Paediatric Rapid Sepsis Trigger (PRST) Tool

Not Applicable

Completed

• Conditions: Infection; Sepsis
• Interventions: Other: Emergency Triage and Treatment (ETAT) guidelines; Device: Pediatric Rapid Sepsis Trigger (PRST) tool

• Registration Number: NCT04304235
• Lead Sponsor: University of British Columbia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-07
• Study First Posted: 2020-03-11
• Study Start: 2020-04-27
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18206

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Emergency Triage and Treatment (ETAT) guidelines	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.
Intervention	Pediatric Rapid Sepsis Trigger (PRST) tool	Hospital nurses will triage participants using the digital triage tool (mhealth intervention).

Primary Outcome Measures

Name	Time	Method
Hospital Admission	1 year	Model Development: Hospital admission (within 5 days of assessment) status determined from hospital records and information system, and a follow up call 7 days post discharge (to ascertain outcome). This will inform development of a clinical prediction model based on need for hospital admission.
Time to administration of an appropriate sepsis bundle of care	1 year	Effectiveness Evaluation of Digital Triage Tool: Time to administration of an appropriate sepsis bundle of care, which includes at least one of antibiotics, intravenous fluids, or oxygen as appropriate for age and clinical syndrome (treatment determined and administered by hospital staff). This will allow us to quantify the change from baseline in the proportion of children in each triage category (emergency, priority, queue) receiving treatment within 60 minutes of arrival at hospital.

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	1 year	Length of hospitalization determined from hospital records, and a follow up call 7 days post-discharge.
7-day readmission status	1 year	7-day readmission status determined from a follow up call 7 days post-discharge.
Clinical diagnosis	1 year	Final diagnosis determined from hospital records.
7-day post-discharge mortality	Phase I and Phase III	7-day post-discharge mortality status determined from a follow up call 7 days post-discharge.

Trial Locations

Locations (3)

Jinja Regional Referral Hospital; 🇺🇬 Jinja, Uganda

Kiambu County Referral Hospital; 🇰🇪 Nairobi, Kenya

Mbagathi County Hospital; 🇰🇪 Nairobi, Kenya