Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04304235 |
| Other study ID # |
H19-02398 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2020 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
