Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR

NCT03921346 | Completed Results

• 1 other identifier: SNSF_32003B_182374
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.

Conditions

Cardiopulmonary Arrest; Resuscitation; Pediatrics; Medication Errors; Emergency Medical Services

Keywords

Medication errors; Drugs; Pediatrics; Biomedical Technology; Mobile applications; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• Medication Dosage Errors

  To measure in each allocation group the number and percentage of medication dosage containing errors that occur during the sequence from drug preparation to drug injection. We define an emergency medication dose administration error as a failure in drug preparation if at least one of the following errors is committed: a deviation in drug dose of more than 10% from the correct weight dose; inability to calculate drug dosage without guidance help from the paramedic investigator (LB) leading the resuscitation in the room; and/or (because of its clinical relevance) a deviation of more than 10% of the final administered concentration of sodium bicarbonate from the prescribed 4.2% concentration. These errors will be measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.

  20 minutes

Secondary Outcomes (5)

• Time to Drug Preparation and Time to Drug Delivery

  20 minutes

• Type of Medication Errors

  During each of the 4 drug preparations, an average of 20 minutes per drug preparation.

• Perceived Stress

  At preintervention and postintervention, a total of 20 minutes will be used to complete the STAI questionnaire.

• Stress Level Measured by Heart Rate Monitoring (Smartwatch).

  Baseline, recovery, and during each of the 4 drug preparations, a total of 20 minutes per participant will be used to continuously record heart rates on the smartwatch. Maximal HRpeak is the maximum HR across all preparations

• Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)

  60 minutes

Study Arms (2)

Arm A (mobile device app)

EXPERIMENTAL

Paramedics preparing drugs with the help of the mobile device app PedAMINES™. Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of the mobile device app PedAMINES™.

Device: Mobile device app (PedAMINES™) 1st drug; Device: Mobile device app (PedAMINES™) 2nd drug; Device: Mobile device app (PedAMINES™) 3rd drug; Device: Mobile device app (PedAMINES™) 4th drug

Arm B (conventional preparation method)

ACTIVE COMPARATOR

Paramedics preparing drugs with the help of conventional method. Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of conventional method

Device: Conventional method 1st drug; Device: Conventional method 2nd drug; Device: Conventional method 3rd drug; Device: Conventional method 4th drug

Interventions

Mobile device app (PedAMINES™) 1st drug DEVICE

To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Arm A (mobile device app)

Mobile device app (PedAMINES™) 2nd drug DEVICE

To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Arm A (mobile device app)

Mobile device app (PedAMINES™) 3rd drug DEVICE

To prepare 4 mL/kg dextrose 10%

Arm A (mobile device app)

Mobile device app (PedAMINES™) 4th drug DEVICE

To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)

Arm A (mobile device app)

Conventional method 1st drug DEVICE

To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)

Arm B (conventional preparation method)

Conventional method 2nd drug DEVICE

To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)

Arm B (conventional preparation method)

Conventional method 3rd drug DEVICE

To prepare 4 mL/kg dextrose 10%

Arm B (conventional preparation method)

Conventional method 4th drug DEVICE

To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)

Arm B (conventional preparation method)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be paramedic certified
• To know how to prepare direct IV drugs
• To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
• Participation agreement

You may not qualify if:

• To have at any time previously used the app PedAMINES™
• To have not undergone the 5-minute introductory course to the use of the app PedAMINES™

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead
• University Hospital, Geneva: collaborator
• University of Lausanne Hospitals: collaborator
• Schutz & Rettung Sanitat: collaborator
• Salva Servizio Ambulanza Locarnese e Valli: collaborator
• Fribourg Emergency Medical Services, Fribourg, Switzerland: collaborator
• Réseau Hospitalier Neuchâtelois: collaborator
• Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland: collaborator

Study Sites (1)

Geneva Emergency Medical Services (ACE Ambulances)

Geneva, 1205, Switzerland

Location

Related Publications (22)

• Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.

  PMID: 30797722 BACKGROUND

• Kaufmann J, Laschat M, Wappler F. Medication errors in pediatric emergencies: a systematic analysis. Dtsch Arztebl Int. 2012 Sep;109(38):609-16. doi: 10.3238/arztebl.2012.0609. Epub 2012 Sep 21.

  PMID: 23093991 BACKGROUND

• Moreira ME, Hernandez C, Stevens AD, Jones S, Sande M, Blumen JR, Hopkins E, Bakes K, Haukoos JS. Color-Coded Prefilled Medication Syringes Decrease Time to Delivery and Dosing Error in Simulated Emergency Department Pediatric Resuscitations. Ann Emerg Med. 2015 Aug;66(2):97-106.e3. doi: 10.1016/j.annemergmed.2014.12.035. Epub 2015 Feb 18.

  PMID: 25701295 BACKGROUND

• Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001 Apr 25;285(16):2114-20. doi: 10.1001/jama.285.16.2114.

  PMID: 11311101 BACKGROUND

• Hoyle JD, Davis AT, Putman KK, Trytko JA, Fales WD. Medication dosing errors in pediatric patients treated by emergency medical services. Prehosp Emerg Care. 2012 Jan-Mar;16(1):59-66. doi: 10.3109/10903127.2011.614043. Epub 2011 Oct 14.

  PMID: 21999707 BACKGROUND

• Hoyle JD Jr, Crowe RP, Bentley MA, Beltran G, Fales W. Pediatric Prehospital Medication Dosing Errors: A National Survey of Paramedics. Prehosp Emerg Care. 2017 Mar-Apr;21(2):185-191. doi: 10.1080/10903127.2016.1227001. Epub 2017 Feb 8.

  PMID: 28257249 BACKGROUND

• Porter E, Barcega B, Kim TY. Analysis of medication errors in simulated pediatric resuscitation by residents. West J Emerg Med. 2014 Jul;15(4):486-90. doi: 10.5811/westjem.2014.2.17922.

  PMID: 25035756 BACKGROUND

• Shah MN, Cushman JT, Davis CO, Bazarian JJ, Auinger P, Friedman B. The epidemiology of emergency medical services use by children: an analysis of the National Hospital Ambulatory Medical Care Survey. Prehosp Emerg Care. 2008 Jul-Sep;12(3):269-76. doi: 10.1080/10903120802100167.

  PMID: 18584491 BACKGROUND

• Su E, Schmidt TA, Mann NC, Zechnich AD. A randomized controlled trial to assess decay in acquired knowledge among paramedics completing a pediatric resuscitation course. Acad Emerg Med. 2000 Jul;7(7):779-86. doi: 10.1111/j.1553-2712.2000.tb02270.x.

  PMID: 10917328 BACKGROUND

• Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.

  PMID: 23339874 BACKGROUND

• Andersen LW, Berg KM, Saindon BZ, Massaro JM, Raymond TT, Berg RA, Nadkarni VM, Donnino MW; American Heart Association Get With the Guidelines-Resuscitation Investigators. Time to Epinephrine and Survival After Pediatric In-Hospital Cardiac Arrest. JAMA. 2015 Aug 25;314(8):802-10. doi: 10.1001/jama.2015.9678.

  PMID: 26305650 BACKGROUND

• Hansen M, Schmicker RH, Newgard CD, Grunau B, Scheuermeyer F, Cheskes S, Vithalani V, Alnaji F, Rea T, Idris AH, Herren H, Hutchison J, Austin M, Egan D, Daya M; Resuscitation Outcomes Consortium Investigators. Time to Epinephrine Administration and Survival From Nonshockable Out-of-Hospital Cardiac Arrest Among Children and Adults. Circulation. 2018 May 8;137(19):2032-2040. doi: 10.1161/CIRCULATIONAHA.117.033067. Epub 2018 Mar 6.

  PMID: 29511001 BACKGROUND

• Fukuda T, Kondo Y, Hayashida K, Sekiguchi H, Kukita I. Time to epinephrine and survival after paediatric out-of-hospital cardiac arrest. Eur Heart J Cardiovasc Pharmacother. 2018 Jul 1;4(3):144-151. doi: 10.1093/ehjcvp/pvx023.

  PMID: 29036580 BACKGROUND

• Foltin GL, Richmond N, Treiber M, Skomorowsky A, Galea S, Vlahov D, Blaney S, Kusick M, Silverman R, Tunik MG. Pediatric prehospital evaluation of NYC cardiac arrest survival (PHENYCS). Pediatr Emerg Care. 2012 Sep;28(9):864-8. doi: 10.1097/PEC.0b013e3182675e70.

  PMID: 22929131 BACKGROUND

• Rittenberger JC, Bost JE, Menegazzi JJ. Time to give the first medication during resuscitation in out-of-hospital cardiac arrest. Resuscitation. 2006 Aug;70(2):201-6. doi: 10.1016/j.resuscitation.2005.12.006. Epub 2006 Jun 27.

  PMID: 16806636 BACKGROUND

• Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.

  PMID: 22209829 BACKGROUND

• Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M; International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE) Reporting Guidelines Investigators. Reporting Guidelines for Health Care Simulation Research: Extensions to the CONSORT and STROBE Statements. Simul Healthc. 2016 Aug;11(4):238-48. doi: 10.1097/SIH.0000000000000150.

  PMID: 27465839 BACKGROUND

• Venkatesh, V., Morris, M. G., Davis, G. B., & Davis, F. D. (2003). User acceptance of information technology: Toward a unified view. MIS quarterly, 425-478.

  BACKGROUND

• Siebert JN, Gosetto L, Sauvage M, Bloudeau L, Suppan L, Rodieux F, Haddad K, Hugon F, Gervaix A, Lovis C, Combescure C, Manzano S, Ehrler F; PedAMINES Trial Group; PedAMINES Prehospital Group. Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials. JMIR Hum Factors. 2022 Mar 1;9(1):e35399. doi: 10.2196/35399.

  PMID: 35230243 DERIVED

• Lacour M, Bloudeau L, Combescure C, Haddad K, Hugon F, Suppan L, Rodieux F, Lovis C, Gervaix A, Ehrler F, Manzano S, Siebert JN; PedAMINES Prehospital Group. Impact of a Mobile App on Paramedics' Perceived and Physiologic Stress Response During Simulated Prehospital Pediatric Cardiopulmonary Resuscitation: Study Nested Within a Multicenter Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Oct 7;9(10):e31748. doi: 10.2196/31748.

  PMID: 34617916 DERIVED

• Siebert JN, Bloudeau L, Combescure C, Haddad K, Hugon F, Suppan L, Rodieux F, Lovis C, Gervaix A, Ehrler F, Manzano S; Pediatric Accurate Medication in Emergency Situations (PedAMINES) Prehospital Group. Effect of a Mobile App on Prehospital Medication Errors During Simulated Pediatric Resuscitation: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2123007. doi: 10.1001/jamanetworkopen.2021.23007.

  PMID: 34459905 DERIVED

• Siebert JN, Bloudeau L, Ehrler F, Combescure C, Haddad K, Hugon F, Suppan L, Rodieux F, Lovis C, Gervaix A, Manzano S. A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial. Trials. 2019 Nov 20;20(1):634. doi: 10.1186/s13063-019-3726-4.

  PMID: 31747951 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Johan N. Siebert
• Organization: University Hospitals of Geneva

Johan.Siebert@hcuge.ch

+41795534072

Study Officials

• Johan N Siebert, MD

  Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding to the direct IV drugs and doses intended for use will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and not released until the paramedics start the scenario. Study team members will be revealed to the participants just before the scenario starts. Paramedics will be unblinded when the simulated scenario starts. Although the intervention could not be masked, all investigators will remain unaware of the outcomes until all data will be unlocked for analysis at the end of the trial. All scenarios will be video-recorded for later analysis. Post-scenario video review will be done without blinding by two reviewers, but undertaken independently and blinded to each other's reviews. In case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD: Deputy Head

Model Details: Prospective, multicenter, randomized, controlled trial

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 19, 2019
• Study Start: September 3, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available from 1 month to 10 years after trial publication.
• Access Criteria: From the corresponding author upon reasonable request.

Locations

CH (1)