ESSENCE Study: E-health Self Symptom AssEssmeNt As a Front Door and Facilitator of CarE, Portugal

A 1.5.1 Study title ESSENCE Study: E-health Self Symptom assEssmeNt as a front door and facilitator of CarE

A 1.5.2 Investigational device 'Ada Assess' (CE-marked), 'Ada Connect' (a software integrating with CE-marked medical devices), and 'Ada Handover' (a CE-marked component of the 'Ada Assess' product that shares the same version number).

A 1.5.3 The Ada Health-CUF Integration To improve MyCUF service, CUF partnered with Ada Health, a symptom assessment application in which the patient can enter their/their children's symptoms, answer follow-up questions, and receive a list of potential causes, additional health information, and advice on if, when, and where to seek medical care.

A 1.5.4 Study design ESSENCE is a Quality Improvement (QI) study that evaluates the impact of Ada's AI-powered core symptom assessment technology on clinical workflow and individual healthcare guidance, following the November 2021 integration of the tool into the CUF hospital network.

A 1.5.5 Study objectives

The study has 3 main objectives:

1. Assess the clinician-perceived appropriateness of the Ada symptom assessment report.
2. Examine the impact of the Ada symptom assessment report on consultation efficiency.
3. Evaluate the effect of the Ada symptom assessment on patients' health-seeking behavior.

A 1.5.6 Primary and secondary endpoints

The primary endpoints of the study include:

(i) Appropriateness of the urgency advice provided by Ada and (ii) appropriateness of the Ada symptom assessment report, including factors such as reasonability of suggested conditions, completeness of symptom/medical history, agreement of medical problem summarized in the report with patient-HCP consultations, and the proportion of condition suggestions matching the main diagnosis.

Secondary endpoints encompass:

(i) The impact of the Ada Symptom Assessment Report on consultation efficiency, including changes in consultation activity distribution and resulting time saved for specific activities, (ii) the influence of the Ada assessment on patients' health-seeking behavior, including changes in health-seeking intent and behavior before and after checking their symptoms, (iII) assessment of the impact of the Ada assessment on the psychological well-being of patients, (iv) an exploration of health economic benefits resulting from the use of Ada's symptom assessment, and (v) an exploration of addition of large language models (LLMs) to the SC to: measure improvements in diagnostic accuracy measure improvements in the quality of differential diagnosis list measure improvements in safety and appropriateness of urgency advice These endpoints collectively aim to provide comprehensive insights into the impact and effectiveness of Ada's symptom assessment tool within the healthcare system.

A 1.5.7 Study size & duration Over the estimated 12 -month study period from November 2023 to October 2024, the study aims to enrol 143 CUF patients as study subjects, who consent both to 'Ada Handover' and to study participation and schedule a consultation with a CUF physician. The study subject number calculation determined that 143 subjects are required to enable primary endpoint analysis, and the study shall continue until this number of subjects for primary endpoint analysis are recruited. It is anticipated that not all patients consenting to participate in the study will schedule an appointment with a CUF physician and therefore no primary endpoint analysis can be performed. For these patients, only the routinely collected information of the symptom assessment flow will be stored in the dedicated electronic data capturing system and used for secondary endpoint/additional data analysis. We will also gather health-seeking behavior of these patients via a follow-up email which will be used for secondary endpoint analyses. It is also anticipated that some participating physicians may miss patients eligible for the primary endpoint due to technical or other difficulties. In this event, only relevant data points will be collected at the end of the study.It is estimated that around 2000 patients will be enrolled to ensure 143 patients are eligible for primary endpoint analysis.

If it is not possible to recruit the target subject number in 12 months, the PI and Sponsor will discuss whether the study shall terminate before this target is reached, and this will be discussed with the Ethics Committee if required. If the target patient recruitment number is reached earlier than the estimated 12 -month study period, the sponsor and Principal Investigator (PI) will discuss increasing the number of enrolled patients to provide additional power for potential sub-analyses. No data will be analysed for those CUF users who did not consent to 'Ada Handover' or study participation.