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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05203146
Other study ID # PIMPmyHospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2021
Est. completion date September 6, 2021

Study information

Verified date January 2022
Source Pediatric Clinical Research Platform
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 [PGY] 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.


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 [PMID 34734879]). This app aims to provide relevant information in real time about the patients ED 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, TN, 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 6, 2021
Est. primary completion date September 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
PIMPmyHospital (mHealth tool)
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.
Other:
Conventional method
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).

Locations

Country Name City State
Switzerland Geneva Children's Hospital, Geneva University Hospitals Geneva

Sponsors (2)

Lead Sponsor Collaborator
Pediatric Clinical Research Platform University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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/SHTI21 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time to reach colleagues Time elapsed between the moment the participant is informed by the mobile app or a study investigator (conventional method) that a colleague requires his or her assistance to perform a technical procedure to when the participant reaches that colleague, measured using a stopwatch. minutes (upper bound arbitrarily set at 2 hours)
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