Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
Primary Purpose
Cardiopulmonary Arrest, Resuscitation, Pediatrics
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mobile device app (PedAMINES™) 1st drug
Mobile device app (PedAMINES™) 2nd drug
Mobile device app (PedAMINES™) 3rd drug
Mobile device app (PedAMINES™) 4th drug
Conventional method 1st drug
Conventional method 2nd drug
Conventional method 3rd drug
Conventional method 4th drug
Sponsored by
About this trial
This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring Medication errors, Drugs, Pediatrics, Biomedical Technology, Mobile applications, Emergency Medical Services
Eligibility Criteria
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™
Sites / Locations
- Geneva Emergency Medical Services (ACE Ambulances)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A (mobile device app)
Arm B (conventional preparation method)
Arm Description
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™.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03921346
First Posted
April 12, 2019
Last Updated
June 5, 2021
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
1. Study Identification
Unique Protocol Identification Number
NCT03921346
Brief Title
Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest, Resuscitation, Pediatrics, Medication Errors, Emergency Medical Services
Keywords
Medication errors, Drugs, Pediatrics, Biomedical Technology, Mobile applications, Emergency Medical Services
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicenter, randomized, controlled trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (mobile device app)
Arm Type
Experimental
Arm Description
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™.
Arm Title
Arm B (conventional preparation method)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Mobile device app (PedAMINES™) 1st drug
Intervention Description
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Intervention Type
Device
Intervention Name(s)
Mobile device app (PedAMINES™) 2nd drug
Intervention Description
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Intervention Type
Device
Intervention Name(s)
Mobile device app (PedAMINES™) 3rd drug
Intervention Description
To prepare 4 mL/kg dextrose 10%
Intervention Type
Device
Intervention Name(s)
Mobile device app (PedAMINES™) 4th drug
Intervention Description
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
Intervention Type
Device
Intervention Name(s)
Conventional method 1st drug
Intervention Description
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Intervention Type
Device
Intervention Name(s)
Conventional method 2nd drug
Intervention Description
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Intervention Type
Device
Intervention Name(s)
Conventional method 3rd drug
Intervention Description
To prepare 4 mL/kg dextrose 10%
Intervention Type
Device
Intervention Name(s)
Conventional method 4th drug
Intervention Description
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
Primary Outcome Measure Information:
Title
Medication dosage errors
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Time to drug preparation and time to drug delivery
Description
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.
Time Frame
20 minutes
Title
Type of medication errors
Description
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.
Time Frame
20 minutes
Title
Stress perceived and satisfaction
Description
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.
Time Frame
20 minutes
Title
Stress level measured by heart rate monitoring (smartwatch).
Description
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.
Time Frame
20 minutes
Title
Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire
Description
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.
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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™
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan N Siebert, MD
Organizational Affiliation
Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva Emergency Medical Services (ACE Ambulances)
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
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Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
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