Clinical informatics case study. Computerized protocols for ventilator management in ARDS patients. Case study.

The implementation of the computerized protocol for mechanical ventilation management should be considered successful. Of the 11 sites, only 4 encountered major difficulties. One site could be considered an implementation failure. At this site the protocol software, which was loaded onto the existing computerized patient documentation system, did not initially function smoothly and it severely affected the trust at the clinical site. At the other three sites system usage was minimal due to time requirements of the study rather than a failure to accept the decision support system. Implementation methods suggested by authors such as Whitten and Bentley were found to be successful. Methods of particular use included obtaining buy-in of key personnel, contacting and working with IS personnel early in the project, providing adequate training and reference materials for clinical and support personnel, and providing extra training for some users, thereby creating a "super-user" role. Finally, factors for success of a clinical trial to evaluate a decision support system are slightly different from those for successful use of the system. Time necessary for research functions such as patient screening and recruitment must be considered at the outset and planned for accordingly.

Efficacy of computerized decision support for mechanical ventilation: results of a prospective multi-center randomized trial.

200 adult respiratory distress syndrome patients were included in a prospective multicenter randomized trial to determine the efficacy of computerized decision support. The study was done in 10 medical centers across the United States. There was no significant difference in survival between the two treatment groups (mean 2 = 0.49 p = 0.49) or in ICU length of stay between the two treatment groups when controlling for survival (F(1df) = 0.88, p = 0.37.) There was a significant reduction in morbidity as measured by multi-organ dysfunction score in the protocol group (F(1df) = 4.1, p = 0.04) as well as significantly lower incidence and severity of overdistension lung injury (F(1df) = 45.2, p < 0.001). We rejected the null hypothesis. Efficacy was best for the protocol group. Protocols were used for 32,055 hours (15 staff person years, 3.7 patient years or 1335 patient days). Protocols were active 96% of the time. 38,546 instructions were generated. 94% were followed. This study indicates that care using a computerized decision support system for ventilator management can be effectively transferred to many different clinical settings and significantly improve patient morbidity.

Automated key process monitors for patient care documentation.

Complete, accurate and timely patient care documentation is an essential part of the practice of medicine. As with any other process in medicine or industry, continuous quality improvement (CQI) is essential to assure the highest quality at the lowest cost. CQI requires objective key process measures that can be assessed routinely. A set of key process monitors designed to assess completeness, accuracy and timeliness were created based on local, regional and national standards. Feasibility was assessed in the LDS Hospital Emergency Department using 31,429 patient visits in the 18 months from June 1995 to November 1996. The logic of the score was programmed into SQL scripts and run against an Oracle database containing the patient care documentation. The results indicate that the chosen key process monitors can be used to provide real time assessment of the patient care documentation process. The general concepts of the key process measures of completeness, accuracy and timeliness are generalizable to many areas of medicine. The overall score provides one method of easily tracking departmental performance while the overall process monitoring database allows powerful, in-depth analysis of individual components of the process. It is recommended that such automated process monitoring tools be integrated into future clinical information systems.

Prototype expert system to assist with the stabilization of neonates prior to transport.

The transport of sick or premature newborns from community hospitals to acute care facilities is often necessary for the infants to receive the level of care required. Prior stabilization of these infants is imperative to a successful transport. The knowledge required to treat and stabilize sick and premature newborns is specialized and may not be available in community hospitals. "The S.T.A.B.L.E. Assistant" is a prototype rule based decision support system based on the educational program "Transporting Newborns the S.T.A.B.L.E. Way". "The S.T.A.B.L.E. Assistant" accepts clinical information related to an infant's breathing status, blood glucose status and selected lab values and provides instructions as to what interventions are needed to stabilize and prepare the infant for transport. The computerized program was evaluated using data collected from 19 charts of newborns requiring transport from a community hospital to a tertiary care center. Patient data were entered into the computerized program and the subsequent instructions were reviewed by a group of neonatology and neonatal transport experts. Reviewers evaluated "The S.T.A.B.L.E. Assistant" for the safety of the program, the extent to which the computerized program follows the educational program guidelines and the degree to which the instructions generated are within the scope of community caregivers' practice. Results were positive, indicating "The S.T.A.B.L.E. Assistant" prototype is safe, and within the guidelines of neonatal clinical practice.

Testing and validation of computerized decision support systems.

Systematic, through testing of decision support systems (DSSs) prior to release to general users is a critical aspect of high quality software design. Omission of this step may lead to the dangerous, and potentially fatal, condition of relying on a system with outputs of uncertain quality. Thorough testing requires a great deal of effort and is a difficult job because tools necessary to facilitate testing are not well developed. Testing is a job ill-suited to humans because it requires tireless attention to a large number of details. For these reasons, the majority of DSSs available are probably not well tested prior to release. We have successfully implemented a software design and testing plan which has helped us meet our goal of continuously improving the quality of our DSS software prior to release. While requiring large amounts of effort, we feel that the process of documenting and standardizing our testing methods are important steps toward meeting recognized national and international quality standards. Our testing methodology includes both functional and structural testing and requires input from all levels of development. Our system does not focus solely on meeting design requirements but also addresses the robustness of the system and the completeness of testing.