Reducing Medication Errors and Time to Drugs Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter RCT

Pediatrics Clinical Trial

Official title:

Reducing Medication Errors and Time to Vasoactive Drugs Preparation and Delivery During Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021122
• Other study ID #: SNSF_32003B_169348
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: January 29, 2018
• Start date: March 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Pediatric Clinical Research Platform
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them step-by-step from order to delivery of these drugs.

1. Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.

2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).

Description:

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. It is well established that CPR duration is inversely correlated to survival, decreasing linearly by 2.1 % per minute, and to decreased risk of neurological sequelae [1].

In this study, the investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or divisions to prepare continuous infusions of vasoactive drugs during a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin (Laerdal SimJunior™). The scenario will take place in the shock room to increase realism.

According to randomization with a 1:1 allocation ratio, nurses will have to prepare and deliver vasoactive drugs following their current conventional methods or by the aim of a mobile tablet application called PedAMINES™ (Pediatric Accurate Medication In Emergency Situations). PedAMINES™ is designed to support nurses step-by-step from order to delivery of a wide range of drugs, especially those requiring continuous infusion. PedAMINES™ has already been shown in a single-center simulation-based study to reduce time to vasoactive drug preparation, to delivery and the rate of medication errors [2].

On the day of participation, after obtaining nurse's written informed consent and randomization, nurses will receive a standardized 5-minute training session on how to use the app. Then, the nurses will be asked to perform a standardized 15-minute highly realistic CPR scenario, including post-return of spontaneous circulation (ROSC). After epinephrine-induced ROSC, nurses will be asked to first prepare a continuous infusion of dopamine, using either PedAMINES™ or a conventional method, and then a continuous infusion of norepinephrine by crossing the procedure. Moreover, 2 questionnaires will be given before and after the scenario to ask the nurses about their demographics data, perceived stress and degree of satisfaction.

1. Primary outcome will be to measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.

2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug delivery (TDD).

All the actions (i.e. primary and secondary outcomes) performed by the nurses during the scenario will be automatically recorded and stored by the responsive simulator detectors, the application and by several video cameras. To avoid assessment bias, two evaluators will then independently review these video recordings. In case of disagreement, a third independent evaluator will help reach a consensus.

We aim to determine whether the use of PedAMINES™ might improve the management of acute life-threatening conditions by quickly delivering expertise in vasoactive drugs administration in other hospitals in Switzerland, even in non-university hospitals where nurses (and physicians) are either little or not exposed to pediatric CPRs. We hypothesize that PedAMINES™ might primary reduce medication errors, and secondary reduce delays to drugs preparation and delivery independently of the existing conventional preparation methods or nurses' skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be nurse certified

• To know how to prepare intravenous drugs injection.

• To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study.

• Participation agreement

Exclusion Criteria:

• To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation.

• To have not undergone the 5-minute introductory course to the use of PedAMINES.

Related Conditions & MeSH terms

• Pediatrics
• Resuscitation

Intervention

Device:
• PedAMINES™ / Conventional Method
Each nurse will be asked to prepare a 5 µg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 µg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • PedAMINES™ (Period 1) and then Conventional Method (Period 2)
• Conventional Method / PedAMINES™
Each nurse will be asked to prepare a 5 µg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 µg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Conventional Method (Period 1) and then PedAMINES™ (Period 2)

Locations

Country	Name	City	State
Switzerland	Inselspital Bern	Bern
Switzerland	HFR Fribourg	Fribourg
Switzerland	Geneva Children's Hospital, Geneva University Hospitals	Geneva
Switzerland	Hôpital de l'Enfance (HEL)	Lausanne	Vaud
Switzerland	Hôpital Neuchâtelois	Neuchâtel
Switzerland	Hôpital du Valais	Sion	Valais

Sponsors (7)

Lead Sponsor	Collaborator
Pediatric Clinical Research Platform	Fribourg Hospital, Fribourg, Switzerland, Neuchâtel Hospital, Neuchâtel, Switzerland, Sion Hospital, Sion, Switzerland, University Hospital Inselspital, Berne, University of Geneva, Switzerland, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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

Siebert JN, Ehrler F, Combescure C, Lacroix L, Haddad K, Sanchez O, Gervaix A, Lovis C, Manzano S. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 1;19(2):e31. doi: 10.2196/jmir.7005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication dosage errors	To measure in each allocation group the number of medication dosage errors committed during each drug preparation sequence until injection.	On the day of study participation
Secondary	Time to drug preparation (TDP) and time to drug delivery (TDD)	To measure in each allocation group the elapsed time in seconds between the oral prescription by the physician to drug preparation completion by the nurse (TDP) and to drug delivery (TDD) by the nurse.	On the day of study participation