Clinical trial NCT04827342: Feasibility and Functionality Test of Ada's DDSS Prototype
Official title: Feasibility and Functionality Test of Ada's DDSS Prototype, Exploring the Potential and Performance When Diagnosing Complex Cases of Dyspnea at the Emergency Department and Ward of Interna! Medicine of the University Hospital Basel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Keywords: Ada DDSS prototype
Diagnostic Decision Support System (DDSS)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Ada Health GmbH
First posted: 2021-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with dyspnoea who come to the emergency room of the University Hospital Basel and are to be transferred to the Internal Medicine Ward due to their illness

Brief summary: This study is to explore with a feasibility and functionality test the potential of the Ada DDSS prototype with cases of dyspnea patients using the data collected at the Emergency Department (ED) and the ward of Internal medicine of the University Hospital Basel.

Detailed description: This is an observational i.e. non-interventional, prospective feasibility study, which assesses, through observation, the potential, functionality and diagnostic performance of the Ada DDSS prototype in evaluating patients presenting with dyspnea as primary predominant complaint to the ED.

Once the consent form is signed, the Investigator documents patients' data, medical history, symptoms and findings with the Ada DDSS prototype. During the entire patient journey through the hospital (presentation at the ED through to admission in the ward of Internal Medicine) relevant information are collected and documented in the Ada DDSS prototype simultaneously to standard documentation by the medical staff.

Examination and treatment are carried out by the attending physician without being influenced or affected by the entry of data in the Ada DDSS prototype.

There is no intervention/change made to the usual care, and therefore neither an intervention patient group nor a control patient group. The "usual care" that each patient receives is the control comparison point for the performance of the Ada DDSS. The diagnoses proposed by the tool at different times (after triage in the emergency centre, when transferred to the ward and when discharged from the hospital) are then compared with those of the attending physician.

Eligibility criteria: Inclusion Criteria:

* Dyspnea as the main symptom when entering the emergency room
* Existence of written consent
* The patient is able to speak, understand and read German or English.

Exclusion Criteria:

* Inability or unwillingness to understand and comply with study procedures due to:
* Language problems
* Acute mental disorders
* Dementia
* Clinical instability (e..B. resuscitation treatment, non-invasive ventilation, etc.)

Primary outcomes:
measure: Feasibility of the Ada DDSS prototype
timeFrame: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
measure: Subjectively perceived benefit from using the Ada DDSS prototype
timeFrame: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timiliotis J, Blumke B, Serfozo PD, Gilbert S, Ondresik M, Turk E, Hirsch MC, Eckstein J. A Novel Diagnostic Decision Support System for Medical Professionals: Prospective Feasibility Study. JMIR Form Res. 2022 Mar 24;6(3):e29943. doi: 10.2196/29943.