search
Back to results

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
Pediatric Clinical Research Platform
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 18, 2022
    Last Updated
    April 5, 2023
    Sponsor
    Pediatric Clinical Research Platform
    search

    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

    We'll reach out to this number within 24 hrs