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Paediatric Rapid Sepsis Trigger (PRST) Tool

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04304235
Acronym
PRST
Enrollment
18693
Registered
2020-03-11
Start date
2020-04-27
Completion date
2023-07-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Sepsis

Keywords

triage, developing countries

Brief 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 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)

Interventions

DEVICEPediatric Rapid Sepsis Trigger (PRST) tool

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.

OTHEREmergency Triage and Treatment (ETAT) guidelines

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

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
Wellcome Trust
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Due to the clinical pre-post intervention design, masking will not be possible.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Administration of an Appropriate Antimicrobial1 dayTime 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.

Other

MeasureTime frameDescription
Readmission7 daysThe child is readmitted to the hospital after being discharged
Mortality7 daysDeath within 7 days
Admission12 hoursAdmission to hospital
Clinical Diagnosis12 hoursThe clinical diagnosis for each participant
Length of Stay7 daysLength of stay in hospital for admitted cases

Countries

Kenya, Uganda

Participant flow

Recruitment details

Recruitment occurred at hospitals in two countries . Each country had a control and intervention site. A baseline period of data collection occurred at all sites except the control site in Uganda (due to COVID 19 pandemic restrictions). Kenya: Intervention site Baseline, Kenya Intervention site Implementation, Kenya Control site Baseline, Kenya Control site Implementation Uganda: Intervention site Baseline, Uganda Intervention site Implementation, Uganda Control site Implementation:

Pre-assignment details

Non infectious illness, routine clinic visit

Participants by arm

ArmCount
Kenya Intervention Baseline
Baseline cohort at Kenya intervention site
2,856
Kenya Intervention Implementation
Implementation cohort at Kenya implementation site
3,428
Kenya Control Baseline
Baseline cohort at Kenya control site
2,520
Kenya Control Implementation
Implementation cohort at Kenya control site
3,177
Uganda Intervention Baseline
Baseline cohort at Uganda intervention site
1,408
Uganda Intervention Implementation
Implementation cohort at Uganda implementation site
1,903
Uganda Control Implementation
Implementation cohort at Uganda control site
2,855
Total18,147

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall Studyincomplete triage data0690028912365

Baseline characteristics

CharacteristicKenya Intervention ImplementationKenya Control BaselineKenya Control ImplementationUganda Intervention BaselineUganda Intervention ImplementationUganda Control ImplementationTotalKenya Intervention Baseline
Age, Continuous31.2 Months17.55 Months13.3 Months13.55 Months15 Months17.3 Months22.4 Months25 Months
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
1466 Participants1207 Participants1504 Participants676 Participants908 Participants1418 Participants8431 Participants1252 Participants
Sex: Female, Male
Male
1962 Participants1313 Participants1673 Participants732 Participants995 Participants1437 Participants9716 Participants1604 Participants
Time to antimicrobial administration123 Minutes239 Minutes261 Minutes255 Minutes239 Minutes212 Minutes206 Minutes115 Minutes

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
29 / 2,85610 / 3,42811 / 2,52010 / 3,17711 / 1,4084 / 1,9032 / 2,855
other
Total, other adverse events
0 / 2,8560 / 3,4280 / 2,5200 / 3,1770 / 1,4080 / 1,9030 / 2,855
serious
Total, serious adverse events
0 / 2,8560 / 3,4280 / 2,5200 / 3,1770 / 1,4080 / 1,9030 / 2,855

Outcome results

Primary

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.

Time frame: 1 day

Population: Children presenting to the outpatient department at facility

ArmMeasureValue (MEAN)
Kenya Intervention BaselineTime to Administration of an Appropriate Antimicrobial115 minutes
Kenya Intervention ImplementationTime to Administration of an Appropriate Antimicrobial123 minutes
Kenya Control BaselineTime to Administration of an Appropriate Antimicrobial239 minutes
Kenya Control ImplementationTime to Administration of an Appropriate Antimicrobial261 minutes
Uganda Intervention BaselineTime to Administration of an Appropriate Antimicrobial255 minutes
Uganda Intervention ImplementationTime to Administration of an Appropriate Antimicrobial239 minutes
Uganda Control ImplementationTime to Administration of an Appropriate Antimicrobial212 minutes
Other Pre-specified

Admission

Admission to hospital

Time frame: 12 hours

Population: All enrolled children

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Kenya Intervention BaselineAdmission581 Participants
Kenya Intervention ImplementationAdmission474 Participants
Kenya Control BaselineAdmission452 Participants
Other Pre-specified

Clinical Diagnosis

The clinical diagnosis for each participant

Time frame: 12 hours

Population: All participants.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Kenya Intervention BaselineClinical DiagnosisMalaria131 Participants
Kenya Intervention BaselineClinical DiagnosisPneumonia139 Participants
Kenya Intervention BaselineClinical DiagnosisBroncholitis3 Participants
Kenya Intervention BaselineClinical DiagnosisDiarrhea/ Gastro15 Participants
Kenya Intervention BaselineClinical DiagnosisMeningitis11 Participants
Kenya Intervention BaselineClinical DiagnosisMalnutrition17 Participants
Kenya Intervention BaselineClinical DiagnosisSepticemia58 Participants
Kenya Intervention BaselineClinical DiagnosisNeonatal sepsis12 Participants
Kenya Intervention BaselineClinical DiagnosisDehydration20 Participants
Kenya Intervention BaselineClinical DiagnosisOther161 Participants
Kenya Intervention ImplementationClinical DiagnosisDehydration12 Participants
Kenya Intervention ImplementationClinical DiagnosisMalaria100 Participants
Kenya Intervention ImplementationClinical DiagnosisMalnutrition5 Participants
Kenya Intervention ImplementationClinical DiagnosisMeningitis6 Participants
Kenya Intervention ImplementationClinical DiagnosisPneumonia154 Participants
Kenya Intervention ImplementationClinical DiagnosisOther123 Participants
Kenya Intervention ImplementationClinical DiagnosisNeonatal sepsis32 Participants
Kenya Intervention ImplementationClinical DiagnosisBroncholitis5 Participants
Kenya Intervention ImplementationClinical DiagnosisSepticemia23 Participants
Kenya Intervention ImplementationClinical DiagnosisDiarrhea/ Gastro12 Participants
Kenya Control BaselineClinical DiagnosisNeonatal sepsis17 Participants
Kenya Control BaselineClinical DiagnosisDiarrhea/ Gastro12 Participants
Kenya Control BaselineClinical DiagnosisMeningitis5 Participants
Kenya Control BaselineClinical DiagnosisMalnutrition8 Participants
Kenya Control BaselineClinical DiagnosisDehydration20 Participants
Kenya Control BaselineClinical DiagnosisSepticemia75 Participants
Kenya Control BaselineClinical DiagnosisMalaria85 Participants
Kenya Control BaselineClinical DiagnosisOther123 Participants
Kenya Control BaselineClinical DiagnosisPneumonia104 Participants
Kenya Control BaselineClinical DiagnosisBroncholitis2 Participants
Other Pre-specified

Length of Stay

Length of stay in hospital for admitted cases

Time frame: 7 days

ArmMeasureValue (MEDIAN)
Kenya Intervention BaselineLength of Stay4 Days
Kenya Intervention ImplementationLength of Stay4 Days
Kenya Control BaselineLength of Stay4 Days
Other Pre-specified

Mortality

Death within 7 days

Time frame: 7 days

Population: All participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Kenya Intervention BaselineMortality39 Participants
Kenya Intervention ImplementationMortality23 Participants
Kenya Control BaselineMortality14 Participants
Post Hoc

Number of Intravenous Antimicrobials in Admitted Cases

Number cases receiving antimicrobials in the cohort of admitted cases

Time frame: 24 hours

Population: Participants admitted to hospital

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Kenya Intervention BaselineNumber of Intravenous Antimicrobials in Admitted Cases512 Participants
Kenya Intervention ImplementationNumber of Intravenous Antimicrobials in Admitted Cases361 Participants
Kenya Control BaselineNumber of Intravenous Antimicrobials in Admitted Cases406 Participants
Other Pre-specified

Readmission

The child is readmitted to the hospital after being discharged

Time frame: 7 days

Population: All participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Kenya Intervention BaselineReadmission57 Participants
Kenya Intervention ImplementationReadmission57 Participants
Kenya Control BaselineReadmission48 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026