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Evaluation of a Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department (OPTIMUM)

Primary Purpose

Length of Stay

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Length of Stay focused on measuring Patient flow, Patient prioritization, Pediatric Emergency Department, Usage assessment

Eligibility Criteria

3 Days - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All children admitted between 10:00 am and 0:00 am Exclusion Criteria: Patients who left without being seen Patients subsequently admitted to the short-stay unit

Sites / Locations

  • Hôpital Roger Salengro, CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Optimum

Control

Arm Description

the secondary prioritization software of patients

the standard dashboard of patients

Outcomes

Primary Outcome Measures

Length of stay
the length of stay for each patient

Secondary Outcome Measures

Number of patients present
Number of patients present at the same time in the pediatric emergency department during the study period
Time intervals between each stage
The time intervals between each stage in patient management from nurse triage to discharge
Pediatric emergency department staff satisfaction
To measure the pediatric emergency department staff's level of satisfaction with the System Usability Scale. Values range from 0 to 100 points. Higher scores mean a better satisfaction.

Full Information

First Posted
July 31, 2023
Last Updated
August 8, 2023
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT05994196
Brief Title
Evaluation of a Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department
Acronym
OPTIMUM
Official Title
Evaluation of a Patient Prioritization Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

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
The goal of this randomized, controlled, open-label trial is to test the use of secondary prioritization software (Optimum®) in the pediatric emergency department (PED). The aim of this study is to determine: whether the use of this secondary prioritization software (Optimum®) reduces the patients' median length of stay (LOS) in the PED how this software is accepted by the staff. The PED staff will be asked to manage the patients according to the Optimum® software indications (intervention) or according to the standard dashboard (control).
Detailed Description
Design: randomized, controlled open-label trial in the PED at Lille University Medical Center, Lille, France. Period: between March 15th and April 23rd, 2021. Randomization: each day was randomized for the use of Optimum® software (intervention group) or the PED's standard patient management dashboard (control group). Inclusion criteria: - All children admitted between 10:00 am and 0:00 am at the PED. Exclusion criteria: Patients who left without being seen Patients admitted to a short-stay unit at the PED. Authorizations: the study protocol was registered with the French National Data Protection Commission (Commission Nationale de l'Informatique et des Libertés, Paris, France; registration number: DEC21-056). This research was submitted to the institutional review board, which replied that this type of study, without patient intervention, did not require validation by the ethics committee. The patients and their parents were shown a study information sheet at the PED reception desk and were free to object to their child's participation. The prioritization software: Optimum® was developed in 2015. Five variables with a statistically significant influence on the LOS were identified; the reason for admission, the number of patients present in the PED simultaneously, the prescription of imaging, the prescription of blood tests, and the prescription of treatment. Optimum®'s purpose is to remove the mental load of prioritization from the PED staff. The software first prioritizes the triage of new patients by the PED staff and the first evaluation of a new patient by the medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and checks on imaging results, blood test results or an evaluation by a specialist (for physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior physician, when appropriate. Primary endpoint: the LOS for each patient. Number of patients needed: with a hypothesis of a 15-minute difference in the LOS between the Optimum® and control groups, when considering a mean of 78 patients/day and a median LOS of 190 minutes, with an α-risk of 0.05 and a power (1-ß risk) of 0.8, a total of 1542 patients had to be included (i.e., 771 per group). Secondary endpoints: number of patients present at the same time in the PED, time intervals between each stage in patient management from nurse triage to discharge, PED staff's level of satisfaction using the standardized System Usability Scale (SUS). Study procedures : training of all the PED staff members in use of Optimum® 2 weeks prior to the study. study setting up: with days randomized to Optimum® vs. the standard dashboard using the "random" formula in Excel® (Microsoft Corporation, Redmond, WA, USA). Weekdays and weekend/public holiday days were randomized separately. An investigator not involved in the management of the patients during the study period was present throughout the inclusion period and prospectively recorded the time intervals for each patient's stay in the PED: time of arrival at the PED, evaluation by the triage nurse, the first medical evaluation (by a medical student or a junior physician), the first evaluation by a senior physician, the evaluation by a specialist physician (if applicable), the results of imaging and lab tests (if prescribed), the final medical decision, and discharge. Data collected: in addition to the LOS and to the time intervals of the different phases of management, the other variables recorded were age, gender, reason for admission, triage level, and mode of discharge. There were five categories of reasons for admission: fever, a respiratory disorder, a digestive tract disorder, trauma, and other reasons. 3) the PED staff involved in the study will fill out the standardized SUS questionnaire as a guide to the perceived utility of the Optimum® software and the level of user satisfaction. According to the literature, the SUS score is considered to be very poor if it is less than 51, poor if between 51 and 68, average if 68, good if between 68 and 80.3, and excellent if greater than 80.3. Statistical analysis: description of patients' characteristics the normality of the data distributions was checked graphically and using the Shapiro-Wilk test. Intergroup comparisons of the total LOS and the various time intervals during patient management times were performed by covariance analysis. Analysis of the standardized System Usability Scale (SUS) questionnaire filled out by the PED staff at th end of the study to perceive the utility of the Optimum® software and the level of user satisfaction. A Spearman's test was used to analyze the correlation between the age of the PED staff and the SUS score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Length of Stay
Keywords
Patient flow, Patient prioritization, Pediatric Emergency Department, Usage assessment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimum
Arm Type
Experimental
Arm Description
the secondary prioritization software of patients
Arm Title
Control
Arm Type
No Intervention
Arm Description
the standard dashboard of patients
Intervention Type
Behavioral
Intervention Name(s)
Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
Intervention Description
Optimum®'s purpose is to remove the mental load of prioritization from the Pediatric ED staff. The software first prioritizes the triage of new patients by the ED staff and the first evaluation of a new patient by the medical team. Optimum® then prioritizes blood sample collections and care (for nurses) and checks on imaging results, blood test results or an evaluation by a specialist (for physicians). Lastly, Optimum® prioritizes the final step in patient management by a senior physician, when appropriate.
Primary Outcome Measure Information:
Title
Length of stay
Description
the length of stay for each patient
Time Frame
from admission to discharge, assessed up to 1 day.
Secondary Outcome Measure Information:
Title
Number of patients present
Description
Number of patients present at the same time in the pediatric emergency department during the study period
Time Frame
1 day
Title
Time intervals between each stage
Description
The time intervals between each stage in patient management from nurse triage to discharge
Time Frame
1 day
Title
Pediatric emergency department staff satisfaction
Description
To measure the pediatric emergency department staff's level of satisfaction with the System Usability Scale. Values range from 0 to 100 points. Higher scores mean a better satisfaction.
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children admitted between 10:00 am and 0:00 am Exclusion Criteria: Patients who left without being seen Patients subsequently admitted to the short-stay unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Dubos, MD, PhD
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25991232
Citation
Schiro J, Marcilly R, Leroy N, Wawrzyniak C, Martinot A, Pelayo S. Design and evaluation of a patient website to reduce crowding in emergency departments: a preliminary study. Stud Health Technol Inform. 2015;210:663-5.
Results Reference
background
PubMed Identifier
25160358
Citation
Windal F, Jeribi K, Ficheur G, Degoul S, Martinot A, Beuscart R, Renard JM. Pediatric emergency department crowding: survival tree clustering for length of patient stay. Stud Health Technol Inform. 2014;205:1095-9.
Results Reference
background
PubMed Identifier
22841173
Citation
Gravel J, Fitzpatrick E, Gouin S, Millar K, Curtis S, Joubert G, Boutis K, Guimont C, Goldman RD, Dubrovsky AS, Porter R, Beer D, Doan Q, Osmond MH. Performance of the Canadian Triage and Acuity Scale for children: a multicenter database study. Ann Emerg Med. 2013 Jan;61(1):27-32.e3. doi: 10.1016/j.annemergmed.2012.05.024. Epub 2012 Jul 27.
Results Reference
background
Links:
URL
https://digital.ahrq.gov/sites/default/files/docs/survey/systemusabilityscale%2528sus%2529_comp%255B1%255D.pdf
Description
Description of the standardized System Usability Scale (SUS)

Learn more about this trial

Evaluation of a Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department

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