- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557331
Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department
Effectiveness of a Mobile App (PIMPmyHospital) in Reducing Therapeutic Turnaround Times in an Emergency Department: Protocol for a Pre-Post Intervention Study
This study is a single center, non-equivalent comparison group, pre-post study in a tertiary pediatric emergency department in Switzerland. the study will compare the control and experimental groups on outcome measures before (12-month period) and after (6-month period) the intervention consisting of the implementation and use of the evidence-based mobile app-the ''Patients In My Pocket in my Hospital'' (PIMPmyHospital) app.
The primary outcome will be the mean elapsed time in minutes between the delivery of lab results and the emergency department caregivers accessing them before (i.e., on the institutional electronic medical records) and after the implementation of the app (i.e, directly on the app).
Study Overview
Status
Intervention / Treatment
Detailed Description
The study objective is to evaluate whether the use of the PIMPmyHospital app alters emergency departments (ED) physicians and nurses' temporal efficiency to learn about laboratory results more quickly while actively working in an ED. Temporal efficiency will be assessed by measuring the time between the release of the laboratory results in the clinical information system and their acknowledgement by these clinicians. Information regarding the app has been published previously (doi.org/10.3390/jpm12030428).
The investigators will conduct an 18-month, single center, non-equivalent comparison group, pre-post study. The study will compare the control and experimental groups on outcome measures before (12-month period) and after (6-month period) the intervention consisting of the use of the app. The study will take place in the pediatric ED of a tertiary referral and major trauma hospital in Switzerland, with an annual volume of 35,000 visits.
Eligible participants will be postgraduate residents pursuing a <6-year residency in pediatrics, pediatric emergency medicine fellows, and registered nurses from the pediatric ED (aged > 18 years). Written informed consent will be obtained from each participant in the interventional group after full information disclosure prior to study participation.
Before the implementation of the app, electronic medical records (EMR)-based data from the past 12 months will be collected retrospectively. These data include the times (i.e., HH:MM:SS) that results issued by the central laboratory were available on the institutional's EMR, as well as the times at which these results were accessed by caregivers via conventional computerized workstations. (ii) After the implementation of the app, data will be collected prospectively over a 6-month period of use. This will include the times (HH:MM:SS) when the results issued by the central laboratory are made available on caregivers' mobile app and access times, as well as concurrent or preferred access times on the conventional computerized workstations should this occur. Individual acceptance of the app on the first day (a priori) and then on the last day of the intervention will be evaluated through the Unified Theory of Acceptance, and Use of Technology (UTAUT). Usability of the app will be measured by the System Usability Scale (SUS).
The primary outcome will be the mean elapsed time in minutes between the delivery of the lab results and the caregiver accessing them, both before and after the implementation of the app.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johan N Siebert, MD
- Phone Number: +41 79 553 40 72
- Email: Johan.Siebert@hcuge.ch
Study Contact Backup
- Name: Frederic Ehrler, PhD
- Email: Frederic.Ehrler@hcuge.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any postgraduate residents pursuing a <6 years residency in pediatrics.
- Any pediatric emergency medicine fellows.
- To be registered nurses from the pediatric emergency department.
- Participation agreement.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Pre-intervention (no app)
Participants before (12-month retrospective period) the implementation of the app in the emergency department.
|
|
Active Comparator: Post-intervention (PIMPmyHospital app)
Participants that will use the mobile heath PIMPmyHospital app during the prospective 6-month period after the implementation of the app in the emergency department.
|
After the implementation of the app, data will be collected prospectively over a 6-month period of use.
This will include the times (HH:MM:SS) when the results issued by the central laboratory are made available on caregivers' mobile app and access times (as well as concurrent or preferred access times on the conventional computerized workstations should this occur).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to lab results review
Time Frame: 1 year (retrospective) and 6 months (prospective)
|
The mean elapsed time in minutes between the delivery of the lab results and the caregiver accessing them, both before and after the implementation of the app.
|
1 year (retrospective) and 6 months (prospective)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Theory of Acceptance, and Use of Technology (UTAUT)
Time Frame: 6 months
|
Acceptance of the app by participants on the first day (a priori) and then on the last day of the intervention will be evaluated through the Unified Theory of Acceptance, and Use of Technology (UTAUT) questionnaire. The UTAUT is a 8-construct, 31-item questionnaire. The items are measure along a 5-point Likert scale, which ranges from "strongly agree" (1) to "strongly disagree" (5). |
6 months
|
System Usability Scale (SUS)
Time Frame: 6 months
|
Usability of the app will be measured by the System Usability Scale (SUS). The SUS comprises a 10-item questionnaire with 5 response options for each item based on their level of agreement, ranging from 1 (strongly disagree) to 5 (strongly agree). For odd-numbered statements (the positively worded items), the score contribution is equal to the scale position minus 1. For even-numbered statements (the negatively worded items), the score contribution is equal to 5 minus the scale position. Each score contribution falls within the range of 0 to 4. The participants' scores for each item are then added up together and multiplied by 2.5 to convert the original scores of 0 to 40 to 0 to 100. The higher the score, the better the usability. |
6 months
|
Emergency department length of stay
Time Frame: 1 year (retrospective) and 6 months (prospective)
|
The emergency department length of stay per patient measured from the point when patients are triaged in the ED to when discharged from the ED, defined as patients leaving the ED whether admitted to the intensive care unit or ward, transferred to another hospital for admission, discharged home, or those who left without being seen.
|
1 year (retrospective) and 6 months (prospective)
|
Cognitive alerts
Time Frame: 1 year (retrospective) and 6 months (prospective)
|
Whether specific alerts, such as a flashing icon or sound for reported pathological values of laboratory results on the mobile app have an impact on the results. This will be measured using a questionnaire that each participant using the app will answer on a 5-point Likert scale, ranging from "strongly agree" (1) to "strongly disagree" (5). |
1 year (retrospective) and 6 months (prospective)
|
Collaborators and Investigators
Investigators
- Study Director: 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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 pre-post study
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
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