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Diarrhea InfectiousOASESNCT07257705

Pilot Trial of a Clinical Decision-Support App for Managing Emergencies Among Clinicians in a Rural Ugandan Hospital

A study testing OASES App in people with Diarrhea Infectious and Seizures, run by University of Milano Bicocca at 1 site in Uganda.

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

This study is testing a new mobile application called the OASES App, developed by the University of Milano-Bicocca. The App is designed to help frontline clinicians (nurses, clinical officers, and nursing assistants) provide faster and more accurate emergency care for patients with life-threatening conditions such as… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diarrhea Infectious, Seizures, Emergency Care
What is being tested?
OASES App
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUganda
Study dates
6 Feb 2026to 14 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Nurses, clinical officers, or nursing assistants currently employed in the outpatient department (OPD) of Dr. Ambrosoli Memorial Hospital.
  • Age ≥18 years.
  • Willing and able to provide written informed consent.
  • Available to participate in both simulation sessions.

Who cannot join

  • Individuals unable or unwilling to participate in both scheduled simulation sessions.
  • Individuals not currently employed in the OPD of Dr. Ambrosoli Memorial Hospital.

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Dr. Ambrosoli Memorial Hospital Kalongo

    Kalongo, Agago District, 47

Other trials in Uganda

About this study

Official title: Evaluation of a Clinical Decision-Support App for Emergency Care in a Rural Ugandan Hospital: A Pilot Randomized Crossover Simulation Trial

This study is testing a new mobile application called the OASES App, developed by the University of Milano-Bicocca. The App is designed to help frontline clinicians (nurses, clinical officers, and nursing assistants) provide faster and more accurate emergency care for patients with life-threatening conditions such as severe diarrhea, breathing difficulties, and seizures.

The OASES App guides clinicians step by step through internationally recognized emergency care guidelines, including triage, diagnosis, and treatment recommendations. It is intended to be used offline on a tablet, making it suitable for rural hospitals with limited resources.

Read more

This is a pilot study to understand whether the App improves the way clinicians manage simulated emergency cases compared to standard practice. About 16 clinicians at Dr. Ambrosoli Memorial Hospital, Kalongo, Uganda will take part in structured simulation exercises using realistic patient scenarios. Each participant will manage cases with and without the App, so that the two approaches can be compared.

The main goal is to evaluate whether the App helps clinicians follow evidence-based guidelines more consistently. Other goals include measuring accuracy of triage, diagnosis, and treatment decisions, as well as the time needed to complete cases and clinicians' perceptions of usability, trust, and feasibility.

No real patients will be involved in this study. All scenarios are simulations conducted in a safe, controlled environment. The results will help refine the App and inform the design of a larger study in the future.

Read the detailed description

Emergency conditions such as severe diarrhea, dyspnea, and seizures remain major causes of morbidity and mortality in low- and middle-income countries. Despite the availability of World Health Organization (WHO) and national guidelines, adherence to evidence-based emergency practices is often suboptimal in rural health facilities. Common challenges include limited training, high workload, and lack of decision-support resources.

The Organization for the Advancement and Support of Emergency Systems (OASES) App was developed in 2025 by the University of Milano-Bicocca as part of a quality improvement collaboration with Dr. Ambrosoli Memorial Hospital, Kalongo, Uganda. The App digitizes validated emergency care algorithms derived from WHO frameworks and Ugandan clinical guidelines. It incorporates the Interagency Integrated Triage Tool (IITT) and provides structured pathways for the management of diarrhea, dyspnea, and seizures in both adults and children. Designed for offline use on Android tablets, the App offers step-by-step decision support for frontline clinicians while also collecting structured clinical data.

This pilot trial uses a randomized, stratified crossover simulation design to evaluate the effectiveness, usability, and feasibility of the OASES App before clinical deployment. Approximately 16 outpatient department (OPD) clinicians at Dr. Ambrosoli Memorial Hospital (including nurses, clinical officers, and nursing assistants) will participate. Each clinician will complete a total of 12 standardized emergency case scenarios, divided into two sessions: one using the OASES App and one using standard practice without the App. To minimize learning effects, sessions will be separated by at least a three-day washout period.

The case scenarios are adapted from WHO training materials (such as Basic Emergency Care and Emergency Triage Assessment and Treatment guidelines) and reflect typical emergency presentations seen in the hospital's OPD. Each participant will manage six scenarios per study arm (two diarrhea, two dyspnea, two seizures), designed in matched pairs for comparability. Scenarios are facilitated by trained researchers and scored against gold-standard checklists derived from WHO and Ugandan guidelines.

The primary objective of the study is to assess whether use of the OASES App improves clinicians' adherence to evidence-based management steps during simulated emergencies. Secondary objectives include assessing triage accuracy, diagnostic accuracy, appropriateness of disposition decisions, completeness of history-taking and physical examination (process quality), time required to complete cases, and clinician perceptions of usability, trust, and feasibility.

The trial involves no real patients; all activities are conducted in controlled, simulation-based environments. Risks to participants are minimal and mainly related to potential discomfort in being assessed. Benefits include the opportunity to practice emergency scenarios and become familiar with digital decision-support tools.

Data are collected electronically using Kobo Toolbox, with facilitator checklists, participant responses, and structured usability surveys. Responses are scored independently by two blinded assessors, with discrepancies resolved by consensus or third-party adjudication. Data will be analyzed using mixed-effects models appropriate for a crossover design.

Findings from this pilot trial will provide preliminary evidence on the effectiveness and acceptability of the OASES App among frontline clinicians in a rural African hospital. Results will inform refinement of the App, guide study procedures, and support the design of a larger powered trial. At a broader level, the study aims to contribute to the evidence base for digital health solutions to strengthen emergency and acute care in resource-limited settings.

Being tested
OASES App
Keywords
OASES App, Clinical Decision Support Systems, Emergency Care, Simulation Trial
Medical subject headings
Dysentery, Seizures, Dyspnea

What participants receive

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

  • OASES AppOther

    Also called Organization for the Advancement and Support of Emergency Systems App, OASES Clinical Decision-Support App

    The OASES App is a tablet-based digital clinical decision-support system (CDSS) developed in 2025 by the University of Milano-Bicocca. The App digitizes validated WHO- and Uganda guideline-based triage and emergency care algorithms, including the Interagency Integrated Triage Tool (IITT) and condition-specific pathways for diarrhea, dyspnea, and seizures in both adults and children. It provides step-by-step guidance for frontline clinicians during emergency case management and simultaneously collects structured clinical data. The App is designed for offline use in rural hospitals with limited infrastructure. In this trial, participants receive a brief orientation but no formal training before using the App during simulation scenarios.

Study groups in NCT07257705
Study groupRoleWhat they receive
OASES App-Assisted Emergency CareExperimentalParticipants will use the OASES tablet-based clinical decision-support system to manage simulated emergency cases of diarrhea, dyspnea, and seizures. The App incorporates the WHO Interagency Integrated Triage Tool (IITT) and evidence-based algorithms from WHO and Ugandan guidelines. It provides real-time guidance for triage, diagnosis, and treatment steps, while also collecting structured data. Before use, participants receive a short orientation to the App but no formal training.
Receives: Other: OASES App
Standard Practice Emergency CareNo interventionParticipants will manage the same simulated emergency cases of diarrhea, dyspnea, and seizures without the OASES App, using their usual knowledge, clinical experience, and available resources. Standard reference materials, including paper-based WHO Interagency Integrated Triage Tool (IITT) and Uganda Clinical Guidelines, are accessible. This arm reflects routine practice in the outpatient department of Dr. Ambrosoli Memorial Hospital.

What is being measured

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

  1. Guideline-Adherent Management of Simulated Emergency Cases

    Proportion of pre-specified, evidence-based diagnostic and treatment actions (critical management steps) correctly performed by participants during simulated scenarios of diarrhea, dyspnea, and seizures. Performance will be scored against gold-standard checklists derived from WHO and Uganda clinical guidelines by two independent blinded assessors. The outcome is expressed as a proportion (0-1) of guideline-consistent critical management actions completed.

    Measured: Immediately after completion of each simulation scenario

Secondary outcomes (7)
  1. Triage Accuracy

    Correct assignment of patients to Interagency Integrated Triage Tool (IITT) categories (Emergency/Red, Urgent/Yellow, Non-urgent/Green), compared to case-specific gold standards. Scoring performed by two blinded assessors.

    Measured: Immediately after completion of each simulation scenario

  2. Disposition Appropriateness

    Correctness of the decision to admit or discharge patients, compared to gold-standard expected dispositions derived from WHO and Ugandan guidelines. Scoring by two blinded assessors.

    Measured: Immediately after completion of each simulation scenario

  3. Diagnostic Accuracy

    Accuracy of working impression (initial stage) and final diagnosis (post-investigation stage), compared with case-specific gold-standard diagnoses. Scoring by two blinded assessors.

    Measured: Immediately after completion of each simulation scenario

  4. Guideline-Adherent Evaluation (Process Quality)

    Proportion of critical history and examination items elicited by clinicians during simulated cases, compared with case-specific lists from WHO guidelines. Scored by facilitators using structured checklists.

    Measured: Immediately after completion of each simulation scenario

  5. Time to Case Completion

    Duration in minutes required by participants to complete each simulated case, measured by facilitators during simulation sessions.

    Measured: Immediately after completion of each simulation scenario

  6. System Usability Scale (SUS) Score

    Usability of the OASES App measured by the validated 10-item System Usability Scale (SUS), completed by participants after simulation sessions involving the App. The scale ranges from 0 to 100, where higher scores indicate better usability.

    Measured: Immediately after completion of the OASES App simulation session

  7. Perceived Usefulness, Trust, Satisfaction, and Feasibility

    Clinicians' perceptions of the OASES App assessed through structured 5-point Likert-scale survey items (1 = strongly disagree to 5 = strongly agree), adapted from Technology Acceptance Model and related frameworks, and short qualitative debriefs.

    Measured: Immediately after completion of the OASES App simulation session

Timeline

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

  1. First posted2 Dec 2025
  2. Study start6 Feb 2026
  3. Primary completion14 Feb 2026
  4. Study completion14 Feb 2026

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
This study uses a randomized, stratified crossover simulation design. Each participant manages standardized emergency scenarios in two periods: one using the OASES App (intervention) and one using standard practice (control). The order of conditions is randomized with permuted blocks, stratified by cadre (nurse/nursing assistant vs. clinical officer) to ensure balance. A washout period of at least three days separates the two periods to minimize learning and carryover effects. Matched pairs of cases (A and B sets) are used to ensure comparable content between periods, and within each period the case order is randomized.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07257705
Sponsor's protocol ID
UNIMIB-972-OASES
Other IDs
2025-CONT-142-BiUniCrowd-OASES
Acronym
OASES
Status last verified
Feb 2026
First submitted
18 Nov 2025
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This pilot study collects simulation-based performance data from a small number of clinicians. Because the dataset is small and involves individual-level performance in a professional setting, sharing could pose confidentiality risks despite de-identification. Aggregate results will be provided, but individual-level data will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing OASES App in people with Diarrhea Infectious and Seizures, run by University of Milano Bicocca at 1 site in Uganda.

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 4 inclusion and 2 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Guideline-Adherent Management of Simulated Emergency Cases (time frame: Immediately after completion of each simulation scenario). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Feb 2026.

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