Pediatrics Clinical Trial
Official title:
A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial
Verified date | June 2021 |
Source | Pediatric Clinical Research Platform |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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™ |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva Emergency Medical Services (ACE Ambulances) | Geneva |
Lead Sponsor | Collaborator |
---|---|
Pediatric Clinical Research Platform | Fribourg Emergency Medical Services, Fribourg, Switzerland, Geneva Emergency Medical Services, Geneva, Switzerland, Lausanne Emergency Medical Services, Lausanne, Switzerland, Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland, Neuchâtel Emergency Medical Services, Neuchâtel, Switzerland, Ticino Emergency Medical Services (SALVA Servizio Ambulanza Locarnese e Valli), Ticino, switzerland, Zürich Emergency Medical Services (Schutz & Rettung Sanität), Zürich, Switzerland |
Switzerland,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2006 Jun 27. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication dosage errors | To measure in each allocation group the number and proportion 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 | Time to drug preparation and time to drug delivery | Secondary outcome will be the elapsed time in seconds between the oral prescription by the physician and a) time to drug preparation completion and b) time to drug delivery by the participant. | 20 minutes | |
Secondary | Type of medication errors | Error in transcription of the physician's order into the medication dose, wrong choice of drug, wrong vial's initial concentration, wrong air purge out of the syringe before injection, stage of error detection: before or after injection, and aseptic errors will be measured. | 20 minutes | |
Secondary | Stress perceived and satisfaction | A 3-item questionnaire using a 10-point Likert scale will be provided to the participants to measure their perceived stress and satisfaction about the preparation method used during the resuscitation scenario.
The questionnaire measures (1) the stress perceived before the scenario starts (On a scale from 1 to 10, how stressed are you now?), (2) the overall stress perceived at the end of the scenario (On a scale of 1 to 10, how stressed [maximum reached] were you during the drug preparation period?), and (3) the satisfaction about the preparation method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your preparation experience?) Scale ranges: from 0 (minimum score) to 10 (maximum score), increments are integers between 0 to 10. For stress, higher values represent a worse score, whereas for satisfaction higher values represent a better score. No subscales will be combined. |
20 minutes | |
Secondary | Stress level measured by heart rate monitoring (smartwatch). | The participants' stress level will be assessed by measuring continuously their heart rate using a Polar A360 smartwatch on their wrist during the resuscitation scenario. Mean delta HR values (difference between HR peak values and baseline HR) will be obtained during some small segments of scenario and correlated to the scenario phases and the preparation methods used. | 20 minutes | |
Secondary | Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire | Acceptability and usability testing of the app will be assessed using a 52-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance.
The questionnaire has 52 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5. |
60 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05975658 -
WIReD: Wireless Interstage Remote Device Study
|
||
Not yet recruiting |
NCT04087070 -
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
|
||
Completed |
NCT04301206 -
Videos and Simple Text to Empower Parents to Handle Their Sick Children
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Recruiting |
NCT05480930 -
Improving Nighttime Access to Care and Treatment; Part 4-Haiti
|
N/A | |
Not yet recruiting |
NCT05815563 -
Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
|
||
Recruiting |
NCT02908113 -
Visual Perception in Preterm Infants
|
N/A | |
Recruiting |
NCT02556541 -
Ultrasound-guided Peripheral Vascular Access in Children
|
N/A | |
Not yet recruiting |
NCT01678066 -
A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor
|
N/A | |
Completed |
NCT04993599 -
Evaluation of Social Robot Usability for Pediatric Patients and Carers
|
N/A | |
Completed |
NCT05537168 -
Bayesian Networks in Pediatric Cardiac Surgery
|
||
Completed |
NCT01603628 -
BOTOX® Treatment in Pediatric Lower Limb Spasticity
|
Phase 3 | |
Completed |
NCT01603615 -
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
|
Phase 3 | |
Completed |
NCT06098105 -
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
|
N/A | |
Completed |
NCT01418846 -
Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients
|
N/A | |
Completed |
NCT01460329 -
Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO
|
N/A | |
Withdrawn |
NCT00666393 -
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
|
Phase 3 | |
Recruiting |
NCT03337581 -
Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric
|
Phase 4 | |
Recruiting |
NCT05275881 -
Impact of Virtual Reality in Pediatric Hematology and Oncology
|
N/A | |
Recruiting |
NCT06146465 -
Mobile Health Applications in Pediatric Patient Management: Clinicians' Perceptions, Expectations and Experiences
|