Feasibility and Functionality Test of Ada's DDSS Prototype (Ada4dyspnoe)

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspnea
• Intervention / Treatment: Other: data collection in the Ada DDSS prototype

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Ada DDSS prototype	Feasibility of the Ada DDSS prototype simultaneously to standard documentation by the medical staff.	during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
Subjectively perceived benefit from using the Ada DDSS prototype	Subjectively perceived benefit from using the Ada DDSS prototype (during patient journey in the hospital) assessed by a physician.	during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Ada Health GmbH
• Investigators: Principal Investigator: Jens Eckstein, Prof. Dr. med., University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): August 7, 2020
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Ada DDSS prototype; Diagnostic Decision Support System (DDSS)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 2020-00095; me19Eckstein3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No