Empirical Investigations
In Situ Medical Simulation Investigation of Emergency Department Procedural Sedation With Randomized Trial of Experimental Bedside Clinical Process Guidance Intervention Nathan A. Siegel, MD; Leo Kobayashi, MD; Jennifer A. Dunbar-Viveiros, RN; Jeffrey Devine, RN, NREMT-P; Rakan S. Al-Rasheed, MBBS; Fenwick G. Gardiner, BS; Krister Olsson, MFA; Stella Lai, BFA; Mark S. Jones, BA; Max Dannecker, NREMT-I; Frank L. Overly, MD; John W. Gosbee, MD, MS; David C. Portelli, MD; Gregory D. Jay, MD, PhD
Introduction: Patient safety during emergency department procedural sedation (EDPS) can be difficult to study. Investigators sought to delineate and experimentally assess EDPS performance and safety practices of senior-level emergency medicine residents through in situ simulation. Methods: Study sessions used 2 pilot-tested EDPS scenarios with critical action checklists, institutional forms, embedded probes, and situational awareness questionnaires. An experimental informatics system was separately developed for bedside EDPS process guidance. Postgraduate year 3 and 4 subjects completed both scenarios in randomized order; only experimental subjects were provided with the experimental system during second scenarios. Results: Twenty-four residents were recruited into a control group (n = 12; 6.2 T 7.4 live EDPS experience) and experimental group (n = 12; 11.3 T 8.2 live EDPS experience [P = 0.10]). Critical actions for EDPS medication selection, induction, and adverse event recognition with resuscitation were correctly performed by most subjects. Presedation evaluations, sedation rescue preparation, equipment checks, time-outs, and documentation were frequently missed. Time-outs and postsedation assessments increased during second scenarios in the experimental group. Emergency department procedural sedation safety probe detection did not change across scenarios in either group. Situational awareness scores were 51% T 7% for control group and 58% T 12% for experimental group. Subjects using the experimental system completed more time-outs and scored higher Simulation EDPS Safety Composite Scores, although without comprehensive improvements in EDPS practice or safety. Conclusions: Study simulations delineated EDPS and assessed safety behaviors in senior emergency medicine residents, who exhibited the requisite medical knowledge base and procedural skill set but lacked some nontechnical skills that pertain to emergency department microsystem functions and patient safety. The experimental system exhibited limited impact only on in-simulation time-out compliance. (Sim Healthcare 10:146Y153, 2015)
Key Words: Adverse effects, Decision support, computerized, Deep sedation, Emergency department, Graduate medical education, Moderate sedation, Emergency treatment, Health care quality improvement, Patient safety, Patient simulation, Safety management.
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mergency department procedural sedation (EDPS) is an essential element of acute patient care. Commensurate with the increasing severity and complexity of emergency department From the Department of Emergency Medicine (N.A.S., L.K., F.L.O., D.C.P., G.D.J.), Alpert Medical School, and School of Engineering (G.D.J.), Brown University; Lifespan Medical Simulation Center (L.K., J.A.D.-V., J.D., R.S.A.-R., M.S.J., M.D., F.L.O.); and Emergency Department (J.D., F.G.G.), Rhode Island Hospital, Providence, RI; College of Nursing (J.A.D.-V.), University of Massachusetts Dartmouth, North Dartmouth, MA; Tree-axis (K.O., S.L.), Los Angeles, CA; Office of Clinical Affairs (J.W.G.), University of Michigan, Ann Arbor, MI; and King Abdulaziz Medical City (R.S.A.-R.), National Guard Health Affairs, Riyadh, Saudi Arabia. Reprints: Leo Kobayashi, MD, Department of Emergency Medicine, Alpert Medical School of Brown University, Lifespan Medical Simulation Center, Suite 106, Coro West Bldg, 1 Hoppin St, Providence, RI 02903 (e level of 0.05 (SAS version 9.3 software; SAS Institute, Cary, NC). Study group, scenario type (A;B), simulation order (first or second), and rater were treated as fixed effects along with all interactions, with the groupYbyYsimulation
order interaction treated as the primary hypothesis test for differential change according to study group. Postsimulation survey data on subjects’ perception of simulation session were examined for differences between study groups (MannYWhitney U test). Experimental group participants’ responses regarding the experimental system’s utility and usability were compiled.
RESULTS Twenty-four PGY-3/PGY-4 resident subjects (56% of potential participant pool) were recruited over 3 academic years between 2010 and 2013. Of 48 potential subjects, 5 were excluded because of participation in pilot phase simulations and the 19 remaining eligible residents did not participate. There were no significant differences in participant and study group baseline characteristics (Table 1 for details). Delineation of Simulated EDPS Performance In-simulation checklists confirmed consistency of monitored in situ simulation parameters for all sessions. During their first/baseline scenarios, subjects spent 13.9 T 3.0 minutes (range, 8.1Y19.3 minutes) in the presedation phase; their sedation induction, maintenance, and recovery phases were completed in 17.4 T 1.2 minutes (range, 16.0Y20.6 minutes). Both groups completed their second scenarios with similar timeline characteristics.
TABLE 1. Study Subject Characteristics Age [range], y Sex, female, % Duration of EM residency training [range], y Live EDPS experience (primary operator; adult EDPS), n [range] Simulation experience (self-reported on level of exposure on a 4-point Likert scale score [0Y3; 0 = ‘‘not comfortable’’]), median score [interquartile range]
Control Group (nc = 12)
Experimental Group (ne = 12)
P*
29.8 T 1.4 [27Y32] 50 3.1 T 0.6 [2.2Y4.0] 6.2 T 7.4 [0Y20] 2 [2Y3]
31.2 T 4.0 [28Y43] 50 3.1 T 0.7 [2.3Y3.9] 11.3 T 8.2 [0Y25] 3 [3Y3]
0.49 1† 0.65 0.10 0.09
*MannYWhitney U test (2 tailed, > = 0.05) unless otherwise specified. †Fisher exact test (2 tailed, > = 0.05).
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Emergency department procedural sedation medications used during first scenarios were etomidate (16 subjects), ketamine (5, including one dosing error by experimental subject), and midazolam with fentanyl (3); medication regimens were similar across groups and during second scenarios (no errors). During their first scenarios, 5 subjects in each study group were distracted from EDPS by engaging fully in shoulder reduction maneuvers; 6 control and 7 experimental subjects were distracted during second scenarios. There were no significant differences in the performance and timeliness of ventilatory resuscitation between groups for all scenarios: the mean delay until resuscitation was 2.0 T 1.0 minutes (range, 0.7Y5.4 minutes), including 2 laryngeal mask airway deployments and 2 rapid sequence induction endotracheal intubations. EDPS Critical Action Research Checklists Emergency department procedural sedation critical action checklists scored control subjects for first-scenario presedation assessment, presedation equipment check, and postsedation assessment at 70% T 13%, 62% T 23%, and 34% T 9%, respectively; the experimental subjects were scored similarly. Control group checklist scores did not change during repeat scenarios; the experimental group exhibited increased performance of only presedation time-outs (P G 0.01) and postsedation assessments (P G 0.01) for their second scenarios (Tables, Supplemental Digital Content 2.1a, http://links.lww.com/SIH/A200, which provide all EDPS research checklist form completion data) (Tables, Supplemental Digital Content 2.1b, http://links.lww.com/SIH/A201, which provide all EDPS research checklist form completion data) (Tables, Supplemental Digital Content 2.1c, http://links.lww.com/SIH/A202, which provide all EDPS research checklist form completion data). Institutional Procedural Sedation Forms The subjects in both study groups completed similar levels of documentation on first-scenario presedation, sedation monitoring, and postsedation institutional form items. Only experimental group subjects increased their documentation of time-outs and postsedation checks during second scenarios (see Tables, Supplemental Digital Content 2.2a, http://links.lww.com/SIH/A203, which provide all institutional EDPS form completion data) (see Tables, Supplemental Digital Content 2.2b, http://links.lww.com/SIH/A204, which provide all institutional EDPS form completion data) (see Tables, Supplemental Digital Content 2.2c, http://links.lww.com/SIH/A205, which provide all institutional EDPS form completion data). Binary Study Probes Detection of the difficult sedation probe was 67% for the control group and 75% for the experimental group at baseline. Two control subjects and 1 experimental subject requested difficult airway management devices during first scenarios; reversal medications were appropriately requisitioned before induction for 25% of all scenarios with reversible EDPS (n = 32) and used on 6 occasions. Adverse event management was scored as optimal for 94% of the scenarios. There were no significant between-group differences or within-group changes across scenarios with respect to the study probes. 150
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Retrospective Situational Awareness Forms Subjects’ situational awareness for their second scenario was 51% T 7% (range, 38%Y62%) for the control group and 58% T 12% (range, 38%Y85%; P = 0.15) for the experimental group on a 100% score metric; no significant differences were detected on the analysis of each situational awareness element. (Table, Supplemental Digital Content Part 2.3, http://links.lww.com/SIH/A206, which displays all subject situational awareness form data). Change in Performance Across Scenarios and Effect of Experimental System Two investigators without conflicts of interest independently reviewed all simulations to test for learning effect in each subject and for the effect of the experimental system across groups and scenarios; their intraclass correlation values were high (0.88Y0.97). Control subjects scored 7.7 T 1.2 (mean of both investigators’ scores) of 10 on their first-simulation Composite Scores. Experimental subjects were similarly scored at 6.9 T 1.8 (P = 0.40) for their first simulations. Post hoc analyses revealed weak correlations between subjects’ duration of EM residency training or live EDPS experience and their initial Composite Scores (rS = 0.1Y0.3, nonsignificant). Changes ($) in the Composite Score from the first to the second scenario were not significant for the control group. Increases in time-out completions (P G 0.01) and postsedation assessment checklist completion (P G 0.01) across scenarios for the experimental group were the only significant changes for both groups for all Composite Score metrics; these accounted for that group’s Composite Score $ (1.9 T 1.9) and the between-group performance difference ($[$]). The $[$] attained significance on independent analysis using a binomial generalized linear mixed model (P G 0.01) (Table 2). Postsimulation Survey on Simulation and Experimental System On 11-point ordinal scales (0Y10), all subjects scored their simulation experience as realistic (median score, 8), relevant (10), and having impact on their clinical practice (7.5). Experimental subjects reported moderate perceived utility of the experimental system for prevention of medical error during EDPS (Table, Supplemental Digital Content Part 2.4, http://links.lww.com/SIH/A207, which summarizes all postsimulation survey response data).
DISCUSSION Procedural sedation in acute care settings is a common, important, and indispensable element of medical care. The tasking of EM resident subjects with the safe and effective administration of appropriate (simulated) procedural sedation enabled the objective delineation of their EDPSrelated performance and observance of patient safety behaviors. Study sessions revealed that subjects frequently omitted important elements of EDPS preparation (eg, review of previous sedation/complication history; assessment of injury mechanism/site/side) were easily distracted and charted incompletely. In-simulation probes that gauged preparedness for adverse events often remained undetected, and investigators recorded suboptimal performance of timeouts and postsedation reassessments. Conversely, subjects Simulation in Healthcare
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TABLE 2. Comparison of Control Group and Experimental Group Simulation EDPS Composite Scores Scenario 1 Control Group (nc = 12)
Investigators Mean Score (Intraclass Correlation Coefficient, 0.97)
Presedation 1. Potential for difficult airway/sedation recognized 2. Defective EDPS equipment (prop) recognized 3. Continuous pulse oximetry (SpO2) probe/monitor applied before sedation start 4. Continuous end-tidal capnometry (ETCO2) probe/monitor applied before sedation start 5. Sedation medication appropriate for patient and procedure 6. Time-out (patient identification) 7. Time-out (procedure confirmationVtype, site, and side) Intrasedation 8. Hypoventilation detected 9. Optimal airway management Postsedation 10. Assessment checklist (composite item)
67% T 44% 67% T 48% 63% T 44%
79% T 40% 63% T 48% 79% T 40%
0.33 0.84 0.47
100% T 0%
1
100% T 0% 71% T 44% 71% T 44%
100% T 0% 75% T 45% 75% T 45%
1 0.82 0.82
100% T 0% 100% T 0%
100% T 0% 100% T 0%
1 1
33% T 9%
38% T 9%
0.75
7.7 T 1.2
8.1 T 1.1
Scenario 1 Investigators Mean Score (Intraclass Correlation Coefficient, 0.94)
Presedation 1. Potential for difficult airway/sedation recognized 2. Defective EDPS equipment (prop) recognized 3. Continuous pulse oximetry (Spo2) probe/monitor applied before sedation start 4. Continuous end-tidal capnometry (ETCO2) probe/monitor applied before sedation start 5. Sedation medication appropriate for patient and procedure 6. Time-out (patient identification) 7. Time-out (procedure confirmationVtype, site, and side) Intrasedation 8. Hypoventilation detected 9. Optimal airway management Postsedation 10. Assessment checklist (composite item)
Investigators Mean Score (Intraclass Correlation Coefficient, 0.90) P*
100% T 0%
Composite Score (10-point) Between-scenario composite score $ within group Experimental Group (ne = 12)
Scenario 2
$
Scenario 2
0.4 T 1.5 P = 0.17* P*
Investigators Mean Score (Intraclass Correlation Coefficient, 0.88)
63% T 48% 58% T 51% 75% T 34%
67% T 44% 63% T 48% 100% T 0%
0.90 0.90 0.09
83% T 33%
100% T 0%
0.31
100% T 0%
1
42% T 51% 42% T 51%
100% T 0% 100% T 0%
0.02 0.02
100% T 0% 92% T 29%
100% T 0% 100% T 0%
1 0.75
35% T 11%
55% T 18%
G0.01
100% T 0%
Composite Score (10-point) Between-scenario composite score $ within group
6.9 T 1.8
8.8 T 1.0
$
Between-scenario $ by group ($[$]) P = 0.06* Analysis of groupYbyYsimulation order interaction with binominal generalized linear mixed model
1.9 T 1.9 P G 0.01*
P G 0.01
*MannYWhitney U test (2 tailed, > = 0.05). Text in italics indicates scenario-embedded probe. ETCO2, end-tidal carbon dioxide; SpO2, oxygen saturation (pulse oximetry).
consistently used proper EDPS medications and managed adverse events in a timely manner. Study findings seem to indicate that senior-level EM residents have the medical knowledge base and procedural skill set to perform EDPS but lack some of the nontechnical skills (ie, anticipatory planning and preparing, information exchange/charting, maintaining situational awareness) that pertain to ED microsystem functions and patient safety. Emergency department trainees may therefore benefit from efforts to explicitly instill a broad awareness and greater appreciation for safety measures during routine as well as emergent, clinical situations. Incorporation of this mindset into EM training may be facilitated by simulation methods, wherein the participant’s adherence to (or neglect of ) recommended Vol. 10, Number 3, June 2015
patient safety behaviors can immediately alter scenario progression and effect experiential learning. Accordingly, study findings have been presented at the research site’s EM residency conference and shared with administrative and educational leadersVcurricular adjustments for ongoing residency simulation sessions are anticipated. The insight and lessons learned from SLIPSTREAM assessments are also being applied to the institution-wide, simulation-based in-servicing and credentialing of all sedation providers who perform ‘‘out of operating room’’ procedural sedations. These measures are in concordance with recent, successful efforts at other health care facilities to achieve institutional standardization in provider skill sets and to attain minimum safe performance requirements of sedation practice.40Y46 With respect to * 2015 Society for Simulation in Healthcare
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SLIPSTREAM program continuation, developed materials are available through the AAMC MedEdPORTAL for collaborative educational and investigative efforts.35 As for the research program’s experimental system, the bedside clinical informatics prototype exhibited limited impact on safety behaviors during simulated EDPS. Although the Composite Score metric was seen to improve in the experimental group, this resulted primarily from increased time-out completions rather than a comprehensive adjustment of the subjects’ approach to EDPS patient safety. Despite reasonable functionality as a workflow guidance system with graphical interface, checklists, automated prompts, and reminder systems, the experimental prototype did not improve subjects’ performance of critical actions in several areas. Given the appearance of some positive utility (and general noninferiority of GLIDEPATH-assisted subjects’ performance when compared with the control group’s EDPS conduct), continued development with training module and use testing may be indicated. Limitations Study design precluded blinding of subjects and investigators to group assignment. Sample size was limited by small target pools and available funding, such that there may have been problems with group randomization and the detection of true performance differences (type II error). (The weak correlations between subjects’ training background or self-reported live EDPS experience and their firstsimulation Composite Scores argue against this.) In terms of the EDPS simulation research methodology and its assessment of expert-level performance levels, the Simulation EDPS Safety Composite Score metric was tested during pilot phase sessions only on novice interns and experienced attending EDPS providers. Its ability to serve as a precise, gradational differentiator of provider performance (and EDPS safety) at intermediate and higher levels had not been examined; the effect of the Composite Score’s relatively low resolution, 10-point spectrum, and the potential ceiling effect on study findings are unclear. In addition, the study’s experimental objective precluded the training of subjects on EDPS practiceVthis likely contributed toward the program’s inability to elicit meaningful advancement toward a practice level approximating that of more experienced providers. Testing of the experimental system did not feature formal usability evaluations or a diverse end user sample. It remains unclear why the experimental system’s explicit prompts and checklists were unable to elicit sizeable changes in recognition of high-risk EDPS patients and checking of essential equipment. Problems with the experimental system’s approach (just-in-time exposure without preceding educational component),47 end user difficulties with the novel technology, and research methodology limitations may all have contributed to the underwhelming results.
CONCLUSIONS Advanced simulations were successfully applied in situ to assess EDPS clinical practice and related safety behaviors in senior EM residents. An experimental, just-in-time bedside clinical process guidance system primarily improved 152
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time-out completions without overall improvement in subjects’ in-simulation safety behaviors or performance. ACKNOWLEDGMENT The authors acknowledge Anna C. Cousins for her insight and assistance in manuscript preparation and Dr Jason Machan PhD for the assistance with the statistical analysis. REFERENCES 1. American College of Emergency Physicians (ACEP). Policy Statement on Sedation in the Emergency Department 2011. Available at: acep.org/ Content.aspx?id=75479. Accessed October 30, 2014. 2. O’Connor RE, Sama A, Burton JH, et al. American College of Emergency Physicians Sedation Task Force. Procedural sedation and analgesia in the emergency department: recommendations for physician credentialing, privileging, and practice. Ann Emerg Med 2011;58:365Y370. 3. Green SM. Research advances in procedural sedation and analgesia. Ann Emerg Med 2007;49:31Y36. 4. Miner JR, Krauss B. Procedural sedation and analgesia research: state of the art. Acad Emerg Med 2007;14:170Y178. 5. Miner JR, Martel ML, Meyer M, Reardon R, Biros MH. Procedural sedation of critically ill patients in the emergency department. Acad Emerg Med 2005;12:124Y128. 6. Campbell SG, Magee KD, Kovacs GJ, et al. Procedural sedation and analgesia in a Canadian adult tertiary care emergency department: a case series. CJEM 2006;8:85Y93. 7. Mensour M, Pineau R, Sahai V, Michaud J. Emergency department procedural sedation and analgesia: a Canadian Community Effectiveness and Safety Study (ACCESS). CJEM 2006;8:94Y99. 8. Symington L, McGugam E, Graham C, Gordon M, Thakore S. Training in conscious sedation techniques: meeting the recommendations of the UK Academy of Medical Royal Colleges. Emerg Med J 2007;24:576Y578. 9. Adams ST, Woods C, Lyall H, Higson M. Standards of practice in UK emergency departments before, during and after conscious sedation. Emerg Med J 2008;25:728Y731. 10. Hodkinson PW, James MF, Wallis LA. Emergency department procedural sedation practice in Cape Town, South Africa. Int J Emerg Med 2009;2:91Y97. 11. Miner JR. Procedural sedation and analgesia research. Methods Mol Biol 2010;617:493Y503. 12. Harvey M, Cave G, Betham C. Contemporary sedation practice in a large New Zealand emergency department. N Z Med J 2011;124:36Y45. 13. Smally AJ, Nowicki TA, Simelton BH. Procedural sedation and analgesia in the emergency department. Curr Opin Crit Care 2011;17:317Y322. 14. Weaver CS, Terrell KM, Bassett R, Swiler W, et al. ED procedural sedation of elderly patients: is it safe? Am J Emerg Med 2011;29:541Y544. 15. Pena BM, Krauss B. Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med 1999;34:483Y491. 16. Cote´ CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics 2000;105:805Y814. 17. Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med 2000;342:938Y945. 18. Malviya S, Voepel-Lewis T, Prochaska G, Tait AR. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics 2000;105:E42. 19. Pitetti RD, Singh S, Pierce MC. Safe and efficacious use of procedural sedation and analgesia by nonanesthesiologists in a pediatric emergency department. Arch Pediatr Adolesc Med 2003;157:1090Y1096. 20. Roback MA, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med 2005;12:508Y513.
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21. Doyle L, Colletti JE. Pediatric procedural sedation and analgesia. Pediatr Clin North Am 2006;53:279Y292. 22. Sacchetti A, Stander E, Ferguson N, Maniar G, Valko P. Pediatric procedural sedation in the community emergency department: results from the ProSCED registry. Pediatr Emerg Care 2007;23:218Y222. 23. Misra S, Mahajan PV, Chen X, Kannikeswaran N. Safety of procedural sedation and analgesia in children less than 2 years of age in a pediatric emergency department. Int J Emerg Med 2008;1:173Y177. 24. Leroy PL, Gorzeman MP, Sury MR. Procedural sedation and analgesia in children by non-anesthesiologists in an emergency department. Minerva Pediatr 2009;61:193Y215. 25. Couloures KG, Beach M, Cravero JP, Monroe KK, Hertzog JH. Impact of provider specialty on pediatric procedural sedation complication rates. Pediatrics 2011;127:e1154Ye1160. 26. Emergency Nurses Association (ENA). Position Statement: Procedural Sedation and Analgesia in the Emergency Department 2005. Available at: www.ena.org/SiteCollectionDocuments/Position%20Statements/ Archived/Procedural_Sedation_Consensus_Statement.pdf. Accessed on March 16, 2015. 27. ENA and ACEP joint position statement: delivery of agents for procedural sedation and analgesia by emergency nurses. Ann Emerg Med. 2005;46:368. 28. The Royal College of Anaesthetists and the College of Emergency Medicine. Safe Sedation of Adults in the Emergency Department 2012. Available at: secure.collemergencymed.ac.uk/code/ document.asp?ID=6691. Accessed October 30, 2014. 29. Nishisaki A, Donoghue AJ, Colborn S, et al. Effect of just-in-time simulation training on tracheal intubation procedure safety in the pediatric intensive care unit. Anesthesiology 2010;113(1):214Y223. 30. Sam J, Pierse M, Al-Qahtani A, Cheng A. Implementation and evaluation of a simulation curriculum for paediatric residency programs including just-in-time in situ mock codes. Paediatr Child Health 2012;17:e16Ye20. 31. Kamdar G, Kessler DO, Tilt L, et al. Qualitative evaluation of just-in-time simulation-based learning: the learners’ perspective. Simul Healthc 2013;8:43Y48. 32. Scholtz AK, Monachino AM, Nishisaki A, Nadkarni VM, Lengetti E. Central venous catheter dress rehearsals: translating simulation training to patient care and outcomes. Simul Healthc 2013;8:341Y349. 33. Blike GT, Christoffersen K, Cravero JP, Andeweg SK, Jensen J. A method for measuring system safety and latent errors associated with pediatric procedural sedation. Anesth Analg 2005;101:48Y58.
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34. Kobayashi L, Dunbar-Viveiros J, Devine J, et al. Pilot phase findings from high-fidelity in situ medical simulation investigation of emergency department procedural sedation. Simul Healthc 2012;7:81Y94. 35. Kobayashi L, Overly F, Gosbee J. Emergency department procedural sedation in situ simulation materials (SLIPSTREAM SD-R study scenarios A + B). MedEdPortal 2012. Available at: mededportal.org/ publication/8220. Accessed October 30, 2014. 36. Wears R, Leape LL. Human error in emergency medicine. Ann Emerg Med 1999;34:370Y372. 37. Chisholm CD, Collison EK, Nelson DR, Cordell WH. Emergency department workplace interruptions: are emergency physicians ‘‘interrupt-driven’’ and ‘‘multitasking’’? Acad Emerg Med 2000;7:1239Y1243. 38. Schenkel S. Promoting patient safety and preventing medical error in emergency departments. Acad Emerg Med 2000;7:1204Y1222. 39. Flowerdew L, Brown R, Vincent C, Woloshynowych M. Identifying nontechnical skills associated with safety in the emergency department: a scoping review of the literature. Ann Emerg Med 2012;59:386Y394. 40. Hoffman GM, Nowakowski R, Troshynski TJ, Berens RJ, Weisman SJ. Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model. Pediatrics 2002;109:236Y243. 41. Babl F, Priestley S, Krieser D, et al. Development and implementation of an education and credentialing programme to provide safe paediatric procedural sedation in emergency departments. Emerg Med Australas 2006;18:489Y497. 42. Pershad J, Gilmore B. Successful implementation of radiology sedation service staffed exclusively by pediatric emergency physicians. Pediatrics 2006;117:e413Ye422. 43. Pitetti R, Davis PJ, Redlinger R, White J, Wiener E, Calhoun KH. Effect on hospital-wide sedation practices after implementation of the 2001 JCAHO procedural sedation and analgesia guidelines. Arch Pediatr Adolesc Med 2006;160:211Y216. 44. Priestley S, Babl FE, Krieser D, et al. Evaluation of the impact of a pediatric procedural sedation credentialing programme on quality of care. Emerg Med Australas 2006;18:498Y504. 45. Shavit I, Keidan I, Hoffman Y, et al. Enhancing patient safety during pediatric sedation: the impact of simulation-based training of nonanesthesiologists.. Arch Pediatr Adolesc Med 2007;161:740Y743. 46. Shavit I, Steiner IP, Idelman S, et al. Comparison of adverse events during procedural sedation between specially trained pediatric residents and pediatric emergency physicians in Israel. Acad Emerg Med 2008;15:617Y622. 47. Leape L. The checklist conundrum. N Engl J Med 2014;370:1063Y1064.
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In Situ Medical Simulation Investigation of Emergency Department Procedural Sedation With Randomized Trial of Experimental Bedside Clinical Process Guidance Intervention Nathan A. Siegel, MD; Leo Kobayashi, MD; Jennifer A. Dunbar-Viveiros, RN; Jeffrey Devine, RN, NREMT-P; Rakan S. Al-Rasheed, MBBS; Fenwick G. Gardiner, BS; Krister Olsson, MFA; Stella Lai, BFA; Mark S. Jones, BA; Max Dannecker, NREMT-I; Frank L. Overly, MD; John W. Gosbee, MD, MS; David C. Portelli, MD; Gregory D. Jay, MD, PhD
Introduction: Patient safety during emergency department procedural sedation (EDPS) can be difficult to study. Investigators sought to delineate and experimentally assess EDPS performance and safety practices of senior-level emergency medicine residents through in situ simulation. Methods: Study sessions used 2 pilot-tested EDPS scenarios with critical action checklists, institutional forms, embedded probes, and situational awareness questionnaires. An experimental informatics system was separately developed for bedside EDPS process guidance. Postgraduate year 3 and 4 subjects completed both scenarios in randomized order; only experimental subjects were provided with the experimental system during second scenarios. Results: Twenty-four residents were recruited into a control group (n = 12; 6.2 T 7.4 live EDPS experience) and experimental group (n = 12; 11.3 T 8.2 live EDPS experience [P = 0.10]). Critical actions for EDPS medication selection, induction, and adverse event recognition with resuscitation were correctly performed by most subjects. Presedation evaluations, sedation rescue preparation, equipment checks, time-outs, and documentation were frequently missed. Time-outs and postsedation assessments increased during second scenarios in the experimental group. Emergency department procedural sedation safety probe detection did not change across scenarios in either group. Situational awareness scores were 51% T 7% for control group and 58% T 12% for experimental group. Subjects using the experimental system completed more time-outs and scored higher Simulation EDPS Safety Composite Scores, although without comprehensive improvements in EDPS practice or safety. Conclusions: Study simulations delineated EDPS and assessed safety behaviors in senior emergency medicine residents, who exhibited the requisite medical knowledge base and procedural skill set but lacked some nontechnical skills that pertain to emergency department microsystem functions and patient safety. The experimental system exhibited limited impact only on in-simulation time-out compliance. (Sim Healthcare 10:146Y153, 2015)
Key Words: Adverse effects, Decision support, computerized, Deep sedation, Emergency department, Graduate medical education, Moderate sedation, Emergency treatment, Health care quality improvement, Patient safety, Patient simulation, Safety management.
E
mergency department procedural sedation (EDPS) is an essential element of acute patient care. Commensurate with the increasing severity and complexity of emergency department From the Department of Emergency Medicine (N.A.S., L.K., F.L.O., D.C.P., G.D.J.), Alpert Medical School, and School of Engineering (G.D.J.), Brown University; Lifespan Medical Simulation Center (L.K., J.A.D.-V., J.D., R.S.A.-R., M.S.J., M.D., F.L.O.); and Emergency Department (J.D., F.G.G.), Rhode Island Hospital, Providence, RI; College of Nursing (J.A.D.-V.), University of Massachusetts Dartmouth, North Dartmouth, MA; Tree-axis (K.O., S.L.), Los Angeles, CA; Office of Clinical Affairs (J.W.G.), University of Michigan, Ann Arbor, MI; and King Abdulaziz Medical City (R.S.A.-R.), National Guard Health Affairs, Riyadh, Saudi Arabia. Reprints: Leo Kobayashi, MD, Department of Emergency Medicine, Alpert Medical School of Brown University, Lifespan Medical Simulation Center, Suite 106, Coro West Bldg, 1 Hoppin St, Providence, RI 02903 (e level of 0.05 (SAS version 9.3 software; SAS Institute, Cary, NC). Study group, scenario type (A;B), simulation order (first or second), and rater were treated as fixed effects along with all interactions, with the groupYbyYsimulation
order interaction treated as the primary hypothesis test for differential change according to study group. Postsimulation survey data on subjects’ perception of simulation session were examined for differences between study groups (MannYWhitney U test). Experimental group participants’ responses regarding the experimental system’s utility and usability were compiled.
RESULTS Twenty-four PGY-3/PGY-4 resident subjects (56% of potential participant pool) were recruited over 3 academic years between 2010 and 2013. Of 48 potential subjects, 5 were excluded because of participation in pilot phase simulations and the 19 remaining eligible residents did not participate. There were no significant differences in participant and study group baseline characteristics (Table 1 for details). Delineation of Simulated EDPS Performance In-simulation checklists confirmed consistency of monitored in situ simulation parameters for all sessions. During their first/baseline scenarios, subjects spent 13.9 T 3.0 minutes (range, 8.1Y19.3 minutes) in the presedation phase; their sedation induction, maintenance, and recovery phases were completed in 17.4 T 1.2 minutes (range, 16.0Y20.6 minutes). Both groups completed their second scenarios with similar timeline characteristics.
TABLE 1. Study Subject Characteristics Age [range], y Sex, female, % Duration of EM residency training [range], y Live EDPS experience (primary operator; adult EDPS), n [range] Simulation experience (self-reported on level of exposure on a 4-point Likert scale score [0Y3; 0 = ‘‘not comfortable’’]), median score [interquartile range]
Control Group (nc = 12)
Experimental Group (ne = 12)
P*
29.8 T 1.4 [27Y32] 50 3.1 T 0.6 [2.2Y4.0] 6.2 T 7.4 [0Y20] 2 [2Y3]
31.2 T 4.0 [28Y43] 50 3.1 T 0.7 [2.3Y3.9] 11.3 T 8.2 [0Y25] 3 [3Y3]
0.49 1† 0.65 0.10 0.09
*MannYWhitney U test (2 tailed, > = 0.05) unless otherwise specified. †Fisher exact test (2 tailed, > = 0.05).
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Emergency department procedural sedation medications used during first scenarios were etomidate (16 subjects), ketamine (5, including one dosing error by experimental subject), and midazolam with fentanyl (3); medication regimens were similar across groups and during second scenarios (no errors). During their first scenarios, 5 subjects in each study group were distracted from EDPS by engaging fully in shoulder reduction maneuvers; 6 control and 7 experimental subjects were distracted during second scenarios. There were no significant differences in the performance and timeliness of ventilatory resuscitation between groups for all scenarios: the mean delay until resuscitation was 2.0 T 1.0 minutes (range, 0.7Y5.4 minutes), including 2 laryngeal mask airway deployments and 2 rapid sequence induction endotracheal intubations. EDPS Critical Action Research Checklists Emergency department procedural sedation critical action checklists scored control subjects for first-scenario presedation assessment, presedation equipment check, and postsedation assessment at 70% T 13%, 62% T 23%, and 34% T 9%, respectively; the experimental subjects were scored similarly. Control group checklist scores did not change during repeat scenarios; the experimental group exhibited increased performance of only presedation time-outs (P G 0.01) and postsedation assessments (P G 0.01) for their second scenarios (Tables, Supplemental Digital Content 2.1a, http://links.lww.com/SIH/A200, which provide all EDPS research checklist form completion data) (Tables, Supplemental Digital Content 2.1b, http://links.lww.com/SIH/A201, which provide all EDPS research checklist form completion data) (Tables, Supplemental Digital Content 2.1c, http://links.lww.com/SIH/A202, which provide all EDPS research checklist form completion data). Institutional Procedural Sedation Forms The subjects in both study groups completed similar levels of documentation on first-scenario presedation, sedation monitoring, and postsedation institutional form items. Only experimental group subjects increased their documentation of time-outs and postsedation checks during second scenarios (see Tables, Supplemental Digital Content 2.2a, http://links.lww.com/SIH/A203, which provide all institutional EDPS form completion data) (see Tables, Supplemental Digital Content 2.2b, http://links.lww.com/SIH/A204, which provide all institutional EDPS form completion data) (see Tables, Supplemental Digital Content 2.2c, http://links.lww.com/SIH/A205, which provide all institutional EDPS form completion data). Binary Study Probes Detection of the difficult sedation probe was 67% for the control group and 75% for the experimental group at baseline. Two control subjects and 1 experimental subject requested difficult airway management devices during first scenarios; reversal medications were appropriately requisitioned before induction for 25% of all scenarios with reversible EDPS (n = 32) and used on 6 occasions. Adverse event management was scored as optimal for 94% of the scenarios. There were no significant between-group differences or within-group changes across scenarios with respect to the study probes. 150
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Retrospective Situational Awareness Forms Subjects’ situational awareness for their second scenario was 51% T 7% (range, 38%Y62%) for the control group and 58% T 12% (range, 38%Y85%; P = 0.15) for the experimental group on a 100% score metric; no significant differences were detected on the analysis of each situational awareness element. (Table, Supplemental Digital Content Part 2.3, http://links.lww.com/SIH/A206, which displays all subject situational awareness form data). Change in Performance Across Scenarios and Effect of Experimental System Two investigators without conflicts of interest independently reviewed all simulations to test for learning effect in each subject and for the effect of the experimental system across groups and scenarios; their intraclass correlation values were high (0.88Y0.97). Control subjects scored 7.7 T 1.2 (mean of both investigators’ scores) of 10 on their first-simulation Composite Scores. Experimental subjects were similarly scored at 6.9 T 1.8 (P = 0.40) for their first simulations. Post hoc analyses revealed weak correlations between subjects’ duration of EM residency training or live EDPS experience and their initial Composite Scores (rS = 0.1Y0.3, nonsignificant). Changes ($) in the Composite Score from the first to the second scenario were not significant for the control group. Increases in time-out completions (P G 0.01) and postsedation assessment checklist completion (P G 0.01) across scenarios for the experimental group were the only significant changes for both groups for all Composite Score metrics; these accounted for that group’s Composite Score $ (1.9 T 1.9) and the between-group performance difference ($[$]). The $[$] attained significance on independent analysis using a binomial generalized linear mixed model (P G 0.01) (Table 2). Postsimulation Survey on Simulation and Experimental System On 11-point ordinal scales (0Y10), all subjects scored their simulation experience as realistic (median score, 8), relevant (10), and having impact on their clinical practice (7.5). Experimental subjects reported moderate perceived utility of the experimental system for prevention of medical error during EDPS (Table, Supplemental Digital Content Part 2.4, http://links.lww.com/SIH/A207, which summarizes all postsimulation survey response data).
DISCUSSION Procedural sedation in acute care settings is a common, important, and indispensable element of medical care. The tasking of EM resident subjects with the safe and effective administration of appropriate (simulated) procedural sedation enabled the objective delineation of their EDPSrelated performance and observance of patient safety behaviors. Study sessions revealed that subjects frequently omitted important elements of EDPS preparation (eg, review of previous sedation/complication history; assessment of injury mechanism/site/side) were easily distracted and charted incompletely. In-simulation probes that gauged preparedness for adverse events often remained undetected, and investigators recorded suboptimal performance of timeouts and postsedation reassessments. Conversely, subjects Simulation in Healthcare
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TABLE 2. Comparison of Control Group and Experimental Group Simulation EDPS Composite Scores Scenario 1 Control Group (nc = 12)
Investigators Mean Score (Intraclass Correlation Coefficient, 0.97)
Presedation 1. Potential for difficult airway/sedation recognized 2. Defective EDPS equipment (prop) recognized 3. Continuous pulse oximetry (SpO2) probe/monitor applied before sedation start 4. Continuous end-tidal capnometry (ETCO2) probe/monitor applied before sedation start 5. Sedation medication appropriate for patient and procedure 6. Time-out (patient identification) 7. Time-out (procedure confirmationVtype, site, and side) Intrasedation 8. Hypoventilation detected 9. Optimal airway management Postsedation 10. Assessment checklist (composite item)
67% T 44% 67% T 48% 63% T 44%
79% T 40% 63% T 48% 79% T 40%
0.33 0.84 0.47
100% T 0%
1
100% T 0% 71% T 44% 71% T 44%
100% T 0% 75% T 45% 75% T 45%
1 0.82 0.82
100% T 0% 100% T 0%
100% T 0% 100% T 0%
1 1
33% T 9%
38% T 9%
0.75
7.7 T 1.2
8.1 T 1.1
Scenario 1 Investigators Mean Score (Intraclass Correlation Coefficient, 0.94)
Presedation 1. Potential for difficult airway/sedation recognized 2. Defective EDPS equipment (prop) recognized 3. Continuous pulse oximetry (Spo2) probe/monitor applied before sedation start 4. Continuous end-tidal capnometry (ETCO2) probe/monitor applied before sedation start 5. Sedation medication appropriate for patient and procedure 6. Time-out (patient identification) 7. Time-out (procedure confirmationVtype, site, and side) Intrasedation 8. Hypoventilation detected 9. Optimal airway management Postsedation 10. Assessment checklist (composite item)
Investigators Mean Score (Intraclass Correlation Coefficient, 0.90) P*
100% T 0%
Composite Score (10-point) Between-scenario composite score $ within group Experimental Group (ne = 12)
Scenario 2
$
Scenario 2
0.4 T 1.5 P = 0.17* P*
Investigators Mean Score (Intraclass Correlation Coefficient, 0.88)
63% T 48% 58% T 51% 75% T 34%
67% T 44% 63% T 48% 100% T 0%
0.90 0.90 0.09
83% T 33%
100% T 0%
0.31
100% T 0%
1
42% T 51% 42% T 51%
100% T 0% 100% T 0%
0.02 0.02
100% T 0% 92% T 29%
100% T 0% 100% T 0%
1 0.75
35% T 11%
55% T 18%
G0.01
100% T 0%
Composite Score (10-point) Between-scenario composite score $ within group
6.9 T 1.8
8.8 T 1.0
$
Between-scenario $ by group ($[$]) P = 0.06* Analysis of groupYbyYsimulation order interaction with binominal generalized linear mixed model
1.9 T 1.9 P G 0.01*
P G 0.01
*MannYWhitney U test (2 tailed, > = 0.05). Text in italics indicates scenario-embedded probe. ETCO2, end-tidal carbon dioxide; SpO2, oxygen saturation (pulse oximetry).
consistently used proper EDPS medications and managed adverse events in a timely manner. Study findings seem to indicate that senior-level EM residents have the medical knowledge base and procedural skill set to perform EDPS but lack some of the nontechnical skills (ie, anticipatory planning and preparing, information exchange/charting, maintaining situational awareness) that pertain to ED microsystem functions and patient safety. Emergency department trainees may therefore benefit from efforts to explicitly instill a broad awareness and greater appreciation for safety measures during routine as well as emergent, clinical situations. Incorporation of this mindset into EM training may be facilitated by simulation methods, wherein the participant’s adherence to (or neglect of ) recommended Vol. 10, Number 3, June 2015
patient safety behaviors can immediately alter scenario progression and effect experiential learning. Accordingly, study findings have been presented at the research site’s EM residency conference and shared with administrative and educational leadersVcurricular adjustments for ongoing residency simulation sessions are anticipated. The insight and lessons learned from SLIPSTREAM assessments are also being applied to the institution-wide, simulation-based in-servicing and credentialing of all sedation providers who perform ‘‘out of operating room’’ procedural sedations. These measures are in concordance with recent, successful efforts at other health care facilities to achieve institutional standardization in provider skill sets and to attain minimum safe performance requirements of sedation practice.40Y46 With respect to * 2015 Society for Simulation in Healthcare
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SLIPSTREAM program continuation, developed materials are available through the AAMC MedEdPORTAL for collaborative educational and investigative efforts.35 As for the research program’s experimental system, the bedside clinical informatics prototype exhibited limited impact on safety behaviors during simulated EDPS. Although the Composite Score metric was seen to improve in the experimental group, this resulted primarily from increased time-out completions rather than a comprehensive adjustment of the subjects’ approach to EDPS patient safety. Despite reasonable functionality as a workflow guidance system with graphical interface, checklists, automated prompts, and reminder systems, the experimental prototype did not improve subjects’ performance of critical actions in several areas. Given the appearance of some positive utility (and general noninferiority of GLIDEPATH-assisted subjects’ performance when compared with the control group’s EDPS conduct), continued development with training module and use testing may be indicated. Limitations Study design precluded blinding of subjects and investigators to group assignment. Sample size was limited by small target pools and available funding, such that there may have been problems with group randomization and the detection of true performance differences (type II error). (The weak correlations between subjects’ training background or self-reported live EDPS experience and their firstsimulation Composite Scores argue against this.) In terms of the EDPS simulation research methodology and its assessment of expert-level performance levels, the Simulation EDPS Safety Composite Score metric was tested during pilot phase sessions only on novice interns and experienced attending EDPS providers. Its ability to serve as a precise, gradational differentiator of provider performance (and EDPS safety) at intermediate and higher levels had not been examined; the effect of the Composite Score’s relatively low resolution, 10-point spectrum, and the potential ceiling effect on study findings are unclear. In addition, the study’s experimental objective precluded the training of subjects on EDPS practiceVthis likely contributed toward the program’s inability to elicit meaningful advancement toward a practice level approximating that of more experienced providers. Testing of the experimental system did not feature formal usability evaluations or a diverse end user sample. It remains unclear why the experimental system’s explicit prompts and checklists were unable to elicit sizeable changes in recognition of high-risk EDPS patients and checking of essential equipment. Problems with the experimental system’s approach (just-in-time exposure without preceding educational component),47 end user difficulties with the novel technology, and research methodology limitations may all have contributed to the underwhelming results.
CONCLUSIONS Advanced simulations were successfully applied in situ to assess EDPS clinical practice and related safety behaviors in senior EM residents. An experimental, just-in-time bedside clinical process guidance system primarily improved 152
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time-out completions without overall improvement in subjects’ in-simulation safety behaviors or performance. ACKNOWLEDGMENT The authors acknowledge Anna C. Cousins for her insight and assistance in manuscript preparation and Dr Jason Machan PhD for the assistance with the statistical analysis. REFERENCES 1. American College of Emergency Physicians (ACEP). Policy Statement on Sedation in the Emergency Department 2011. Available at: acep.org/ Content.aspx?id=75479. Accessed October 30, 2014. 2. O’Connor RE, Sama A, Burton JH, et al. American College of Emergency Physicians Sedation Task Force. Procedural sedation and analgesia in the emergency department: recommendations for physician credentialing, privileging, and practice. Ann Emerg Med 2011;58:365Y370. 3. Green SM. Research advances in procedural sedation and analgesia. Ann Emerg Med 2007;49:31Y36. 4. Miner JR, Krauss B. Procedural sedation and analgesia research: state of the art. Acad Emerg Med 2007;14:170Y178. 5. Miner JR, Martel ML, Meyer M, Reardon R, Biros MH. Procedural sedation of critically ill patients in the emergency department. Acad Emerg Med 2005;12:124Y128. 6. Campbell SG, Magee KD, Kovacs GJ, et al. Procedural sedation and analgesia in a Canadian adult tertiary care emergency department: a case series. CJEM 2006;8:85Y93. 7. Mensour M, Pineau R, Sahai V, Michaud J. Emergency department procedural sedation and analgesia: a Canadian Community Effectiveness and Safety Study (ACCESS). CJEM 2006;8:94Y99. 8. Symington L, McGugam E, Graham C, Gordon M, Thakore S. Training in conscious sedation techniques: meeting the recommendations of the UK Academy of Medical Royal Colleges. Emerg Med J 2007;24:576Y578. 9. Adams ST, Woods C, Lyall H, Higson M. Standards of practice in UK emergency departments before, during and after conscious sedation. Emerg Med J 2008;25:728Y731. 10. Hodkinson PW, James MF, Wallis LA. Emergency department procedural sedation practice in Cape Town, South Africa. Int J Emerg Med 2009;2:91Y97. 11. Miner JR. Procedural sedation and analgesia research. Methods Mol Biol 2010;617:493Y503. 12. Harvey M, Cave G, Betham C. Contemporary sedation practice in a large New Zealand emergency department. N Z Med J 2011;124:36Y45. 13. Smally AJ, Nowicki TA, Simelton BH. Procedural sedation and analgesia in the emergency department. Curr Opin Crit Care 2011;17:317Y322. 14. Weaver CS, Terrell KM, Bassett R, Swiler W, et al. ED procedural sedation of elderly patients: is it safe? Am J Emerg Med 2011;29:541Y544. 15. Pena BM, Krauss B. Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med 1999;34:483Y491. 16. Cote´ CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics 2000;105:805Y814. 17. Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med 2000;342:938Y945. 18. Malviya S, Voepel-Lewis T, Prochaska G, Tait AR. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics 2000;105:E42. 19. Pitetti RD, Singh S, Pierce MC. Safe and efficacious use of procedural sedation and analgesia by nonanesthesiologists in a pediatric emergency department. Arch Pediatr Adolesc Med 2003;157:1090Y1096. 20. Roback MA, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med 2005;12:508Y513.
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