Care Bundles in the ICU
By James E. McFeely, MD, Medical Director Critical Care Units, Alta Bates Summit Medical Center, Berkeley, CA, is Associate Editor for Critical Care Alert.
Dr. McFeely reports no financial relationship to this field of study.
The Institute of Medicine has documented that the hospital—and the ICU in particular—is an environment in which errors are all too frequent.1,2 The work environment in the ICU can be chaotic, and we are all familiar with the many distractions that are present as we attempt to write orders to implement a plan of care for any particular patient. Monitors alarm, pagers go off, and other caregivers frequently interrupt your train of thought with questions that may or may not be related to the patient on whom you are trying to focus. These variables, as well as the simple fact of human fallibility, result in decreased reliability and chaotic decision-making in the ICU.
All intensivists like to think that they do well at implementing what they consider to be the best practice for their patients. Despite our best efforts, however, it is well documented that we fail to do so on a daily basis. The literature is replete with examples such as the failure of best institutions to implement low-tidal-volume ventilation in patients with the acute respiratory distress syndrome (ARDS) up to 30-40% of the time,3 or the well-documented failure rate for implementation of management guidelines for treatment of congestive heart failure.4 In a prospective study of implementation of a bundle for management of sepsis, there was only a 52% compliance with all elements, even in a research setting.5
It is not that physicians think these interventions are inappropriate for any given number of patients; rather, the high failure rates reflect the unreliability of the systems currently in place for implementation. Indeed, in this respect every institution has room for improvement.6 Those institutions that think they have 100% compliance with any given care plan would be advised to measure their compliance. In almost all cases you’ll find yourself falling short of the mark unless you have a multifaceted systematic approach to optimize implementation.
It is well known from the manufacturing industry that scripting work processes stabilizes the system and improves both reliability and reproducibility. In health care, use of care bundles performs a similar function. Bundles are combinations of several interventions that are scientifically demonstrated to improve outcomes in a given disease state. When executed as a group the interventions produce better outcomes than when implemented individually or on an ad hoc basis. In sepsis, for example, implementation of a bundle for the first 6 hours of care resulted in a reduction in mortality from 49% of 23%.5 The various elements of any given bundle derive from evidence-based medicine, and are included only if they are generally accepted as best practice for a given disease state. When properly implemented, bundles take advantage of the best advancements in medicine as well as in organizational science.
Arguments against the use of bundles focus on the fact that unlike manufacturing processes, which can be readily standardized, treating human illness requires integration of unique data sets for each patient. Indeed, some argue that the use of bundles of care or order sets can result in "cookbook" medicine and might inhibit the individualization of care that may be appropriate in a particular case. Further, the typical intensivist is not the sort that likes to be constrained by fixed order sets.
On the other hand, while it is certainly true that diseases do not necessarily follow the same path in every given patient, for many illnesses—such as sepsis, ventilator-associated pneumonia, and acute myocardial infarction—there are elements of care that can generally be agreed upon as appropriate for almost all patients. The idea, therefore, is not to replace physician expertise with fixed instructions, but to use standardized protocols or bundles as ever-present prompts for each supported intervention in order to minimize human error. By combining the use of bundles of care with the individual expertise of an experienced clinician, you can improve patient care by using the strengths of both. Those institutions that have the best outcomes tend to be the ones using care bundles to optimize their implementation.
In developing and implementing care bundles, only well-accepted, validated interventions should be included. As a rule of thumb, if you can’t cite "the reference"—for example, "Rivers’s Early Goal Directed Therapy,"7 or the "ARDSNet Ventilation Strategy"8—it doesn’t belong in the bundle. A care bundle is no place for the latest fad that’s unsupported by the medical literature. Bundles are best kept succinct with clearly defined elements that can be understood by all members of the care team. Moreover, recognizing that diseases do not necessarily follow the same path in every patient, the same level of vigilance needs to remain once bundles are implemented, to be sure that they are appropriately used as part of any given patient’s care plan.
Implementation of bundles is a multi-step process:9
- Obtain agreement on what should be included in a given bundle as supported by the medical literature.
- Measure current performance with each element of the bundle in your institution.
- Collaboratively develop implementation tools (eg, order sets; checklists) that are appropriate for each hospital’s practice environment and obtain buy-in from all relevant stakeholders.
- Begin to use the tools that have been developed and adjust as necessary in the real world environment.
- Reassess performance in all measured indicators and adjust appropriately.
Simpler implementation tools are better. Order sets that are too long or present too many choices are unwieldy, increase the risk of error, and decrease the reliability of the end product. Time spent keeping the protocol brief and clear is time well spent.
There are several currently recommended bundles appropriate to the ICU that have been promoted by various societies. In the attached tables you’ll see bundles for treatment of sepsis, prevention of ventilator-associated pneumonia, management of acute myocardial infarction, and management of acute congestive heart failure. These are all well established with excellent support in the medical literature and would be excellent choices to begin improving the reliability of care within your ICU.
- Institute of Medicine. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, Eds. Washington, DC: National Academic Press; 2000.
- Leape LL, Berwick DM. Five years after To Err Is Human: what have we learned? JAMA. 2005;293:2384-2390.
- Brower RG, et al. Clinical Trial of mechanical Ventilation with Traditional Versus Lower Tidal Volumes in Acute Lung Injury and Acute Respiratory Distress Syndrome: Effects on Physician Practices. Am J Respir Crit Care Med. 2004;169:A256.
- Fonarow GC, et al. Adherence to heart failure quality-of-care indicators in US hospitals: analysis of the ADHERE Registry. Arch Intern Med. 2005;165:1469-1477.
- Gao F, et al. The impact of compliance with 6-hour and 24-hour sepsis bundles on hospital mortality in patients with severe sepsis: a prospective observational study. Crit Care. 2005;9:R764-R770.
- Reason J. Human error: models and management. BMJ. 2000;320:768-770.
- Rivers E, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345:1368-1377.
- [No authors listed]. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000;342:1301-1308.
- Clemmer TP, Spuhler VJ. Developing and gaining acceptance for patient care protocols. New Horiz. 1998;6:12-19.
- Resar R, et al. Using a bundle approach to improve ventilator care processes and reduce ventilator-associated pneumonia. Jt Comm J Qual Patient Saf. 2005;31:243-248.
- Dellinger RP, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med. 2004;30:536-555.
- van den Berghe G, et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001;345:1359-1367.
- Antman EM, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004;44:E1-E211.
- Hunt SA, et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult-Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): Developed in Collaboration With the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: Endorsed by the Heart Rhythm Society. Circulation. 2005;112:1825-1852.
- Nohria A, et al. Evaluation and monitoring of patients with acute heart failure syndromes. Am J Cardiol. 2005;96(6A):32G-40G.
- Solomon SD, et al. Effect of candesartan on cause-specific mortality in heart failure patients: the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM) program. Circulation. 2004;110:2180-2183.