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,
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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
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* 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 |
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