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. Author manuscript; available in PMC: 2015 Feb 1.
Published in final edited form as: Crit Care Med. 2014 Feb;42(2):344–356. doi: 10.1097/CCM.0b013e3182a275d7

Structure, process and annual intensive care unit mortality across 69 centers: United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS)

William Checkley 1, Greg S Martin 2, Samuel M Brown 3, Steven Y Chang 4, Ousama Dabbagh 5, Richard D Fremont 6, Timothy D Girard 7, Todd W Rice 7, Michael D Howell 8, Steven B Johnson 9, James O'Brien 10, Pauline K Park 11, Stephen M Pastores 12, Namrata T Patil 13, Anthony P Pietropaoli 14, Maryann Putman 15, Leo Rotello 16, Jonathan Siner 17, Sahul Sajid 18, David J Murphy 2, Jonathan E Sevransky 2; USCIITG-CIOS Investigators
PMCID: PMC4035482  NIHMSID: NIHMS510446  PMID: 24145833

Abstract

Objective

Hospital-level variations in structure and process may affect clinical outcomes in intensive care units (ICUs). We sought to characterize the organizational structure, processes of care, use of protocols and standardized outcomes in a large sample of U.S. ICUs.

Design

We surveyed 69 ICUs about organization, size, volume, staffing, processes of care, use of protocols, and annual ICU mortality.

Setting

ICUs participating in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS).

Measurements and Main Results

We characterized structure and process variables across ICUs, investigated relationships between these variables and annual ICU mortality, and adjusted for illness severity using APACHE II. Ninety-four ICU directors were invited to participate in the study and 69 ICUs (73%) were enrolled, of which 25 (36%) were medical, 24 were surgical (35%) and 20 (29%) were of mixed type, and 64 (93%) were located in teaching hospitals with a median number of 5 trainees per ICU. Average annual ICU mortality was 10.8%, average APACHE II score was 19.3, 58% were closed units and 41% had a 24-hour in-house intensivist. In multivariable linear regression adjusted for APACHE II and multiple ICU structure and process factors, annual ICU mortality was lower in surgical ICUs than in medical ICUs (5.6% lower, 95% CI 2.4%–8.8%) or mixed ICUs (4.5% lower, 95% CI 0.4%–8.7%). We also found a lower annual ICU mortality among ICUs that had a daily plan of care review (5.8% lower, 95% CI 1.6%–10.0%) and a lower bed-to-nurse ratio (1.8% lower when the ratio decreased from 2:1 to 1.5:1; 95% CI 0.25%–3.4%). In contrast, 24-hour intensivist coverage (p=0.89) and closed ICU status (p=0.16) were not associated with a lower annual ICU mortality.

Conclusions

In a sample of 69 ICUs, a daily plan of care review and a lower bed-to-nurse ratio were both associated with a lower annual ICU mortality. In contrast to 24-hour intensivist staffing, improvement in team communication is a low-cost, process-targeted intervention strategy that may improve clinical outcomes in ICU patients.

Keywords: protocols, structure, process, ICU management, intensivist, ICU administration

INTRODUCTION

Caring for the critically ill is a resource intensive process that requires a specialized clinical team and real-time monitoring to provide life-sustaining interventions. In the United States, each day of intensive care costs on average 3500 US dollars and intensive care units (ICUs) account for 13% of hospital costs, 4% of the national health expenditures and approximately 1% of the GDP (1, 2). Clinical outcomes vary substantially between ICUs (58), which can be attributed to heterogeneous patient case-mix and differences in organizational structure and processes of care within an ICU. With the increasing demand and cost of critical care worldwide, it is important to understand the organizational characteristics and process of care variables associated with optimal outcomes and costs.

Recently it has been recognized that both organizational structure (i.e., the conditions under which patient care is provided) and processes of care (i.e., activities that constitute patient care) in an ICU directly influence clinical outcomes and are an important platform for care improvements. Structure-driven factors previously shown to be associated with clinical outcomes include the type of ICU (3, 4), hospital and ICU case volume (57), open or closed ICU format (810), 24-hour presence of an intensivist (1113), nurse staffing (1417) and staff workload (18). Several of these characteristics, are resource-intensive (e.g., 24-hour intensivist staffing or higher ratio nurse staffing) or immutable (e.g., case volume or type of ICU). Processes of care frequently involve disease-driven interventions, such as lung protective ventilation and conservative fluid management strategies for Acute Respiratory Distress Syndrome (19, 20), and early goal-directed therapy for sepsis (21). Process-driven interventions offer a potentially cost-effective alternative to reduce practice variation and improve clinical outcomes across ICUs. Previous investigations in single-center studies have demonstrated that the use of a standardized protocol vs. physician-directed assessment (i.e., usual care) of spontaneous breathing trials alone (22) or in combination with a spontaneous awakening trial (23) resulted in better patient outcomes. Similarly, another investigation in a single center-study found that use of a daily plan of care checklist was associated with 50% decrease in length of stay (24).

In this study, we sought to characterize the heterogeneity in organizational characteristics in a sample of 69 ICUs in the United States, to identify variations in processes of care and use of protocols; and, describe the ecological association between these variables and annual ICU mortality.

MATERIALS AND METHODS

Study design

The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS has been described in detail elsewhere (25). Briefly, CIOS is a large, prospective, observational study of ICU patients. Participating investigators were selected from a range of institutions participating in USCIITG. CIOS was conducted in two stages. In the first stage, participating investigators were asked to complete a standardized questionnaire about physician and nurse staffing, number of beds and case volume of the hospital and study ICU, processes of care including rounding practices and use of protocols, and the most recent annual reported ICU mortality for the study ICU. After recruitment into the study but before enrollment of individual patient data, investigators were asked to first complete this standardized questionnaire regarding ICU structure and process. All investigators were given a manual of operations that provided definitions for each potential answer (See Online Supplement). This standardized questionnaire was also pilot tested at a couple of our facilities and independently validated by our study staff prior to use. Moreover, once completed, each standardized questionnaire was individually reviewed by the Principal Investigator and the responses were discussed with individual investigators over the telephone. We chose to use annual ICU mortality for this study because it is a highly reliable, standardized metric used at most hospitals. With the exception of APACHE II data, which is not a commonly available quality metric collected by hospitals or ICUs, we limited our analyses to data collected in the first stage of CIOS (i.e., structural questionnaire). We obtained the average Acute Physiology and Chronic Health Evaluation II (APACHE II) score for each ICU from individual patient data collected prospectively in approximately 100 patients per ICU. We instructed investigators to enroll all newly admitted patients on randomly chosen days, with 5 to 10 days between enrollments to allow for patient turnover (25). CIOS was approved by the ethics review boards of all participating institutions.

Definitions

We defined an intensivist as a physician who is board-eligible or board-certified in Critical Care Medicine, board-certified in Emergency Medicine and completed a Critical Care fellowship in an accredited program, or board-certified in Medicine, Anesthesiology, Pediatrics or Surgery who completed training prior to the availability of Critical Care Medicine certification and who provides at least six weeks of full-time ICU care annually since 1987. We defined an ICU as: open if any credentialed physician could admit and manage a patient in the unit, and semi-open if any credentialed physician could admit to the unit, but an automatic critical care consult occurred if certain parameters such as expected length of stay are exceeded. The type of ICU was: medical if it managed exclusively medical or cardiac patients; surgical if it managed only surgical, cardiothoracic, trauma, burn or neurosurgical patients; and, mixed if it managed both medical and surgical or neurology patients. We defined a trainee as either a resident or fellow. We categorized case volume as high or low according to the median number of annual ICU admissions, and bed capacity as high or low according to the median number of ICU beds. We considered an ICU as having a daily plan of care review if it either had a checklist for daily goals of care or if the attending physician reviewed the plan of care with the charge nurse. We defined rounds as multidisciplinary if it included at least two other clinical specialties beyond the ICU physician and nurse.

We defined a protocol as a precise and detailed plan for a regimen of therapy, which included a set of guiding rules initiated by a physician order or included as part of standing orders during admission. We grouped protocols into the following categories: pulmonary and ventilator management bundle (lung protective ventilation, weaning and ventilator-associated pneumonia prevention), infection control bundle (sepsis treatment, rapid antibiotic use, stress ulcer prevention, catheter placement, oral hygiene and ventilator-associated pneumonia prevention), nutrition bundle (nutrition and glucose control), thromboembolism management bundle (deep vein thrombosis prevention and venous thromboembolism), delirium management bundle (delirium assessment and delirium treatment), sedation management bundle (daily discontinuation of sedation or other sedation protocol), neuroprotective bundle (stroke treatment, acute brain injury, intracerebral hemorrhage and hypothermia after acute cardiac arrest) and transfusion management bundle (massive transfusion or transfusion restriction). We defined a protocol with a high requirement for a physician order if >75% of the ICUs in the study required a physician order to initiate a protocol.

Biostatistical methods

We summarized structure and process variables stratified by type of ICU. In unadjusted analysis, we compared proportions across types of ICU using Fisher exact tests, and compared continuous variables across types of ICU using one-way analysis of variance as appropriate. We used multivariable linear regression adjusted to determine structure and process factors associated with annual ICU mortality adjusted for the APACHE II at each center. Specifically, the multivariable linear regression model included the following variables: average APACHE II score, ICU type, case volume, bed capacity, 24-hour intensivist coverage, bed-to-nurse ratio, trainee-to-bed ratio, ICU organization (open vs. closed), computerized order entry, daily plan of care review, multidisciplinary rounding, and use of protocols guiding management of electrolytes, mobility, codes, neuroprotection, delirium, and transfusions. We selected these variables a priori based on biological plausibility and previous research. We did not include protocol bundles that were ubiquitously used across ICUs (>97%) such as pulmonary and ventilator management, infection control, nutrition and thromboembolism management protocols. For example, 68 centers (99%) had either the lung protective ventilation, weaning or ventilator-associated pneumonia prevention protocols, i.e., the pulmonary and ventilator management bundle. Due to the high number of covariates included, which can increase the risk of overfitting, we also conducted sensitivity analyses examining the association between each of the structure and process variables and annual ICU mortality, adjusted only for average APACHE II score and ICU type. Although all structure and process data were complete, 11 ICUs were missing average APACHE II scores. We therefore used multiple imputation analysis to perform multivariable linear regression, to a total of 20 imputations. In sensitivity analyses, the use of 50 and 100 imputations did not affect the results (See Online Supplement). Additional exploratory analyses demonstrated reasonable ranges for the imputed values. As a further sensitivity analysis, we conducted a multivariable linear regression in which we excluded the 11 ICUs without average APACHE II scores and found that the point estimates were similar (See Online Supplement). Finally, since a large percentage of centers only contributed data for 1 or 2 ICUs of a different type (the median number of ICUs per hospital center was 1), we assume that ICUs are independent and identically distributed units in our analyses. We conducted all statistical analyses in R (www.r-project.org) and STATA 12 (Stata Corp., College Station, USA).

RESULTS

Hospital characteristics and utilization

We approached 94 ICU directors in the United States and 69 (73%) agreed to participate in the study. All 69 participating investigators completed the structure and process form for their ICUs without any missing data. A total of 25 hospital centers contributed data for 1 ICU only, 10 centers contributed data for 2 ICUs, 5 centers contributed data of 3 ICUs, 1 center contributed data of 4 ICUs and 1 center contributed data of 5 ICUs. The median number of ICUs per hospital center was 1. We summarized hospital characteristics and demographics in Table 1. Briefly, 25 (36%) ICUs were medical, 24 (35%) were surgical and 20 (29%) were of mixed type. Average annual ICU mortality was 10.8% (median 9%); average APACHE II score was 19.3 (median 19.1); 64% of hospitals were private non-profit and 18% were non-federal public. 80% were located in urban centers; 93% had a resident training program and 83% had a critical care training program; 90% had electronic patient records and 81% had computerized patient order entry.

Table 1.

Hospital characteristics and utilization by Intensive Care Unit (ICU) type.

All (n=69) Medical (n=25) Surgical (n=24) Mixed (n=20) P
Annual ICU mortality, median (range) 9.0 (1.5 – 38.6) 14.8 (6.2 – 38.6) 5.5 (1.5 – 22.0) 8.4 (3.3 – 22.0) <0.001
Mean APACHE II, median (range) 19.1 (9.7 – 29.2) 20.2 (13.3 – 28.4) 17.7 (9.7 – 24.8) 20.6 (15.6 – 29.2) 0.02
Type of hospital, n (%)
  Private non-profit 44 (64) 18 (72) 16 (67) 10 (50) 0.14
  Non-federal public 18 (26) 7 (28) 6 (25) 5 (25)
  Private for profit 4 (6) 0 (0) 2 (8) 2 (10)
  Federal 3 (4) 0 (0) 0 (0) 3 (15)
Hospital location
  Urban (vs. Suburban) 55 (80) 22 (88) 19 (79) 14 (70) 0.29
Hospital characteristics, n (%)
  Teaching hospital 64 (93) 25 (100) 24 (100) 15 (75) <0.01
  Critical care training program 57 (83) 24 (96) 22 (92) 11 (55) <0.001
  Rapid response team 66 (96) 24 (96) 22 (92) 20 (100) 0.63
  Electronic patient record 62 (90) 23 (92) 22 (92) 18 (90) 1
  Computer physician order entry 56 (81) 21 (84) 21 (88) 14 (70) 0.37
Number of Beds, median (range)
  Adult beds at hospital 611 (10 – 1300) 618 (16 – 1300) 718.5 (10 – 1113) 364.5 (41 – 1113) <0.01
  Adult ICU beds at hospital 82 (4 – 184) 84 (35 – 184) 99.5 (35 – 180) 41 (4 – 158) <0.001
  Adult step down beds at hospital 31 (0 – 539) 36 (0 – 202) 48 (0 – 539) 15 (0 – 202) 0.04
  Pediatric ICU beds at hospital 48 (0 – 214) 48 (0 – 122) 50 (0 – 107) 27 (0 – 214) 0.77
  Beds in study ICU 16 (4 – 44) 16 (8 – 44) 17.5 (10 – 36) 19 (4 – 33) 0.55
Utilization, median (range)
  Annual ED visits 65660 (0– 156519) 75000 (29816 – 156519) 65660 (29816 – 106000) 54287.5 (0– 106000) 0.02
  Annual hospital admissions 34856 (1170 – 56330) 35000 (19021 – 56330) 37580 (19021 – 56330) 23348 (1170 – 56330) <0.001
  Annual study ICU admissions 1299 (230 – 4556) 1200 (581 – 4556) 1119.5 (496 – 2500) 1313 (230 – 3816) 0.46

Abbreviations: Acute Physiology and Chronic Health Evaluation II (APACHE II), Emergency Department (ED).

Staffing, organization and rounding practices

We summarize staffing, organization and rounding practices in Table 2. Overall, 100% of participating ICUs had attending intensivists; 100% had a medical director and 99% had a nurse manager; 58% were closed units; 41% had 24-hour intensivist coverage. Mean bed-to-nurse ratio was 1.8:1 (median 1.7:1), mean number of critical care trainees was 5.9 (median 5, range 0 to 29), 4% had electronic ICU coverage. Multidisciplinary rounds were performed in 41% of units, but included palliative care in only 7% of ICUs. Nurses performed delirium assessment while charting in 67% of ICUs, and 87% conducted a daily plan of care review.

Table 2.

Staffing and organization by Intensive Care Unit (ICU) type.

All (n=69) Medical (n=25) Surgical (n=24) Mixed (n=20) P
ICU staffing
  Intensivist in ICU (%) 69 (100%) 25 (100%) 24 (100%) 20 (100%) 1
  24/7 intensivist (%) 28 (41%) 9 (36%) 11 (46%) 8 (40%) 0.78
  Leapfrog compliant? 57 (83%) 19 (76%) 22 (92%) 16 (80%) 0.37
  Median number of ICU fellows (range) 1 (0 – 10) 1 (0 – 4) 1 (0 – 5) 0.5 (0 – 10) 0.95
  24/7 ICU fellow 18 (26%) 3 (12%) 11 (46%) 4 (20%) 0.03
  Median number of ICU residents (range) 4 (0 – 16) 6 (0 – 16) 3.5 (0 – 9) 3 (0 – 14) 0.04
  Median number of RTs in ICU (range) 2 (1 – 7) 2 (1 – 7) 1 (1 – 5) 2 (1 – 3) 0.38
  Median number of ICU nurses (range) 10 (2 – 30) 8 (4 – 30) 9.5 (5 – 24) 10 (2 – 30) 0.92
  Median ratio of beds to nurses (range) 1.7:1 (0.8:1 – 5.2:1) 1.7:1 (0.8:1 – 4.4:1) 1.7:1 (0.8:1 – 5.2:1) 1.9:1 (0.9:1 – 2.7:1) 0.70
  Median number of PAs (range) 0 (0 – 4) 0 (0 – 4) 0 (0 – 4) 0 (0 – 1) 0.18
  Median number of NPs (range) 0 (0 – 12) 0 (0 – 5) 0 (0 – 12) 0 (0 – 3) 0.38
  Charge nurse provides patient care? 26 (38%) 9 (36%) 10 (42%) 7 (35%) 0.91
ICU Organization, n (%)
  Closed units 40 (58%) 20 (80%) 12 (50%) 8 (40%) 0.02
  Mandatory critical care consult in open or semi open units 16 (55%) 1 (20%) 11 (92%) 4 (33%) <0.01
  Has medical director 69 (100%) 25 (100%) 24 (100%) 20 (100%) 1
  Has nurse manager 68 (99%) 25 (100%) 24 (100%) 19 (95%) 0.29
  Has clinical nurse specialist 57 (83%) 20 (80%) 20 (83%) 17 (85%) 0.92
  Electronic ICU coverage 3 (4%) 2 (8%) 1 (4%) 0 (0%) 0.77
  CRRT in ICU 59 (86%) 23 (92%) 22 (92%) 14 (70%) 0.09
  Sustained Low Efficiency Dialysis 38 (55%) 11 (44%) 13 (54%) 14 (70%) 0.21
ICU rounding practices, n (%)
  Pharmacist on rounds 63 (91%) 25 (100%) 21 (88%) 17 (85%) 0.10
  Respiratory therapist on rounds 41 (59%) 13 (52%) 13 (54%) 15 (75%) 0.24
  Physical therapist on rounds 7 (10%) 1 (4%) 1 (4%) 5 (25%) 0.04
  Social worker on rounds 18 (26%) 6 (24%) 1 (4%) 11 (55%) <0.001
  Nutritionist on rounds 28 (41%) 5 (20%) 9 (38%) 14 (70%) <0.01
  Palliative care on rounds 5 (7%) 1 (4%) 1 (4%) 3 (15%) 0.43
  Delirium assessment by nursing 45 (65%) 20 (80%) 14 (58%) 11 (55%) 0.14
  Daily goals of care sheet 47 (68%) 17 (68%) 19 (79%) 11 (55%) 0.24
  Daily meeting between physician and charge nurse 49 (71%) 17 (68%) 17 (71%) 15 (75%) 0.94
  Median number of protocols (range) 19 (5 – 27) 18 (6 – 27) 19 (10 – 27) 18.5 (5 – 27) 0.26

Abbreviations: Respiratory Therapist (RT), Physician Assistant (PA), Nurse Practitioner (NP), Continuous renal replacement therapy (CRRT).

Protocols

The median number of protocols was 19 for all ICUs (Table 2) and 93% of the ICUs had 10 or more protocols in place. We summarized the availability of protocols and need for a physician order to initiate the protocol rules in Table 3. Pulmonary and ventilator management, infection control, nutrition and thromboembolism management protocols were ubiquitous with 97% to 99% coverage across ICUs. Neuroprotective and sedation management protocols were also very common with 84% and 86% coverage, respectively. In contrast, only 36% of ICUs had early mobility protocols, 55% had transfusion management protocols, 57% had acute coronary syndrome protocols, 62% had delirium management protocols and 81% had electrolyte protocols in place. When we examined individual protocols, only 48% used a rapid antibiotic protocol and 48% had a palliative care protocol, and these were consistently low across all types of ICUs. Most protocols had a high requirement (i.e., >75%) for a physician order (Table 3). Examples of specific protocols with a lower requirement for a physician order included such as catheter placement, ventilator associated pneumonia prevention, oral hygiene, daily interruption of sedation, both delirium assessment and treatment and Advanced Cardiovascular Life Support/Critical care code.

Table 3.

Types of protocols available and requirement of physician order by Intensive Care unit (ICU) type, n (%).

Available Physician Order required
Protocol All
(n=69)
Medical
(n=25)
Surgical
(n=24)
Mixed
(n=20)
P All
(n=69)
Medical
(n=25)
Surgical
(n=24)
Mixed
(n=20)
P
Ventilator Management
  Lung protective ventilation 55 (80) 18 (72) 19 (79) 18 (90) 0.34 52 (95) 18 (100) 19 (100) 15 (83) 0.06
  Ventilator Weaning 61 (88) 23 (92) 21 (88) 17 (85) 0.81 43 (70) 15 (65) 16 (76) 12 (71) 0.73
Infection Control
  Sepsis treatment 46 (67) 18 (72) 16 (67) 12 (60) 0.73 42 (91) 17 (94) 14 (88) 11 (92) 0.82
  Rapid antibiotics 33 (48) 12 (48) 12 (50) 9 (45) 0.95 30 (91) 11 (92) 10 (83) 9 (100) 0.76
  Stress ulcer prevention 59 (86) 20 (80) 22 (92) 17 (85) 0.52 54 (92) 19 (95) 19 (86) 16 (94) 0.61
  Catheter placement 53 (77) 22 (88) 21 (88) 10 (50) <0.01 30 (57) 14 (64) 9 (43) 7 (70) 0.30
  Oral hygiene 63 (91) 24 (96) 23 (96) 16 (80) 0.17 24 (38) 8 (33) 11 (48) 5 (31) 0.52
  Ventilator associated pneumonia prevention 66 (96) 25 (100) 24 (100) 17 (85) 0.02 35 (53) 9 (36) 14 (58) 12 (71) 0.08
Nutrition
  Nutrition 46 (67) 15 (60) 18 (75) 13 (65) 0.53 41 (89) 15 (100) 16 (89) 10 (77) 0.17
  Glucose control 66 (96) 24 (96) 24 (100) 18 (90) 0.28 61 (92) 23 (96) 21 (88) 17 (94) 0.62
  Electrolyte replacement 56 (81) 18 (72) 23 (96) 15 (75) 0.06 54 (96) 17 (94) 22 (96) 15 (100) 1
Venous Thromboembolism
  Deep vein thrombosis prevention 62 (90) 22 (88) 23 (96) 17 (85) 0.48 58 (94) 21 (95) 21 (91) 16 (94) 1
  Venous thromboembolism 55 (80) 17 (68) 21 (88) 17 (85) 0.24 55 (100) 17 (100) 21 (100) 17 (100) 1
Sedation Management
  Daily interruption of sedation 53 (77) 20 (80) 18 (75) 15 (75) 0.88 34 (76) 9 (45) 12 (67) 13 (87) 0.04
  Other sedation 45 (65) 18 (72) 17 (71) 10 (50) 0.27 42 (93) 17 (94) 15 (88) 10 (100) 0.60
  Delirium assessment 39 (57) 18 (72) 14 (58) 7 (35) 0.05 8 (21) 3 (17) 3 (21) 2 (29) 0.87
  Delirium treatment 25 (36) 13 (52) 8 (33) 4 (20) 0.08 25 (36) 13 (100) 8 (100) 4 (100) 1
Neuroprotective
  Acute brain injury 22 (32) 5 (20) 13 (54) 4 (20) 0.02 21 (95) 4 (80) 13 (100) 4 (100) 0.41
  Stroke treatment 46 (67) 15 (60) 18 (72) 13 (65) 0.53 46 (100) 15 (100) 18 (100) 13 (100) 1
  Intracerebral hemorrhage 23 (33) 7 (28) 11 (46) 5 (25) 0.29 23 (100) 7 (100) 11 5 (100) 1
  Hypothermia after cardiac arrest 55 (80) 23 (92) 18 (75) 14 (70) 0.13 55 (100) 23 (100) 18 (100) 14 (100) 1
  Early mobility 25 (36) 11 (44) 9 (38) 5 (25) 0.42 15 (60) 5 (45) 5 (56) 5 (100) 0.13
Transfusion
  Transfusion restriction 27 (39) 10 (40) 11 (46) 6 (30) 0.58 20 (75) 8 (80) 6 (55) 6 (100) 0.12
  Massive transfusion 30 (43) 9 (36) 11 (46) 10 (50) 0.65 26 (87) 7 (78) 9 (82) 10 (100) 0.42
Other
  Palliative care 33 (48) 12 (48) 9 (38) 12 (60) 0.35 30 (91) 10 (83) 8 (89) 12 (100) 0.47
  Acute Coronary Syndrome 39 (57) 13 (52) 13 (54) 13 (65) 0.68 39 (100) 13 (100) 13 (100) 13 (100) 1
  Advanced Cardiovascular Life Support/Critical care code 48 (70) 16 (36) 18 (33) 14 (25) 0.72 26 (54) 7 (44) 10 (56) 9 (64) 0.51

Structure and process factors associated with ICU mortality

In single variable analyses, both APACHE II score and type of ICU were associated with annual ICU mortality as were several structure and process variables (first column of Table 4). Several of these relationships, however, were likely confounded by either severity of illness, type of ICU or other factors, and most of the associations found in single variable analyses became non-significant in multivariable analyses (second and third columns of Table 4). In multivariable linear regression adjusted for average APACHE II score among other organizational characteristics, annual ICU mortality was lower in surgical ICUs than in medical and mixed ICUs (third column of Table 4). In addition, we found that the adjusted annual ICU mortality was lower among ICUs that had a daily plan of care review (5.8% lower than having no daily review, 95% CI 1.6%–10.0%) and a lower bed-to-nurse ratio (1.8% lower when the ratio decreased from 2:1 to 1.5:1; 95% CI 0.25%–3.4%). In contrast, 24-hour intensivist coverage and closed ICU status were not associated with a lower annual ICU mortality. In sensitivity analyses examining structure and process factors in models adjusting only for severity of illness and ICU type, results were similar to those found in the full multivariable model with a few exceptions: the association between bed-to-nurse ratio and mortality was less robust, and associations between electrolyte and mobility protocols and mortality became significant when adjusting only for average APACHE II and ICU type.

Table 4.

Single variable and multivariable linear regression analysis of annual ICU hospital mortality as a function of organizational structure and process factors.

Single variable analysis Adjusted for APACHE II score and type of ICU Multivariable analysis

% difference in annual
ICU mortality (95% CI)
P % difference in annual
ICU mortality (95% CI)
P % difference in annual
ICU mortality (95% CI)
P
Severity of illness
  APACHE II (per unit score) 0.5 (0.01 to 1.1) 0.05 0.3 (−0.3 to 0.8) 0.35
Type of ICU
  Medical ICU 3.0 (0.6 to 5.4) 0.01 5.6 (2.4 to 8.8) <0.001
  Mixed ICU 0.8 (−1.2 to 2.8) 0.44 4.6 (0.4 to 8.7) 0.03
Utilization
  High case volume 3.0 (1.5 to 4.6) <0.001 −0.6 (−3.4 to 2.2) 0.65 −2.0 (−4.9 to 0.9) 0.17
  High bed capacity 0.6 (−1.3 to 2.4) 0.54 −0.2 (−3.2 to 2.7) 0.88 2.0 (−1.6 to 5.6) 0.26
Staffing
  24-hour intensivist 5.6 (4.0 to 7.3) <0.001 −1.5 (−4.2 to 1.3) 0.29 0.2 (−2.9 to 3.4) 0.89
  Bed-to-nurse ratio (per 1:1 unit increase) 2.4 (1.8 to 3.1) <0.001 2.1 (−0.3 to 4.6) 0.09 3.7 (0.5 to 6.8) 0.02
  Trainee-to-bed ratio (per 1:1 unit increase) 2.5 (−1.7 to 6.8) 0.24 2.0 (−5.1 to 9.1) 0.58 2.7 (−3.8 to 9.1) 0.41
ICU organization
  Closed ICU −2.0 (−3.6 to −0.4) 0.02 2.3 (−0.5 to 5.3) 0.11 2.0 (−0.8 to 4.8) 0.16
  Computerized patient order entry −4.7 (−6.5 to −2.9) <0.001 −0.5 (−4.2 to 3.2) 0.80 0.5 (−3.1 to 4.1) 0.79
Rounding practices
  Daily plan of care review −9.6 (−11.3 to −7.7) <0.001 −6.2 (−10.0 to −2.5) <0.01 −5.8 (−10.0 to −1.6) <0.01
  Multidisciplinary rounding −3.6 (−5.2 to −2.0) <0.001 −0.8 (−3.9 to 2.4) 0.93 0.4 (−2.8 to 3.6) 0.82
Protocols
  Electrolyte protocol −1.5 (−3.6 to 0.6) 0.15 −4.8 (−8.2 to −1.3) <0.01 −3.0 (−6.7 to 0.7) 0.11
  Mobility protocol 4.6 (2.9 to 6.3) <0.001 3.3 (0.6 to 6.1) 0.02 1.8 (−1.1 to 4.8) 0.22
  Critical care code −5.2 (−7.4 to −3.0) <0.001 −0.5 (−3.5 to 2.5) 0.74 1.4 (−1.4 to 4.3) 0.32
  Neuroprotective protocol 9.3 (7.5 to 11.2) <0.001 2.9 (−1.2 to 6.9) 0.17 2.7 (−1.6 to 7.0) 0.21
  Delirium management protocol 0.3 (−1.3 to 1.9) 0.35 1.2 (−1.8 to 4.2) 0.42 1.8 (−1.3 to 4.9) 0.26
  Transfusion protocol 2.7 (1.2 to 4.3) 0.001 −0.4 (−3.2 to 2.4) 0.78 −1.2 (−4.7 to 2.2) 0.48

DISCUSSION

Our study identified substantial heterogeneity in both ICU organizational structure and processes of care across 69 centers in the United States, most of which were located in teaching hospitals. While annual ICU mortality varied by type of ICU, the primary factors that were strongly associated with a lower ICU mortality were improved daily team communication strategies and a lower bed-to-nurse ratio. We did not find that 24-hour attending intensivist staffing (vs. fewer attending hours) or a closed ICU format (vs. open) was associated with a lower annual ICU mortality in the USCIITG-CIOS cohort.

We identified that daily team communication strategies was a process-driven factor associated with a lower ICU mortality in the 69 participating centers, after adjusting for case volume, utilization, severity of illness, type of ICU and other organizational factors. In our study, more than 25% of ICUs reported either not having a checklist for daily goals of care or not having a daily meeting between the attending intensivist and charge nurse to discuss the plan of care. This proportion may be higher in community hospitals; however, we do not have data to substantiate this statement as >92% of participating ICUs were in teaching hospitals. Improved team communication via a daily meeting or checklist is a modifiable process-driven factor that is simple, cost-effective and is associated with improved clinical outcomes (11, 26, 27).

The ratio of beds to nurses was a structure-driven factor that was associated with a lower ICU mortality in multivariable analysis. Our study is in agreement with findings of previous studies and systematic reviews, which identified that a higher number of nursing care hours or a higher relative number of nurses to patients (or beds) was related to improved clinical outcomes (1417, 28). An increase in nursing staff is costly and may be challenging for some centers, especially those with limited resources (e.g., safety net and critical access hospitals). Moreover,, intensive care nursing requires a high level of qualifications and competencies (29) and is associated with a high rate of burnout, each of which contribute to nursing shortages to adequately cover the growing demand for critical care. Thus, while nurse staffing may be important to achieve optimal clinical outcomes, it is constrained by both financial and workforce limitations.

Our study did not confirm previous findings that the presence of a 24-hour intensivist was associated with improved clinical outcomes (1113, 30). A large number of the previous studies, however, were single-center based, whereas our study summarizes information across 69 ICUs using a standardized survey. It seems likely that, since the majority of our ICUs were located in teaching hospitals with critical care trainees, this may obscure the impact of 24-hour intensivist staffing. Our findings were consistent with a recent cross-over trial of two intensivist staffing models in Manitoba which found no difference in hospital mortality with greater intensivist staffing (31) and with a recent retrospective study which found that addition of night-time intensivist coverage was not associated with a reduction in mortality in ICUs with high-intensity daytime staffing (32). A closed ICU format was also not associated with a lower annual ICU mortality, and counters previous studies (810, 33). One potential explanation for this difference is this ICU cohort was highly managed (100% of ICUs were covered by a medical director and 99% had a nurse manager) and included a large number of protocols, both likely decreasing practice variation across admitting, non-intensivist trained physicians.

Limitations of our study include a modest sample of participating ICUs in the United States, limited representation of community hospitals, use of standardized annual ICU mortality as the outcome, and voluntary participation by ICU directors. We did not collect any information in non-participating ICUs to evaluate the potential risk of a self-selection bias in our sample. Another potential shortcoming is that our findings may not be generalizable to all hospital ICUs, especially to those found in community hospitals. Our findings are based on a sample of hospitals participating in USCITTG, which is primarily composed of leading academic institutions and university hospitals from around the country. Several structure and process variables may be different in our sample of ICUs vs. those in community hospitals: such as the median number of ICU beds (84 beds), hospital locations (80% found in urban settings), a large number of available protocols (median of 19 per ICU), the ubiquitous presence of electronic patient records (90%), and a high number of median number of ICU trainees (5 trainees per ICU). Similar process and structure relationships still need to be studied in community hospitals which are markedly different in terms of staffing characteristics, protocol utilization, patient case-mix and ICU resource availability. Several of these factors may limit the generalizability of our findings. Moreover, our sample size may also affect both the effect size and significance of our findings; however, the association between improved daily team communication or bed-to-nurse ratio and annual ICU mortality were relatively robust in both single variable and multivariable analyses. While we based our analysis on reported annual ICU mortality, we believe that this reported value is quite robust as this is a common statistic measured and utilized by hospital units and it summarizes mortality using a denominator of thousands of patients seen over a one-year period. Thus, the use of annual reported ICU mortality may provide a more precise estimate of the actual mortality in any given ICU. Annual ICU mortality is a standardized metric, however, factors beyond ICU care such as hospital throughput and transfer practices can influence this metric. For example, the Critical Care Societies Collaborative has recommended that ICU mortality, even when risk-adjusted, not be used to evaluate ICU quality or performance. Instead measures such as 30-day mortality or duration on mechanical ventilation can more reliably indicate quality. There are other clinically-important endpoints such as ICU length-of-stay, ventilator-free days, case and severity adjusted cost of care that did not examine in this report but which could also be affected different structural and process of care variables. Although we had complete structure and process data for participating ICUs, we had to use multiple imputation analysis because 11 ICUs (16%) were missing average APACHE II scores. However, in sensitivity analyses, we found that the multiple imputation and case-deletion approaches yielded similar point estimates for the variables under study. We chose to report the results of multiple imputation analysis because it will result in less biased estimates under the assumption of missing at random than a case-deletion approach. The fact that APACHE II was not associated with ICU mortality in our multivariable analysis may be due to sample size, potential unmeasured confounders or lack of APACHE II calibration for contemporary ICU outcomes. It is also possible that the structural and process factors examined in this study were unaccounted in the original APACHE II derivation, and their inclusion in our study mitigated the predictive power of APACHE II. Finally, we did not collect the period of time in which APACHE II score were obtained at each center. Therefore, it is possible that variations in the data period collection may influence the average severity of illness measured across ICUs.

Our study also has significant strengths. We used a standardized questionnaire supported with a manual of operations that standardized the definitions of our structure and process variables, which were then individually checked for consistency by study staff. Second, our study directly obtained comprehensive structure and process information from multiple geographically and organizationally disparate ICUs, and it is one of the first aimed to investigate the effects of multiple process-driven factors on clinical outcomes independent of other organizational factors in the ICU and utilization such as case volume. Third, we also aimed to include a similar number of medical, surgical and mixed ICUs to capture the full spectrum of critical care services.

Increasing evidence points to the importance of organization, structure and process within an ICU in the management of critically ill patients (33, 3440). Heterogeneity in structure and process can contribute to practice variation and, in turn, affect clinical outcomes across ICUs, and it provides a unique opportunity to implement structure-and-process driven interventions to test whether clinical outcomes can be improved. Our results suggest that heterogeneity in both structure-and-process and type of ICU (medical vs. surgical vs. mixed) may play an important confounding or effect-modifying role in the interpretation of multi-center observational studies in critical care. We recommend that future observational studies that involve multiple ICUs collect both organizational structure and process data for adjustment in multivariable analyses.

In summary, we found that better daily team communication and greater nurse staffing were associated with patient-related outcomes in ICUs; these ICU structure and process factors are amenable to intervention. In particular, improvement in team communication is a low-cost process-targeted intervention that may improve clinical outcomes in ICU patients.

Supplementary Material

1

Acknowledgments

Drs. Checkley, Brown, and Sevransky received support for article research from the National Institutes of Health.

Dr. Martin’s institution received grant support from FDA, Baxter Healthcare, and Abbott. Dr. Brown’s institution received grant support from NIH (K23GM094465). Drs. Martin and Girard’s institutions received grant support from NIH. Dr. Pastores’ institution received grant support from Spectral Diagnostics (is the principal investigator at MSKCC for an ongoing Phase 3 septic shock clinical trial) and Altor Biosciences (was the principal investigator at MSKCC for a phase 2 sepsis-induced ARDS clinical trial in 2011–2012). Dr. Patil’s institution received research grant support from NIH/NIAID and from Canyon Pharmaceuticals. Dr. Sevransky’s institution received grant support from NIGMS and Abott Labs.

Dr. Martin has board membership with Cumberland Pharmaceuticals and Pulsion Medical Systems (no money paid). Dr. O'Brien serves as Chairman of Board of Sepsis Alliance and is the vice-chair of Quality Improvement Committee of ACCP (neither provide any financial reimbursement).

Dr. Martin consulted for AstraZeneca and Agennix. Dr. Rice consulted for GlaxoSmithSkline, LLC and Asiva Pharma, LLC. Dr. Johnson consulted for Becton-Dickenson and Medimmune.

Dr. Girard lectured for Hospira (honoraria for non-promotional 78 presentation). Dr. Pastores lectured for the American Physician Institute and the International Multiprofessional critical care review course (Korea and Saudi Arabia). Dr. Pastores spoke at the Medical Grand Rounds Conferences for New York Downtown Hospital, Coney Island Hospital, and Pinnacle Healthcare System.

Dr. Girard received support for travel from Hospira. Dr. Patil received support for travel from the FTCTS-Care Foundation.

Dr. Johnson is employed by the American College of Surgeons and Banner Health. Dr. Patil has stock options with Microsoft, GE, Intel, Walmart, and Bank of America.

Sources of funding: William Checkley was supported by a Pathway to Independence Award (R00 HL096955) from the National Heart, Lung and Blood Institute, National Institutes of Health. Jonathan E Sevransky was supported in part by K23 GM071399. Greg S. Martin was supported in part by R01 FD003440,P50 AA013757 and UL1 TR000454.

USIITG-CIOS investigators

ARIZONA: University of Arizona Medical Center, Tucson, AZ, Terence O’Keeffe (PI), Coy Collins; Laurel Rokowski; CALIFORNIA: LA County-University of South California Hospital, Los Angeles, CA, Janice Liebler (PI), Ali Ahoui, Anahita Nersiseyan, Usman Shah, Hidenobu Shigemitsu, Nanditha Thaiyananthan; Stanford University Medical Center, Stanford, CA, Joe Hsu (PI), Lawrence Ho; VA Palo Alto Health Care System, Juliana Barr (PI); CONNECTICUT: Bridgeport Hospital, Bridgeport, CT; David Kaufman (PI) Yale University Hospital, New Haven, CT, Jonathan M. Siner (PI), Mark D. Siegel; GEORGIA: Emory University Hospital, Atlanta, GA, Greg S. Martin (PI), Craig Coopersmith, Micah Fisher,David Gutteridge, Mona Brown, SangLee, Apryl Smith; Emory University Midtown Hospital, Atlanta, GA, Greg S. Martin (PI), Kenneth Leeper, Mona Brown; Grady Memorial Hospital, Atlanta, GA ,Greg S. Martin (PI), Sushma Cribbs, Annette Esper, Mona Brown, David Gutteridge ;Emory University Hospital, Atlanta, GA, Greg S. Martin (PI), Craig Coopersmith, Sushma, Cribbs, Annette Esper, Micah Fisher ,David Gutteridge, Olufunmilayo Dosunmu; KANSAS: VA Medical Ctr., Wichita, Ka, Zubair Hassan(PI) Co-PI: Jing Liu Bart Ridder; ILLINOIS: Northwest Community Hospital, Arlington Heights, IL,Melanie Atkinson (PI), Aimee Draftz, Jackie Durgin, Yelena Rikhman, Jessica Scheckel, Mary Walthers; Saint Francis Hospital, Evanston, IL, Gerald Luger (PI), Carol Downer; University of Illinois Medical Center, Chicago, IL, Ruxana T. Sadikot (PI), Kamran Javaid, Daniel Rodgers, Vibhu Sharma; MARYLAND: Johns Hopkins University, Baltimore, MD, Jon Sevransky (PI), William Checkley, Romer Geocadin, David Murphy, Dale Needham, Adam Sapirstein, Steven Schwartz, Glenn Whitman, Brad Winters, Addisu Workneh, Sammy Zakaria; St. Agnes Hospital, Baltimore, MD, Anthony Martinez (PI), Fran Keith; University of Maryland Medical Center, Baltimore, MD, Steven Johnson (PI), Dan Herr, Giora Netzer Carl Shanholtz, Arabela Sampaio, JenniferTitus; NIH Clinical Center, Bethesda, MD; Michael Eberlein Suburban Hospital Bethesda, Bethesda, MD, Leo Rotello (PI), Jennifer Anderson; MASSACHUSETTS: Beth Israel Deaconess Medical Center, Boston, MA, Sajid Shahul (PI), Valerie Banner-Goodspeed, Michael Howell, Sabina Hunziker, VictoriaNielsen, Jennifer Stevens, Daniel Talmor; Brigham and Women’s Hospital, Boston, MA, Namrata Patil (PI), LisaChin, Michael Myers, Stanthia Ryan; MICHIGAN: St Joseph Mercy Health System, Ann Arbor Michigan Joseph Bander, (PI) University of Michigan Health Systems, Ann Arbor, MI, Pauline Park (PI), James Blum, VivekArora, Kristin Brierley, Jessica DeVito, Julie Harris, Elizabeth Jewell, Deborah Rohner; Kathleen To; MINNESOTA: Mayo Clinic Rochester, Rochester, MN, Brian W. Pickering (PI), Jyothsna Giru, Rahul Kashyap, Naman Trivedi; Mayo Clinic Rochester; MISSOURI: University ofMissouri-Columbia Hospital, Columbia, Missouri; KansasCity VA Hospital, Kansas City, MO, Timothy Dwyer (PI),Kyle Brownback; NEW JERSEY: University of Medicine and Dentistry of New Jersey, Newark, NJ, Steven Chang(PI), Zaza Cohen, Frank Italiano, Zeeshan Kahn, Amee Patrawalla; NEW MEXICO: Presbyterian Healthcare Services, Albequerque, NM, Denise Gonzales (PI), Paul Campbell; NEW YORK: Columbia University Medical Center, New York, NY, David Chong (PI), Matthew Baldwin ,Luke Benvenuto, Natalie Yip; Memorial Sloan Kettering Cancer Center, New York, NY; Steven M Pastores, University of Rochester Medical Center, Rochester, NY, Anthony Pietropaoli(PI), Kathleen Falkner, Timothy Bouck, Ann Marie Mattingly; NORTH CAROLINA: Wake Forest University Health Science, Durham, NC, Peter E. Morris (PI), Lori S. Flores; East Carolina University, Greenville, NC, Abid Butt (PI) , Mark Mazer, Kelly Jernigan; Cone Health, Greensboro,NC, Patrick Wright (PI), Sarah Groce, Jeanette McLean, Arshena Overton; OHIO: Cleveland Clinic, Cleveland, OH, Jorge A. Guzman (PI), Mohammed Abou El Fadl,Tonya Frederick, Gustavo-Cumbo-Nacheli, John Komara; The Ohio State Wexner University Medical Center, Columbus, OH, James M. O’Brien (PI), Naeem Ali, Matthew Exline; PENNSYLVANIA: Eastern Regional Medical Center Cancer Treatment Centers of America, Philadelphia, PA, Jeffrey Hoag (PI), Daniela Albu, Pat McLaughlin; Hahnemann University Hospital, Philadelphia, PA Jeffrey Hoag (PI); Emil Abramian, John Zeibeq.; Hospital of the University of Pennsylvania, Philadelphia, PA, Meeta Prasad (PI), Scott Zuick; TENNESSEE: Meharry Medical College Hospital, Nashville, TN, Richard D. Fremont (PI), Chinenye O. Emuwa , Victor C. Nwazue, Olufemi S. Owolabi; Vanderbilt University Medical Center, Nashville, TN, Bryan Cotton (PI), George Hart, Judy Jenkins; Vanderbilt University Medical Center, Nashville, TN, Todd W. Rice (PI), Timothy D. Girard, Margaret Hays, Susan Mogan; TEXAS: University of Texas-Houston Medical Center, Houston, TX; Imo P. Aisiku (PI) UTAH: Intermountain Medical Center, Murray, Utah, Samuel Brown (PI), Colin Grissom, Russ Miller III, Anita Austin, Heather Gallo, Naresh Kumar, David Murphy; VIRGINIA: Inova Health Systems, Falls Church, VA, Maryann Putman (PI), Joanne Ondrush.

Footnotes

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Disclosures:

The remaining authors have disclosed that they do not have any potential conflicts of interest.

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