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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.

ABSTRACT: BACKGROUND:Emergency drug preparation and administration in children is both complex and time-consuming and places this population at a higher risk than adults for medication errors. Moreover, survival and a favorable neurological outcome from cardiopulmonary resuscitation are inversely correlated to drug preparation time. We developed a mobile device application (the pediatric Accurate Medication IN Emergency Situations (PedAMINES) app) as a step-by-step guide for the preparation to delivery of drugs requiring intravenous injection. In a previous multicenter randomized trial, we 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 pediatric resuscitations. This trial aims to evaluate the effectiveness of this app during pediatric out-of-hospital cardiopulmonary resuscitation. METHODS/DESIGN:We will conduct a multicenter, prospective, randomized controlled trial to compare the PedAMINES app with conventional calculation methods for the preparation of direct intravenously administered emergency medications during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios using a high-fidelity manikin. One hundred and twenty paramedics will be randomized (1:1) in several emergency medical services located in different regions of Switzerland. Each paramedic will be asked to prepare, sequentially, four intravenously administered emergency medications using either the app or conventional methods. The primary endpoint is the medication error rates. Enrollment will start in mid-2019 and data analysis in late 2019. We anticipate that the intervention will be completed in early 2020 and study results will be submitted in late 2020 for publication (expected in early 2021). DISCUSSION:This clinical trial will assess the impact of an evidence-based mobile device app to reduce the rate of medication errors, time to drug preparation and time to drug delivery during prehospital pediatric resuscitation. As research in this area is scarce, the results generated from this study will be of great importance and may be sufficient to change and improve prehospital pediatric emergency care practice. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03921346. Registered on 18 April 2019.

SUBMITTER: Siebert JN

PROVIDER: S-EPMC6868759 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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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.

Siebert Johan N JN Bloudeau Laurie L Ehrler Frédéric F Combescure Christophe C Haddad Kevin K Hugon Florence F Suppan Laurent L Rodieux Frédérique F Lovis Christian C Gervaix Alain A Manzano Sergio S

Trials 20191120 1

<h4>Background</h4>Emergency drug preparation and administration in children is both complex and time-consuming and places this population at a higher risk than adults for medication errors. Moreover, survival and a favorable neurological outcome from cardiopulmonary resuscitation are inversely correlated to drug preparation time. We developed a mobile device application (the pediatric Accurate Medication IN Emergency Situations (PedAMINES) app) as a step-by-step guide for the preparation to del ...[more]

PMID: 31747951

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Project description:ImportanceMedication errors are a leading cause of injury and avoidable harm, affecting millions of people worldwide each year. Children are particularly susceptible to medication errors, but innovative interventions for the prevention of these errors in prehospital emergency care are lacking.ObjectiveTo assess the efficacy of an evidence-based mobile app in reducing the occurrence of medication errors compared with conventional preparation methods during simulated pediatric out-of-hospital cardiac arrest scenarios.Design, setting, and participantsThis nationwide, open-label, multicenter, randomized clinical trial was conducted at 14 emergency medical services centers in Switzerland from September 3, 2019, to January 21, 2020. The participants were 150 advanced paramedics with drug preparation autonomy. Each participant was exposed to a 20-minute, standardized, fully video-recorded, realistic pediatric out-of-hospital cardiac arrest cardiopulmonary resuscitation scenario concerning an 18-month-old child. Participants were tested on sequential preparations of 4 intravenous emergency drugs of varying degrees of preparation difficulty (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate).InterventionParticipants were randomized (1:1 ratio) to the support of an app designed to assist with pediatric drug preparation (intervention; n = 74) or to follow conventional drug preparation methods without assistance (control; n = 76).Main outcomes and measuresThe primary outcome was the rate of medication errors, defined as a failure in drug preparation according to predefined, expert consensus-based criteria. Logistic regression models with mixed effects were used to assess the effect of the app on binary outcomes. Secondary outcomes included times to drug preparation and delivery, assessed with linear regression models with mixed effects.ResultsIn total, 150 advanced paramedics (mean [SD] age, 35.6 [7.2] years; 101 men [67.3%]; mean [SD] time since paramedic certification, 8.0 [6.2] years) participated in the study and completed 600 drug preparations. Of 304 preparations delivered using the conventional method, 191 (62.8%; 95% CI, 57.1%-68.3%) were associated with medication errors compared with 17 of 296 preparations delivered using the app (5.7%; 95% CI, 3.4%-9.0%). When accounting for repeated measures, with the app, the proportion of medication errors decreased in absolute terms by 66.5% (95% CI, 32.6%-83.8%; P < .001), the mean time to drug preparation decreased by 40 seconds (95% CI, 23-57 seconds; P < .001), and the mean time to drug delivery decreased by 47 seconds (95% CI, 27-66 seconds; P < .001). The risk of medication errors varied across drugs with conventional methods (19.7%-100%) when compared with the app (4.1%-6.8%).Conclusions and relevanceCompared with conventional methods, the use of a mobile app significantly decreased the rate of medication errors and time to drug delivery for emergency drug preparation in a prehospital setting. Dedicated mobile apps have the potential to improve medication safety and change practices in pediatric emergency medicine.Trial registrationClinicalTrials.gov Identifier: NCT03921346.

Project description:BACKGROUND:During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. OBJECTIVE:The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. METHODS:The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. RESULTS:A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95% CI 102-154) and 308.1 s (95% CI 216-400), respectively (180 s reduction, P=.002). Mean TDD was 214 s (95% CI 171-256) and 391 s (95% CI 298-483), respectively (177.3 s reduction, P=.002). Medication errors were reduced from 70% to 0% (P<.001) by using PedAMINES when compared with conventional methods. CONCLUSIONS:In this simulation-based study, PedAMINES dramatically reduced TDP, to delivery and the rate of medication errors.

Project description:BACKGROUND:During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. OBJECTIVE:The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. METHODS:This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral prescription by the physician to drug delivery by the nurse in each allocation group. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by questionnaire and recorded by the heart rate monitor of a fitness watch. The study is formatted according to the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) and the Reporting Guidelines for Health Care Simulation Research. RESULTS:Enrollment and data analysis started in March 2017. We anticipate the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid-2018. Results will be reported in line with recommendations from CONSORT-EHEALTH and the Reporting Guidelines for Health Care Simulation Research . CONCLUSIONS:This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to drug delivery during pediatric resuscitation. As research in this area is scarce, results generated from this study will be of great importance and might be sufficient to change and improve the pediatric emergency care practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122 (Archived by WebCite at http://www.webcitation.org/6nfVJ5b4R).

Project description:BackgroundOut-of-hospital cardiac arrests (OHCAs) are stressful, high-stake events that are associated with low survival rates. Acute stress experienced in this situation is associated with lower cardiopulmonary resuscitation performance in calculating drug dosages by emergency medical services. Children are particularly vulnerable to such errors. To date, no app has been validated to specifically support emergency drug preparation by paramedics through reducing the stress level of this procedure and medication errors.ObjectiveThis study aims to determine the effectiveness of an evidence-based mobile app compared with that of the conventional preparation methods in reducing acute stress in paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios.MethodsIn a parent, multicenter, randomized controlled trial of 14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy was assessed during a 20-minute, standardized, fully video-recorded, and highly realistic pediatric OHCA scenario in an 18-month-old child. The primary outcome was participants' self-reported psychological stress perceived during sequential preparations of 4 intravenous emergency drugs (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate) with the support of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app designed to help pediatric drug preparation (intervention) or conventional methods (control). The State-Trait Anxiety Inventory and Visual Analog Scale questionnaires were used to measure perceived stress. The secondary outcome was physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography.ResultsFrom September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization. A total of 74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group). A total of 600 drug doses were prepared. Higher State-Trait Anxiety Inventory-perceived stress increase from baseline was observed during the scenario using the conventional methods (mean 35.4, SD 8.2 to mean 49.8, SD 13.2; a 41.3%, 35.0 increase) than when using the app (mean 36.1, SD 8.1 to mean 39.0, SD 8.4; a 12.3%, 29.0 increase). This revealed a 30.1% (95% CI 20.5%-39.8%; P<.001) lower relative change in stress response in participants who used the app. On the Visual Analog Scale questionnaire, participants in the control group reported a higher increase in stress at the peak of the scenario (mean 7.1, SD 1.8 vs mean 6.4, SD 1.9; difference: -0.8, 95% CI -1.3 to -0.2; P=.005). Increase in heart rate during the scenario and over the 4 drugs was not different between the 2 groups.ConclusionsCompared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations. These findings can help advance the development and evaluation of mobile apps for OHCA management and should be encouraged.Trial registrationClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346.International registered report identifier (irrid)RR2-10.1186/s13063-019-3726-4.

Project description:BackgroundReporting of medication errors is one of the essential mechanisms to identify risky health care systems and practices that lead to medication errors. Unreported medication errors are a real issue; one of the identified causes is a burdensome medication error reporting system. An anonymous and user-friendly mobile app for reporting medication errors could be an alternative method of reporting medication error in busy health care settings.ObjectiveThe objective of this paper is to report usability testing of the Medication Error Reporting App (MERA), a mobile app for reporting medication errors anonymously.MethodsQuantitative and qualitative methods were employed involving 45 different testers (pharmacists, doctors, and nurses) from a large tertiary hospital in Malaysia. Quantitative data was retrieved using task performance and rating of MERA and qualitative data were retrieved through focus group discussions. Three sessions, with 15 testers each session, were conducted from January to March 2018.ResultsThe majority of testers were pharmacists (23/45, 51%), female (35/45, 78%), and the mean age was 36 (SD 9) years. A total of 135 complete reports were successfully submitted by the testers (three reports per tester) and 79.2% (107/135) of the reports were correct. There was significant improvement in mean System Usability Scale scores in each session of the development process (P<.001) and mean time to report medication errors using the app was not significantly different between each session (P=.70) with an overall mean time of 6.7 (SD 2.4) minutes. Testers found the app easy to use, but doctors and nurses were unfamiliar with terms used especially medication process at which error occurred and type of error. Although, testers agreed the app can be used in the future for reporting, they were apprehensive about security, validation, and abuse of feedback featured in the app.ConclusionsMERA can be used to report medication errors easily by various health care personnel and it has the capacity to provide feedback on reporting. However, education on medication error reporting should be provided to doctors and nurses in Malaysia and the security of the app needs to be established to boost reporting by this method.

Project description:BACKGROUND:Evidence-based best practices are the cornerstone to guide optimal cardiopulmonary arrest resuscitation care. Adherence to the American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite advances in resuscitation science and survival improvement over the last decades, only approximately 38% of children survive to hospital discharge after in-hospital cardiac arrest and only 6%-20% after out-of-hospital cardiac arrest. OBJECTIVE:We investigated whether a mobile app developed as a guide to support and drive CPR providers in real time through interactive pediatric advanced life support (PALS) algorithms would increase adherence to AHA guidelines and reduce the time to initiation of critical life-saving maneuvers compared to the use of PALS pocket reference cards. METHODS:This study was a randomized controlled trial conducted during a simulation-based pediatric cardiac arrest scenario caused by pulseless ventricular tachycardia (pVT). A total of 26 pediatric residents were randomized into two groups. The primary outcome was the elapsed time in seconds in each allocation group from the onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, including the time intervals between defibrillation attempts and drug doses, shock doses, and the number of shocks. All outcomes were assessed for deviation from AHA guidelines. RESULTS:Mean time to the first defibrillation attempt (121.4 sec, 95% CI 105.3-137.5) was significantly reduced among residents using the app compared to those using PALS pocket cards (211.5 sec, 95% CI 162.5-260.6, P<.001). With the app, 11 out of 13 (85%) residents initiated chest compressions within 60 seconds from the onset of pVT and 12 out of 13 (92%) successfully defibrillated within 180 seconds. Time to all other defibrillation attempts was reduced with the app. Adherence to the 2018 AHA pVT algorithm improved by approximately 70% (P=.001) when using the app following all CPR sequences of action in a stepwise fashion until return of spontaneous circulation. The pVT rhythm was recognized correctly in 51 out of 52 (98%) opportunities among residents using the app compared to only 19 out of 52 (37%) among those using PALS cards (P<.001). Time to epinephrine injection was similar. Among a total of 78 opportunities, incorrect shock or drug doses occurred in 14% (11/78) of cases among those using the cards. These errors were reduced to 1% (1/78, P=.005) when using the app. CONCLUSIONS:Use of the mobile app was associated with a shorter time to first and subsequent defibrillation attempts, fewer medication and defibrillation dose errors, and improved adherence to AHA recommendations compared with the use of PALS pocket cards.

Dataset Information

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.

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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.

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