- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05203146
PIMPmyHospital: a Mobile App to Improve Emergency Care Efficiency and Communication
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emergency care is very complex in that it requires patient-centered care in a coordinated manner among multiple providers in a highly distractible, unpredictable, multi-tasking, and stressful environment. Due to the inherent characteristics of specimen processing and laboratory instruments, the turnaround time from laboratory test ordering to availability of results can be long. As a result, caregivers must continue their multiple tasks while waiting for these results and, in the absence of reminder alerts, they must remember to check their availability. This can lead to oversights or delays in their consideration. Lack of follow-up of abnormal laboratory results can lead to missed information that could impact patient care and safety. Moreover, sharing information efficiently between providers in this environment is difficult. Caregivers are often far away from each other, busy with their tasks, without the ability to quickly communicate face-to-face with their colleagues to exchange important information regarding their patients.
Connecting emergency service providers to each other through a digital communication channel could improve the efficiency of synchronous information sharing and emergency care, as well as instant retrieval of laboratory results at the point of care. To this end, the investigators have developed a mobile application (app) dedicated to emergency department caregivers, PIMPmyHospital (Patients In My Pocket in my Hospital [PubMed Identifier number 34734879]). This app aims to provide relevant information in real time about the patients emergency departments' caregivers are caring for, including laboratory results, as well as a chat and secure messaging platform to virtually connect physicians and nurses caring for the same patients.
This clinical trial is a pilot, prospective, single-center, randomized, controlled trial in a tertiary pediatric emergency department (>33,000 consultations/year) with two parallel groups of voluntary PGY 1 to 5 pediatric residents and registered pediatric emergency nurses. It aims to assess the impact of the app in a real pediatric emergency department environment through standardized, semi-simulated scenarios. Ten participants (5 residents and 5 nurses) are randomized 1:1.
During their actual clinical tasks, each participant is asked to take note of laboratory results about a fictional patient that randomly occur once during the course of the scripted scenario, using either the app (study arm A) or conventional methods (study arm B), and secondly, to then respond to requests from a remote colleague to go to a specific location in the emergency room to assist with a technical procedure (the request being relayed either by the app or one of the study investigators depending on the study arm allocation).
The primary endpoint is the time from the availability of new laboratory results to their consideration by participants, measured in minutes using a stopwatch.
The secondary endpoint is the time from when the participant is informed that a colleague requires his or her assistance to perform a technical procedure to when the participant reaches that colleague, measured in minutes using a stopwatch.
Data collection is carried out by two study investigators. Deidentified data are safely stored in duplicate on papers and secured hard-disk drives in a locked room at the Geneva Children's Hospital, Switzerland. This study offers the major advantage to observe a unique period per participant during their regular shift. Therefore, neither follow-up nor retention plans is necessary. The REDCap database (REDCap, Vanderbilt University, Nashville, Tennessee, USA) will be used for data collection. Study data will be de-identified and a master linking log (code key) with identifiers (ie, participant identification list on paper format) will be kept and stored separately from the data by the study investigators in a secured cabinet in a locked room at Geneva Children's Hospital, Switzerland, under the responsibility of the principal investigator.
This clinical trial will assess the impact of a collaborative mHealth tool to increase timely medical information retrieval at the point of care and team communication in an emergency department. The results of this pilot study will be used to set up a larger randomized controlled trial. As research in this area is scarce, the results generated from this study could be of importance to improve in-hospital pediatric emergency care practice and communication in an era of communication technologies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Geneva Children's Hospital, Geneva University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any postgraduate residents pursuing a <6 years residency in pediatrics.
- To be registered nurses from the pediatric emergency department.
- To have previously completed a standardized 5-min introductory course on the use of the PIMPmyHospital tool dispensed by the study investigators.
- Participation agreement.
Exclusion Criteria:
- To have not undergone the standardized 5-min introductory course on the use of the PIMPmyHospital tool dispensed by the study investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm B (Conventional methods)
Participants that will use conventional methods (i.e., without mobile app support) during the semi-simulation-based scenario.
|
Each participant will first be asked to retrieve a factious patient's laboratory results from the emergency department's computerized patient data system when randomly made available, and then contact a colleague (role played by a study investigator) when asked to do so (request made by a second study investigator).
|
|
Experimental: Arm A (PIMPmyHospital)
Participants that will use the mobile heath PIMPmyHospital tool during the semi-simulation-based scenario.
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Each participant will first be asked to retrieve a factious patient's laboratory results on the app when randomly made available, and then reach a colleague (role played by a study investigator) when asked to do so by a text message on the app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Laboratory Results
Time Frame: minutes (upper bound arbitrarily set at 2 hours)
|
Time elapsed between the availability of new laboratory results on either the mobile app or the pediatric emergency department's computerized patient data system and their consideration by the participant on the allocated medium (i.e., the mobile app or computerized patient data system), measured using a stopwatch.
|
minutes (upper bound arbitrarily set at 2 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Reach Colleagues
Time Frame: minutes (upper bound arbitrarily set at 2 hours)
|
The elapsed time (in minutes) from the moment the participant was informed by the mobile app or a statement given by a study investigator (conventional method) that a nurse required assistance to perform a technical procedure up to the point in time when the participant reached that nurse.
|
minutes (upper bound arbitrarily set at 2 hours)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Johan N Siebert, MD, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
Publications and helpful links
General Publications
- Ehrler F, Tuor C, Rey R, Siebert JN. A Mobile App to Improve Patient Management in Emergency Departments: Caregiver Needs Analysis, Design and Early Technology Acceptance Assessment. Stud Health Technol Inform. 2021 Oct 27;285:233-238. doi: 10.3233/SHTI210605.
- Ehrler F, Tuor C, Trompier R, Berger A, Ramusi M, Rey R, Siebert JN. Effectiveness of a Mobile App in Reducing Therapeutic Turnaround Time and Facilitating Communication between Caregivers in a Pediatric Emergency Department: A Randomized Controlled Pilot Trial. J Pers Med. 2022 Mar 9;12(3):428. doi: 10.3390/jpm12030428.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIMPmyHospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
- Data will be made available from the corresponding author upon approval of a proposal and with a signed data access agreement.
- Deidentified participant data will be made available to qualified external researchers whose proposed use of the data has been approved by their Institutional Review Board.
- Data will be made available for a specified research purpose.
- The request proposal must include a statistician.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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