CyberLiver Dashboard IFU (Brief)

CLINICIAN INFORMATION

BRIEF SUMMARY INSTRUCTIONS

PRESCRIPTION DIGITAL THERAPEUTIC SOFTWARE

The Clinician Information leaflet does not include all the information needed to use the CyberLiver dashboard effectively. Please read the full Clinician user guide that is part of your induction.

Intended Use

The intended use of the CyberLiver dashboard is to facilitate the generation of digital prescriptions for liver diseases, enable remote patient management and monitoring, provide near-real-time alerts, offer supported diagnoses to prevent potential complications, manage treatment plans, and facilitate bidirectional communication between patients and the clinical team.

Indications for Use

The CyberLiver dashboard is intended for use by clinicians in the out-of-hospital specialist hepatology management follow-up of adult patients aged 18 and older. The dashboard is intended to help clinicians to perform the following functions:

• Creation and management of patients
• Management of prescriptions for various liver diseases
• Remote patient monitoring and management
  • Assisted diagnoses and early interventions
  • Reduction of hospitalisations through proactive monitoring
  • Seamless two-way communication between clinicians and patients

The CyberLiver dashboard is intended for active remote management of patients for up to 90 days. Patients on the prescribed treatment plan for up to 90 days can then transition back to a more standard medium-term outpatient clinical follow-up pathway. For those who remain unstable or with signs of frequent new complications, management can be extended beyond 90 days.

Important Safety Information

Please note that the CyberLiver dashboard is not intended for emergencies. It is a supplementary tool for specialised hepatology management and ongoing patient care outside of the hospital setting. Clinicians should not use the CyberLiver dashboard to communicate with their patients about emergency medical issues. Patients should be instructed not to use two-way communication to communicate urgent, critical, or emergent information to their clinicians. Patients should be instructed to go to the nearest A&E or urgent care in an emergency.

The CyberLiver dashboard is not a stand-alone assessment for determining a patient’s treatment. Treatment decisions should be based on medical history, patient data, and the clinician’s best judgment.

Effectiveness

The duration of each prescription interval is 90 days. Additional 90-day access intervals to the prescribed therapy may benefit patients, as determined by the clinician; however, the benefits of prescription extension have not been evaluated.

What is the CyberLiver dashboard?

The CyberLiver dashboard will help clinicians with the remote care management of out-of-hospital patients enrolled in the prescription therapy program. Clinicians can monitor multiple patients and get early alerts and diagnoses to help prevent further complications and provide early interventions. The dashboard helps in saving valuable time spent on patient reviews and helps prioritise diagnoses and interventions based on patient risk levels.

How to start using CyberLiver dashboard?

View patient treatment history, including measurements, events, medications etc.

Once you register with CyberLiver, you will receive the login credentials. If you are working as a part of a hospital or a clinic, your admin will be able to create your login and manage access.

As part of patient management, you will be able to

Create patients to enrol them in the prescription therapy program

Assign/Modify prescriptions to patients

Assign/Modify healthkits to patients as appropriate

Assign/Modify medications schedule

Request for patient measurements as applicable

Review and approve measurements as applicable

Complete the onboarding to enable home therapy for patients on discharge

As part of everyday patient remote care management, you will be able to

Do a quick daily review of all patients, prioritised by risk levels, to help with immediate interventions and actions

Review and confirm diagnostics for the patient, and modify the treatment plan if required

View diagnostic and monitoring alerts for patients

View daily patient measurements/progress

View and monitor patient treatment plan/medication adherence

View/Modify treatment schedule for patient

Request for additional patient symptoms and measurements to validate the diagnosis, as applicable

Have seamless two-directional communication with the patient

Adding a new patient to CyberLiver is easy! Here are a few simple steps to get you started:

1. Sign In and Access the Menu

Ensure you’re signed in to the CyberLiver Dashboard.

3. Complete the Patient Information Form

• A patient information form will appear.
• Fill out all mandatory fields marked with an asterisk (*).
• For faster address entry, enter the patient’s postcode in the designated field.

4. Save the New Patient:

• Once you’ve completed the form, click the “Save” button to add the new patient to your system.

Additional Tip:

• Double-check the information entered for accuracy before saving.

Following these steps will allow you to assign a therapy and admit a patient:

1. View and Select Therapy:

In this example, you see “CirrhoCare 90D” and “AlcoChange DTx 90D.” Choose the appropriate therapy for the patient.

After adding a patient, you’ll see a list of available therapies designated for your organisation.

3. Set the Start Date and Confirm:

• A pop-up will appear allowing you to choose the start date for the patient’s prescription. Select the desired date using the provided calendar or date picker.
• Confirm your selection by clicking the “Confirm” button.

4. Admit the Patient (Optional- can be done later as well):

• After assigning the prescription, you will see the patient and prescription details.
• You will see a button “Admit onto <therapy name>”.
• Clicking this button initiates the onboarding process for the patient’s chosen therapy.
• You can do it immediately after assigning the patient or you can do this step later.

Additional tip:

You can revoke the prescription using the “Remove prescription” option

This guide outlines the steps involved in onboarding a patient onto the CirrhoCare therapy. There are 4 main steps involved in onboarding a patient onto CirrhoCare.

1. Clinical assessment:

• Enter the patient’s initial clinical examination findings on Hepatic Encephalopathy, Peripheral oedema, Jaundice and other clinical scores.

In the “Admitted under” field, specify the primary consultant responsible for the patient’s care.

Click “Save and Continue” to proceed

2. Assign HealthKit and Therapy personalisation

Select an available HealthKit from the list.

• Set patient engagement preferences, such as:
  • Measurement reminder times
  • Questionnaire schedule

Click “Save and Continue” to proceed.

3. Treatment Plan:

Add details of the patient’s supportive contacts (up to 3).

Choose any new liver medications from the available list.

These medications will be listed on the patient’s treatment plan, which you can review and modify during daily patient reviews, if required.

Add any relevant onboarding notes.

• Choose to either:
  • Proceed to baseline measurements by clicking “Save & continue”
  • Skip baseline and initiate pre-therapy by clicking “Save treatment plan & start pre-therapy”

4. Baseline measurements:

Important: Before requesting baseline measurements, ensure the patient has agreed to the terms on the patient app and confirmed the start of therapy.

• Click the “Request baseline measurements” button to prompt the patient to complete them on the app.
• Once completed, the measurements will be displayed on the dashboard. You can edit or choose from multiple readings, if available.

Click “Save and complete” to save the baseline measurements and finish the onboarding process.

Daily patient review is an easy and straightforward process. With a quick glance at the dashboard, you can view all assigned patients and prioritise at-risk ones. Clicking on a patient card unlocks their detailed information, allowing you to efficiently perform reviews and manage their care. The same can be achieved by clicking on the ‘Review ..’ buttons on the top-right of the dashboard.

Select whether to review individual patient, all patients or at-risk patients

• To review an individual patient, select on the patient card from the home screen

• To review all patients one after the other, select the ‘Review all patients’ or similar button on the top right of the dashboard.
• To review at-risk patients one after the other, select the ‘Review at-risk patients’ or similar button on the top right of the dashboard.

If there are no at-risk patients, this button will be disabled and you will see ‘No at-risk patients to review‘.

This guide outlines the daily review process for patients receiving CirrhoCare therapy. Daily reviews allow you to monitor patient progress, assess treatment effectiveness, and make informed decisions about their care plan.

This step-by-step guide will help you do daily review for patients on CirrhoCare therapy. If patients are on multiple therapies. you will be able review once therapy after the other.

For each patient, you will be able to see the ‘Review Summary’ tab along with other tabs. For this guide, we’ll focus on the “Review Summary” tab, which provides a comprehensive overview of key patient data. Other tabs will be discussed in other articles on the HelpDesk.

As part of the daily clinical review, you will be able do the following:

• Check and confirm/modify diagnosis/risk of complications
• View patient digital biomarkers
• Check medication adherence
• View any patient reported symptoms added from the app or add symptoms if discussed offline with patient.
• Add review notes
• Modify any treatment plan (if required)
• Request measurements (if required)

Once you completed the patient review, you can Confirm and save the review.

Check and confirm/modify diagnosis/risk of complications

While the CyberLiver platform and algorithm offer a diagnosis based on available data, you may want to modify the risk level for each complication based on your clinical assessment and clinical expertise.

• View the CyberLiver (CL) inference.
• To make adjustments, change the diagnosis as needed.

2. View patient biomarkers

You will be able to see patient’s biomarkers; you will also be able to switch between day view and week view.

3. Check Medication adherence

This section displays the patient’s medication adherence. You can easily see if they are taking their medications as prescribed or if there have been any missed doses.

4. Add review notes

• View any patient reported symptoms added from the patient app. You can also add symptoms if discussed offline with patient.

• Mark any any clinical actions taken during the review.
• Additionally, you can add detailed review notes to capture important observations and decisions.

5. Confirm and save review

• Once you have completed the daily review, you can Save the review summary

This guide outlines the daily review process for patients receiving AlcoChange therapy. Daily reviews allow you to monitor patient progress, assess treatment effectiveness, and make informed decisions about their care plan.

This step-by-step guide will help you do daily review for patients on AlcoChange therapy. If patients are on multiple therapies. you will be able review once therapy after the other.

For each patient, you will be able to see the ‘Review Summary’ tab along with other tabs. For this guide, we’ll focus on the “Review Summary” tab, which provides a comprehensive overview of key patient data. Other tabs will be discussed in other articles on the HelpDesk.

As part of the daily clinical review, you will be able do the following:

• 1. Check and confirm/modify diagnosis/risk of complications
• 2. Check medication adherence
• 3. View any patient reported symptoms added from the app or add symptoms if discussed offline with patient.
• 4. Add review notes

Once you completed the patient review, you can Confirm and save the review.

1. 1. Check and confirm/modify diagnosis/risk of complications

While the CyberLiver platform and algorithm offer a diagnosis based on available data, you may want to modify the risk level for each complication based on your clinical assessment and clinical expertise.

• 1. View the CyberLiver (CL) inference.
• 2. To make adjustments, change the diagnosis as needed.

2. 2. Check Medication adherence

This section displays the patient’s medication adherence. You can easily see if they are taking their medications as prescribed or if there have been any missed doses.

3. 3. Add review notes

• View any patient reported symptoms added from the patient app. You can also add symptoms if discussed offline with patient.

• Mark any any clinical actions taken during the review.
• Additionally, you can add detailed review notes to capture important observations and decisions.

4. Confirm and save review

• Once you have completed the daily review, you can Save the review summary

You can modify the treatment plan in two ways:

• Review Summary tab: Alternatively, modify the treatment plan by clicking on ‘Current treatment schedule’ in the “Review Summary” tab. You will see a list of current medications. You can edit or delete the medication. You can also add new medications from the list of medications.
  
• Treatment plan tab: Click on the “Treatment plan” tab. You will see the current day’s medication schedule as well as the ‘Current treatment schedule’ as mentioned above. You can modify accordingly.

Make changes to the treatment plan

Click on the edit button to edit the frequency and dosage for each medication and select from the available list of schedules.

Select from the list of schedules or add new schedule.

Click on Plus to add the schedule.

2. Save the treatment plan changes

• Once the changes to the treatment plan are done, click on ‘Save’.

Additional tips:

• You can any medication if you are removing it from the patient’s treatment plan.
• A notification will be sent to the patient app for acceptance and confirmation after modification.

The ‘Vitals’ tab shows the patients vitals across all therapies.

It gives you a snapshot of the patient’s vitals in the last 7 days.

Additional Notes:

• It’s important to remember that the “Vitals” tab is for informational purposes only. You cannot edit or modify the displayed data.

Utilise the ‘Journal’ feature to obtain a quick view of the patient’s entire therapy journey from the beginning to the end, organized day-wise. On the journal, you can see a list of all therapies, including past ones. Each therapy can be viewed individually.

Against each day, you’ll find the following details:

Hospital review: If the patient was admitted to or discharged from the hospital, that information will be displayed.

Decompensated events: If there were any events on the day, they will be displayed.

Change in treatment plan: Any changes in the treatment plan made on the day will be visible.

Clinical actions: Display of any clinical actions performed on that day, such as tele-consultations, patient recommendations, or review notes.

Additional tips:

• The vitals snapshot provides a glimpse into a more comprehensive patient journal. However, within the “Vitals” tab, this journal is view-only.
  
• To access and potentially modify details for a specific day, click directly on the corresponding date within the snapshot. This will likely take you to a more detailed view for that particular day,

For each patient, the monitoring alerts display relevant information. If there are no alerts from the patient, the monitoring alerts section will be empty. However, in the presence of alerts, you can view and address them through the ‘Monitoring Alerts’ tab for each patient.

Within the monitoring alerts, you will find details related to the following:

Compliance Alerts
Measurements, Progress tracking, Non-engagement – triggers notifications

Digital Bio-marker Alerts
Values outside the normal range

HealthKit Alert
Both system-generated and patient-reported issues with HealthKit

You can also click on ‘Configure’ to modify the baseline measurements for the particular patient.

This feature provides a comprehensive overview of patient data, empowering you to respond promptly and effectively.

This guide will outline how to view the status of all questionnaires scheduled for a particular patient.

1. Setting up of the questionnaire schedule
   • 1. As part of the patient onboarding, you would have set up health questionnaires to be sent to the patient at various intervals, personalised for each patient.
   • 2. As per the schedule set, these questionnaires will be delivered on to the patient app.

Viewing the schedule and completion status

On this tab, you will be able to see the list of all questionnaires that have been scheduled for this patient along with the date and completion status:

Not completed/Not attended
Completed
Next scheduled on

By clicking on the Info (i) icon next to each questionnaire, you can access detailed information, including the questions and patient responses if the questionnaire has been completed.

The CyberLiver Dashboard offers a convenient feature called the “Communication Desk” tab, designed specifically for sending messages to your patients. This chat-style interface allows for seamless two-way communication, enabling you to send messages and receive and respond to patient inquiries.

Receive and Respond: The patient will receive your message notification on their Patient app. They can then reply to your message directly within the app, and you will receive their response within the Communication Desk.

Compose and Send Message: The Communication Desk functions similarly to a chat window. You can compose your message directly in the designated area and send it to the patient.

Additional tips:

• Messages sent through the Communication Desk are delivered to the patient app, ensuring they receive timely updates and can easily respond.
  
• The Communication Desk goes beyond basic text messages. You can also attach additional media files to enhance your communication with patients.

To ensure all items are present and functional, perform an inspection upon receiving a HealthKit from CyberLiver using the ‘Manage HealthKits’ menu.

Access the ‘Manage HealthKits’ Menu:

Click the top left menu icon
Select “Manage HealthKits“.

2. Inspection steps:

• There are 2 main steps involved in inspection
  • Physical inspection to confirm receipt of all items
  • HealthKit diagnosis to assess the working condition

3. Initiate Inspection:

• In the “Manage HealthKits” menu, locate the “Perform Incoming HealthKit Inspection” button (top right) and click it.
  • Below that, you will be able to see the number of HealthKits that await inspection.

4. How to inspect:

• Once you click on the ‘Perform Incoming HealthKit inspection’, you will be able to inspect the HealthKits one by one.
  • You can do physical inspect of all HealthKits one after the other and do the diagnosis later.
    • If you choose to diagnosis later, you can click on “Inspect next HealthKit”. You can find the list of all the HealthKits that have completed physical inspection in the “Available to prepare” status. You can choose from the list and prepare them for use (diagnose) later.
      
    • If you choose to diagnose immediately after the physical inspection, you can click on the “Prepare to use this HealthKit” button.

5. Conduct Physical Inspection:

• With the HealthKit readily accessible next to you, verify the presence of all listed items. Ensure their packaging is intact and free of damage.

6. Diagnose HealthKit:

• You can diagnose the HealthKit immediately after the physical inspection or can choose any HealthKit in the “Available to Prepare” state from the list of HealthKits to do the diagnosis.
  • Follow the on-screen instructions to test each item’s working condition.
  • Utilise the provided video guide for visual assistance.

7. Complete diagnosis:

• Once the HealthKit is diagnosed, if there are no issues, you can ‘Mark as ready for use’.
• If you encounter any issues during inspection, you can mark the HealthKit for return.
  • HealthKit can be marked for return in the following scenarios
    • If there are missing or damaged items
    • If diagnosis fails

Following these steps will allow you to assign a therapy and onboard a patient:

View Go to menu and select Therapy and prescription:

AlcoChange supported phones and How to download the AlcoChange app?

1. To find out if a phone is compatible with AlcoChange, search using the phone model or brand name

Options to download AlcoChange app via QR or App store/ Google play

Choose the prescription and click on “Enter patient details to get prescription code”

Fill the patient details to generate prescription code:

1. Enter patient deatils and click generate prescription code

Confirm the patient details to generate the prescription – Click back to edit the patient details and Click confirm to generate the prescription

Prescription details

1. Able to view the “Patient access code” and “Site PIN”. Also the patient will receive an email of prescription details

1. Able to download or print the prescription information

Click Back to patient list to exit the Therapy and prescription flow, and close to get back to Therapy and prescription page, and click Enter patient details to get prescription code to generate code for another patient

The anonymous mode will mask all identifiable information

To enable, turn on the anonymous mode toggle

Enable anonymous mode:

Choose how long to enable the anonymous mode. Click confirm to enable the anonymous mode with the selected duration and click close to cancel the anonymous mode

After turned on the time will start running as per selected duration and it will mask all identifiable information like patients detials and clinician details

2. Disable anonymous mode:

1. The anonyomus mode will be disabled after the duration and ask for extend option. Click on “Extend” to extend the anonyomus mode with selected duration or click on “Turn off” to diable the anontomus mode

To disable, turn off the anonymous mode toggle. And click Confirm to disable the anonymous mode or click close to resume

This shows the patient daily measurements in 14, 21 and 28 days trend view

Click the “Trends” to view the deafult 28 days trends

Able to refresh for the latest data and able to choose the trends to be viewed in 14 days or 21 days or 28 days and able to “move back/future by 1 day” and scroll to view all the digital biomarkers in a select days trends and click “Close” exit the trends view