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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07257705
Acronym
OASES
Enrollment
15
Registered
2025-12-02
Start date
2026-02-06
Completion date
2026-02-14
Last updated
2026-02-24

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

Conditions

Clinical Decision Support Systems, Diarrhea Infectious, Dyspnea, Emergency Care, Rural Health, Seizures

Keywords

OASES App, Clinical Decision Support Systems, Emergency Care, Simulation Trial

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.

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.

Interventions

OTHEROASES 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.

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Guideline-Adherent Management of Simulated Emergency CasesImmediately after completion of each simulation scenarioProportion 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.

Secondary

MeasureTime frameDescription
Triage AccuracyImmediately after completion of each simulation scenarioCorrect 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.
Disposition AppropriatenessImmediately after completion of each simulation scenarioCorrectness 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.
Diagnostic AccuracyImmediately after completion of each simulation scenarioAccuracy of working impression (initial stage) and final diagnosis (post-investigation stage), compared with case-specific gold-standard diagnoses. Scoring by two blinded assessors.
Guideline-Adherent Evaluation (Process Quality)Immediately after completion of each simulation scenarioProportion 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.
Time to Case CompletionImmediately after completion of each simulation scenarioDuration in minutes required by participants to complete each simulated case, measured by facilitators during simulation sessions.
System Usability Scale (SUS) ScoreImmediately after completion of the OASES App simulation sessionUsability 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.
Perceived Usefulness, Trust, Satisfaction, and FeasibilityImmediately after completion of the OASES App simulation sessionClinicians' 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.

Countries

Uganda

Contacts

PRINCIPAL_INVESTIGATORMichele Bombelli, MD

University of Milano Bicocca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026