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Academia and the Profession |

Developing and Implementing Computerized Protocols for Standardization of Clinical Decisions

Alan H. Morris, MD
[+] Article and Author Information

From LDS Hospital and University of Utah School of Medicine, Salt Lake City, Utah.


Acknowledgments: The author thanks the medical, nursing, and respiratory therapy staffs of the Intermountain Respiratory Intensive Care Unit and the Shock-Trauma/Intermountain Respiratory Intensive Care Unit and the Respiratory Care Department of LDS Hospital for collaboration during the past 25 years. He recognizes the contributions of Drs. James Orme Jr., Terry Clemmer, Lin Weaver, Frank Thomas, Tom East, Jane Wallace, George Thomsen, James Pearl, Nat Dean, and Brad Rasmusson for collaboration in protocol development and implementation. He thanks Drs. Robert Crapo and C. Gregory Elliott for critically reviewing the manuscript and Drs. Roberta Goldring, Robert Rogers, and Waldemar Johanson who, through their vision and insight 14 years ago, enabled this decision-support effort.

Grant Support: By the National Institutes of Health (RO1-HL-36787, NO1-HR-46062), the Agency for Healthcare Research and Quality (HS 06594), the Deseret Foundation, the Respiratory Distress Syndrome Foundation, LDS Hospital, and IHC, Inc.

Requests for Single Reprints: Alan H. Morris, MD, Pulmonary Division, LDS Hospital, Eighth Avenue and C Street, Salt Lake City, UT 84143; e-mail, ldamorri@ihc.com

Requests To Purchase Bulk Reprints (minimum, 100 copies): Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.


Ann Intern Med. 2000;132(5):373-383. doi:10.7326/0003-4819-132-5-200003070-00007
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Humans have only a limited ability to incorporate information in decision making. In certain situations, the mismatch between this limitation and the availability of extensive information contributes to the varying performance and high error rate of clinical decision makers. Variation in clinical practice is due in part to clinicians' poor compliance with guidelines and recommended therapies. The use of decision-support tools is a response to both the information revolution and poor compliance. Computerized protocols used to deliver decision support can be configured to contain much more detail than textual guidelines or paper-based flow diagrams. Such protocols can generate patient-specific instructions for therapy that can be carried out with little interclinician variability; however, clinicians must be willing to modify personal styles of clinical management. Protocols need not be perfect. Several defensible and reasonable approaches are available for clinical problems. However, one of these reasonable approaches must be chosen and incorporated into the protocol to promote consistent clinical decisions. This reasoning is the basis of an explicit method of decision support that allows the rigorous evaluation of interventions, including use of the protocols themselves. Computerized protocols for mechanical ventilation and management of intravenous fluid and hemodynamic factors in patients with the acute respiratory distress syndrome provide case studies for this discussion.

Figures

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Figure 1.
Bedside scene at LDS Hospital with a terminal of the HELP (Health Evaluation through Logical Processing) hospital-wide electronic patient data management system(81-84).

Information is exchanged with the bedside nurse through the computer terminal. All nine intravenous pumps and the monitor above the bed are directly wired to the HELP system's integrated patient database. Data on such factors as intravenous flow, intravenous drug administration, and physiologic monitoring are automatically sampled. Other data are entered through the computer keyboard. Protocol instructions are displayed on the computer screen.

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Figure 2.
Bedside scene at an external hospital with a stand-alone personal computer system.

The LDS Hospital HELP (Health Evaluation through Logical Processing) ventilation protocols for patients with the acute respiratory distress syndrome were exported to this system, which is not directly connected to a hospital or intensive care unit database. All data are entered through the computer keyboard. Protocol instructions are displayed on the computer screen.

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Figure 3.
Selected page from a protocol for management of intravenous fluid and hemodynamic factors in patients in the intensive care unit.

The protocol, which is more than 50 pages long, is currently being tested and refined. The numbers at the top of each logical element serve to identify the element. The round-cornered rectangles are subroutines (lower-level protocols). Levophed (norepinephrine bitartrate) is manufactured by Abbott Laboratories, North Chicago, Illinois. av = average; BP = blood pressure; HR = heart rate; Rx = drug; Var = variable.

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Figure 4.
Specific use of terms in protocols.high

The judgmental term in the left panel has been made explicit by the thresholds in the middle panel (200 mm Hg and 90 mm Hg). The use of inexplicit terms makes protocol application variable because clinician judgment at the bedside must make up for the lack of specificity. The middle panel shows the specific thresholds for defining “high BP” and requires both systolic and diastolic hypertension for a “Yes” response. There are only two outputs. The more detailed, right panel shows the specific thresholds for defining “high BP” independently by using systolic hypertension or diastolic hypertension. Different therapeutic responses will follow systolic hypertension (“Store Syst Instruction”) and diastolic hypertension (“Store Diast Instruction”). There are four outputs (no hypertension; diastolic hypertension; systolic hypertension; diastolic and systolic hypertension). BP = blood pressure (mm Hg); Diast = diastolic; Syst = systolic.

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Figure 5.
Protocol refinement through an iterative review process. Top.Bottom.

Before a robust protocol can routinely be used in clinical practice, four major levels of development take place: 1) consensus generation of a paper-based flow diagram, 2) prospective bedside testing of sections or of the entire paper-based flow diagram, 3) computerization of the paper-based flow diagram logic, and 4) validation and refinement of the computerized protocol. At levels 2, 3, and 4, problems must be identified. Specific reasons for the problems, including clinician refusal to follow protocol instructions (“Decline Instruction”), must be captured and fed back to the consensus committee. If the specific reason for refusal to follow protocol instructions is not captured, an opportunity to refine the protocol is lost.

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Figure 6.
An unsatisfactory logical element for assessing deterioration in oxygenation of a patient with the acute respiratory distress syndrome.2CO2O22o22210

The element (a question, indicated by the diamond shape) was taken from one of the first handwritten versions of our mechanical ventilation oxygenation protocols, which dates from 1985. C(a − [OV0456])o = (arterial − mixed venous) oxygen content difference; lactate = serum lactate concentration; Pa = arterial carbon dioxide partial pressure; Pa = arterial oxygen partial pressure; pHa = arterial pH; P[OV0456]o = mixed venous oxygen partial pressure; [OV0422]t = cardiac output; Sa = arterial oxygen saturation; S[OV0456]o = mixed venous oxygen saturation; [OV0312]o = oxygen consumption. There are 10 input variables within the unsatisfactory logical element. Each variable has 2 outcomes (yes or no). Thus, there are a total of 2 outcome combinations, only 2 of which are reflected by the “Yes” and “No” of the unsatisfactory logical element.

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