Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department

April 1, 2024 updated by: Johan Siebert, MD, Pediatric Clinical Research Platform

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

Not yet recruiting

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

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Johan N Siebert, MD, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 8, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 18, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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