NCT05203146

Brief Summary

This pilot study is a prospective, single-center, randomized, controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary post-graduate year 1 to 5 pediatric residents and registered pediatric emergency nurses. The impact of an mHealth support tool will be compared to conventional methods on the retrieval of laboratory data from the patient's electronic record, and on team collaboration in a semi-simulated emergency department environment. Ten participants are randomized (1:1). The primary endpoint is the time from the availability of new laboratory results for a given patient to their consideration by participants, measured in minutes using a stopwatch.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 7, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

January 7, 2022

Results QC Date

June 15, 2022

Last Update Submit

November 5, 2024

Conditions

Keywords

Information technologiesMobile ApplicationsLaboratory Result DeliveryInformation Storage and RetrievalHospital Communication SystemsCommunicationPediatric Emergency MedicineEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Time to Laboratory Results

    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 Outcomes (1)

  • Time to Reach Colleagues

    minutes (upper bound arbitrarily set at 2 hours)

Study Arms (2)

Arm A (PIMPmyHospital)

EXPERIMENTAL

Participants that will use the mobile heath PIMPmyHospital tool during the semi-simulation-based scenario.

Device: PIMPmyHospital (mobile health tool)

Arm B (Conventional methods)

ACTIVE COMPARATOR

Participants that will use conventional methods (i.e., without mobile app support) during the semi-simulation-based scenario.

Other: Conventional method

Interventions

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.

Arm A (PIMPmyHospital)

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).

Arm B (Conventional methods)

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • To have not undergone the standardized 5-min introductory course on the use of the PIMPmyHospital tool dispensed by the study investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Children's Hospital, Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

CommunicationEmergencies

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Johan N. Siebert
Organization
University Hospitals of Geneva

Study Officials

  • Johan N Siebert, MD

    Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinding to the outcomes will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software (www.sealedenvelope.com) and will not be released until the participants start the scenario. A post-scenario review will be done without blinding by two study investigators, but undertaken independently with each blinded to the other's reviews. In the case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will not be blinded to group allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A prospective, single center, randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Deputy Head

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 24, 2022

Study Start

September 6, 2021

Primary Completion

September 6, 2021

Study Completion

September 6, 2021

Last Updated

November 7, 2024

Results First Posted

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Individual Participant Data will be deidentified and the study investigators will house the data locally on paper files and 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, recognizing that these data will only provide results for the current pilot trial and not for future randomized controlled trials that would follow. Only deidentified/anonymized data will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Available from 6 month to 5 years after trial publication.
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.

Locations