Pediatric Emergency MedicineNCT05203146
PIMPmyHospital: a Mobile App to Improve Emergency Care Efficiency and Communication
A study testing PIMPmyHospital (mobile health tool) and Conventional method in people with Pediatric Emergency Medicine and Communication, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
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 1 to 5 pediatric residents and registered pediatric emergency nurses. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Emergency Medicine, Communication
- What is being tested?
- PIMPmyHospital (mobile health tool) and Conventional method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Sep 2021to 6 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- To have not undergone the standardized 5-min introductory course on the use of the PIMPmyHospital tool dispensed by the study investigators.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva Children's Hospital, Geneva University Hospitals
Geneva, 1205
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Pediatric Emergency Medicine, Communication
- Being tested
- PIMPmyHospital (mobile health tool), Conventional method
- Keywords
- Information technologies, Mobile Applications, Laboratory Result Delivery, Information Storage and Retrieval, Hospital Communication Systems, Communication, Pediatric Emergency Medicine, Emergency Department
- Medical subject headings
- Communication, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIMPmyHospital (mobile health tool)Device
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.
Conventional methodOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm A (PIMPmyHospital) | Experimental | Participants that will use the mobile heath PIMPmyHospital tool during the semi-simulation-based scenario. Receives: 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. Receives: Other: Conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minutes (upper bound arbitrarily set at 2 hours)
Secondary outcomes (1)
Time to Reach Colleagues
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.
Measured: minutes (upper bound arbitrarily set at 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start6 Sep 2021
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric Emergency MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single center, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Johan Siebert, MD, Pediatric Clinical Research Platform
- Investigators
- Johan N Siebert, MD, Principal investigator, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203146
- Sponsor's protocol ID
- PIMPmyHospital
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2022
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34734879Ehrler 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.
PubMed 35330427
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05203146
- Acronym / sponsor ID
- PIMPmyHospital
- Conditions
- Pediatric Emergency Medicine, Communication
- Keywords
- Information technologies, Mobile Applications, Laboratory Result Delivery, Information Storage and Retrieval, Hospital Communication Systems, Communication, Pediatric Emergency Medicine, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, single center, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm A (PIMPmyHospital) | Experimental | Device: PIMPmyHospital (mobile health tool)Participants that will use the mobile heath PIMPmyHospital tool during the semi-simulation-based scenario. |
| Arm B (Conventional methods) | Active comparator | Other: Conventional methodParticipants that will use conventional methods (i.e., without mobile app support) during the semi-simulation-based scenario. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- To have not undergone the standardized 5-min introductory course on the use of the PIMPmyHospital tool dispensed by the study investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIMPmyHospital (mobile health 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. | Device | Arm A (PIMPmyHospital) |
| Conventional methodEach 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). | Other | Arm B (Conventional methods) |
Primary outcome
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.
1 secondary outcome
Time to Reach Colleagues
Time frame: minutes (upper bound arbitrarily set at 2 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34734879Ehrler 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.
- Results publication: PubMed 35330427Ehrler 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan N Siebert, MD principal investigator
Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIMPmyHospital (mobile health tool) and Conventional method in people with Pediatric Emergency Medicine and Communication, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Laboratory Results (time frame: minutes (upper bound arbitrarily set at 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.