Feasibility and Functionality Test of Ada's DDSS Prototype

NCT ID: NCT04827342

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-06
• Study Completion Date: 2020-08-07

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.

Conditions

Dyspnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

data collection in the Ada DDSS prototype

Entry of patients' data (medical history, symptoms and findings) in the Ada DDSS prototype. The tool then automatically creates a list of possible diagnostic suggestions based on the information, which are compared with the diagnoses of the attending physician.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ada Health GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Eckstein, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35323125 (View on PubMed)

Other Identifiers

2020-00095; me19Eckstein3

Identifier Type: -

Identifier Source: org_study_id