NCT07257705

Brief 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 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

8 days

First QC Date

November 18, 2025

Last Update Submit

February 20, 2026

Conditions

Keywords

OASES AppClinical Decision Support SystemsEmergency CareSimulation Trial

Outcome Measures

Primary Outcomes (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.

    Immediately after completion of each simulation scenario

Secondary Outcomes (7)

  • Triage Accuracy

    Immediately after completion of each simulation scenario

  • Disposition Appropriateness

    Immediately after completion of each simulation scenario

  • Diagnostic Accuracy

    Immediately after completion of each simulation scenario

  • Guideline-Adherent Evaluation (Process Quality)

    Immediately after completion of each simulation scenario

  • Time to Case Completion

    Immediately after completion of each simulation scenario

  • +2 more secondary outcomes

Study Arms (2)

OASES App-Assisted Emergency Care

EXPERIMENTAL

Participants 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.

Other: OASES App

Standard Practice Emergency Care

NO INTERVENTION

Participants 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.

Interventions

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.

Also known as: Organization for the Advancement and Support of Emergency Systems App, OASES Clinical Decision-Support App
OASES App-Assisted Emergency Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ambrosoli Memorial Hospital Kalongo

Kalongo, Agago District, 47, Uganda

Location

Related Links

MeSH Terms

Conditions

DysenterySeizuresDyspnea

Interventions

Organizations

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

  • Michele Bombelli, MD

    University of Milano Bicocca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent outcome assessors who score participants' responses against gold-standard checklists are blinded to study allocation. They do not know whether the responses come from the OASES App-assisted or standard practice sessions. Participants, facilitators, and investigators are not masked due to the nature of the simulation design.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine and Surgery, University of Milano-Bicocca

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 2, 2025

Study Start

February 6, 2026

Primary Completion

February 14, 2026

Study Completion

February 14, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations