Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department
Primary Purpose
Pediatric Emergency Medicine, Therapeutic Turnaround Time
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PIMPmyHospital (mobile app)
Sponsored by
About this trial
This is an interventional basic science trial for Pediatric Emergency Medicine focused on measuring Information technologies, Mobile Applications, Laboratory Result Delivery, Therapeutic turnaround time, Information Storage and Retrieval, Hospital Communication Systems, Pediatric Emergency Medicine, Emergency Department
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Pre-intervention (no app)
Post-intervention (PIMPmyHospital app)
Arm Description
Participants before (12-month retrospective period) the implementation of the app in the emergency department.
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.
Outcomes
Primary Outcome Measures
Time to lab results review
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.
Secondary Outcome Measures
Unified Theory of Acceptance, and Use of Technology (UTAUT)
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).
System Usability Scale (SUS)
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.
Emergency department length of stay
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.
Cognitive alerts
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).
Full Information
NCT ID
NCT05557331
First Posted
September 18, 2022
Last Updated
April 5, 2023
Sponsor
Pediatric Clinical Research Platform
1. Study Identification
Unique Protocol Identification Number
NCT05557331
Brief Title
Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department
Official Title
Effectiveness of a Mobile App (PIMPmyHospital) in Reducing Therapeutic Turnaround Times in an Emergency Department: Protocol for a Pre-Post Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pediatric Clinical Research Platform
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Emergency Medicine, Therapeutic Turnaround Time
Keywords
Information technologies, Mobile Applications, Laboratory Result Delivery, Therapeutic turnaround time, Information Storage and Retrieval, Hospital Communication Systems, Pediatric Emergency Medicine, Emergency Department
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A single center, non-equivalent comparison group, pre-post study.
Masking
Outcomes Assessor
Masking Description
Although neither the participants nor the study investigators can be blinded to the intervention, both will be blinded to the results of the study until their final analysis by the statistician. Participants will be informed only of the overall purpose of the study, which is to evaluate the effects of the app on quality of care, but not about the aim of reducing the time to access laboratory results to minimize bias. The statistician will remain blinded to allocation until the final analysis.
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-intervention (no app)
Arm Type
No Intervention
Arm Description
Participants before (12-month retrospective period) the implementation of the app in the emergency department.
Arm Title
Post-intervention (PIMPmyHospital app)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PIMPmyHospital (mobile app)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time to lab results review
Description
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.
Time Frame
1 year (retrospective) and 6 months (prospective)
Secondary Outcome Measure Information:
Title
Unified Theory of Acceptance, and Use of Technology (UTAUT)
Description
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).
Time Frame
6 months
Title
System Usability Scale (SUS)
Description
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.
Time Frame
6 months
Title
Emergency department length of stay
Description
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.
Time Frame
1 year (retrospective) and 6 months (prospective)
Title
Cognitive alerts
Description
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).
Time Frame
1 year (retrospective) and 6 months (prospective)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan N Siebert, MD
Phone
+41 79 553 40 72
Email
Johan.Siebert@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic Ehrler, PhD
Email
Frederic.Ehrler@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan N Siebert, MD
Organizational Affiliation
Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data will be deidentified and the study investigators will house the data locally on REDCap hosted on secured servers at the Geneva University Hospitals. 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 pre-post study and not for future trials that would follow. Only deidentified/anonymized data will be shared.
IPD Sharing Time Frame
Available from 6 month to 5 years after trial publication.
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.
Citations:
PubMed Identifier
34734879
Citation
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.
Results Reference
result
PubMed Identifier
35330427
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department
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