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

June 5, 2021 updated by: Johan Siebert, Pediatric Clinical Research Platform

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children represent a vulnerable population with specific medical needs compared to adults. Fast, accurate, and safe preparation and administration of IV drugs is both complex and time consuming in pediatric critical situations, such as cardiopulmonary resuscitation (CPR). Most drugs given IV to children are provided in vials originally prepared for the adult population, which leads to the need for a specific individual, weight-based drug dose calculation and preparation for each child that varies widely across age groups. This error-prone process and the lower dosing error tolerance of children place them at a high risk for life-threatening medication errors. Despite well equipped and staffed environments with numerous available safeguards, direct IV medication errors have been reported in up to 41% of cases during simulated in-hospital pediatric resuscitations, 65% of which were incorrect medication dosage, making it the most common error. The rate of errors is also important in the prehospital setting, occurring in more than 30% of all pediatric drugs administered. As paramedics have little exposure to critically ill children, they have limited opportunities to administer resuscitation drugs at pediatric doses and to train this skill.

Moreover, in resuscitation, time is inversely correlated to survival. During the first 15 min of in-hospital pediatric CPR, survival and favorable neurological outcome decrease linearly by 2,1% and 1,2% per min, respectively, and rely in part on drug preparation time either in- or out-of-hospital. Among non-shockable pediatric out-of-hospital cardiac arrests, each minute delay to epinephrine delivery is associated with 9% decrease in the odds of survival. Regrettably, in the prehospital setting, the majority of patients receive epinephrine more than 10 minutes after EMS arrival. The chain of survival therefore critically relies on early out-of-hospital CPR by EMS, and onsite administration of IV emergency drugs without delay before a rapid transfer to pediatric emergency departments and advanced care.

In a previous multicenter, randomized crossover trial, medication errors, time to drug preparation, and time to drug delivery for continuous infusions during simulation-based pediatric in-hospital postcardiac arrest scenarios were significantly reduced by using a mobile device app - the pediatric accurate medication in emergency situations (PedAMINES™) app - designed to help pediatric drug preparation.

The present multicenter trial aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios. The investigators hypothesized that use of the app might extend and scale up the previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.

In this trial, the investigators will recruit paramedics in many EMS in Switzerland to prepare direct IV emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario with a high-fidelity WiFi manikin (Laerdal SimBaby). The scenario will take place out-of-hospital in a simulated children's room to increase realism.

On the day of participation after random allocation (1:1 allocation ratio), each participating paramedic will (1) complete a survey collecting data regarding their demographics, care training, and simulation and computer experience, (2) receive a standardized 5-min training session on how to use the app, and (3) be presented the simulation manikin characteristics. The paramedics will then be asked to perform a 20-min highly realistic pediatric CPR scenario on the high-fidelity manikin. Each paramedic will be asked to prepare sequentially 4 intravenous emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of the mobile app. The procedure is standardized across all sites to follow the same chronological progression and range of difficulty to ensure each participant is exposed to exactly the same case, with similar challenges in decision making and treatment preparation provided on the same manikin.

All the actions (i.e. primary and secondary outcomes) performed by the paramedics during the scenario will be automatically recorded and stored by the responsive simulator detectors, the app, and by several GoPro Hero 5 Black edition action video cameras worn by the paramedics and placed within the room.

The study will be carried out in accordance with the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) guidelines and the Reporting Guidelines for Health Care Simulation Research.

This study aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios, were paramedics are little exposed to pediatric CPRs. The investigators hypothesize that use of the app might extend and scale up their previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva Emergency Medical Services (ACE Ambulances)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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™

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A (mobile device app)

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
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Device: Mobile device app (PedAMINES™) 2nd drug
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Device: Mobile device app (PedAMINES™) 3rd drug
To prepare 4 mL/kg dextrose 10%
Device: Mobile device app (PedAMINES™) 4th drug
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
ACTIVE_COMPARATOR: Arm B (conventional preparation method)

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
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Device: Conventional method 2nd drug
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Device: Conventional method 3rd drug
To prepare 4 mL/kg dextrose 10%
Device: Conventional method 4th drug
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication dosage errors
Time Frame: 20 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to drug preparation and time to drug delivery
Time Frame: 20 minutes
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
Type of medication errors
Time Frame: 20 minutes
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
Stress perceived and satisfaction
Time Frame: 20 minutes

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
Stress level measured by heart rate monitoring (smartwatch).
Time Frame: 20 minutes
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
Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire
Time Frame: 60 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatric Clinical Research Platform

Collaborators

Geneva Emergency Medical Services, Geneva, Switzerland
Lausanne Emergency Medical Services, Lausanne, Switzerland
Zürich Emergency Medical Services (Schutz & Rettung Sanität), Zürich, Switzerland
Ticino Emergency Medical Services (SALVA Servizio Ambulanza Locarnese e Valli), Ticino, switzerland
Fribourg Emergency Medical Services, Fribourg, Switzerland
Neuchâtel Emergency Medical Services, Neuchâtel, Switzerland
Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2019

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (ACTUAL)

April 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNSF_32003B_182374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.

IPD Sharing Time Frame

Available from 1 month to 10 years after trial publication.

IPD Sharing Access Criteria

From the corresponding author upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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