Preventable medical error is the third leading cause of death in the United States.1 Medication errors (also known as adverse drug events [ADEs]) make up a considerable proportion of these errors and occur across all health care settings.2-6 There is unambiguous evidence indicating the need to improve medication administration processes. Reports indicate that at least 19% of all administered doses of medications are incorrect,7 and hospitalized patients encounter an average of 1 medication error each hospital day.8
Adverse drug events occur at any point in the administration process, but happen most frequently during administration and prescribing.7 All health care providers can commit medication errors, but ADEs are the most common nursing error.9 Novice nurses are particularly susceptible to committing medication errors because of their relative lack of experience.10 Dilles et al11 found that novice nurses had incomplete knowledge of pharmacology and lacked the ability to perform requisite medication calculations to ensure safe medication administration. Amster and colleagues12 reported a 40% incidence of students administering a contraindicated medication to a simulated patient.12
As part of our efforts to increase opportunities for our students to meet the Quality and Safety Education for Nurses (QSEN) competencies, we implemented 2 anonymous reporting systems, a clinical near-miss reporting system (C-NMRS) and a simulated adverse event system (S-AERS).13,14 These systems were added to the curriculum in 2013. The C-NMRS provides a practice system for students to report near-miss events occurring during clinical rotations; the S-AERS offers a practice system where students can report adverse events including errors, near misses, and sentinel events occurring during simulation encounters. These systems are also a repository of data on events occurring in the clinical and simulation arenas and provide data that can be used for research and programmatic quality improvement purposes.13,14
As part of routine analysis of the data from the reporting systems, we uncovered ADE rates similar to what has been found in published research. Our local data revealed that ADEs accounted for as many as 80% of the reported events captured in the C-NMRS and 28% of the events in the S-AERS, making ADEs the number 1 cause of our locally reported adverse events.
Conversations with our instructors further confirmed our findings; specific medication-related practice gaps including those related to administration of high-risk medications such as insulin were verbalized. Our nursing students receive a considerable amount of didactic medication administration content, yet gaps in students’ ability to apply content in clinical or simulated settings were observed. The data coupled with faculty observations validated a need to improve medication administration knowledge, skills, and attitudes and an opportunity to fully incorporate the QSEN safety and patient-centered care competencies into our pharmacology course.15
Theory-practice gaps are common in health care education but are not easily addressed with lecture alone.16-19 Lecture-based learning is valuable, but it has been suggested that it may not be as effective as experiential and active learning.20 Students receiving experiential-based education demonstrate improved outcomes and more meaningful learning experiences compared with those in traditional formats.21,22 Reflective skills developed through experiential learning experiences such as simulation can assist in bridging theory-practice gaps.16
Simulation is used frequently to provide opportunities to develop critical thinking and reflective practice skills important in safe nursing practice. These skills have the ability to safeguard novice nurses from the “culture shock” experienced related to gaps in theory and practice when entering professional practice.16 Despite successes of simulation, it has been underused to build requisite skills and knowledge needed for safe medication administration practices.23-25 A literature search demonstrated a scarcity of studies exploring simulation as an adjunct teaching method in nursing pharmacology. Insufficient research combined with faculty observations and programmatic data prompted the development of the current study to examine the effect of simulation-enhanced pharmacology (SEP) on 3 areas: (1) self-reported medication administration competence and confidence, (2) self-reported ADEs, and (3) observed medication administration practices.
The study intervention also provided a new platform to build students’ medication safety practices and integrate QSEN safety and patient-centered competencies into the pharmacology course. The intervention included concepts around human factors and their contributions to unsafe practices and an introduction into the limitations of safety-enhancing technologies. In addition, the intervention highlighted strategies that can be incorporated into practice to reduce harm and introduced tools to reduce the reliance on memory and improve adherence to standards. Finally, debriefing included discussions around the roles individuals play in preventing errors.
A quasi-experimental longitudinal design was used for the study. A convenience sample was used consisting of 2 cohorts of students enrolled in pharmacology in an accelerated option bachelor of science in nursing program. After institutional review board approval, 1 cohort was designated as the control (teaching as usual) and 1 as the intervention (SEP). Enrollment of the 2 groups overlapped (the control group was a semester ahead of the intervention group). The data collection began with the control group to minimize the possibility of information sharing that could have affected the outcomes. In total, 120 students participated (n = 60 control, n = 60 intervention).
The SEP included 4 manikin-based scenarios divided into two 2-hour sessions. The scenarios focused on medication administration skills that aligned with QSEN safety competency knowledge, skills, and attitudes including calculation of dosages, high alert medication procedures, hand hygiene, appropriate donning of personal protective equipment, researching medication information, and checking appropriate laboratory values and vital signs before administering medications. Specific medications were focused on, including the administration of subcutaneous insulin, oral antiarrhythmic medications, intravenous heparin, intravenous corticosteroids, and intravenous piggyback administration of antibiotics. Aligned with the QSEN patient-centered care competency, the participants were required to explain the purpose of the medication and possible adverse effects to the simulated patient.
Pairs of students completed the scenarios together and were facilitated by an instructor. Encounters were run as stop-action simulation where the action could be paused on-demand by the students when they were unsure of next steps or the instructor whenever they sensed that the students were unsure or progressing incorrectly. The faculty led mini debriefing or didactic teaching encounters as appropriate to assist with getting students’ efforts aligned back with scenario objectives.
The data collection included (1) self-reported medication administration confidence and competence (2 time points: on completion of pharmacology and just before graduation), (2) observation of medication administration actions occurring during simulation encounters postpharmacology through graduation, (3) self-reported adverse events from all simulation encounters subsequent to completion of pharmacology through graduation, and (4) postintervention participant evaluations collected immediately after completion of simulation scenarios.
Four tools were used to collect data; 3 were developed specifically for the study (the self-reported medication administration competence and confidence scale [MACCS], the medication administration observation tool [MAOT], and a post intervention evaluation). The fourth tool, S-AERS, had been previously developed.12,13 The MACCS was used to collect confidence and competence data. The MACCS is a 16-item measure that elicits participants’ ratings of their level of confidence and competence of pharmacology tasks or knowledge using an 11-point scale (0 not at all confident/competent to 10 fully confident/competent) (see Figure, Supplemental Digital Content 1, http://links.lww.com/NE/A374). The total scores are aggregated item totals. Scale analysis for MACCS demonstrated good reliability (α = 0.90, all item-total correlations > 0.30).
The MAOT was used to collect observed medication administration actions (see Document, Supplemental Digital Content 2, http://links.lww.com/NE/A375). The MAOT consists of 20 observable actions. Observations are recorded as having been completed, not completed, not applicable, or unable to observe and coded as errors or near misses. Extracted data from the S-AERS provided the data on self-reported adverse events. Finally, the post intervention evaluation measure prompted participants to share their opinions of benefits and satisfaction with the SEP scenarios using a 5-point Likert scale (strongly agree to strongly disagree).
Scale analysis, descriptive statistics, Student t tests, Spearman’s ρ, χ2, and Fischer’s exact tests were used to analyze the data. Student t tests were used to analyze confidence and competence data (aggregated scores). Spearman’s ρ was used to calculate interrater reliability for the MAOT, and χ2 and Fisher’s exact tests were used to analyze the data from the medication administration observations. Descriptive statistics were used to analyze the data from the S-AERS. The SPSS version 20 (IBM Corp, Armonk, NY) was used for all analyses.
Confidence and Competence
Self-reported confidence and competence analysis revealed statistically significant time effects (P < .001, Table 1). Improvements in competence over time were noted in both groups (P < .001); the intervention group, however, only demonstrated an improvement in confidence (P < .001). The control group data showed a decrease in confidence over time (P < .001).
Competence and confidence scores were compared at time 1 and time 2 using t tests. Group mean comparisons revealed statistical significance at time 2 for competence (control, M = 72.12; intervention, M = 68.00; P = .034). Time 1 competence data were not statistically different (intervention, M = 55.52; control, M = 70.45; P = .221). There were no differences between groups on self-reported confidence at time 1 (control, M = 54.68; intervention, M = 55.65; P = .718) or time 2 (control, M = 52.58; intervention, M = 67.18; P = .096); individual item data are shown in Table 2, and Table 2 displays differences between groups using independent t tests.
Observed Medication Administration Actions
The MOAT interrater reliability for the tool was good (Spearman’s ρ average = 0.82; range, 0.71-0.93). Actions demonstrating statistically significant differences included infusing medications over the correct time (P = .021) and performing proper hand hygiene (P = .017). Observations approaching significance included administering the correct medication (P = .066) and checking vital signs (P = .076). All other findings are reported in Table 3.
Adverse Event Reporting
The control group reported greater numbers of adverse events coded as errors (n = 67 vs n = 56), incorrect medication administration events (n = 26 vs n = 9), incorrect route events (n = 12 vs n = 8), failure to check 2 forms of identification events (n = 13 vs n = 10), problems with equipment events (n = 9 vs n = 6), problems with handling of medication events (n = 19 vs n = 12), problems with the medication administration record (n = 2 vs n = 0), events caused by knowledge deficits (n = 27 vs n = 24), and events related to feelings of personal work overload (n = 7 vs n = 4). The Figure provides visualization of the full data analysis.
Postintervention SEP Evaluation
The participants overwhelmingly found SEP beneficial. When asked about how the simulation benefited learning of pharmacology concepts, skills, and knowledge, 94% agreed or strongly agreed that it was valuable. When asked whether the simulation experience was an effective use of curricular time, 94% agreed or strongly agreed. Most students (96%) also agreed or strongly agreed that simulation fostered the integration of previously learned pharmacology skills and knowledge. Finally, 95% agreed that simulation improved their medication administration safety.
Participants’ comments further demonstrated the effect. Examples include “the simulations have helped me understand what I am learning in lab by actually being able to do it hands-on, and I learned from the mistakes I made”; “I appreciate the fact that we get to see proper administration of drugs, and that experience will definitely help us in the hospital setting. Please do more of this, this is great”; and “this was truly a help to my skill set as part of learning the routes and how to feel comfortable with administration.”
In this study, SEP demonstrated benefits for students’ achievement of safety outcomes. The findings mirrored others’ research findings including Campbell’s26 and Mould et al’s27 exploration of changes in participants’ confidence after a simulation intervention, Sears et al’s29 study demonstrating positive effects on medication error commission after an education intervention, and studies by Bowling29 and Harris et al30 showing improvements in medication administration skills after simulation.
We did not find differences in confidence and competence across all measured variables. It is possible that the small sample of matched pairs limited the ability to fully demonstrate statistical significance. It is also possible that some findings failed to reach significance because learners experience simulation differently than previously thought. Simulation may have the additional benefit of improving self-awareness of knowledge and skill deficiencies, thus explaining the lower intervention group confidence and competence scores found at graduation. It is conceivable that simulation does not only change the participants’ medication administration actions but also their perceptions of the process and the inherent risks involved. The intervention group participants seemed to have a more attuned sense of potential fallibility associated with medication administration. This cognizance may only be realized when challenged to perform skills independently, hence the smaller gains in confidence and competence among the intervention group. This assertion is consistent with the literature; a meta-analysis demonstrated mixed results in the ability for simulation to affect clinical skill confidence and competence.25
Despite smaller gains in confidence and competence, the intervention group had improvements in medication administration actions, albeit only a small number reached or approached significance. The overall trends support simulation as able to positively affect medication administration safety practices. In addition, there were positive effects noted in the number and type of reported ADEs, further demonstrating the effects of the approach. Finally, positive participant post intervention evaluation comments highlighted the value and importance that students have for simulation-based education. This finding alone may be enough to support its expanded use in pharmacology. In summary, the findings provide beginning evidence that simulation has the potential to improve medication administration safety practices.
Limitations and Strengths
The study had several limitations including a single site, the inability to track effects of the SEP as the students transitioned into professional practice, having limited control of factors occurring during the non-intervention simulation encounters, and observing only group simulation encounters. The failure to account for potential confounding variables including clinical exposures, variability in learning opportunities, and differences in clinical instruction are further limitations.
Strengths of this study include diverse data and examination of the medication administration process from both observers’ and interpersonal perspectives. In addition, including self-reported ratings that reflect patient safety (self-reported ADEs) and the inclusion of self-reported confidence and competence represent a novel and completed approach. This research is also among the first to examine the effect of simulation not only on medication administration confidence and competence but also on reported ADEs and observed medication administration actions. The findings are encouraging; however, further research is needed to determine if repeated exposure throughout the curriculum is more effective than a single time point. Qualitative data may also uncover the more nuanced interpersonal learner experiences of simulation. Currently, the findings are being used to justify the addition of medication-specific scenarios; the scenarios developed for the study have been woven throughout our curriculum.
This study demonstrates the feasibility of including simulation in undergraduate nursing pharmacology. It is also an exemplar of the use of simulation to incorporate the safety and patient-centered care QSEN competencies. The findings provide additional evidence that support the use of simulation to expand nursing students’ understanding of their role in patient safety during medication administration; improve medication administration confidence, competence, and actions; and reduce the incidence of reported ADEs. This study adds to what is known about the inclusion of simulation in undergraduate nursing education and provides beginning evidence that simulation is an important method to build skills of reflection, to improve critical thinking, and as a technique to bridge theory-practice gaps. Simulation is helping educators to realize that it is not only what you learn but also how you learn that matters most.
A special thanks to the simulation staff at the University of Miami School of Nursing and Health Studies, International Academy for Clinical Simulation and Research
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