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Length of StayOPTIMUMNCT05994196

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

A study testing Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED) in people with Length of Stay, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 3 days to 16 years
Conditions the study is for
Length of Stay
What is being tested?
Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,599 participants
Where
1 siteFrance
Study dates
15 Mar 2021to 23 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 days to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All children admitted between 10:00 am and 0:00 am

Who cannot join

  • Patients who left without being seen
  • Patients subsequently admitted to the short-stay unit

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Roger Salengro, CHU

    Lille

Other trials in France

About this study

Official title: Evaluation of a Patient Prioritization Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department

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:

  1. whether the use of this secondary prioritization software (Optimum®) reduces the patients' median length of stay (LOS) in the PED
  2. 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).
Read the 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 :

  1. training of all the PED staff members in use of Optimum® 2 weeks prior to the study.
  2. 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.

  1. 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:

  1. description of patients' characteristics
  2. the normality of the data distributions was checked graphically and using the Shapiro-Wilk test.
  3. Intergroup comparisons of the total LOS and the various time intervals during patient management times were performed by covariance analysis.
  4. 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.
Conditions
Length of Stay
Being tested
Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
Keywords
Patient flow, Patient prioritization, Pediatric Emergency Department, Usage assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)Behavioural

    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.

Study groups in NCT05994196
Study groupRoleWhat they receive
OptimumExperimentalthe secondary prioritization software of patients
Receives: Behavioral: Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)
ControlNo interventionthe standard dashboard of patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of stay

    the length of stay for each patient

    Measured: from admission to discharge, assessed up to 1 day.

Secondary outcomes (3)
  1. Number of patients present

    Number of patients present at the same time in the pediatric emergency department during the study period

    Measured: 1 day

  2. Time intervals between each stage

    The time intervals between each stage in patient management from nurse triage to discharge

    Measured: 1 day

  3. 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.

    Measured: through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start15 Mar 2021
  3. Primary completion23 Apr 2021
  4. Study completion23 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994196
Sponsor's protocol ID
NI2021_01
Acronym
OPTIMUM
Status last verified
Aug 2023
First submitted
31 Jul 2023
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25991232
  • 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.

    PubMed 25160358
  • 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.

    PubMed 22841173
  • Lun T, Schiro J, Cailliau E, Tchokokam J, Liber M, de Jorna C, Martinot A, Dubos F. Randomized controlled open-label trial to evaluate prioritization software for the secondary triage of patients in the pediatric emergency department. Int J Emerg Med. 2024 Apr 8;17(1):53. doi: 10.1186/s12245-024-00623-3.

    PubMed 38589780

Questions about this trial

What is this clinical trial studying?

A study testing Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED) in people with Length of Stay, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay (time frame: from admission to discharge, assessed up to 1 day.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994196, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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