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SepsisPRSTNCT04304235

Paediatric Rapid Sepsis Trigger (PRST) Tool

A study testing Pediatric Rapid Sepsis Trigger (PRST) tool and Emergency Triage and Treatment (ETAT) guidelines in people with Sepsis and Infection, run by University of British Columbia at 3 sites in 2 countries.

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

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent… Read more about this study

Who is it for?
Ages Up to 19 years
Conditions the study is for
Sepsis, Infection
What is being tested?
Pediatric Rapid Sepsis Trigger (PRST) tool and Emergency Triage and Treatment (ETAT) guidelines
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,693 participants
Where
3 sitesin 2 countries
Study dates
27 Apr 2020to 1 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All paediatric outpatients presenting to the study hospitals for medical treatment. The lower age limit will include children aged from 0 days, and the upper age limit will be in accordance to respective hospitals' practice for paediatric admissions (this may be 12, 15 or 19 years).
  • Informed parental/guardian consent provided.
  • Assent from children older than 13 years in addition to parental/guardian consent provided.

Who cannot join

  • -Patients presenting to the outpatient department for elective cases (e.g. elective surgery or change of dressing) or for clinical review appointment.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Kenya2 sites
  • Kiambu County Referral Hospital

    Nairobi

  • Mbagathi County Hospital

    Nairobi

Other trials in Kenya

Uganda1 site
  • Jinja Regional Referral Hospital

    Jinja

Other trials in Uganda

About this study

Official title: Smart Triage: Triage and Management of Sepsis in Children Using the Point-of-care Paediatric Rapid Sepsis Trigger (PRST) Tool

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use.

The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.

Read the detailed description

This is a pre-post intervention study involving pediatric patients presenting to the study hospitals in seek of medical care for an acute illness. The study involves three phases: (I) Baseline Period, (II) Interphase Period, (III) Intervention Period.

Phase I (3-6 months) will be a prospective observational cohort at Mbagathi County Hospital in Nairobi, Kenya, and Jinja Regional Referral Hospital in Jinja, Uganda. During this period, there will be no changes to healthcare delivery procedures in the study hospitals. Triage will continue to be performed by hospital staff using Emergency Triage and Treatment (ETAT) guidelines, the system that is currently in effect at the study hospitals. Data collection will be undertaken in the triage waiting area. While participants are waiting for their turn to be seen by the hospital triage nurses, our trained study nurses will collect data on a pre-selected list of predictor variables. These data will be used to develop a clinical prediction model based on the need for hospital admission.

Control Site (Phase I, 12 months): Kiambu County Referral Hospital in Nairobi, Kenya will serve as the control site and no intervention will be implemented. At this site, Phase I will commence for a period of 12 months. There will be no Phase II or Phase III.

Phase II (1-3 months) will involve technology development, usability testing, and training.

Phase IIa: Technology Development. A risk prediction model will be derived using the data collected in Phase I and implemented in a Digital Triaging Platform, along with a digitized version of the ETAT+ guidelines. The Digital Triaging Platform, including vital sign measurement devices (PhoneOx and RRate and the mobile application and clinical dashboard has already been developed and evaluated. Once the digital triage tool has been developed, it will be evaluated in potential users using simulated patient scenarios and a 'Think Aloud' method.

Phase IIb: Usability Testing and Training. The digital triage tool will be evaluated for ease of interface navigation, functionality and basic workflow. A sample of 15 health workers in the study hospitals to represent the primary user groups will be selected for participation in the 60-minute-long usability testing initiatives. Participants will be recruited through word of mouth as there is a very small cadre of potential participants. The objective of the training is to (1) ensure healthcare workers understand how to correctly collect and interpret patient information, and (2) to obtain feedback on the digitization of the tool. Training will use a framework that meets key international norms for testing digital tools, including, the think-aloud method and a questionnaire.

Each training session will be conducted by a moderator and observer. During the evaluation, the observer will be seated next to the participant and will record user interaction with each interface, comments, errors, and duration of each task. Participants will be given 3-5 patient scenarios which will list hypothetical information to be entered into the app. This information will be designed to represent routine data collected during triage examination at the study hospitals. The moderator will provide the fictional charts to participants and instruct them throughout the tasks. During the simulated patient scenarios, participants will be asked to think aloud, in order to assess their thought process as they used the app. Participants will be specifically instructed to comment on the layout of the app screen, the dialogue on each interface, the order of tasks, and any additional observations or opinions. After learning the basics of the digital platform, the participants will be read the think aloud instructions and asked to perform the list of tasks and answer questions. The observer will complete a checklist to ensure that all tasks were completed, questions will be asked to evaluate task comprehension, and notes will be taken about whether help was needed in completing each task. At the end of the training session, participants will complete a triage tool training questionnaire to provide an understanding of the practical benefits and drawbacks of incorporating the digital triage tool into a clinical context. The questionnaire will utilize open ended questions and comment responses. from this evaluation. Responses from the survey will be anonymous. The data generated from the training phase is fictitious and will not be linked to any individual subject.

Transcriptions and Think Aloud observations will be analyzed using the Framework Method to assess attitudes of health workers. Responses will be transcribed and coded for the identification, examination and interpretation of emerging themes and patterns. Results from the analysis, feedback from the questionnaires, and comments on the observer checklists will be used to generate a report with suggested improvements to be shared with the quality improvement implementation team prior to Phase III.

Phase III (3-6 months) will be an interventional period involving routine use of the digital triage tool by the hospital triage nurses at Mbagathi County Hospital in Nairobi, Kenya, and Jinja Regional Referral Hospital in Jinja, Uganda. The digital triage tool will not replace triage policies already in place at the study hospitals, but rather it will supplement and strengthen existing triage systems. As done in Phase I, study nurses will collect data on the pre-selected list of predictor variables in the triage waiting area while participants are waiting to be seen by the hospital triage nurses (who will be using the digital triage tool). Continued collection of predictor variables will allow comparison of participant characteristics in the pre-intervention cohort and the post-intervention cohort. (Funder: Wellcome Trust Innovator Award # 215695/Z/19/Z)

Conditions
Sepsis, Infection
Being tested
Pediatric Rapid Sepsis Trigger (PRST) tool, Emergency Triage and Treatment (ETAT) guidelines
Keywords
triage, developing countries
Medical subject headings
Sepsis, Infections

What participants receive

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

  • Pediatric Rapid Sepsis Trigger (PRST) toolDevice

    The digital platform consists of a mobile application integrating a pulse oximetry sensor attached to this device, with embedded smart algorithms that predict a critically ill state, or level of risk (below) in a child presenting at the hospital. The platform also includes an interactive dashboard located in strategic locations (e.g., laboratory, consultation rooms), which connects to the mobile application through a secure local network and displays the triage data to provide real-time monitoring for the physicians who manage the patients.

  • Emergency Triage and Treatment (ETAT) guidelinesOther

    These are the triage guidelines currently applied in the study hospital sites. This will be the comparator group.

Study groups in NCT04304235
Study groupRoleWhat they receive
Kenya intervention baselineActive comparatorHospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.
Receives: Other: Emergency Triage and Treatment (ETAT) guidelines
Kenya intervention implementationExperimentalHospital nurses will triage participants using the digital triage tool (mhealth intervention).
Receives: Device: Pediatric Rapid Sepsis Trigger (PRST) tool
Kenya control baselineActive comparatorHospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.
Receives: Other: Emergency Triage and Treatment (ETAT) guidelines
Kenya control implementationActive comparatorHospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.
Receives: Other: Emergency Triage and Treatment (ETAT) guidelines
Uganda intervention baselineActive comparatorHospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.
Receives: Other: Emergency Triage and Treatment (ETAT) guidelines
Uganda intervention implementationExperimentalHospital nurses will triage participants using the digital triage tool (mhealth intervention)
Receives: Device: Pediatric Rapid Sepsis Trigger (PRST) tool
Uganda control implementationActive comparatorHospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.
Receives: Other: Emergency Triage and Treatment (ETAT) guidelines

What is being measured

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

  1. Time to Administration of an Appropriate Antimicrobial

    Time in minutes to administer an appropriate antimicrobial, which includes at least one antibiotic or antimalarial (treatment determined and administered by hospital staff). The time is measured from when the child arrives at the facility (time of the first registration) until the antimicrobial administration is started.

    Measured: 1 day

Timeline

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

  1. First posted11 Mar 2020
  2. Study start27 Apr 2020
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

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
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a pre-post intervention study involving pediatric outpatients at Jinja Hospital in Jinja, Uganda, and Mbagathi Hospital in Nairobi, Kenya. The study has three phases: (I) Baseline Period: data is collected on key predictors and outcomes before implementation of the digital triage tool, (II) Interphase Period: model/technology development and usability testing, (III) Intervention Period: data is collected on key predictors and outcomes after implementation of the digital triage tool. Patients who present to the study hospitals in seek of medical care for an acute illness during Phase I will be part of the baseline cohort. Patients who present to the study hospitals in seek of medical care for an acute illness during Phase III will be part of the interventional cohort. A third hospital site, Kiambu Hospital in Nairobi Kenya, will serve as a control hospital, and will only participate in Phase I for the entire duration of the study.
Masking
None (open label)
Enrolment
18,693 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04304235
Sponsor's protocol ID
H19-02398
Acronym
PRST
Status last verified
Apr 2025
First submitted
3 Mar 2020
Last updated
13 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After the study period, a de-identified copy of the data will be prepared for deposition in a repository with open access with proper governance mechanisms. We will make every effort to prevent re-identification of subjects by coding data that has the potential of being identifiable. The de-identified study data will be made publicly available using the Harvard Dataverse (https://dataverse.harvard.edu/), which is the data repository for KWTRP, and a URL will be made accessible. To enhance visibility, sharing and collating datasets with other collaborating sites for increased usability/re-use, de-identified will also be shared availed to reputable data hosting service such as the INDEPTH Data Repository (http://www.indepth-ishare.org/index.php/home), or through the newly established Pediatric Sepsis CoLab (sponsored by the World Federation of Pediatric Critical and Intensive care Societies).

Publications

  • Ansermino JM, Pillay Y, Tagoola A, Zhang C, Dunsmuir D, Kamau S, Kigo J, Agaba C, Aye IA, Hwang B, Novakowski SK, Huxford C, Wiens MO, Kimutai D, Ouma M, Ahmed I, Mwaniki P, Oyella F, Tenywa E, Nambuya H, Toliva BO, Kenya-Mugisha N, Kissoon N, Akech S; Pediatric Sepsis CoLab. Implementation of Smart Triage combined with a quality improvement program for children presenting to facilities in Kenya and Uganda: An interrupted time series analysis. PLOS Digit Health. 2025 Mar 10;4(3):e0000466. doi: 10.1371/journal.pdig.0000466. eCollection 2025 Mar.

    PubMed 40063663
  • Li ECK, Tagoola A, Komugisha C, Nabweteme AM, Pillay Y, Ansermino JM, Khowaja AR. Cost-effectiveness analysis of Smart Triage, a data-driven pediatric sepsis triage platform in Eastern Uganda. BMC Health Serv Res. 2023 Aug 31;23(1):932. doi: 10.1186/s12913-023-09977-5.

    PubMed 37653477
  • Li ECK, Grays S, Tagoola A, Komugisha C, Nabweteme AM, Ansermino JM, Mitton C, Kissoon N, Khowaja AR. Cost-effectiveness analysis protocol of the Smart Triage program: A point-of-care digital triage platform for pediatric sepsis in Eastern Uganda. PLoS One. 2021 Nov 17;16(11):e0260044. doi: 10.1371/journal.pone.0260044. eCollection 2021.

    PubMed 34788338
  • Mawji A, Li E, Komugisha C, Akech S, Dunsmuir D, Wiens MO, Kissoon N, Kenya-Mugisha N, Tagoola A, Kimutai D, Bone JN, Dumont G, Ansermino JM. Smart triage: triage and management of sepsis in children using the point-of-care Pediatric Rapid Sepsis Trigger (PRST) tool. BMC Health Serv Res. 2020 Jun 3;20(1):493. doi: 10.1186/s12913-020-05344-w.

    PubMed 32493319

Questions about this trial

What is this clinical trial studying?

A study testing Pediatric Rapid Sepsis Trigger (PRST) tool and Emergency Triage and Treatment (ETAT) guidelines in people with Sepsis and Infection, run by University of British Columbia at 3 sites in 2 countries.

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 3 inclusion and 1 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kenya, Uganda. 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?

Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Administration of an Appropriate Antimicrobial (time frame: 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 NCT04304235, 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 13 May 2025.

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