Skip to main content

Protocol-driven care in the intensive care unit: a tool for quality


Advances in organization and patient management in the intensive care unit (ICU) have led to reductions in the morbidity and mortality suffered by critically ill patients. Two such advances include multidisciplinary teams (MDTs) and the development of clinical protocols. The use of protocols and MDTs does not necessarily guarantee instant improvement in the quality of care, but it does offer useful tools for the pursuit of such objectives. As ICU physicians increasingly assume leadership roles in the pursuit of higher quality ICU care, their knowledge and skills in the discipline of quality improvement will become essential.


Advances in patient management in the ICU have led to reductions in the morbidity and mortality suffered by critically ill patients [1]. As with medicine in general, continued improvements in ICU patient outcomes require the development of a health care system that is effective, efficient, safe, patient-centered, timely, and equitable [2]. Achieving such a system in the ICU will require constant vigilance in order to minimize potentially harmful variations in care. One approach has been the development of protocols. However, there has been criticism that protocols might replace clinical judgment. Papers such as that by Chan et al., published in this issue of Critical Care (page 349), show that protocols are a useful tool in the provider's armamentarium if they are implemented with an understanding of the basic theories necessary for improving the quality of ICU care [3].

Evidence supports intensive care unit protocols

Many randomized controlled trials have demonstrated improved outcomes when protocols are implemented into critical care decision-making. Noteworthy areas include anemia management [4,5], sedation and analgesia [6,7], ventilator weaning [8,9], and the use of low tidal volume ventilation in acute lung injury/acute respiratory distress syndrome [10].

Many physicians have been and remain wary of 'cookbook medicine', however. Critics of clinical protocols worry that these decisional aids may reduce the quality of care by supplanting clinical judgment, breeding complacency, or stifling learning. These concerns cannot be ignored. In a highly technological era, when physician bedside skills have arguably reached a nadir, critics argue that we may be further jeopardizing the decision-making skills of our profession.

Master physicians already make clinical decisions using personalized algorithms, which were learned early in their careers and then refined through clinical experience and lifelong learning. Hence, many seasoned physicians view protocols as unnecessary. Despite these beliefs studies continue to demonstrate that ventilator weaning and extubation protocols can decrease potentially harmful variations in care, enhance efficiency, and improve outcomes [1,11].

Extubation protocols: a multidisciplinary approach

Considerable interest and time has been devoted to the study of extubation protocols [12,13]. In the present issue of Critical Care, Chan et al. [3] describe their experiences with developing and implementing an extubation protocol, illustrating the successes of using a MDT for this task. Their analysis consisted of 47 consecutive patients extubated according to their new protocol, and outcomes were compared with those of historical control individuals. The primary outcome (staff satisfaction and acceptance during the protocol development and implementation phases) was reported as favorable and positive. Unfortunately, that study neither describes how these satisfaction data were measured nor how the validity of such results was established. Secondary outcomes (mechanical ventilator days [mean 6.7 days], duration of ICU stay [mean 9.3 days], and reintubation rate [10.6%]) were similar to those in the historical control cohort. The study's small sample size limited its ability to show a difference in outcomes. In addition, the initiation of spontaneous breathing trials required a physician order, a step that promotes inefficiency and prolongs ventilator times [8].

That study raised several interesting issues. First, the results suggested that protocol ownership can be fostered through involvement of a MDT early in the development phase. In particular, Chan et al. commented on the staff's perception of increased autonomy and desire to assist with protocol compliance. This suggests an area for future study, namely whether protocols developed by a MDT have higher rates of staff adherence than those developed by a small group of researchers [14,15]. Second, the MDT rapidly developed and implemented their protocol. This was an important achievement, because efforts at clinical improvement need to be efficient and effective. The high attendance at team meetings suggests that MDT members were highly motivated, a feature that may affect reproducibility at other sites.

Quality improvement in the intensive care unit

Perhaps one of the most provocative comments made by Chan et al. [3] is found in the abstract of their report: "... research evidence does not necessarily provide guidance on how to implement changes in individual intensive care units." Indeed, physicians want to improve their delivery of care, but often lack an understanding of the basic theories that are necessary for their quality improvement efforts. This knowledge deficit has been termed 'change-process illiteracy' [16]. Although most ICU physicians have a sophisticated understanding of pathophysiology and pharmacokinetics, few clinicians or researchers possess formalized training in systems thinking, the process of quality improvement, concepts regarding changing physician behavior and practice, or outcomes measurement [16,17,18,19,20].

A well designed ICU protocol does not constrain decision-making, but rather focuses a provider's attention on the common aspects of patients with a well described illness. Protocol-driven care does not eliminate the need for clinical judgment. In fact, it demands constant attention to the subtleties inherent to each patient and may require deviations from the protocols. Protocol-driven care does not obviate the need for lifelong learning. On the contrary, it requires continual appraisal of evidence from the published literature so that protocols may be modified when new strategies of care have been demonstrated as effective and efficient. The continual improvement in ICU care requires valid and reliable metrics to document and monitor expected and unexpected outcomes of protocol implementation.


The modern ICU is an important focus for quality improvement efforts. The combination of enormous costs and inherently high morbidity will ensure constant attention from hospital administrators, third party payers, and patient representatives. The use of protocols and MDTs does not guarantee instant improvement in the quality of care. However, it does offer tools for the pursuit of this objective if it is implemented and applied with clinical acumen, with attention to individual subtleties, and with an understanding of the basic theories of quality improvement. As ICU physicians increasingly assume leadership roles in the pursuit of higher quality ICU care, their 'change-process literacy' will become essential.



ICU = intensive care unit


MDT = multidisciplinary team.


  1. Holcolm BW, Wheeler AP, Ely EW: New ways to improve unnecessary variation and improve outcomes in the intensive care unit. Curr Opin Crit Care 2001, 7: 304-311. 10.1097/00075198-200108000-00015

    Article  Google Scholar 

  2. Kohn LT, Corrigan JM, Donaldson MS: To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999.

    Google Scholar 

  3. Chan PKO, Fischer S, Stewart TE, Hallett DC, Hynes-Gay P, Lapinsky SE, MacDonald R, Mehta S: Practising evidence-based medicine: the design and implementation of a multidisciplinary team-driven extubation protocol. Crit Care 2001, 5: 349-354. 10.1186/cc1068

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  4. Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E: A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999, 340: 409-417. 10.1056/NEJM199902113400601

    Article  CAS  PubMed  Google Scholar 

  5. Corwin HL, Gettinger A, Rodriguez RM, Pearl RG, Gubler KD, Enny C, Colton T, Corwin MJ: Efficacy of recombinant human erythropoietin in the critically ill patient: a randomized, double-blind, placebo-controlled trial. Crit Care Med 1999, 27: 2346-2350. 10.1097/00003246-199911000-00004

    Article  CAS  PubMed  Google Scholar 

  6. Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH: Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med 1999, 27: 2609-2615. 10.1097/00003246-199912000-00001

    Article  CAS  PubMed  Google Scholar 

  7. Kress JP, Pohlman AS, O'Connor MF, Hall JB: Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med 2000, 342: 1471-1477. 10.1056/NEJM200005183422002

    Article  CAS  PubMed  Google Scholar 

  8. Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF: Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med 1996, 335: 1864-1869. 10.1056/NEJM199612193352502

    Article  CAS  PubMed  Google Scholar 

  9. Kollef MH, Shapiro SD, Silver P, St John RE, Prentice D, Sauer S, Ahrens TS, Shannon W, Baker-Clinkscale D: A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Crit Care Med 1997, 25: 567-574. 10.1097/00003246-199704000-00004

    Article  CAS  PubMed  Google Scholar 

  10. The Acute Respiratory Distress Syndrome Network: Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000, 342: 1301-1308. 10.1056/NEJM200005043421801

    Article  Google Scholar 

  11. Ely EW, Meade MO, Haponik EF, Kollef MH, Cook DJ, Guyatt GH, Stoller JK: Mechanical ventilator weaning protocols driven by non-physician helath care professionals: clinical practice guidelines of the ACCP, SCCM, and AARC. Chest 2001, in press.

    Google Scholar 

  12. Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS: Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med 1997, 156: 459-465.

    Article  CAS  PubMed  Google Scholar 

  13. Epstein SK, Ciubotaru RL: Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care 1998, 158: 489-493.

    Article  CAS  Google Scholar 

  14. Kollef MH, Shapiro SD, Clinkscale D, Cracchiolo L, Clayton D, Wilner R, Hossin L: The effect of respiratory therapist-initiated treatment protocols on patient outcomes and resource utilization. Chest 2000, 117: 467-475. 10.1378/chest.117.2.467

    Article  CAS  PubMed  Google Scholar 

  15. Stoller JK, Mascha EJ, Kester L, Haney D: Randomized controlled trial of physician-directed versus respiratory therapy consult service-directed respiratory care to adult non-ICU inpatients. Am J Respir Crit Care Med 1998, 158: 1068-1075.

    Article  CAS  PubMed  Google Scholar 

  16. Nelson EC, Batalden PB, Ryer JC: Clinical Improvement Action Guide. Oakbrook Terrace, Illinois: Joint Commission; 1998.

    Google Scholar 

  17. Berwick DM: Developing and testing changes in delivery of care. Ann Intern Med 1998, 128: 651-656.

    Article  CAS  PubMed  Google Scholar 

  18. Reinertsen JL: Physicians as leaders in the improvement of health care systems. Ann Intern Med 1998, 128: 833-888.

    Article  CAS  PubMed  Google Scholar 

  19. Joint Commission: Pocket Guide to Using Performance Improvement Tools. Oakbrook Terrace, Illinois: Joint Commission; 1996.

    Google Scholar 

  20. Langley GJ, Nolan KM, Nolan TW, Provost LP, Norman CL: The Improvement Guide: a Practical Approach to Enhancing Organizational Performance. San Francisco: Jossey-Bass; 1996.

    Google Scholar 

Download references


The authors would like to acknowledge their affilitations with the following organizations: RJW is affiliated with the VA National Quality Scholars Program; RSD with the VA National Quality Scholars Program and the Geriatric Research Education and Clinical Center, VA Tennessee Valley Healthcare System; and EWE with the Geriatric Research Education and Clinical Center, VA Tenessee Valley Healthcare System, Nashville, TN, USA.

Author information

Authors and Affiliations


Corresponding author

Correspondence to E Wesley Ely.

Additional information

Competing interests

None declared.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Wall, R.J., Dittus, R.S. & Ely, E.W. Protocol-driven care in the intensive care unit: a tool for quality. Crit Care 5, 283 (2001).

Download citation

  • Published:

  • DOI:


  • clinical protocols
  • critical care
  • mechanical ventilation
  • multidisciplinary team
  • quality of health care