval process at our institution allows 1‐time stat doses of restricted antimicrobials to be ordered without preapproval at night (10 _PM to 8 _AM), but not during the day. This allowed us to compare the time‐to‐administration of restricted antimicrobials to their unrestricted counterparts and to themselves during this exempt time period.

Methods

Results

In total, 3337 orders for stat antimicrobials were written during the study period, of which 86 (2.6%) were excluded based on being outside the specified 4‐hour window. This left a total of 3251 orders in 3251 discrete patients for analysis.

We found that a statistically significantly higher percentage of delays in antimicrobial administration when the antimicrobial was restricted as compared to unrestricted. This was the case for both our primary outcome of a >1 hour delay (Figure 1) and our secondary outcome of a delay of >2 hours (Figure 2). For restricted antimicrobial, delays of >1 hr occurred with 46.1% of orders during the day and with 38.8% of orders at night (when exempt from approval), P < 0.001. For unrestricted antimicrobials, delays of >1 hr occurred in 36.4% and 36.6% of instances, respectively (P = 0.57). The odds ratio for a delay in administration of 1 hour for restricted antimicrobials was 1.49 (95% CI = 1.23‐1.82).

Figure 1

Figure 2

Delays beyond 2 hours occurred 24.0% of the time for restricted antimicrobials during the day versus 16.4% at night. Unrestricted antimicrobials were delayed >2 hrs only 15.1% and 14.3% of the time for day and night periods, respectively (P = 0.35). The odds ratio for a two‐hour or greater delay was 1.78 (95% CI = 1.39‐2.21), P < 0.0001 when the antimicrobial was restricted.

These odds ratios and statistical significance were unchanged by adjustment for primary service (medicine vs. non‐medicine), age, sex, ethnicity or whether the order was placed on a weekend or weekday (data not shown).

Discussion

We found that our institution's antimicrobial approval process was associated with statistically significant delays in the administration of antimicrobials that were ordered stat by the prescribing clinician. These delays were evident both when comparing restricted antimicrobials to unrestricted ones and when these restricted antimicrobials were compared to themselves during the overnight time period when they were temporarily exempt from the approval process. This suggests that the delay is associated with the approval process itself and not the specific drug or the time of day. We also found that over one‐third of all stat antimicrobial orders were not carried out in the within one hour. This rate approached nearly 50% for restricted drugs ordered stat. This high baseline rate for all stat‐ordered antimicrobials underscores system challenges that seem to be exacerbated when restricted antimicrobials are chosen.

We do not know if the delays we observed resulted in patient harm. Indeed it is possible, if not likely, that patient care at our institution is improved by the judicious use of certain antimicrobials, even if the process required to enforce their use may result in delayed antimicrobial administration in some instances. Since we did not collect clinical information on baseline diagnoses or severity of illness, and we did not have information on clinical outcomes, we cannot determine whether the clinical delays we observed might have caused harm. Determining the impact these approval policies have on patient outcomes would require a separate study designed to collect the necessary clinical data to answer that question.

An additional limitation was that we did not ascertain the indications for the antimicrobials to determine whether they truly needed to be given stat. We suspect that antimicrobials are sometimes ordered stat even when the infection being treated is not likely to be serious or life‐threatening. Additionally, since we relied on the nurse‐charted time of administration, it is possible that in some instances there was a charted delay in administration when in reality the patient received the antimicrobial in a timely fashion. In urgent situations, the nurses may be too busy to document that the medication was given until long after the dose is given, and this may result in inaccuracies in the charted administration time. However, this type of documentation error would be expected to affect restricted and unrestricted antimicrobials similarly and would be unlikely to result in a systematic bias.

Because we conducted this study at a single institution, the results may not be applicable to other medical institutions, especially since restriction policies and antimicrobial approval processes vary from hospital to hospital. The burden of delays may be related to the number of restricted antimicrobials on formulary, the types of antimicrobials restricted, the number of steps required to have them released from the pharmacy, whether the approval process is initiated from within the order entry system, and other factors that may streamline or hamper the approval process.

In our institution, there are several steps in the process, any of which might contribute to the delay. Faxed approval sheets may take time to arrive to and be acted upon by the pharmacy, errant pages may delay communication between the provider and the person providing approval, and there may be delays in the final approval being relayed to the pharmacy by the individual providing approval. In fact, an alternative explanation for the observed administration delays is that once ordered in CPOE, the prescribing physicians themselves are slow in initiating the approval process. While this is certainly possible, especially given the stresses surrounding the management of a seriously ill patient on the general ward, this still suggests that having to go through the approval process may impact the process of care.

Other possible explanations for the delays observed when the restrictive antimicrobial policy was in effect may include pharmacy staffing. Since the workload in the pharmacy would be expected to be greater during the day, when more patient care activity is occurring such as clinics and operating rooms, this increased workload may have slowed down the pharmacy filling the orders. However, such human resource‐workload imbalances would also be expected to slow most pharmacy processes and should lead to delays in filling the orders for other medications including the unrestricted antimicrobials. We did not track other non‐antimicrobial medications to examine their patterns of delay. Nursing workload also varies between day and night but the time period where the antimicrobial administration delays occurred is the time when nursing is favorably staffed unlike the night when nurse to patient ratios are low. It is possible that despite better nurse to patient ratios during the day, the workload‐to‐nursing ratio remains high and contributes to delays in administration of otherwise stat‐ordered antimicrobials. Again, it is unclear why this would disproportionately affect the restricted class of antimicrobials.

We do not advocate the abandonment of antimicrobial control policies. The process described here is very institution‐specific and while its benefits are proven, energy should be channeled where appropriate to facilitate this process. These policies are clearly necessary to help reduce costs, limit the unwarranted use of these drugs, and slow the proliferation of ever more resistant strains of microorganisms. However, we do advocate careful consideration of the components of the approval process itself, ensuring that delays in antimicrobial administration are kept to a minimum and are avoided altogether in critically ill patients. One way to accomplish this might be to not require approval for the first administration of a stat antibiotic, but to require approval for subsequent doses. Our institution's overnight exempt period data suggest that this would eliminate the incremental delays incurred by the approval process itself. As important, our results show that even for unrestricted antibiotics, we fall short of achieving recommended best practices, highlighting the challenges inherent to carrying out multi‐step clinical tasks in an efficient fashion.

In‐hospital administration of antimicrobials is often subject to controls and policies designed to limit the indiscriminant use of antimicrobials in situations where they are not warranted, to control costs, and to reduce the potential for the development of resistant microorganismsa major public health threat and patient safety concern. These controls and policies may include strategies such as limiting the choices of antimicrobials on formulary, rotational schedules of available antimicrobials, and antimicrobial approval processes.16 Antimicrobial approval processes commonly require that the bedside clinician obtain permission from a secondary source to administer a particular antimicrobial. This approval process may take the form of submitting written justification forms and/or direct telephone/fax requests to an Infectious Disease specialist, Clinical Pharmacist, or other surrogate prior to release of the antibiotic from the pharmacy. While these approval processes and other strategies have been shown to reduce the development of resistance,7, 8 improve outcomes,8 and provide education and revision of antimicrobial choice that may be more appropriate for the patient and suspected infection,9 they have the potential to delay the administration of the necessary antimicrobial by adding additional steps to the sequence of ordering, obtaining, and administering the medication. While it is certainly desirable to control the indiscriminant use of these medications, delays in antimicrobial administration may, in turn, worsen outcomes, thus counteracting the beneficial effects of control policies. The early and timely administration of appropriate broad spectrum antimicrobials chosen to cover the most expected organisms has been consistently shown to improve outcomes1027 and has been cited as an essential element of the Surviving Sepsis Campaign (http://www.survivingsepsis.org/emmplement/resources/guidelines), for which the rapid administration of broad‐spectrum coverage within 1 hour of making the diagnosis of possible or probable sepsis is a best‐practices goal. While not all orders for antimicrobials are stat or have severe sepsis or septic shock as an indication, most infections in hospitalized patients confer the risk of progressing to serious morbidity. When a clinician orders a medication, treatment or test stat, it is assumed that the clinician believes that timely execution of the order is important.

At our institution, the antimicrobial approval process requires written justification forms and/or a call or fax to an Infectious Disease specialist or Clinical Pharmacist prior to the antimicrobial being released from the pharmacy. We hypothesized that this process is associated with significant delays in patients receiving their prescribed antimicrobials when a restricted drug was chosen. The antibiotic approval process at our institution allows 1‐time stat doses of restricted antimicrobials to be ordered without preapproval at night (10 _PM to 8 _AM), but not during the day. This allowed us to compare the time‐to‐administration of restricted antimicrobials to their unrestricted counterparts and to themselves during this exempt time period.

Methods

Results

In total, 3337 orders for stat antimicrobials were written during the study period, of which 86 (2.6%) were excluded based on being outside the specified 4‐hour window. This left a total of 3251 orders in 3251 discrete patients for analysis.

We found that a statistically significantly higher percentage of delays in antimicrobial administration when the antimicrobial was restricted as compared to unrestricted. This was the case for both our primary outcome of a >1 hour delay (Figure 1) and our secondary outcome of a delay of >2 hours (Figure 2). For restricted antimicrobial, delays of >1 hr occurred with 46.1% of orders during the day and with 38.8% of orders at night (when exempt from approval), P < 0.001. For unrestricted antimicrobials, delays of >1 hr occurred in 36.4% and 36.6% of instances, respectively (P = 0.57). The odds ratio for a delay in administration of 1 hour for restricted antimicrobials was 1.49 (95% CI = 1.23‐1.82).

Figure 1

Figure 2

Delays beyond 2 hours occurred 24.0% of the time for restricted antimicrobials during the day versus 16.4% at night. Unrestricted antimicrobials were delayed >2 hrs only 15.1% and 14.3% of the time for day and night periods, respectively (P = 0.35). The odds ratio for a two‐hour or greater delay was 1.78 (95% CI = 1.39‐2.21), P < 0.0001 when the antimicrobial was restricted.

These odds ratios and statistical significance were unchanged by adjustment for primary service (medicine vs. non‐medicine), age, sex, ethnicity or whether the order was placed on a weekend or weekday (data not shown).

Discussion

We found that our institution's antimicrobial approval process was associated with statistically significant delays in the administration of antimicrobials that were ordered stat by the prescribing clinician. These delays were evident both when comparing restricted antimicrobials to unrestricted ones and when these restricted antimicrobials were compared to themselves during the overnight time period when they were temporarily exempt from the approval process. This suggests that the delay is associated with the approval process itself and not the specific drug or the time of day. We also found that over one‐third of all stat antimicrobial orders were not carried out in the within one hour. This rate approached nearly 50% for restricted drugs ordered stat. This high baseline rate for all stat‐ordered antimicrobials underscores system challenges that seem to be exacerbated when restricted antimicrobials are chosen.

We do not know if the delays we observed resulted in patient harm. Indeed it is possible, if not likely, that patient care at our institution is improved by the judicious use of certain antimicrobials, even if the process required to enforce their use may result in delayed antimicrobial administration in some instances. Since we did not collect clinical information on baseline diagnoses or severity of illness, and we did not have information on clinical outcomes, we cannot determine whether the clinical delays we observed might have caused harm. Determining the impact these approval policies have on patient outcomes would require a separate study designed to collect the necessary clinical data to answer that question.

An additional limitation was that we did not ascertain the indications for the antimicrobials to determine whether they truly needed to be given stat. We suspect that antimicrobials are sometimes ordered stat even when the infection being treated is not likely to be serious or life‐threatening. Additionally, since we relied on the nurse‐charted time of administration, it is possible that in some instances there was a charted delay in administration when in reality the patient received the antimicrobial in a timely fashion. In urgent situations, the nurses may be too busy to document that the medication was given until long after the dose is given, and this may result in inaccuracies in the charted administration time. However, this type of documentation error would be expected to affect restricted and unrestricted antimicrobials similarly and would be unlikely to result in a systematic bias.

Because we conducted this study at a single institution, the results may not be applicable to other medical institutions, especially since restriction policies and antimicrobial approval processes vary from hospital to hospital. The burden of delays may be related to the number of restricted antimicrobials on formulary, the types of antimicrobials restricted, the number of steps required to have them released from the pharmacy, whether the approval process is initiated from within the order entry system, and other factors that may streamline or hamper the approval process.

In our institution, there are several steps in the process, any of which might contribute to the delay. Faxed approval sheets may take time to arrive to and be acted upon by the pharmacy, errant pages may delay communication between the provider and the person providing approval, and there may be delays in the final approval being relayed to the pharmacy by the individual providing approval. In fact, an alternative explanation for the observed administration delays is that once ordered in CPOE, the prescribing physicians themselves are slow in initiating the approval process. While this is certainly possible, especially given the stresses surrounding the management of a seriously ill patient on the general ward, this still suggests that having to go through the approval process may impact the process of care.

Other possible explanations for the delays observed when the restrictive antimicrobial policy was in effect may include pharmacy staffing. Since the workload in the pharmacy would be expected to be greater during the day, when more patient care activity is occurring such as clinics and operating rooms, this increased workload may have slowed down the pharmacy filling the orders. However, such human resource‐workload imbalances would also be expected to slow most pharmacy processes and should lead to delays in filling the orders for other medications including the unrestricted antimicrobials. We did not track other non‐antimicrobial medications to examine their patterns of delay. Nursing workload also varies between day and night but the time period where the antimicrobial administration delays occurred is the time when nursing is favorably staffed unlike the night when nurse to patient ratios are low. It is possible that despite better nurse to patient ratios during the day, the workload‐to‐nursing ratio remains high and contributes to delays in administration of otherwise stat‐ordered antimicrobials. Again, it is unclear why this would disproportionately affect the restricted class of antimicrobials.

We do not advocate the abandonment of antimicrobial control policies. The process described here is very institution‐specific and while its benefits are proven, energy should be channeled where appropriate to facilitate this process. These policies are clearly necessary to help reduce costs, limit the unwarranted use of these drugs, and slow the proliferation of ever more resistant strains of microorganisms. However, we do advocate careful consideration of the components of the approval process itself, ensuring that delays in antimicrobial administration are kept to a minimum and are avoided altogether in critically ill patients. One way to accomplish this might be to not require approval for the first administration of a stat antibiotic, but to require approval for subsequent doses. Our institution's overnight exempt period data suggest that this would eliminate the incremental delays incurred by the approval process itself. As important, our results show that even for unrestricted antibiotics, we fall short of achieving recommended best practices, highlighting the challenges inherent to carrying out multi‐step clinical tasks in an efficient fashion.

In‐hospital administration of antimicrobials is often subject to controls and policies designed to limit the indiscriminant use of antimicrobials in situations where they are not warranted, to control costs, and to reduce the potential for the development of resistant microorganismsa major public health threat and patient safety concern. These controls and policies may include strategies such as limiting the choices of antimicrobials on formulary, rotational schedules of available antimicrobials, and antimicrobial approval processes.16 Antimicrobial approval processes commonly require that the bedside clinician obtain permission from a secondary source to administer a particular antimicrobial. This approval process may take the form of submitting written justification forms and/or direct telephone/fax requests to an Infectious Disease specialist, Clinical Pharmacist, or other surrogate prior to release of the antibiotic from the pharmacy. While these approval processes and other strategies have been shown to reduce the development of resistance,7, 8 improve outcomes,8 and provide education and revision of antimicrobial choice that may be more appropriate for the patient and suspected infection,9 they have the potential to delay the administration of the necessary antimicrobial by adding additional steps to the sequence of ordering, obtaining, and administering the medication. While it is certainly desirable to control the indiscriminant use of these medications, delays in antimicrobial administration may, in turn, worsen outcomes, thus counteracting the beneficial effects of control policies. The early and timely administration of appropriate broad spectrum antimicrobials chosen to cover the most expected organisms has been consistently shown to improve outcomes1027 and has been cited as an essential element of the Surviving Sepsis Campaign (http://www.survivingsepsis.org/emmplement/resources/guidelines), for which the rapid administration of broad‐spectrum coverage within 1 hour of making the diagnosis of possible or probable sepsis is a best‐practices goal. While not all orders for antimicrobials are stat or have severe sepsis or septic shock as an indication, most infections in hospitalized patients confer the risk of progressing to serious morbidity. When a clinician orders a medication, treatment or test stat, it is assumed that the clinician believes that timely execution of the order is important.

At our institution, the antimicrobial approval process requires written justification forms and/or a call or fax to an Infectious Disease specialist or Clinical Pharmacist prior to the antimicrobial being released from the pharmacy. We hypothesized that this process is associated with significant delays in patients receiving their prescribed antimicrobials when a restricted drug was chosen. The antibiotic approval process at our institution allows 1‐time stat doses of restricted antimicrobials to be ordered without preapproval at night (10 _PM to 8 _AM), but not during the day. This allowed us to compare the time‐to‐administration of restricted antimicrobials to their unrestricted counterparts and to themselves during this exempt time period.

Methods

Results

In total, 3337 orders for stat antimicrobials were written during the study period, of which 86 (2.6%) were excluded based on being outside the specified 4‐hour window. This left a total of 3251 orders in 3251 discrete patients for analysis.

We found that a statistically significantly higher percentage of delays in antimicrobial administration when the antimicrobial was restricted as compared to unrestricted. This was the case for both our primary outcome of a >1 hour delay (Figure 1) and our secondary outcome of a delay of >2 hours (Figure 2). For restricted antimicrobial, delays of >1 hr occurred with 46.1% of orders during the day and with 38.8% of orders at night (when exempt from approval), P < 0.001. For unrestricted antimicrobials, delays of >1 hr occurred in 36.4% and 36.6% of instances, respectively (P = 0.57). The odds ratio for a delay in administration of 1 hour for restricted antimicrobials was 1.49 (95% CI = 1.23‐1.82).

Figure 1

Figure 2

Delays beyond 2 hours occurred 24.0% of the time for restricted antimicrobials during the day versus 16.4% at night. Unrestricted antimicrobials were delayed >2 hrs only 15.1% and 14.3% of the time for day and night periods, respectively (P = 0.35). The odds ratio for a two‐hour or greater delay was 1.78 (95% CI = 1.39‐2.21), P < 0.0001 when the antimicrobial was restricted.

These odds ratios and statistical significance were unchanged by adjustment for primary service (medicine vs. non‐medicine), age, sex, ethnicity or whether the order was placed on a weekend or weekday (data not shown).

Discussion

We found that our institution's antimicrobial approval process was associated with statistically significant delays in the administration of antimicrobials that were ordered stat by the prescribing clinician. These delays were evident both when comparing restricted antimicrobials to unrestricted ones and when these restricted antimicrobials were compared to themselves during the overnight time period when they were temporarily exempt from the approval process. This suggests that the delay is associated with the approval process itself and not the specific drug or the time of day. We also found that over one‐third of all stat antimicrobial orders were not carried out in the within one hour. This rate approached nearly 50% for restricted drugs ordered stat. This high baseline rate for all stat‐ordered antimicrobials underscores system challenges that seem to be exacerbated when restricted antimicrobials are chosen.

We do not know if the delays we observed resulted in patient harm. Indeed it is possible, if not likely, that patient care at our institution is improved by the judicious use of certain antimicrobials, even if the process required to enforce their use may result in delayed antimicrobial administration in some instances. Since we did not collect clinical information on baseline diagnoses or severity of illness, and we did not have information on clinical outcomes, we cannot determine whether the clinical delays we observed might have caused harm. Determining the impact these approval policies have on patient outcomes would require a separate study designed to collect the necessary clinical data to answer that question.

An additional limitation was that we did not ascertain the indications for the antimicrobials to determine whether they truly needed to be given stat. We suspect that antimicrobials are sometimes ordered stat even when the infection being treated is not likely to be serious or life‐threatening. Additionally, since we relied on the nurse‐charted time of administration, it is possible that in some instances there was a charted delay in administration when in reality the patient received the antimicrobial in a timely fashion. In urgent situations, the nurses may be too busy to document that the medication was given until long after the dose is given, and this may result in inaccuracies in the charted administration time. However, this type of documentation error would be expected to affect restricted and unrestricted antimicrobials similarly and would be unlikely to result in a systematic bias.

Because we conducted this study at a single institution, the results may not be applicable to other medical institutions, especially since restriction policies and antimicrobial approval processes vary from hospital to hospital. The burden of delays may be related to the number of restricted antimicrobials on formulary, the types of antimicrobials restricted, the number of steps required to have them released from the pharmacy, whether the approval process is initiated from within the order entry system, and other factors that may streamline or hamper the approval process.

In our institution, there are several steps in the process, any of which might contribute to the delay. Faxed approval sheets may take time to arrive to and be acted upon by the pharmacy, errant pages may delay communication between the provider and the person providing approval, and there may be delays in the final approval being relayed to the pharmacy by the individual providing approval. In fact, an alternative explanation for the observed administration delays is that once ordered in CPOE, the prescribing physicians themselves are slow in initiating the approval process. While this is certainly possible, especially given the stresses surrounding the management of a seriously ill patient on the general ward, this still suggests that having to go through the approval process may impact the process of care.

Other possible explanations for the delays observed when the restrictive antimicrobial policy was in effect may include pharmacy staffing. Since the workload in the pharmacy would be expected to be greater during the day, when more patient care activity is occurring such as clinics and operating rooms, this increased workload may have slowed down the pharmacy filling the orders. However, such human resource‐workload imbalances would also be expected to slow most pharmacy processes and should lead to delays in filling the orders for other medications including the unrestricted antimicrobials. We did not track other non‐antimicrobial medications to examine their patterns of delay. Nursing workload also varies between day and night but the time period where the antimicrobial administration delays occurred is the time when nursing is favorably staffed unlike the night when nurse to patient ratios are low. It is possible that despite better nurse to patient ratios during the day, the workload‐to‐nursing ratio remains high and contributes to delays in administration of otherwise stat‐ordered antimicrobials. Again, it is unclear why this would disproportionately affect the restricted class of antimicrobials.

We do not advocate the abandonment of antimicrobial control policies. The process described here is very institution‐specific and while its benefits are proven, energy should be channeled where appropriate to facilitate this process. These policies are clearly necessary to help reduce costs, limit the unwarranted use of these drugs, and slow the proliferation of ever more resistant strains of microorganisms. However, we do advocate careful consideration of the components of the approval process itself, ensuring that delays in antimicrobial administration are kept to a minimum and are avoided altogether in critically ill patients. One way to accomplish this might be to not require approval for the first administration of a stat antibiotic, but to require approval for subsequent doses. Our institution's overnight exempt period data suggest that this would eliminate the incremental delays incurred by the approval process itself. As important, our results show that even for unrestricted antibiotics, we fall short of achieving recommended best practices, highlighting the challenges inherent to carrying out multi‐step clinical tasks in an efficient fashion.

Hospitalists commonly encounter the challenges of infectious diseases in their hospitalized patients. Choosing the correct antibiotic, interpreting blood cultures, working up causes of fever, treating patients with an allergy to penicillin, and caring for patients with human immunodeficiency virus (HIV) commonly confront the hospitalist. This article presents evidence‐based pearls which will help hospitalists avoid common infectious disease pitfalls and guide their decision about when to consult an infectious diseases specialist.

1. Avoid Spiraling Empiricism and Understand Common Fallacies in Prescribing Empiric Antimicrobial Therapy

The term spiraling empiricism describes the inappropriate treatment, or the unjustifiable escalation of treatment, of suspected but undocumented infectious diseases.1 Initiation of carefully considered empiric broad‐spectrum antibiotic therapy for an acutely ill patient is an entirely appropriate and reasonable strategy. But all too often, practitioners are confronted with clinical dilemmas such as persistent fever or lack of response to therapy. In these circumstances, clinicians are faced with deciding whether to add or change antibiotics to broaden coverage. Changes in empiric therapy should be made sparingly, and only when there is new information or symptoms to justify an addition or change. In order to make an accurate assessment of response, steady‐state levels should be achieved and usually 3 to 5 days should be allowed to pass. Lack of response to broad‐spectrum therapy should trigger further investigation for occult infection or consideration of noninfectious etiologies and not simply the addition of a new antimicrobial agent. If a microbial pathogen is isolated from a blood culture(s) or other relevant source, antimicrobials should be tailored to the narrowest spectrum and least toxic therapy based on the sensitivities of that organism. For critically ill patients or patients who do not appear to be improving, an infectious diseases consultation may be warranted.

2. Know the Important Drug‐Drug Interactions Between Antimicrobials and Commonly‐used Inpatient Medications, Particularly With Those Involving Warfarin

Most antimicrobials (especially antifungals, quinolones, metronidazole, and sulfonamides) can cause unpredictable elevations in the international normalized ratio (INR) concurrent with warfarin administration, either through inhibition of warfarin metabolism or alterations in vitamin Kproducing gut flora. When using antimicrobials in patients on warfarin, the patient's INR should be carefully monitored and adjustment of the warfarin dose may be necessary. Antimicrobials that are inhibitors of cytochrome P‐450 enzymes include ciprofloxacin, levofloxacin, isoniazid, fluconazole, and clarithromycin. In contrast, rifampin is a potent inducer of most known cytochrome P‐450 enzymes and increases the metabolism of many drugs used in patients in the hospital setting, including anticonvulsants, beta‐blockers, calcium channel blockers, and other antibiotics like fluoroquinolones, and sulfonylureas. Moreover, the concurrent oral intake of tablets or solutions (including tube feeds) with a high concentration of trivalent and divalent cations (such as aluminum, magnesium, and, to a lesser extent, calcium, iron, and zinc) impairs gastrointestinal absorption of fluoroquinolones and should be avoided or spaced apart in time. Since fluoroquinolones can potentially prolong the QT interval, careful monitoring is necessary when a patient is prescribed other QT prolonging agents. Finally, many antimicrobials reduce the effectiveness of oral or other systemic hormonal contraceptives and patients should be routinely advised to use nonhormonal methods of birth control during therapy.

3. Positive Blood Cultures for Bacteria or Fungus Should be Repeated Serially Every 24 to 48 Hours Until the Cultures Are Negative

An important step in the management of a positive blood culture for bacteria or yeast is to check follow‐up blood cultures every 24 to 48 hours until the bacteremia or fungemia has cleared. This is particularly true of bacteremia caused by Staphylococcus aureus (S. aureus), Enterococcus species, and fungemia caused by Candida species. The duration of bacteremia or fungemia has a significant impact on the predictive values of further testing for endovascular or deep‐seated sources of infection as well as treatment duration. This is particularly true for the treatment of candidemia in nonneutropenic adults and for bacterial endocarditis, in which the recommended duration of treatment starts from the day of the last positive blood culture.2, 3 In addition to repeat blood cultures, a blood culture positive for S. aureus should always prompt an aggressive workup for a source (including strong consideration of a transesophageal echocardiogram to evaluate for endocarditis). S. aureus bacteremia should never be disregarded as a contaminant, and should prompt strong consideration of removal of all indwelling intravenous lines.4

4. Removal of Indwelling Intravascular Catheters Is Essential in the Management of Patients with Candidemia. In These Patients, Retention of Central Lines Is Significantly Related to Poor Outcomes

In patients with culture‐proven Candida fungemia, all intravascular catheters must be removed if at all possible. In a study by Nguyen et al.,5 the mortality rate for patients with a catheter‐related candidemia in whom catheters were retained was significantly higher than that of patients in whom the catheters were removed (41% vs. 21%, P < 0.001). Likewise, in a separate study, Luzzati et al.6 noted that central line removal independently reduced the high mortality of the disease. This recommendation applies to all Candida species.

5. Although Candida Species Are Frequently Noted to Colonize Sputum and Urine Cultures, Their Recovery From Multiple Sites May Be an Indicator of Occult Candidemia in an Acutely Ill Patient

Candida species uncommonly cause pneumonia or urinary tract infection, so their isolation from cultures of the respiratory and genitourinary tract often represents colonization. However, the presence of Candida species at multiple sites may be an indicator of occult candidemia in a patient with multiple risk factors for candidemia, including intensive care unit (ICU) admission, immunosuppression (particularly neutropenia and recent receipt of corticosteroids), central venous catheterization, total parenteral nutrition, recent broad‐spectrum antibiotics, and recent abdominal or gastrointestinal surgery.7

6. Patients with Asymptomatic Bacteriuria, With or Without Pyuria, Should Not Be Treated with Antibiotics. Pregnant Women and Patients Undergoing a Genitourinary Procedure Are the Exception and Should Be Treated With Antibiotics

Asymptomatic bacteriuria is commonly encountered in the hospital setting, but is usually benign. Bacteriuria is defined as a voided urine specimen with 1 bacterial species isolated in a quantitative count of 10⁵ cfu/mL. Treatment of asymptomatic bacteriuria is only recommended for pregnant women or prior to invasive genitourinary procedures, including transurethral resection of the prostate. Patients with structural or functional abnormalities of the urinary tract may have a high prevalence of bacteriuria. Despite its prevalence, asymptomatic bacteriuria is seldom associated with adverse outcomes. Studies have noted that antimicrobial treatment of asymptomatic bacteriuria does not decrease recurrence. Negative outcomes with antimicrobial treatment do occur, including adverse drug reactions and reinfection with organisms of increasing resistance. Clinical trials in spinal‐cord injury patients, diabetic women, elderly patients living in the community or nursing home, and patients with indwelling urethral catheters have consistently found no benefit with treatment of asymptomatic bacteriuria.8, 9 The presence or absence of pyuria does not differentiate symptomatic from asymptomatic urinary infection. Patients with symptomatic urinary tract infection (fever and/or dysuria) should be treated after urine cultures are obtained. Other causes of pyuria in the absence of an acute urinary tract infection include urethritis, tuberculosis, prostatitis, nephrolithiasis, and malignancy.

7. Evaluate All Patients Who Have a History of Penicillin Allergy and Consider Desensitization for Patients With a History Consistent With Immunoglobulin Emediated Allergy Who Require Treatment With a Beta‐Lactam Antibiotic

Patients commonly claim to have an allergy to penicillin. True penicillin allergy is very serious and can be life‐threatening. Because of this, patients labeled as penicillin allergic are typically not treated with beta‐lactam antibiotics. Instead, they may be prescribed medications which are typically less effective, more toxic, have a broader spectrum, or are more expensive.10, 11 Many patients are inappropriately labeled as having a penicillin allergy. A history of penicillin allergy is reported in approximately 10% of hospitalized patients, but only approximately 10% of those who report a history of penicillin allergy actually have an allergic reaction when treated with penicillin. Exanthems are frequently associated with beta‐lactam use during an episode of infectious mononucleosis but these are not considered an allergic reaction. Such patients are generally able to tolerate beta‐lactams subsequent to this episode. Nonpruritic maculopapular rashes are also reported in 3% to 7% of children taking amoxicillin and are not a contraindication for future beta‐lactam or cephalosporin use.12 All patients who describe an allergy should be questioned in detail about the type of penicillin received, as well as the type, severity, and timing of the reaction. Typical immunoglobulin E (IgE)‐mediated severe reactions to penicillin include urticaria, pruritus, angioedema, bronchospasm, and hypotension. These patients should not be given other agents that share the same beta‐lactam ring, including cephalosporins (risk of cross‐reactivity is greatest with first‐generation and second‐generation cephalosporins). Carbapenems have minimal cross‐reactivity, particularly meropenem.13 Monobactams (eg, aztreonam) do not cross‐react. While skin testing to penicillin can be considered in patients with a history of a severe reaction to penicillin, neither the major nor minor determinants are commercially available at this time. In patients with a history of a possible IgE‐mediated reaction and when there is no suitable alternative antibiotic (usually determined from infectious diseases consultation), desensitization to beta‐lactams or carbapenems can be considered. Desensitization should be reserved only for clinicians experienced with these techniques, preferably in consultation with a specialist in allergy and immunology. Patients who report a non‐IgE‐mediated reaction may be prescribed a cephalosporin if necessary (preferably a third‐generation or fourth‐generation).14

8. An Abrupt Increase in Leukocytosis In a Hospitalized Patient Should Prompt Consideration of Clostridium difficile Infection

In recent years, there has been a marked increase in the incidence and severity of Clostridium difficile (C. difficile) infection (CDI). A new hypervirulent strain, NAP1/BI/027, has emerged and is becoming endemic in the United States, Canada, and Europe. Typically C. difficile causes diarrhea, abdominal pain, and fever. Often patients have received antibiotics in the recent past, placing them at higher risk, but cases can occur sporadically (even in the community setting) or be transmitted nosocomially. Early detection appears to be essential in reducing the serious morbidity and mortality associated with this disease. Observational studies suggested that C. difficile infection is a common cause of unexplained leukocytosis or a sudden worsening of preexisting leukocytosis.15, 16 In a prospective study evaluating 60 patients with unexplained leukocytosis (white blood cell count 15,000/mm³), 58% of patients with leukocytosis in the absence of localizing symptoms and signs of infection were subsequently diagnosed with CDI. The authors believe that the percent may have been as high as 73% when they included patients with a negative toxin assay who rapidly responded to metronidazole therapy.17 White blood cell counts can range from 10,000 to 20,000/mm³ in moderate disease. Counts as high as 40,000/mm³ can occur, especially in patients with severe disease. Although the use of clindamycin and cephalosporins have been classically associated with the subsequent development of CDI, the current widespread use of fluoroquinolones has led to significant fluoroquinolone resistance among strains of C. difficile, especially the hypervirulent NAP1/BI/027 strain.18 The judicious use of antibiotics, especially fluoroquinolones, remains the cornerstone in preventing CDI. Remember that hand washing with soap and water is essential as alcohol‐based hand sanitizers do not eradicate the C. difficile spores. The drug of choice for initial treatment of mild to moderate CDI remains oral metronidazole, and it may be used for a first recurrence of CDI. Increasing data support the use of oral vancomycin for moderately severe to severe CDI or for multiple recurrences.19 Intravenous metronidazole is often added to oral vancomycin in patients with ileus, but it is not reliably effective alone for CDI.

9. Fever Is Common in the First 48 Hours After a Major Surgical Procedure, and Is a Poor Indicator of Infection. The use of Antibiotics in Response to Fever in the Absence of Other Localizing Signs and Symptoms of Infection Should Be Avoided

Early postoperative fever is relatively common but most fevers that develop within the first 48 hours after surgery do not have an infectious etiology.2023 However, fever that begins or persists beyond the fifth postoperative day is much more likely to represent a clinically significant infection. The continued use of antibiotics outside the window for wound prophylaxis (>24 hours) does not decrease the risk of postoperative infection but it does increase the risk of acquiring resistant bacteria and adverse drug reactions, including CDI.

10. Facts All Clinicians Should Know About Patients with HIV Infection

The 2 most common laboratory abnormalities routinely associated with antiretroviral therapy for HIV infection are unconjugated hyperbilirubinemia associated with atazanavir and an elevated mean corpuscular volume (MCV) associated with zidovudine (and, to a lesser extent, stavudine). Immune reconstitution inflammatory syndrome (IRIS) is a condition seen in patients with advanced acquired immune deficiency syndrome (AIDS) who have recently started antiretroviral therapy. As the immune system begins to recover, it may respond to a previously acquired opportunistic infection with an overwhelming inflammatory response that paradoxically makes the symptoms of infection worse. IRIS is associated with a pathological inflammatory response that can have substantial morbidity and mortality.24 For this reason, when considering whether to start or stop continuous or highly active antiretroviral therapy (also known as HAART), an infectious diseases consult is recommended. Pneumocystis jiroveci (PCP) remains a cause of pneumonia in patients with advanced AIDS' though in the era of HAART, its presentation may be more subtle. Finally, the principle of parsimony (Occam's razor) often does not hold in the diagnosis of opportunistic infections in patients with advanced AIDS, as these patients can often present with multiple infections simultaneously.25, 26

Conclusion

Infectious diseases are commonly encountered by physicians who care for hospitalized patients. Early recognition, evaluation, and appropriate treatment and/or referral to an infectious diseases specialist are necessary to moderate the significant morbidity and mortality that are often associated with infectious diseases.

Hospitalists commonly encounter the challenges of infectious diseases in their hospitalized patients. Choosing the correct antibiotic, interpreting blood cultures, working up causes of fever, treating patients with an allergy to penicillin, and caring for patients with human immunodeficiency virus (HIV) commonly confront the hospitalist. This article presents evidence‐based pearls which will help hospitalists avoid common infectious disease pitfalls and guide their decision about when to consult an infectious diseases specialist.

1. Avoid Spiraling Empiricism and Understand Common Fallacies in Prescribing Empiric Antimicrobial Therapy

The term spiraling empiricism describes the inappropriate treatment, or the unjustifiable escalation of treatment, of suspected but undocumented infectious diseases.1 Initiation of carefully considered empiric broad‐spectrum antibiotic therapy for an acutely ill patient is an entirely appropriate and reasonable strategy. But all too often, practitioners are confronted with clinical dilemmas such as persistent fever or lack of response to therapy. In these circumstances, clinicians are faced with deciding whether to add or change antibiotics to broaden coverage. Changes in empiric therapy should be made sparingly, and only when there is new information or symptoms to justify an addition or change. In order to make an accurate assessment of response, steady‐state levels should be achieved and usually 3 to 5 days should be allowed to pass. Lack of response to broad‐spectrum therapy should trigger further investigation for occult infection or consideration of noninfectious etiologies and not simply the addition of a new antimicrobial agent. If a microbial pathogen is isolated from a blood culture(s) or other relevant source, antimicrobials should be tailored to the narrowest spectrum and least toxic therapy based on the sensitivities of that organism. For critically ill patients or patients who do not appear to be improving, an infectious diseases consultation may be warranted.

2. Know the Important Drug‐Drug Interactions Between Antimicrobials and Commonly‐used Inpatient Medications, Particularly With Those Involving Warfarin

Most antimicrobials (especially antifungals, quinolones, metronidazole, and sulfonamides) can cause unpredictable elevations in the international normalized ratio (INR) concurrent with warfarin administration, either through inhibition of warfarin metabolism or alterations in vitamin Kproducing gut flora. When using antimicrobials in patients on warfarin, the patient's INR should be carefully monitored and adjustment of the warfarin dose may be necessary. Antimicrobials that are inhibitors of cytochrome P‐450 enzymes include ciprofloxacin, levofloxacin, isoniazid, fluconazole, and clarithromycin. In contrast, rifampin is a potent inducer of most known cytochrome P‐450 enzymes and increases the metabolism of many drugs used in patients in the hospital setting, including anticonvulsants, beta‐blockers, calcium channel blockers, and other antibiotics like fluoroquinolones, and sulfonylureas. Moreover, the concurrent oral intake of tablets or solutions (including tube feeds) with a high concentration of trivalent and divalent cations (such as aluminum, magnesium, and, to a lesser extent, calcium, iron, and zinc) impairs gastrointestinal absorption of fluoroquinolones and should be avoided or spaced apart in time. Since fluoroquinolones can potentially prolong the QT interval, careful monitoring is necessary when a patient is prescribed other QT prolonging agents. Finally, many antimicrobials reduce the effectiveness of oral or other systemic hormonal contraceptives and patients should be routinely advised to use nonhormonal methods of birth control during therapy.

3. Positive Blood Cultures for Bacteria or Fungus Should be Repeated Serially Every 24 to 48 Hours Until the Cultures Are Negative

An important step in the management of a positive blood culture for bacteria or yeast is to check follow‐up blood cultures every 24 to 48 hours until the bacteremia or fungemia has cleared. This is particularly true of bacteremia caused by Staphylococcus aureus (S. aureus), Enterococcus species, and fungemia caused by Candida species. The duration of bacteremia or fungemia has a significant impact on the predictive values of further testing for endovascular or deep‐seated sources of infection as well as treatment duration. This is particularly true for the treatment of candidemia in nonneutropenic adults and for bacterial endocarditis, in which the recommended duration of treatment starts from the day of the last positive blood culture.2, 3 In addition to repeat blood cultures, a blood culture positive for S. aureus should always prompt an aggressive workup for a source (including strong consideration of a transesophageal echocardiogram to evaluate for endocarditis). S. aureus bacteremia should never be disregarded as a contaminant, and should prompt strong consideration of removal of all indwelling intravenous lines.4

4. Removal of Indwelling Intravascular Catheters Is Essential in the Management of Patients with Candidemia. In These Patients, Retention of Central Lines Is Significantly Related to Poor Outcomes

In patients with culture‐proven Candida fungemia, all intravascular catheters must be removed if at all possible. In a study by Nguyen et al.,5 the mortality rate for patients with a catheter‐related candidemia in whom catheters were retained was significantly higher than that of patients in whom the catheters were removed (41% vs. 21%, P < 0.001). Likewise, in a separate study, Luzzati et al.6 noted that central line removal independently reduced the high mortality of the disease. This recommendation applies to all Candida species.

5. Although Candida Species Are Frequently Noted to Colonize Sputum and Urine Cultures, Their Recovery From Multiple Sites May Be an Indicator of Occult Candidemia in an Acutely Ill Patient

Candida species uncommonly cause pneumonia or urinary tract infection, so their isolation from cultures of the respiratory and genitourinary tract often represents colonization. However, the presence of Candida species at multiple sites may be an indicator of occult candidemia in a patient with multiple risk factors for candidemia, including intensive care unit (ICU) admission, immunosuppression (particularly neutropenia and recent receipt of corticosteroids), central venous catheterization, total parenteral nutrition, recent broad‐spectrum antibiotics, and recent abdominal or gastrointestinal surgery.7

6. Patients with Asymptomatic Bacteriuria, With or Without Pyuria, Should Not Be Treated with Antibiotics. Pregnant Women and Patients Undergoing a Genitourinary Procedure Are the Exception and Should Be Treated With Antibiotics

Asymptomatic bacteriuria is commonly encountered in the hospital setting, but is usually benign. Bacteriuria is defined as a voided urine specimen with 1 bacterial species isolated in a quantitative count of 10⁵ cfu/mL. Treatment of asymptomatic bacteriuria is only recommended for pregnant women or prior to invasive genitourinary procedures, including transurethral resection of the prostate. Patients with structural or functional abnormalities of the urinary tract may have a high prevalence of bacteriuria. Despite its prevalence, asymptomatic bacteriuria is seldom associated with adverse outcomes. Studies have noted that antimicrobial treatment of asymptomatic bacteriuria does not decrease recurrence. Negative outcomes with antimicrobial treatment do occur, including adverse drug reactions and reinfection with organisms of increasing resistance. Clinical trials in spinal‐cord injury patients, diabetic women, elderly patients living in the community or nursing home, and patients with indwelling urethral catheters have consistently found no benefit with treatment of asymptomatic bacteriuria.8, 9 The presence or absence of pyuria does not differentiate symptomatic from asymptomatic urinary infection. Patients with symptomatic urinary tract infection (fever and/or dysuria) should be treated after urine cultures are obtained. Other causes of pyuria in the absence of an acute urinary tract infection include urethritis, tuberculosis, prostatitis, nephrolithiasis, and malignancy.

7. Evaluate All Patients Who Have a History of Penicillin Allergy and Consider Desensitization for Patients With a History Consistent With Immunoglobulin Emediated Allergy Who Require Treatment With a Beta‐Lactam Antibiotic

Patients commonly claim to have an allergy to penicillin. True penicillin allergy is very serious and can be life‐threatening. Because of this, patients labeled as penicillin allergic are typically not treated with beta‐lactam antibiotics. Instead, they may be prescribed medications which are typically less effective, more toxic, have a broader spectrum, or are more expensive.10, 11 Many patients are inappropriately labeled as having a penicillin allergy. A history of penicillin allergy is reported in approximately 10% of hospitalized patients, but only approximately 10% of those who report a history of penicillin allergy actually have an allergic reaction when treated with penicillin. Exanthems are frequently associated with beta‐lactam use during an episode of infectious mononucleosis but these are not considered an allergic reaction. Such patients are generally able to tolerate beta‐lactams subsequent to this episode. Nonpruritic maculopapular rashes are also reported in 3% to 7% of children taking amoxicillin and are not a contraindication for future beta‐lactam or cephalosporin use.12 All patients who describe an allergy should be questioned in detail about the type of penicillin received, as well as the type, severity, and timing of the reaction. Typical immunoglobulin E (IgE)‐mediated severe reactions to penicillin include urticaria, pruritus, angioedema, bronchospasm, and hypotension. These patients should not be given other agents that share the same beta‐lactam ring, including cephalosporins (risk of cross‐reactivity is greatest with first‐generation and second‐generation cephalosporins). Carbapenems have minimal cross‐reactivity, particularly meropenem.13 Monobactams (eg, aztreonam) do not cross‐react. While skin testing to penicillin can be considered in patients with a history of a severe reaction to penicillin, neither the major nor minor determinants are commercially available at this time. In patients with a history of a possible IgE‐mediated reaction and when there is no suitable alternative antibiotic (usually determined from infectious diseases consultation), desensitization to beta‐lactams or carbapenems can be considered. Desensitization should be reserved only for clinicians experienced with these techniques, preferably in consultation with a specialist in allergy and immunology. Patients who report a non‐IgE‐mediated reaction may be prescribed a cephalosporin if necessary (preferably a third‐generation or fourth‐generation).14

8. An Abrupt Increase in Leukocytosis In a Hospitalized Patient Should Prompt Consideration of Clostridium difficile Infection

In recent years, there has been a marked increase in the incidence and severity of Clostridium difficile (C. difficile) infection (CDI). A new hypervirulent strain, NAP1/BI/027, has emerged and is becoming endemic in the United States, Canada, and Europe. Typically C. difficile causes diarrhea, abdominal pain, and fever. Often patients have received antibiotics in the recent past, placing them at higher risk, but cases can occur sporadically (even in the community setting) or be transmitted nosocomially. Early detection appears to be essential in reducing the serious morbidity and mortality associated with this disease. Observational studies suggested that C. difficile infection is a common cause of unexplained leukocytosis or a sudden worsening of preexisting leukocytosis.15, 16 In a prospective study evaluating 60 patients with unexplained leukocytosis (white blood cell count 15,000/mm³), 58% of patients with leukocytosis in the absence of localizing symptoms and signs of infection were subsequently diagnosed with CDI. The authors believe that the percent may have been as high as 73% when they included patients with a negative toxin assay who rapidly responded to metronidazole therapy.17 White blood cell counts can range from 10,000 to 20,000/mm³ in moderate disease. Counts as high as 40,000/mm³ can occur, especially in patients with severe disease. Although the use of clindamycin and cephalosporins have been classically associated with the subsequent development of CDI, the current widespread use of fluoroquinolones has led to significant fluoroquinolone resistance among strains of C. difficile, especially the hypervirulent NAP1/BI/027 strain.18 The judicious use of antibiotics, especially fluoroquinolones, remains the cornerstone in preventing CDI. Remember that hand washing with soap and water is essential as alcohol‐based hand sanitizers do not eradicate the C. difficile spores. The drug of choice for initial treatment of mild to moderate CDI remains oral metronidazole, and it may be used for a first recurrence of CDI. Increasing data support the use of oral vancomycin for moderately severe to severe CDI or for multiple recurrences.19 Intravenous metronidazole is often added to oral vancomycin in patients with ileus, but it is not reliably effective alone for CDI.

9. Fever Is Common in the First 48 Hours After a Major Surgical Procedure, and Is a Poor Indicator of Infection. The use of Antibiotics in Response to Fever in the Absence of Other Localizing Signs and Symptoms of Infection Should Be Avoided

Early postoperative fever is relatively common but most fevers that develop within the first 48 hours after surgery do not have an infectious etiology.2023 However, fever that begins or persists beyond the fifth postoperative day is much more likely to represent a clinically significant infection. The continued use of antibiotics outside the window for wound prophylaxis (>24 hours) does not decrease the risk of postoperative infection but it does increase the risk of acquiring resistant bacteria and adverse drug reactions, including CDI.

10. Facts All Clinicians Should Know About Patients with HIV Infection

The 2 most common laboratory abnormalities routinely associated with antiretroviral therapy for HIV infection are unconjugated hyperbilirubinemia associated with atazanavir and an elevated mean corpuscular volume (MCV) associated with zidovudine (and, to a lesser extent, stavudine). Immune reconstitution inflammatory syndrome (IRIS) is a condition seen in patients with advanced acquired immune deficiency syndrome (AIDS) who have recently started antiretroviral therapy. As the immune system begins to recover, it may respond to a previously acquired opportunistic infection with an overwhelming inflammatory response that paradoxically makes the symptoms of infection worse. IRIS is associated with a pathological inflammatory response that can have substantial morbidity and mortality.24 For this reason, when considering whether to start or stop continuous or highly active antiretroviral therapy (also known as HAART), an infectious diseases consult is recommended. Pneumocystis jiroveci (PCP) remains a cause of pneumonia in patients with advanced AIDS' though in the era of HAART, its presentation may be more subtle. Finally, the principle of parsimony (Occam's razor) often does not hold in the diagnosis of opportunistic infections in patients with advanced AIDS, as these patients can often present with multiple infections simultaneously.25, 26

Conclusion

Infectious diseases are commonly encountered by physicians who care for hospitalized patients. Early recognition, evaluation, and appropriate treatment and/or referral to an infectious diseases specialist are necessary to moderate the significant morbidity and mortality that are often associated with infectious diseases.

Hospitalists commonly encounter the challenges of infectious diseases in their hospitalized patients. Choosing the correct antibiotic, interpreting blood cultures, working up causes of fever, treating patients with an allergy to penicillin, and caring for patients with human immunodeficiency virus (HIV) commonly confront the hospitalist. This article presents evidence‐based pearls which will help hospitalists avoid common infectious disease pitfalls and guide their decision about when to consult an infectious diseases specialist.

1. Avoid Spiraling Empiricism and Understand Common Fallacies in Prescribing Empiric Antimicrobial Therapy

The term spiraling empiricism describes the inappropriate treatment, or the unjustifiable escalation of treatment, of suspected but undocumented infectious diseases.1 Initiation of carefully considered empiric broad‐spectrum antibiotic therapy for an acutely ill patient is an entirely appropriate and reasonable strategy. But all too often, practitioners are confronted with clinical dilemmas such as persistent fever or lack of response to therapy. In these circumstances, clinicians are faced with deciding whether to add or change antibiotics to broaden coverage. Changes in empiric therapy should be made sparingly, and only when there is new information or symptoms to justify an addition or change. In order to make an accurate assessment of response, steady‐state levels should be achieved and usually 3 to 5 days should be allowed to pass. Lack of response to broad‐spectrum therapy should trigger further investigation for occult infection or consideration of noninfectious etiologies and not simply the addition of a new antimicrobial agent. If a microbial pathogen is isolated from a blood culture(s) or other relevant source, antimicrobials should be tailored to the narrowest spectrum and least toxic therapy based on the sensitivities of that organism. For critically ill patients or patients who do not appear to be improving, an infectious diseases consultation may be warranted.

2. Know the Important Drug‐Drug Interactions Between Antimicrobials and Commonly‐used Inpatient Medications, Particularly With Those Involving Warfarin

Most antimicrobials (especially antifungals, quinolones, metronidazole, and sulfonamides) can cause unpredictable elevations in the international normalized ratio (INR) concurrent with warfarin administration, either through inhibition of warfarin metabolism or alterations in vitamin Kproducing gut flora. When using antimicrobials in patients on warfarin, the patient's INR should be carefully monitored and adjustment of the warfarin dose may be necessary. Antimicrobials that are inhibitors of cytochrome P‐450 enzymes include ciprofloxacin, levofloxacin, isoniazid, fluconazole, and clarithromycin. In contrast, rifampin is a potent inducer of most known cytochrome P‐450 enzymes and increases the metabolism of many drugs used in patients in the hospital setting, including anticonvulsants, beta‐blockers, calcium channel blockers, and other antibiotics like fluoroquinolones, and sulfonylureas. Moreover, the concurrent oral intake of tablets or solutions (including tube feeds) with a high concentration of trivalent and divalent cations (such as aluminum, magnesium, and, to a lesser extent, calcium, iron, and zinc) impairs gastrointestinal absorption of fluoroquinolones and should be avoided or spaced apart in time. Since fluoroquinolones can potentially prolong the QT interval, careful monitoring is necessary when a patient is prescribed other QT prolonging agents. Finally, many antimicrobials reduce the effectiveness of oral or other systemic hormonal contraceptives and patients should be routinely advised to use nonhormonal methods of birth control during therapy.

3. Positive Blood Cultures for Bacteria or Fungus Should be Repeated Serially Every 24 to 48 Hours Until the Cultures Are Negative

An important step in the management of a positive blood culture for bacteria or yeast is to check follow‐up blood cultures every 24 to 48 hours until the bacteremia or fungemia has cleared. This is particularly true of bacteremia caused by Staphylococcus aureus (S. aureus), Enterococcus species, and fungemia caused by Candida species. The duration of bacteremia or fungemia has a significant impact on the predictive values of further testing for endovascular or deep‐seated sources of infection as well as treatment duration. This is particularly true for the treatment of candidemia in nonneutropenic adults and for bacterial endocarditis, in which the recommended duration of treatment starts from the day of the last positive blood culture.2, 3 In addition to repeat blood cultures, a blood culture positive for S. aureus should always prompt an aggressive workup for a source (including strong consideration of a transesophageal echocardiogram to evaluate for endocarditis). S. aureus bacteremia should never be disregarded as a contaminant, and should prompt strong consideration of removal of all indwelling intravenous lines.4

4. Removal of Indwelling Intravascular Catheters Is Essential in the Management of Patients with Candidemia. In These Patients, Retention of Central Lines Is Significantly Related to Poor Outcomes

In patients with culture‐proven Candida fungemia, all intravascular catheters must be removed if at all possible. In a study by Nguyen et al.,5 the mortality rate for patients with a catheter‐related candidemia in whom catheters were retained was significantly higher than that of patients in whom the catheters were removed (41% vs. 21%, P < 0.001). Likewise, in a separate study, Luzzati et al.6 noted that central line removal independently reduced the high mortality of the disease. This recommendation applies to all Candida species.

5. Although Candida Species Are Frequently Noted to Colonize Sputum and Urine Cultures, Their Recovery From Multiple Sites May Be an Indicator of Occult Candidemia in an Acutely Ill Patient

Candida species uncommonly cause pneumonia or urinary tract infection, so their isolation from cultures of the respiratory and genitourinary tract often represents colonization. However, the presence of Candida species at multiple sites may be an indicator of occult candidemia in a patient with multiple risk factors for candidemia, including intensive care unit (ICU) admission, immunosuppression (particularly neutropenia and recent receipt of corticosteroids), central venous catheterization, total parenteral nutrition, recent broad‐spectrum antibiotics, and recent abdominal or gastrointestinal surgery.7

6. Patients with Asymptomatic Bacteriuria, With or Without Pyuria, Should Not Be Treated with Antibiotics. Pregnant Women and Patients Undergoing a Genitourinary Procedure Are the Exception and Should Be Treated With Antibiotics

Asymptomatic bacteriuria is commonly encountered in the hospital setting, but is usually benign. Bacteriuria is defined as a voided urine specimen with 1 bacterial species isolated in a quantitative count of 10⁵ cfu/mL. Treatment of asymptomatic bacteriuria is only recommended for pregnant women or prior to invasive genitourinary procedures, including transurethral resection of the prostate. Patients with structural or functional abnormalities of the urinary tract may have a high prevalence of bacteriuria. Despite its prevalence, asymptomatic bacteriuria is seldom associated with adverse outcomes. Studies have noted that antimicrobial treatment of asymptomatic bacteriuria does not decrease recurrence. Negative outcomes with antimicrobial treatment do occur, including adverse drug reactions and reinfection with organisms of increasing resistance. Clinical trials in spinal‐cord injury patients, diabetic women, elderly patients living in the community or nursing home, and patients with indwelling urethral catheters have consistently found no benefit with treatment of asymptomatic bacteriuria.8, 9 The presence or absence of pyuria does not differentiate symptomatic from asymptomatic urinary infection. Patients with symptomatic urinary tract infection (fever and/or dysuria) should be treated after urine cultures are obtained. Other causes of pyuria in the absence of an acute urinary tract infection include urethritis, tuberculosis, prostatitis, nephrolithiasis, and malignancy.

7. Evaluate All Patients Who Have a History of Penicillin Allergy and Consider Desensitization for Patients With a History Consistent With Immunoglobulin Emediated Allergy Who Require Treatment With a Beta‐Lactam Antibiotic

Patients commonly claim to have an allergy to penicillin. True penicillin allergy is very serious and can be life‐threatening. Because of this, patients labeled as penicillin allergic are typically not treated with beta‐lactam antibiotics. Instead, they may be prescribed medications which are typically less effective, more toxic, have a broader spectrum, or are more expensive.10, 11 Many patients are inappropriately labeled as having a penicillin allergy. A history of penicillin allergy is reported in approximately 10% of hospitalized patients, but only approximately 10% of those who report a history of penicillin allergy actually have an allergic reaction when treated with penicillin. Exanthems are frequently associated with beta‐lactam use during an episode of infectious mononucleosis but these are not considered an allergic reaction. Such patients are generally able to tolerate beta‐lactams subsequent to this episode. Nonpruritic maculopapular rashes are also reported in 3% to 7% of children taking amoxicillin and are not a contraindication for future beta‐lactam or cephalosporin use.12 All patients who describe an allergy should be questioned in detail about the type of penicillin received, as well as the type, severity, and timing of the reaction. Typical immunoglobulin E (IgE)‐mediated severe reactions to penicillin include urticaria, pruritus, angioedema, bronchospasm, and hypotension. These patients should not be given other agents that share the same beta‐lactam ring, including cephalosporins (risk of cross‐reactivity is greatest with first‐generation and second‐generation cephalosporins). Carbapenems have minimal cross‐reactivity, particularly meropenem.13 Monobactams (eg, aztreonam) do not cross‐react. While skin testing to penicillin can be considered in patients with a history of a severe reaction to penicillin, neither the major nor minor determinants are commercially available at this time. In patients with a history of a possible IgE‐mediated reaction and when there is no suitable alternative antibiotic (usually determined from infectious diseases consultation), desensitization to beta‐lactams or carbapenems can be considered. Desensitization should be reserved only for clinicians experienced with these techniques, preferably in consultation with a specialist in allergy and immunology. Patients who report a non‐IgE‐mediated reaction may be prescribed a cephalosporin if necessary (preferably a third‐generation or fourth‐generation).14

8. An Abrupt Increase in Leukocytosis In a Hospitalized Patient Should Prompt Consideration of Clostridium difficile Infection

In recent years, there has been a marked increase in the incidence and severity of Clostridium difficile (C. difficile) infection (CDI). A new hypervirulent strain, NAP1/BI/027, has emerged and is becoming endemic in the United States, Canada, and Europe. Typically C. difficile causes diarrhea, abdominal pain, and fever. Often patients have received antibiotics in the recent past, placing them at higher risk, but cases can occur sporadically (even in the community setting) or be transmitted nosocomially. Early detection appears to be essential in reducing the serious morbidity and mortality associated with this disease. Observational studies suggested that C. difficile infection is a common cause of unexplained leukocytosis or a sudden worsening of preexisting leukocytosis.15, 16 In a prospective study evaluating 60 patients with unexplained leukocytosis (white blood cell count 15,000/mm³), 58% of patients with leukocytosis in the absence of localizing symptoms and signs of infection were subsequently diagnosed with CDI. The authors believe that the percent may have been as high as 73% when they included patients with a negative toxin assay who rapidly responded to metronidazole therapy.17 White blood cell counts can range from 10,000 to 20,000/mm³ in moderate disease. Counts as high as 40,000/mm³ can occur, especially in patients with severe disease. Although the use of clindamycin and cephalosporins have been classically associated with the subsequent development of CDI, the current widespread use of fluoroquinolones has led to significant fluoroquinolone resistance among strains of C. difficile, especially the hypervirulent NAP1/BI/027 strain.18 The judicious use of antibiotics, especially fluoroquinolones, remains the cornerstone in preventing CDI. Remember that hand washing with soap and water is essential as alcohol‐based hand sanitizers do not eradicate the C. difficile spores. The drug of choice for initial treatment of mild to moderate CDI remains oral metronidazole, and it may be used for a first recurrence of CDI. Increasing data support the use of oral vancomycin for moderately severe to severe CDI or for multiple recurrences.19 Intravenous metronidazole is often added to oral vancomycin in patients with ileus, but it is not reliably effective alone for CDI.

9. Fever Is Common in the First 48 Hours After a Major Surgical Procedure, and Is a Poor Indicator of Infection. The use of Antibiotics in Response to Fever in the Absence of Other Localizing Signs and Symptoms of Infection Should Be Avoided

Early postoperative fever is relatively common but most fevers that develop within the first 48 hours after surgery do not have an infectious etiology.2023 However, fever that begins or persists beyond the fifth postoperative day is much more likely to represent a clinically significant infection. The continued use of antibiotics outside the window for wound prophylaxis (>24 hours) does not decrease the risk of postoperative infection but it does increase the risk of acquiring resistant bacteria and adverse drug reactions, including CDI.

10. Facts All Clinicians Should Know About Patients with HIV Infection

The 2 most common laboratory abnormalities routinely associated with antiretroviral therapy for HIV infection are unconjugated hyperbilirubinemia associated with atazanavir and an elevated mean corpuscular volume (MCV) associated with zidovudine (and, to a lesser extent, stavudine). Immune reconstitution inflammatory syndrome (IRIS) is a condition seen in patients with advanced acquired immune deficiency syndrome (AIDS) who have recently started antiretroviral therapy. As the immune system begins to recover, it may respond to a previously acquired opportunistic infection with an overwhelming inflammatory response that paradoxically makes the symptoms of infection worse. IRIS is associated with a pathological inflammatory response that can have substantial morbidity and mortality.24 For this reason, when considering whether to start or stop continuous or highly active antiretroviral therapy (also known as HAART), an infectious diseases consult is recommended. Pneumocystis jiroveci (PCP) remains a cause of pneumonia in patients with advanced AIDS' though in the era of HAART, its presentation may be more subtle. Finally, the principle of parsimony (Occam's razor) often does not hold in the diagnosis of opportunistic infections in patients with advanced AIDS, as these patients can often present with multiple infections simultaneously.25, 26

Conclusion

Infectious diseases are commonly encountered by physicians who care for hospitalized patients. Early recognition, evaluation, and appropriate treatment and/or referral to an infectious diseases specialist are necessary to moderate the significant morbidity and mortality that are often associated with infectious diseases.

A looming gap in the supply of intensivists prompted the American College of Chest Physicians (ACCP), the American Thoracic Society (ATS), and the Society of Critical Care Medicine (SCCM) to publish a report in 2000 by the Committee on Manpower for Pulmonary and Critical Care Societies (COMPACCS). This study predicted that beginning in 2007 a shortfall would become apparent and steadily increase to 22% by 2020 and to 35% by 2030. Subsequent reports have reiterated those projections, including a report to Congress in 2006 by the U.S. Department of Health and Human Services/Health Resources and Services Administration.14

The concern regarding the shortage of intensivists has been increased by the growing evidence that supports improved critical care outcomesespecially decreased intensive care unit (ICU) and hospital mortalitywith intensivist staffing of ICUs.5, 6 Based on this data and on recommendations from the Society of Critical Care Medicine, the Leapfrog Group made onsite, high‐intensity ICU staffing with intensivists 1 of their 4 leaps.7 A paper by Pronovost et al.8 published in 2001, however, noted that in order for all ICUs in the United States to meet the Leapfrog ICU Physician Staffing (IPS) standard, the number of intensivists would need to increase by a factor of 2.6. Interestingly, a retrospective study published in the Annals of Internal Medicine in June of 2008 by Levy et al.9 suggested that mortality rates may actually be higher in intensivist‐staffed ICUs. An accompanying editorial raised concerns about limitations of the study design, but endorsed Levy's recommendation that more carefully designed, prospective studies were needed; (ie, we still are not certain as to optimal physician staffing for the care of patients requiring the sophisticated treatment available only in an ICU.)10

The health policy challenge, however, remains clear: while there is basic consensus that care of critically ill patients by intensivists improves outcomes, the reality is that the shortage of intensivists in the United States as predicted by the COMPACCS report will only increase, leading some to refer to this as a healthcare crisis. Two major task forces attempted to address this situation, resulting in the publication of the 2004 Framing Options for Critical Care in the United States (FOCCUS) report, The Critical Care Medicine Crisis: A Call for Federal ActionA White Paper from the Critical Care Professional Societies; and the 2007 Prioritizing the Organization and Management of Intensive Care Services in the Unites States (PrOMIS) Conference Report.11, 12 Both reports made specific recommendations including, for example, development of uniform standards for accreditation of institutional critical care capacity, identification and endorsement of core competencies in critical care, investment in health services research, the use of uniform protocols for ICU care, leverage of information technology to promote standardization and improve efficiency, and the development of incentives to attract healthcare professionals to critical care medicine.

A Possible Solution: The Role of Hospitalists

Multiple important efforts are already underway to increase the competency of professionals providing critical care services including the Society of Critical Care's Fundamentals in Critical Care Support (FCCS) program. Additionally, physician assistants and nurse practitioners are playing an increasingly important role as members of critical care services. As another component of this collaborative effort, the PrOMIS Report noted the potential impact of hospitalists in addressing this crisis.

As early as 1999, surveys revealed that as many as 35% of hospitalists were providing critical care services.13 According to the 2005/2006 Society of Hospital Medicine (SHM) National Survey, that number has increased to 75% with a low of 66% in the eastern United States and a high of 84% in the western United States. In community hospitals, 87% of hospitalists care for patients in the ICU, and 30% provide critical care services in academic medical centers.13 While there is some research14, 15 and many anecdotal reports that suggest hospitalists perform well in the ICU, there is, unfortunately, little data addressing outcomes for patients cared for by hospitalists. The results from a prospective, severity‐adjusted study from the Emory University Section of Hospital Medicine and the Division of Pulmonary/Critical Care Medicine examining outcomes for critical care patients cared for by hospitalists with criteria for Pulmonary/Intensivist consults vs. patients cared for by the Pulmonary/Critical Care Medical ICU Service await peer‐review publication.

Despite the lack of outcome data regarding adult hospitalists, it is clear that by default they are already providing a significant proportion of critical care services across the healthcare system, including in tertiary care centers. The two primary models of care include: (1) hospitalists serving as the primary provider without critical care consultant services and (2) comanagement of patients where intensivists and hospitalists collaborate. These collaborative models involve hospitalists actively co‐managing critical care patients along with intensivists or hospitalists managing less critically ill patients with intensivist consultation when indicated. In hospitals lacking intensivists, hospitalists often manage critically ill patients either with intensivist phone consultation, or with the intent to stabilize and transfer. Electronic ICUs are another expanding model of care that provide intensivist support to hospitalists and other primary care providersdecreasing ICU length of stay and severity‐adjusted ICU mortality.16 There are now 40 electronic ICU programs in the United States, and that number continues to grow.

In 2003, there were approximately 10,000 hospitalists in the United States,17 and recent data from an American Hospital Association survey indicates that the number has grown to about 28,000 in 2009. Recent research also documents that hospitalists are soon likely to care for the majority of elderly hospitalized patients in America.18 Aware that the number of intensivists is unlikely to change significantly over the next 25 years the question is no longer if hospitalists should be in the ICU; rather, the question is how to assure quality and improved clinical outcomes through enhanced collaboration between Hospital Medicine and Critical Care Medicine.

Recommendations

There are 3 steps that should be taken urgently to meet this challenge:

• 1

  Per the recommendation of the FOCCUS Report and the PrOMIS Conference Report, uniform protocols for intensive care treatmentmany of which already exist but are not used consistentlyshould be identified and implemented across all ICUs regardless of the level or certification of the provider.

• 2

  Also per the PrOMIS Report, a process for certification of physicians providing critical care services should be established by the appropriate governing bodies, including the Society for Critical Care Medicine, the Society of Hospital Medicine, and the American Thoracic Society, among others. While the PrOMIS Report called for cross‐training of hospital‐based providers to provide intensive care services in lower tier hospitals, a more realistic recommendation given current involvement of hospitalists in the provision of critical care services in secondary and tertiary centers is a competency‐assurance process that includes hospitalists practicing at all levels. This would not be equivalent to board certification, but would be based on a rigorous, comprehensive education and skills training process leading to recognition that would distinguish the recipient as having competencies beyond those obtained in internal medicine residency training. Models for certification could include 4‐month onsite training or a distance learning curriculum with regular blocks of onsite training. Another strategy might be for appropriate governing bodies to establish basic criteria for competency that would then be provided by individual institutions. Emory University, for example, has developed a pilot program incorporating significant components from the European Society for Critical Care Medicine's Syllabus for Competency Based Training in Intensive Care Medicine in Europe.19 Other institutions are also exploring the creation of certification/competency programs. Minimally, and prior to any decision about establishing formal criteria, institutions could identify designated hospitalists within groups who have particular interest and ability in the critical care setting. These providers, based on models already in place at sites across the United States, could, as an example, be required to spend a minimum of 50% of their clinical time in the ICU and to complete 10 to 20 hours of critical care continuing medical education (CME) per year. One strategy to address this issue and develop clear consensus and guidelines would be to convene the often discussed PrOMIS II working group.

• 3

  Per both the FOCCUS Report and the PrOMIS Report as well as a number of other publications,19 health services research in ICU care should be identified, funded, and implemented. A major focus of this effort should be the evaluation of clinical outcomes for ICU patients cared for by hospitalists. This research is needed for at least 2 reasons:

• As noted, there is little research that has assessed hospitalists' impact on outcomes of ICU patients. Hospitalists are already caring for patients in ICUs across the United States and given the research that has identified the outcomes benefit provided by intensivists, it is important to know objectively if hospitalists have similar levels of performance.

• An increasing number of hospitals and healthcare systems are now committed to achieving the Leapfrog IPS standard‐a challenge for many because of the difficulty with recruiting intensivists. If new research reveals that hospitalists with board certification in Internal Medicine, and more specifically with additional competency training in critical care, also improve outcomes in the ICU then it may be possible for Leapfrog to revise the criteria for meeting the IPS standard.

Summary

As discussed in a number of publications,20 including an article from the Mayo Clinic in the April 2009 edition of Chest entitled, Physicians Staffing Models and Patient Safety in the ICU,21 along with an accompanying editorial, Should Intensive Care Medicine Itself Be on the Critical List,22 creative and realistic solutions are urgently needed to address the crisis in critical care in the U.S. Collaborative efforts between Critical Care Medicine and Hospital Medicine to meet this challenge benefit all involved:

• Intensivists will continue to direct tertiary care units and/or co‐manage patients in tertiary and secondary care centers with Hospitalists.

• Hospitalists will benefit by having the opportunity to secure critical care competency training and by having their appropriate role in the ICU defined.

• All secondary and tertiary care institutions will have a realistic opportunity to meet Leapfrog IPS criteria and therefore benefit from the potential decreased length of stay (LOS), decreased mortality, and improved quality.

• Patients benefit by receiving uniform, evidence‐based, protocol‐driven care.

There is now a need and an opportunity for ACCP, SCCM, ATS, and the American Association of Critical Care Nurses (ACCN), to expand the important work they have already begun through the Critical Care Workforce Partnership. The Partnership should join with the SHM to take the lead in supporting and promoting this collaborative relationship between intensivists and hospitalists: aware that in the final analysis, it is the patients we serve who will benefit the most.

A looming gap in the supply of intensivists prompted the American College of Chest Physicians (ACCP), the American Thoracic Society (ATS), and the Society of Critical Care Medicine (SCCM) to publish a report in 2000 by the Committee on Manpower for Pulmonary and Critical Care Societies (COMPACCS). This study predicted that beginning in 2007 a shortfall would become apparent and steadily increase to 22% by 2020 and to 35% by 2030. Subsequent reports have reiterated those projections, including a report to Congress in 2006 by the U.S. Department of Health and Human Services/Health Resources and Services Administration.14

The concern regarding the shortage of intensivists has been increased by the growing evidence that supports improved critical care outcomesespecially decreased intensive care unit (ICU) and hospital mortalitywith intensivist staffing of ICUs.5, 6 Based on this data and on recommendations from the Society of Critical Care Medicine, the Leapfrog Group made onsite, high‐intensity ICU staffing with intensivists 1 of their 4 leaps.7 A paper by Pronovost et al.8 published in 2001, however, noted that in order for all ICUs in the United States to meet the Leapfrog ICU Physician Staffing (IPS) standard, the number of intensivists would need to increase by a factor of 2.6. Interestingly, a retrospective study published in the Annals of Internal Medicine in June of 2008 by Levy et al.9 suggested that mortality rates may actually be higher in intensivist‐staffed ICUs. An accompanying editorial raised concerns about limitations of the study design, but endorsed Levy's recommendation that more carefully designed, prospective studies were needed; (ie, we still are not certain as to optimal physician staffing for the care of patients requiring the sophisticated treatment available only in an ICU.)10

The health policy challenge, however, remains clear: while there is basic consensus that care of critically ill patients by intensivists improves outcomes, the reality is that the shortage of intensivists in the United States as predicted by the COMPACCS report will only increase, leading some to refer to this as a healthcare crisis. Two major task forces attempted to address this situation, resulting in the publication of the 2004 Framing Options for Critical Care in the United States (FOCCUS) report, The Critical Care Medicine Crisis: A Call for Federal ActionA White Paper from the Critical Care Professional Societies; and the 2007 Prioritizing the Organization and Management of Intensive Care Services in the Unites States (PrOMIS) Conference Report.11, 12 Both reports made specific recommendations including, for example, development of uniform standards for accreditation of institutional critical care capacity, identification and endorsement of core competencies in critical care, investment in health services research, the use of uniform protocols for ICU care, leverage of information technology to promote standardization and improve efficiency, and the development of incentives to attract healthcare professionals to critical care medicine.

A Possible Solution: The Role of Hospitalists

Multiple important efforts are already underway to increase the competency of professionals providing critical care services including the Society of Critical Care's Fundamentals in Critical Care Support (FCCS) program. Additionally, physician assistants and nurse practitioners are playing an increasingly important role as members of critical care services. As another component of this collaborative effort, the PrOMIS Report noted the potential impact of hospitalists in addressing this crisis.

As early as 1999, surveys revealed that as many as 35% of hospitalists were providing critical care services.13 According to the 2005/2006 Society of Hospital Medicine (SHM) National Survey, that number has increased to 75% with a low of 66% in the eastern United States and a high of 84% in the western United States. In community hospitals, 87% of hospitalists care for patients in the ICU, and 30% provide critical care services in academic medical centers.13 While there is some research14, 15 and many anecdotal reports that suggest hospitalists perform well in the ICU, there is, unfortunately, little data addressing outcomes for patients cared for by hospitalists. The results from a prospective, severity‐adjusted study from the Emory University Section of Hospital Medicine and the Division of Pulmonary/Critical Care Medicine examining outcomes for critical care patients cared for by hospitalists with criteria for Pulmonary/Intensivist consults vs. patients cared for by the Pulmonary/Critical Care Medical ICU Service await peer‐review publication.

Despite the lack of outcome data regarding adult hospitalists, it is clear that by default they are already providing a significant proportion of critical care services across the healthcare system, including in tertiary care centers. The two primary models of care include: (1) hospitalists serving as the primary provider without critical care consultant services and (2) comanagement of patients where intensivists and hospitalists collaborate. These collaborative models involve hospitalists actively co‐managing critical care patients along with intensivists or hospitalists managing less critically ill patients with intensivist consultation when indicated. In hospitals lacking intensivists, hospitalists often manage critically ill patients either with intensivist phone consultation, or with the intent to stabilize and transfer. Electronic ICUs are another expanding model of care that provide intensivist support to hospitalists and other primary care providersdecreasing ICU length of stay and severity‐adjusted ICU mortality.16 There are now 40 electronic ICU programs in the United States, and that number continues to grow.

In 2003, there were approximately 10,000 hospitalists in the United States,17 and recent data from an American Hospital Association survey indicates that the number has grown to about 28,000 in 2009. Recent research also documents that hospitalists are soon likely to care for the majority of elderly hospitalized patients in America.18 Aware that the number of intensivists is unlikely to change significantly over the next 25 years the question is no longer if hospitalists should be in the ICU; rather, the question is how to assure quality and improved clinical outcomes through enhanced collaboration between Hospital Medicine and Critical Care Medicine.

Recommendations

There are 3 steps that should be taken urgently to meet this challenge:

• 1

  Per the recommendation of the FOCCUS Report and the PrOMIS Conference Report, uniform protocols for intensive care treatmentmany of which already exist but are not used consistentlyshould be identified and implemented across all ICUs regardless of the level or certification of the provider.

• 2

  Also per the PrOMIS Report, a process for certification of physicians providing critical care services should be established by the appropriate governing bodies, including the Society for Critical Care Medicine, the Society of Hospital Medicine, and the American Thoracic Society, among others. While the PrOMIS Report called for cross‐training of hospital‐based providers to provide intensive care services in lower tier hospitals, a more realistic recommendation given current involvement of hospitalists in the provision of critical care services in secondary and tertiary centers is a competency‐assurance process that includes hospitalists practicing at all levels. This would not be equivalent to board certification, but would be based on a rigorous, comprehensive education and skills training process leading to recognition that would distinguish the recipient as having competencies beyond those obtained in internal medicine residency training. Models for certification could include 4‐month onsite training or a distance learning curriculum with regular blocks of onsite training. Another strategy might be for appropriate governing bodies to establish basic criteria for competency that would then be provided by individual institutions. Emory University, for example, has developed a pilot program incorporating significant components from the European Society for Critical Care Medicine's Syllabus for Competency Based Training in Intensive Care Medicine in Europe.19 Other institutions are also exploring the creation of certification/competency programs. Minimally, and prior to any decision about establishing formal criteria, institutions could identify designated hospitalists within groups who have particular interest and ability in the critical care setting. These providers, based on models already in place at sites across the United States, could, as an example, be required to spend a minimum of 50% of their clinical time in the ICU and to complete 10 to 20 hours of critical care continuing medical education (CME) per year. One strategy to address this issue and develop clear consensus and guidelines would be to convene the often discussed PrOMIS II working group.

• 3

  Per both the FOCCUS Report and the PrOMIS Report as well as a number of other publications,19 health services research in ICU care should be identified, funded, and implemented. A major focus of this effort should be the evaluation of clinical outcomes for ICU patients cared for by hospitalists. This research is needed for at least 2 reasons:

• As noted, there is little research that has assessed hospitalists' impact on outcomes of ICU patients. Hospitalists are already caring for patients in ICUs across the United States and given the research that has identified the outcomes benefit provided by intensivists, it is important to know objectively if hospitalists have similar levels of performance.

• An increasing number of hospitals and healthcare systems are now committed to achieving the Leapfrog IPS standard‐a challenge for many because of the difficulty with recruiting intensivists. If new research reveals that hospitalists with board certification in Internal Medicine, and more specifically with additional competency training in critical care, also improve outcomes in the ICU then it may be possible for Leapfrog to revise the criteria for meeting the IPS standard.

Summary

As discussed in a number of publications,20 including an article from the Mayo Clinic in the April 2009 edition of Chest entitled, Physicians Staffing Models and Patient Safety in the ICU,21 along with an accompanying editorial, Should Intensive Care Medicine Itself Be on the Critical List,22 creative and realistic solutions are urgently needed to address the crisis in critical care in the U.S. Collaborative efforts between Critical Care Medicine and Hospital Medicine to meet this challenge benefit all involved:

• Intensivists will continue to direct tertiary care units and/or co‐manage patients in tertiary and secondary care centers with Hospitalists.

• Hospitalists will benefit by having the opportunity to secure critical care competency training and by having their appropriate role in the ICU defined.

• All secondary and tertiary care institutions will have a realistic opportunity to meet Leapfrog IPS criteria and therefore benefit from the potential decreased length of stay (LOS), decreased mortality, and improved quality.

• Patients benefit by receiving uniform, evidence‐based, protocol‐driven care.

There is now a need and an opportunity for ACCP, SCCM, ATS, and the American Association of Critical Care Nurses (ACCN), to expand the important work they have already begun through the Critical Care Workforce Partnership. The Partnership should join with the SHM to take the lead in supporting and promoting this collaborative relationship between intensivists and hospitalists: aware that in the final analysis, it is the patients we serve who will benefit the most.

A looming gap in the supply of intensivists prompted the American College of Chest Physicians (ACCP), the American Thoracic Society (ATS), and the Society of Critical Care Medicine (SCCM) to publish a report in 2000 by the Committee on Manpower for Pulmonary and Critical Care Societies (COMPACCS). This study predicted that beginning in 2007 a shortfall would become apparent and steadily increase to 22% by 2020 and to 35% by 2030. Subsequent reports have reiterated those projections, including a report to Congress in 2006 by the U.S. Department of Health and Human Services/Health Resources and Services Administration.14

The concern regarding the shortage of intensivists has been increased by the growing evidence that supports improved critical care outcomesespecially decreased intensive care unit (ICU) and hospital mortalitywith intensivist staffing of ICUs.5, 6 Based on this data and on recommendations from the Society of Critical Care Medicine, the Leapfrog Group made onsite, high‐intensity ICU staffing with intensivists 1 of their 4 leaps.7 A paper by Pronovost et al.8 published in 2001, however, noted that in order for all ICUs in the United States to meet the Leapfrog ICU Physician Staffing (IPS) standard, the number of intensivists would need to increase by a factor of 2.6. Interestingly, a retrospective study published in the Annals of Internal Medicine in June of 2008 by Levy et al.9 suggested that mortality rates may actually be higher in intensivist‐staffed ICUs. An accompanying editorial raised concerns about limitations of the study design, but endorsed Levy's recommendation that more carefully designed, prospective studies were needed; (ie, we still are not certain as to optimal physician staffing for the care of patients requiring the sophisticated treatment available only in an ICU.)10

The health policy challenge, however, remains clear: while there is basic consensus that care of critically ill patients by intensivists improves outcomes, the reality is that the shortage of intensivists in the United States as predicted by the COMPACCS report will only increase, leading some to refer to this as a healthcare crisis. Two major task forces attempted to address this situation, resulting in the publication of the 2004 Framing Options for Critical Care in the United States (FOCCUS) report, The Critical Care Medicine Crisis: A Call for Federal ActionA White Paper from the Critical Care Professional Societies; and the 2007 Prioritizing the Organization and Management of Intensive Care Services in the Unites States (PrOMIS) Conference Report.11, 12 Both reports made specific recommendations including, for example, development of uniform standards for accreditation of institutional critical care capacity, identification and endorsement of core competencies in critical care, investment in health services research, the use of uniform protocols for ICU care, leverage of information technology to promote standardization and improve efficiency, and the development of incentives to attract healthcare professionals to critical care medicine.

A Possible Solution: The Role of Hospitalists

Multiple important efforts are already underway to increase the competency of professionals providing critical care services including the Society of Critical Care's Fundamentals in Critical Care Support (FCCS) program. Additionally, physician assistants and nurse practitioners are playing an increasingly important role as members of critical care services. As another component of this collaborative effort, the PrOMIS Report noted the potential impact of hospitalists in addressing this crisis.

As early as 1999, surveys revealed that as many as 35% of hospitalists were providing critical care services.13 According to the 2005/2006 Society of Hospital Medicine (SHM) National Survey, that number has increased to 75% with a low of 66% in the eastern United States and a high of 84% in the western United States. In community hospitals, 87% of hospitalists care for patients in the ICU, and 30% provide critical care services in academic medical centers.13 While there is some research14, 15 and many anecdotal reports that suggest hospitalists perform well in the ICU, there is, unfortunately, little data addressing outcomes for patients cared for by hospitalists. The results from a prospective, severity‐adjusted study from the Emory University Section of Hospital Medicine and the Division of Pulmonary/Critical Care Medicine examining outcomes for critical care patients cared for by hospitalists with criteria for Pulmonary/Intensivist consults vs. patients cared for by the Pulmonary/Critical Care Medical ICU Service await peer‐review publication.

Despite the lack of outcome data regarding adult hospitalists, it is clear that by default they are already providing a significant proportion of critical care services across the healthcare system, including in tertiary care centers. The two primary models of care include: (1) hospitalists serving as the primary provider without critical care consultant services and (2) comanagement of patients where intensivists and hospitalists collaborate. These collaborative models involve hospitalists actively co‐managing critical care patients along with intensivists or hospitalists managing less critically ill patients with intensivist consultation when indicated. In hospitals lacking intensivists, hospitalists often manage critically ill patients either with intensivist phone consultation, or with the intent to stabilize and transfer. Electronic ICUs are another expanding model of care that provide intensivist support to hospitalists and other primary care providersdecreasing ICU length of stay and severity‐adjusted ICU mortality.16 There are now 40 electronic ICU programs in the United States, and that number continues to grow.

In 2003, there were approximately 10,000 hospitalists in the United States,17 and recent data from an American Hospital Association survey indicates that the number has grown to about 28,000 in 2009. Recent research also documents that hospitalists are soon likely to care for the majority of elderly hospitalized patients in America.18 Aware that the number of intensivists is unlikely to change significantly over the next 25 years the question is no longer if hospitalists should be in the ICU; rather, the question is how to assure quality and improved clinical outcomes through enhanced collaboration between Hospital Medicine and Critical Care Medicine.

Recommendations

There are 3 steps that should be taken urgently to meet this challenge:

• 1

  Per the recommendation of the FOCCUS Report and the PrOMIS Conference Report, uniform protocols for intensive care treatmentmany of which already exist but are not used consistentlyshould be identified and implemented across all ICUs regardless of the level or certification of the provider.

• 2

  Also per the PrOMIS Report, a process for certification of physicians providing critical care services should be established by the appropriate governing bodies, including the Society for Critical Care Medicine, the Society of Hospital Medicine, and the American Thoracic Society, among others. While the PrOMIS Report called for cross‐training of hospital‐based providers to provide intensive care services in lower tier hospitals, a more realistic recommendation given current involvement of hospitalists in the provision of critical care services in secondary and tertiary centers is a competency‐assurance process that includes hospitalists practicing at all levels. This would not be equivalent to board certification, but would be based on a rigorous, comprehensive education and skills training process leading to recognition that would distinguish the recipient as having competencies beyond those obtained in internal medicine residency training. Models for certification could include 4‐month onsite training or a distance learning curriculum with regular blocks of onsite training. Another strategy might be for appropriate governing bodies to establish basic criteria for competency that would then be provided by individual institutions. Emory University, for example, has developed a pilot program incorporating significant components from the European Society for Critical Care Medicine's Syllabus for Competency Based Training in Intensive Care Medicine in Europe.19 Other institutions are also exploring the creation of certification/competency programs. Minimally, and prior to any decision about establishing formal criteria, institutions could identify designated hospitalists within groups who have particular interest and ability in the critical care setting. These providers, based on models already in place at sites across the United States, could, as an example, be required to spend a minimum of 50% of their clinical time in the ICU and to complete 10 to 20 hours of critical care continuing medical education (CME) per year. One strategy to address this issue and develop clear consensus and guidelines would be to convene the often discussed PrOMIS II working group.

• 3

  Per both the FOCCUS Report and the PrOMIS Report as well as a number of other publications,19 health services research in ICU care should be identified, funded, and implemented. A major focus of this effort should be the evaluation of clinical outcomes for ICU patients cared for by hospitalists. This research is needed for at least 2 reasons:

• As noted, there is little research that has assessed hospitalists' impact on outcomes of ICU patients. Hospitalists are already caring for patients in ICUs across the United States and given the research that has identified the outcomes benefit provided by intensivists, it is important to know objectively if hospitalists have similar levels of performance.

• An increasing number of hospitals and healthcare systems are now committed to achieving the Leapfrog IPS standard‐a challenge for many because of the difficulty with recruiting intensivists. If new research reveals that hospitalists with board certification in Internal Medicine, and more specifically with additional competency training in critical care, also improve outcomes in the ICU then it may be possible for Leapfrog to revise the criteria for meeting the IPS standard.

Summary

As discussed in a number of publications,20 including an article from the Mayo Clinic in the April 2009 edition of Chest entitled, Physicians Staffing Models and Patient Safety in the ICU,21 along with an accompanying editorial, Should Intensive Care Medicine Itself Be on the Critical List,22 creative and realistic solutions are urgently needed to address the crisis in critical care in the U.S. Collaborative efforts between Critical Care Medicine and Hospital Medicine to meet this challenge benefit all involved:

• Intensivists will continue to direct tertiary care units and/or co‐manage patients in tertiary and secondary care centers with Hospitalists.

• Hospitalists will benefit by having the opportunity to secure critical care competency training and by having their appropriate role in the ICU defined.

• All secondary and tertiary care institutions will have a realistic opportunity to meet Leapfrog IPS criteria and therefore benefit from the potential decreased length of stay (LOS), decreased mortality, and improved quality.

• Patients benefit by receiving uniform, evidence‐based, protocol‐driven care.

There is now a need and an opportunity for ACCP, SCCM, ATS, and the American Association of Critical Care Nurses (ACCN), to expand the important work they have already begun through the Critical Care Workforce Partnership. The Partnership should join with the SHM to take the lead in supporting and promoting this collaborative relationship between intensivists and hospitalists: aware that in the final analysis, it is the patients we serve who will benefit the most.