Background: Errors involving medication use are common. Computerized physician order entry (CPOE) can improve prescribing practices. Few studies have examined the effect of CPOE in combination with decision support tools on prescribing practices in the outpatient setting. Less is known about prescribers' adherence to laboratory monitoring recommendations.
Objective: To evaluate if reminders presented during CPOE for medications would increase physicians' compliance with guidelines for laboratory monitoring at initiation of therapy.
Study Design: Randomized prospective intervention study.
Methods: Two hundred seven primary care physicians in a group-model managed care organization were randomized to receive or not receive drug laboratory monitoring alerts within the CPOE system. Adherence to laboratory monitoring recommendations for patients prescribed selected medications was compared between physician groups.
Results: There was no significant difference between the control and intervention group physicians in the overall rate of compliance with ordering the recommended laboratory monitoring for patients prescribed study medications. Laboratory monitoring was performed as recommended 56.6% of the time in the intervention group compared with 57.1% of the time in the control group (P = .31). In cases in which a statistically significant difference was demonstrated, improved compliance favored the intervention group (eg, 71.2% vs 62.3% [P = .003] for gemfibrozil and 75.7% vs 73.9% [P = .05] for statins).
Conclusions: As CPOE becomes more prevalent, additional research is needed to determine effective decision support tools. These findings then should be communicated to the developers and users of computerized medical record systems.
(Am J Manag Care. 2006;12:389-395)
The Institute of Medicine report To Err Is Human: Building a Safer Health System identified the prevention of medication errors as one of the priority areas for transforming healthcare.1 The Institute of Medicine also stated that increasing the use of information technology is a priority to reduce the error rate during the delivery of healthcare.2 Errors in medication use are one of the most common types of medical errors.3-9 In the Harvard Medical Practice Study II,7 adverse drug events accounted for 19% of injuries in hospitalized patients. Medication use in the ambulatory care setting carries similar risks.10-15 For example, Gandhi et al11 found that 25% of ambulatory patients experienced adverse drug events. Furthermore, published research suggests that 25% to 75% of all adverse drug events are preventable.3,11,16
Errors can occur at several points in the process of medication use, including drug ordering, dispensing, administration, and monitoring for efficacy or toxicity. One of the strategies advocated to prevent medication dispensing errors is the adoption of alerts and reminders at the point of ordering medications within a computerized physician order entry (CPOE) system. Studies have shown that computerized order entry has improved prescribing practices,17 as well as the appropriateness of ordering diagnostic tests.18 In controlled settings, computer-generated reminders increase physicians' adherence to practice guidelines.19,20 Using CPOE within the inpatient setting decreased the inappropriate use of medications and improved patient outcomes.17,21
Electronic medical record (EMR) systems and decision support systems use nonintrusive or intrusive alerts and reminders. Nonintrusive alerts generate warnings or present information on the computer screens but do not require specific actions. Intrusive alerts do not allow EMR users to complete an order or task until they respond to the alerts by canceling the alert message, changing the order, or giving a reason why they are continuing with the current task without changes.22 A disadvantage of intrusive alerts and reminders is their potential to intrude into and to disrupt the clinical work flow. In addition, nonintrusive and intrusive alerts, if frequent, tend to be ignored and foster "work-arounds" to avoid the alerts. Users of CPOE who were surveyed indicated that nonintrusive alerts and guidelines were preferred as the method for presenting drug prescribing information, although they also acknowledged that these would likely be less effective than a more intrusive alert.22 Nonintrusive interventions are less intrusive to work flow.
Many medication safety initiatives have focused on detecting medication interactions or risky medication use in high-risk patients. For certain medications with well-defined undesirable organ-system effects, clinicians should monitor patients' key laboratory values before starting therapy and at regular intervals after starting therapy. There should also be a focus on medication safety initiatives to ensure laboratory monitoring. Few studies have examined the effect of CPOE in combination with decision support tools on prescribing practices or on laboratory monitoring in the outpatient setting. A new arena for studying practical applications of computerized alerts and reminders is the use of computerized medication ordering combined with nonintrusive decision support information in the outpatient setting to guide clinicians in the appropriate use of laboratory monitoring. The objective of this study was to evaluate whether nonintrusive reminders presented on the computerized order entry screen for medication orders in the outpatient setting would increase clinicians' compliance with guidelines for laboratory monitoring on initiation of selected medications.
The setting for this study was a group-model managed care organization with more than 350 000 members at the time the study was conducted. During the study period, the organization used a fully integrated EMR with a CPOE system. This proprietary system (Clinical Information System) was developed in a joint venture with IBM (Boulder, Colo). The system was entirely "paperless," it was used at every outpatient encounter, and the various sections (eg, outpatient documentation, pharmacy, laboratory, and radiology) interacted with each other. The total population of healthcare professionals who used the Clinical Information System included approximately 550 physicians, 3900 health plan staff, and 100 medical students or resident physicians. The Clinical Information System was used to document all patient care contacts in the outpatient setting. The system used a controlled medical terminology (also called the lexicon) that allowed clinicians to use expressive clinically accurate terms to document interventions (including synonyms, acronyms, and abbreviations). The controlled medical terminology lexicon was used to document patient complaints and assessments and to order tests and medications during the delivery of patient care. All patient progress notes, medication orders, and laboratory results were archived for the purpose of retrieval, research, and analysis. This system was continuously available to providers at 16 ambulatory practice sites. Between 1998 and 2003, more than 10 million medications were prescribed using this system. Within the EMR, each clinician had a "custom formulary" of medications downloaded into his or her computerized order entry index.
After approval by the Kaiser Permanente Institutional Review Board, internal medicine and family practice physicians within the 16 clinical facilities of the managed care organization were randomized into 2 groups. The randomization was performed using SAS (SAS Institute Inc, Cary, NC). Physicians randomized to the control group received the standard list of medications loaded into their custom formularies. Physicians randomized to the intervention group also received the standard list of medications, but their medication list contained additional information in the pharmacy information field of the order entry screen that was specific to recommended laboratory monitoring for selected medications (Table 1). This field was positioned directly under the "instructions for use" field of the order entry screen and was clearly visible at the time of ordering each time an intervention physician ordered one of the medications listed in Table 1. The intent was to make the decision support function (guideline information) closely linked to each specific medication and integrated within the order entry system. The added information was specific for the individual medication and presented guidelines for appropriate baseline (eg, monitoring at therapy initiation) and ongoing (eg, monitoring during continuing therapy) laboratory monitoring for that particular medication, although baseline laboratory monitoring is the focus of the research we present herein. Development of the alert messages has been previously described.23 Briefly, drugs and laboratory tests were selected based on the presence of Food and Drug Administration black box warnings, published clinical guidelines, and potentials for adverse clinical consequences related to lack of monitoring. Black box warnings are typically used for drugs that carry the potential for life-threatening adverse events. In a sequential process, first the Physicians' Desk Reference (http://www.pdr.net/) was reviewed to identify drugs prescribed in ambulatory care that had black box warnings for baseline laboratory monitoring. The information gleaned from this review was supplemented with information from the Food and Drug Administration Web site (http://www.fda.gov/). Next, nationally available published guidelines and internal clinical guidelines were searched for other medication-related laboratory monitoring recommendations. A draft list of recommended drug-laboratory monitoring pairs was compiled from these sources and was circulated to practicing physicians, clinical pharmacists, and clinician leaders in the health plan. Their feedback was incorporated into the final list of drugs requiring laboratory monitoring. Table 1 lists the medications and the laboratory monitoring alerts associated with each medication that were displayed on the order entry screen and that we analyzed for baseline laboratory monitoring. Several clinical physicians reviewed the language of the alerts to ensure clarity and usability. The nonintrusive alerts were modeled after a previously published study23 that used intrusive alerts at the point of filling the prescription in the pharmacy, which was shown to work well.
Physicians in the intervention arm received academic detailing before the start of the study. During academic detailing, each intervention clinician received 1-on-1 training sessions designed to teach him or her where to look for the information on the order entry screen and how to use this information to change medication dosing or to order laboratory tests at the time of order entry. Only intervention group physicians were made aware of the nonintrusive alerts. Control group physicians were not informed of the study and did not receive the nonintrusive alerts on the order entry screen.