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.
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
- 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
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)
- 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 group | Role | What they receive |
|---|---|---|
| Kenya intervention baseline | Active comparator | Hospital 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 implementation | Experimental | Hospital nurses will triage participants using the digital triage tool (mhealth intervention). Receives: Device: Pediatric Rapid Sepsis Trigger (PRST) tool |
| Kenya control baseline | Active comparator | Hospital 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 implementation | Active comparator | Hospital 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 baseline | Active comparator | Hospital 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 implementation | Experimental | Hospital nurses will triage participants using the digital triage tool (mhealth intervention) Receives: Device: Pediatric Rapid Sepsis Trigger (PRST) tool |
| Uganda control implementation | Active comparator | Hospital 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.
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.
- First posted11 Mar 2020
- Study start27 Apr 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Wellcome Trust
- Responsible party
- Principal investigator, (John) Ansermino, University of British Columbia
- Investigators
- John M Ansermino, Principal investigator, The University of British Columbia
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 40063663Li 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 37653477Li 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 34788338Mawji 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Triage: Triage and Management of Sepsis in Children Using the Point-of-care Paediatric Rapid Sepsis Trigger (PRST) Tool
- ClinicalTrials.gov ID
- NCT04304235
- Acronym / sponsor ID
- PRST / H19-02398
- Keywords
- triage, developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,693 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Wellcome Trust
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kenya intervention baseline | Active comparator | Other: Emergency Triage and Treatment (ETAT) guidelinesHospital 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. |
| Kenya intervention implementation | Experimental | Device: Pediatric Rapid Sepsis Trigger (PRST) toolHospital nurses will triage participants using the digital triage tool (mhealth intervention). |
| Kenya control baseline | Active comparator | Other: Emergency Triage and Treatment (ETAT) guidelinesHospital 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. |
| Kenya control implementation | Active comparator | Other: Emergency Triage and Treatment (ETAT) guidelinesHospital 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. |
| Uganda intervention baseline | Active comparator | Other: Emergency Triage and Treatment (ETAT) guidelinesHospital 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. |
| Uganda intervention implementation | Experimental | Device: Pediatric Rapid Sepsis Trigger (PRST) toolHospital nurses will triage participants using the digital triage tool (mhealth intervention) |
| Uganda control implementation | Active comparator | Other: Emergency Triage and Treatment (ETAT) guidelinesHospital 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. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Patients presenting to the outpatient department for elective cases (e.g. elective surgery or change of dressing) or for clinical review appointment.
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 |
|---|---|---|
| Pediatric Rapid Sepsis Trigger (PRST) toolThe 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. | Device | Kenya intervention implementation, Uganda intervention implementation |
| Emergency Triage and Treatment (ETAT) guidelinesThese are the triage guidelines currently applied in the study hospital sites. This will be the comparator group. | Other | Kenya control baseline, Kenya control implementation, Kenya intervention baseline, Uganda control implementation, Uganda intervention baseline |
Primary outcome
Time to Administration of an Appropriate Antimicrobial
Time frame: 1 day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40063663Ansermino 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.
- Derived from this study: PubMed 37653477Li 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.
- Derived from this study: PubMed 34788338Li 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.
- Derived from this study: PubMed 32493319Mawji 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.
- Individual participant dataSharing planned: 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).
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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.
John M Ansermino principal investigator
The University of British Columbia
3 sites in 2 countries: see every site and its status.
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.