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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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).
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 :
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Optimum | Experimental | the secondary prioritization software of patients Receives: Behavioral: Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED) |
| Control | No intervention | the standard dashboard of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
the length of stay for each patient
Measured: from admission to discharge, assessed up to 1 day.
Secondary outcomes (3)
Number of patients present
Number of patients present at the same time in the pediatric emergency department during the study period
Measured: 1 day
Time intervals between each stage
The time intervals between each stage in patient management from nurse triage to discharge
Measured: 1 day
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.
- First posted16 Aug 2023
- Study start15 Mar 2021
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Length of StayStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Dubos, MD, PhD, Principal investigator, University Hospital, Lille
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 25991232Windal 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 25160358Gravel 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 22841173Lun 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient Prioritization Software for the Secondary Prioritization of Patients in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05994196
- Acronym / sponsor ID
- OPTIMUM / NI2021_01
- Conditions
- Length of Stay
- Keywords
- Patient flow, Patient prioritization, Pediatric Emergency Department, Usage assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,599 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimum | Experimental | Behavioral: Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)the secondary prioritization software of patients |
| Control | No intervention | –the standard dashboard of patients |
Who may qualify
- Ages
- 3 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children admitted between 10:00 am and 0:00 am
Key exclusion criteria (2 listed)
- Patients who left without being seen
- Patients subsequently admitted to the short-stay unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimum, a secondary prioritization software of patients in the pediatric emergency department (ED)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. | Behavioural | Optimum |
Primary outcome
Length of stay
Time frame: from admission to discharge, assessed up to 1 day.
the length of stay for each patient
3 secondary outcomes
Number of patients present
Time frame: 1 day
Time intervals between each stage
Time frame: 1 day
Pediatric emergency department staff satisfaction
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 25991232Schiro 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.
- Background: PubMed 25160358Windal 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.
- Background: PubMed 22841173Gravel 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.
- Derived from this study: PubMed 38589780Lun 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.
- Description of the standardized System Usability Scale (SUS)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Dubos, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
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.