Assessing the Impact of a Mobile Device App to Improve Emergency Care Efficiency and Remote Collaborative and Synchronous Communication in a Pediatric Emergency Department: a Pilot Randomized Controlled Trial
Phase: NA
Conditions: Pediatric Emergency Medicine, Communication
Sponsor: Pediatric Clinical Research Platform

 
v1.0, 15.07.2021 
1/4 
Study Protocol 
 
 
Name of the project: 
International name: PIMPmyHospital (local name: PIMPmyHUG) 
Name of the institution: 
Geneva Children’s Hospital, Geneva University Hospitals 
Name of the PI: 
Dr Johan N. Siebert 
Affiliation 
Children’s Hospital, Geneva University Hospitals, 47 Avenue de la 
Roseraie, 1205 Geneva, Switzerland, contact: Johan.Siebert@hcuge.ch 
National Clinical Trial 
Identifier Number 
NCT05203146 
Registered on 
Jan 21, 2022 
Funding 
None 
Sponsor 
None 
Version number 
v.1.0, Jul 15, 2021 
 
 
Objective(s)/Aim: 
To assess the impact of a newly developed mobile application 
(PIMPmyHospital) on pediatric emergency physicians and nurses to 
improve remote collaborative and synchronous communication in a 
pediatric emergency department (via a chat messaging system) and to 
reduce the time spent walking/traveling in between destinations 
(emergency rooms, etc.) when caring for patients, when compared to 
current methods not using the mobile app. This app aims to provide relevant 
information in real-time about the patients they care for, as well as a secure 
chat and messaging platform to virtually connect physicians and nurses 
caring for the same patients. 
Outcome/Endpoints 
Primary outcome 
The time taken (in minutes, within a upper time limit set at 120 minutes) for 
each allocation group to consider new laboratory results, whether accessed 
through the mobile app or the institutional Electronic Health Record (EHR) 
patient data system, from the point of availability to participant review on 
the designated medium (mobile app or EHR). 
 
Secondary outcomes 
The time elapsed (in minutes, within a upper time limit set at 120 minutes) 
from the notification received by the participant through the mobile app or 
a statement from a study investigator (conventional method), indicating that 
a nurse needed assistance for a technical procedure, up to the moment 
when the participant reached the designated nurse. 
Project design and 
procedures 
This will be a single-center, non-blind, two-arm, randomized, controlled pilot 
trial. This study aims to assess two methods for processing laboratory 
results (specifically, the post-analytical phase) and facilitating collaborative 
actions in standardized, semi-simulated scenarios mimicking everyday 
situations within a Pediatric Emergency Department (PED). Participants will 
be randomly allocated to perform these actions either utilizing the dedicated 
mobile 
app 
PIMPmyHospital 
(intervention 
group) 
or 
employing 
conventional methods (i.e., the EHR, control group). The primary 
hypotheses posited that the use of the mobile app would result in a 
reduction in both the time taken to access laboratory results and the time 
required for remote communication with colleagues. 
 
The trial will take place in a real-world environment at the Pediatric 
Emergency Department (PED) of the Geneva Children’s Hospital, 
Switzerland, during caregivers’ shifts, but no patients will be enrolled, nor 

their medical data collected. The recordings will not be used for any 
purpose other than this project. 
 
The trial will be registered on Clinicaltrials.gov. 
Project population, 
inclusion and exclusion 
criteria 
A convenience sample of 10 caregivers. Eligible participants will be 
postgraduate residents pursuing a <6-year residency in pediatrics and 
registered nurses from the PED of the Geneva Children’s Hospital (aged > 
18 years). They must have previously completed a standardized 5-minute 
introductory course on app usage provided by the study investigators on 
the day of participation. Exclusion criteria encompass participants who 
have not completed the introductory course. Recruitment of participants 
adheres to Cohen’s calculation, with an anticipated effect size of 2.0, a type 
I error of 0.05, and a power of 80%.  
Recruitment, screening 
and informed consent 
procedure 
Participants will be recruited from the PED of the Geneva Children’s 
Hospital. On the day of participation, in the presence of the study 
investigators, participants will provide informed consent, provided they had 
ample time for consideration and opportunity to ask questions. No financial 
compensation will be offered to participants. 
Involvement of 
samples or health 
related data 
No patients will be enrolled in this trial. Hence, no patient’s samples or data 
will be collected. 
Randomization and 
Blinding 
Participants will be randomized using a single, constant 1:1 allocation ratio 
determined through web-based software www.sealedenvelope.com. 
Allocation concealment will be maintained with the use of the allocation 
software, and it will not be released until participants initiate the scenario. 
To minimize preparation bias, participants will be kept unaware of the 
scenario during recruitment. Following randomization at the scenario's 
commencement, they will be unblinded to their assigned study arm. The 
study investigators involved in the scenario, assuming the role of a fellow 
nurse to be located by participants, will be revealed to participants before 
the scenario begins. All investigators will remain uninformed about the 
outcomes until all data are unsealed for analysis at the conclusion of the 
trial. 
Intervention 
Following randomized allocation, participants will complete a brief 
demographic survey on the day of participation. Subsequently, they will 
undergo a standardized 5-minute training session on mobile app usage, 
designed solely to explain its functionality for the upcoming intervention. To 
maintain study integrity, the PED signage and layout will remain unaltered, 
taking into account participants' presumed familiarity with their daily working 
environment after a minimum of 3 months of common PED assignment. 
 
Participants will then encounter a semi-simulated scenario involving a 
fictitious patient combined with real clinical activities. Retrieving simulated 
patient laboratory results from the EHR, participants will have the option to 
use the app or the institutional computerized system without app support. 
After obtaining results, participants will be tasked with locating a nurse, 
played by a study investigator, either prompted by an app message or an 
oral request from a second investigator. Assessing the app's impact on 
remote communication, this task will address communication challenges in 
a PED. No nurse location information will be given; participants will have to 
physically find the nurse, prohibiting virtual contact. Procedures will be 
standardized to ensure consistent exposure to the same case, minimizing 
preparation bias. The app will be interfaced on an Apple iPhone X, with 
identical functionality on Android OS. Data access will be restricted to study 
investigators. 
 
The functionalities of the mobile app have been previously published 
(PMID: 34734879) 

 
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Confidentiality 
Information about study subjects will be kept confidential. All data will be 
entered into a Microsoft Excel spreadsheet where all data on study subjects 
are assigned an individual identifying code that does not contain identifying 
information. 
Are the samples/data 
irreversibly 
anonymized? 
YES. Data will be saved in duplicate on secured hard disk drives in a locked 
cabinet at the Geneva Children’s Hospital. 
 
All electronic patient data exchanged between the institutional 
computerized patient record (i.e., the Geneva University Hospital servers) 
and the app is secured. No patient data will be used as an outcome or for 
analysis. Only the time taken by participants to access the data will be 
recorded and analyzed. 
Withdrawal and 
discontinuation 
Withdrawal and discontinuation will be limited since this study offers the 
advantage of taking place in a single center and during a single, short 
intervention period during a regular working day within the emergency 
department. In case of withdrawal after informed consent, individual’s 
collected data so far and related to the intervention will be 
destroyed/deleted. Any withdrawal and/or discontinuation will be justified 
and reported in final publications in coded form. 
 
 
Statistics 
The Statistical Analysis Plan (SAP) is attached to the study protocol 
submitted on clinicaltrials.gov 
 
 
Regulatory aspects 
and safety 
• 
Local regulations / Declaration of Helsinki 
The research project will be conducted in accordance with the 
protocol, the Declaration of Helsinki [PMID: 24141714], the 
principles of Good Clinical Practice [PMID: 10532877]. 
 
• 
Notification of safety and protective measure 
The study investigators anticipate no circumstances that could 
compromise patient safety, given the project's design, which does 
not involve patient enrollment and does not expose participants to 
risks beyond those of their daily practice throughout the course of 
this study. 
 
• 
Serious events 
No serious events are anticipated. Study investigators do not 
foresee the need to implement any specific security measures 
 
• 
Risk-Benefit assessment 
Risks to project participants are minimized as the intervention is 
integrated into their routine clinical practice. The only real 
difference, devoid of any risk, will be the procedure using a mobile 
app rather than conventional methods to retrieve lab results and 
communicate with colleagues. Risk of unauthorized data access 
and/or unwanted identification of project participants will be 
guaranteed by using Microsoft Excel software secured by protected 
access passwords and hosted by the Geneva University Hospitals 
on secured servers. No direct benefits are anticipated for study 
participants. 
Overall ethical 
considerations 
According to the International Committee of Medical Journal Editors and 
SwissEthics (i.e., the National Ethic board in Switzerland), the trial protocol 
received a declaration of no objection by SwissEthics and the Geneva 
institutional ethics committee (Switzerland) since the purpose of the study 
will be to assess the effect of the intervention on healthcare providers and 
not on patients. 

Will this project 
generate generalizable 
knowledge?  
 
YES. The goal of this study is to generate evidence-based data in order to 
be able to deploy this mobile app in the near future within the University 
Hospitals of Geneva, and beyond to other hospitals.  
 
To date and to the best of our knowledge, no study has measured such 
data and for the same purpose as this trial. 
Is it solely a quality 
control for institution-
internal purposes 
This is a pilot randomized controlled trial to assess the impact of a newly 
developed mobile app on caregivers’ work efficiency, and aimed to improve 
patient-centered care. 
 
 
Prior submission to an 
Ethics Committee? 
The preliminary evaluation study of the app PimpMyHospital via semi-
structured interviews was accepted by SwissEthics on July 2nd 2021 (Req-
2021-00740). 
 
Date and signature:  
 
 
14 July 2021