Full User Manual: Ongoing remote patient monitoring

Full User Manual: Ongoing remote patient monitoring


User Manual

Remote Patient Monitoring


Version 1.1

Release date: November 12 2021

Introduction

This user manual is developed for clinicians who are responsible for remote monitoring of patients using the Levvel.connect. 

The user manual has been written in a way that is thorough and understandable. In addition to this manual, user training is provided. All clinicians must either read this entire user manual or take the training provided before using Levvel.connect. 

Intended use of Levvel.connect software

Levvel.connect is a software platform for Remote Patient monitoring. It consists of two integrated parts:

  • The clinician portal, a web application 

  • Patient interface, a mobile device application 

Through the mobile device application, patients can enter and follow their health data, and answer questions on their well-being. The clinician portal enables the healthcare team to monitor patients’ vital signs and follow disease development.

This combination of objective data and subjective responses enables the healthcare team to make informed, timely care decisions for better outcomes.

Indication for Use

Levvel.connect is an informational tool only. It is not to be used as a substitute for professional judgement of healthcare providers in diagnosing and treating patients.

Levvel.connect is indicated for use by patients and by healthcare professionals for collection and review of data from patients who are capable and willing to engage in the use of Remote Patient Monitoring.

The flexibility of the system allows the healthcare team to design and distribute individual or generic electronic questionnaires. It is furthermore possible to add threshold values for reference when reviewing reported data in the web application.

The Levvel.connect software must be configured by clinical users in order to be utilised to collect data as described above. The software does not in itself provide any protocols or procedures to obtain data from patients.

Levvel.connect does not provide any real time alerts and is not intended to provide automated treatment decisions or diagnosis.



  1. Navigation

General Navigation

Log in to the system

  1. Enter the URL you have received in your web browser or click on the link you have received.

  2. Enter your username and password.

The first time you log in, you will be asked to change your password.

  1. Click "Login"


Note

Your username and initial temporary password will be provided by the administrator.

Passwords must be at least 8 alphanumeric characters in length and must contain 1 number.

Change password and log out of the system

  1. Click on "Profile" at the top right.

  2. Enter your current password, then enter your new password and repeat the password. 

  3. Click "Update".

  4. When you are ready to log out of the system, click on "Log out" in the upper right corner.





Tip

The Clinician Portal is a web-based application and can be used anywhere as long as you have access to the internet. The website functions best with Google Chrome, Mozilla Firefox, or Microsoft Edge.

Navigate to the main menu 

The main menu

At login, the Overview page shows patients who have been assigned to you and who have pending alarms. Menu and general navigation functions are described below:

  1. Overview page; this is the default page displayed at login.

  2. The main menu panel provides access to the submenus: Overview, Calendar (Optional), Patient Group Messages (Optional), Find Patient, Create Patient, and All Notes for My Team Pages.

  3. Top menu bar showing the username you are logged in with; Administrator Menu button to access the Administrator Menu; Profile to change your login password and; Logout button to log off the system when desired.

  4. In the drop-down menu, it is possible to select a patient group and then press the "Filter" button.

Overview 

The overview page is interactive and will show different functions depending on the patient's status and your interaction.

  1. Filter patient groups.

  2. Patients' names and alarm colors. Click on the patient's name to view the patient profile. Click on the alarm color to see unapproved questionnaires for the patient and answer them accordingly.

  3. Patients' CPR number.

  4. Unread patient note.

  5. Receive green alarms directly from the overview.

  6. Create patient

  7. note Unread messages from patient.

  8. Read message from patient



Tip

Hover over the icons to see additional information


Alarm color description

  • Red: the alarm is exceeded by one or more values ​​(which fall outside the normal range).

  • Yellow: one or more values ​​to be observed (which fall outside the normal range).

  • Blue: data not received before the expected deadline.

  • Orange: clinical attention to reviewing data in questionnaires.

  • Green: no alarm limits are exceeded (however, it is important to note that a patient's condition may gradually worsen before an alarm is triggered).

  • Gray: No new measurements, but an unread message to or from the patient.


Find a patient

  1. Click "Find patient" in the main menu panel.

  2. Enter the patient's first name and last name.

  3. Make sure the status is set to "Active" in the drop-down menu.

  4. To fill in the form: Click on "Reset form" and enter new information as needed.

  5. Click on "Find patient".

  6. Search results for patients are displayed. Click on the patient's name to draw up the patient chart.


Tip

You can also search for a patient.

Just click on the field on the Find Patient page, enter the information and click on "Find Patient". The patient's search results are displayed.

Search for

  • Social security number

  • Telephone number

  • Username and / or

  • patient group

Review all notes for my team

  1. Click on "All notes for my team" from the main menu panel.

  2. All notes for your team / patients are displayed. Each row shows the patient name, documented note, type (eg Normal or important), reminder date, whether it was seen by you and whether it was seen by another member of the team. Notes can be sorted by each column by simply clicking on the title (eg the image below is sorted by patient name AZ, by clicking on reminder date, notes are sorted by date). You can move up and down the list by clicking the up arrow and down arrow.

  3. Click on the patient's name to view the patient profile.

  4. Click directly on the note to see further details about the note.

  5. Indicates whether a note has been viewed

  6. After clicking directly on the note, click "Mark as read" to indicate that you have read the message.

Navigating the patient menu

The patient menu

When you click on a patient profile, the patient menu is displayed. The patientcontains: 

  1. menuProfile data for the selected patient

  2. Link to the following subpages:

  • Measurements

  • Enter measurements

  • Master data

  • Messages to / from patient

  • Notes

  • Pausemaster data

  • Graphs

  • All measurements

  • Monitoring planmonitoring process


  1. Patient

Create patient

Assess the patient's suitability

Before starting the patient's remote, the patient's suitability must be assessed.

A patient should:

  • Have a diagnosis of one or more chronic diseases, NON-ACUTE condition.

  • Or have a non-acute clinical condition / condition of a temporary nature (ie pregnancy, post-op, etc.)

  • Or be unhindered by any known disease state.

  • Be able to read.

  • Has the cognitive skills required to operate a simple app and the necessary medical devices.

Create a new patient

  1. Click the "Create patient" button.

  2. Click "Next"

  3. Enter username and temporary password. Usernames must be unique in the system. Use the generated temporary password, or enter a new one; passwords must be at least eight characters long and contain at least one number.


Note

An asterisk (*) indicates mandatory fields to be filled out. The patient's "Health Care ID" is the unique patient identifier. Additional information (gray box) is provided if you hover over the field with the mouse. Enter the patient information in the fields displayed.


  1. Click on "Next"


  1. Select / click on the desired patient group or groups. It is possible to link more than one patient group to a patient by pressing the "ctrl" key when selecting patient groups.

  2. Click "Next". (Pay attention to the navigation settings: "Back" to return to the previous page, "Save" and "Save + Go to monitoring plan".)

  3. Enter / Create patient threshold values. Threshold values ​​are inherited from the patient group or groups associated with the patient.

  4. Click "Next."


  1.   Write patient comments as 
      needed.

  2.   Click "Next."

 10b Click "Add to Relatives."



  1.   Enter the patient relative contact information.

  2.   Click "Save".


Click "Add to care circle" to add additional relative contact information as needed.


  1.   Patient information is displayed.     
      Review the patient information.

  2.    Click "Save".

Patient information is displayed as shown below. When it is in a patient context, the patient menu displays the patient's information at a glance (eg patient name, health ID, comments, contact information and their relatives' contact information)         


Tip

The "Stay logged in" check box at the beginning of the stream allows patients to log in only once and then be remembered / automatically logged in for all subsequent uses of the system. Only use this if the patient has problems logging in, as it allows anyone with access to the tablet to use the patient app. If "Stay logged in" is checked, a disclaimer is displayed, which must be confirmed before the patient flow creation process continues.

Edit monitoring plan

  1. Click on "Monitoring plan" in the patient menu.

The patient monitoring page is displayed. By default, the start date will be the date the patient profile was created.

  1. Click "Edit" to change the date as needed.       



  1. Click on the calendar icon. The calendar is displayed. Select the date on which the plan is to begin.

  2. Click "Update".


Assign Questionnaire


  1. Click on "Assign Questionnaire".

  2. Select the patient's questionnaire by clicking on the drop-down menu.

  3. Select / click on the frequency / schedule for completing the questionnaire. See more information vdr. schedule setup in the chapter “Creating and Editing Monitoring Schedule”.

  4. When the frequency is selected, additional settings are displayed on the screen below. See more information vdr. schedule setup in the chapter “Creating and Editing Monitoring Schedule”.

  5. Fill in the information in the field as shown.

  6. Click "Assign" The

  7. The Monitoring Schedule page appears with the Monitoring Schedule and Schedule entered.








Questionnaire for questionnaire schedule:


Unscheduled

The questionnaire can be filled in at any time and as many times as you want

Weekdays - several daily measurements

The questionnaire can be filled in on specific weekdays, and it is possible to make several measurements per. Today

Weekdays - a daily measure

Questionnaires have to be completed on certain days of the week with a single measurement per day

date (s) of the mouth

Questionnaires have to be completed on certain dates of the month, eg the 1st and 15th of the month

Every Nth day

The questionnaire can be completed every nth day, e.g. A measurement every 3 days.

Specific date

The questionnaire can be completed on a specific date.

The deadline in the

questionnaire must be completed at the specified time of day. If a measuring frequency with several measurements per Today, multiple measurement times can be specified by clicking the "+" button

Reminder

sent a specified number of minutes before the deadline for the Questionnaire

Schedule

Window Used to specify how long before a deadline a sent in questionnaire result is recorded as the result of a questionnaire. This is used to indicate a period in which a delayed questionnaire result is not counted as a time result until the next deadline for the questionnaire. 

Weekdays

  1. First period: select the length of this period, e.g. 2 weeks. Then choose which days of the week you want to answer the questionnaire, eg Monday, Wednesday and Friday. 

  2. Second period: Choose which weekdays e.g. Monday and Friday to answer the questionnaire. 

  3. The second measurement period is valid as long as this questionnaire is valid for this patient





























Assign group of questionnaires

  1. Click on "Monitoring plan"

  2. Click on "Edit questionnaire groups" 

"Assign / remove questionnaire groups" is displayed with the questionnaire groups the patient has already assigned

  1. Select " Questionnaire group "in the drop-down menu, which shows the group's questionnaires in the table below. Click the "+ Add" button to add the questionnaire group to the monitoring plan.

  2. Added questionnaire groups are displayed here along with the names of the questionnaires in each group. Click "Assign".

The monitoring plan is updated with the new list of assigned questionnaire groups.



Note

It is also possible to link a questionnaire group to the patient. Thus, each questionnaire is automatically assigned to the patient using the standard questionnaire plan from the questionnaire group. Any changes to the list of questionnaires in the group are then reflected in the patient's monitoring plan.

Documenting patient holidays / pausing monitoring schedule

To mark patient holidays or when a patient is away, access the “Passive Interval” page from the patient menu. Even if patients are marked on vacation in the system, they can still perform scheduled questionnaires as needed. Through the monitoring plan, the nurse advises which questionnaires are to be carried out on holiday.

  1. Click "Passive intervals" in the patient menu.

  2. The pages with passive intervals are displayed with documented previous holidays and / or periods of absence.

  3. Click "Create".

  1. Click on the calendar icon and select "First passive date" in the calendar. The "first passive date" is the date on which the patient is away on holiday and / or unable to complete the questionnaire. Click on the calendar icon and select "First day after break" in the calendar. The "first day after break" is the date on which the patient will be available to complete the questionnaire again.

  2. Write / enter comment as needed.

  3. Click "Create"

  4. The next page will appear. Click "Edit" if you need to edit the interval, or click "Delete" to delete.

Patient information

View and change the patient master data

  1. Click on "master data" in the patient menu.

  2. Scroll to the bottom of the page and click "Edit". 

  3. In this section you can enter and edit patient information, including:

  • Demographic information

  • Patient groups

  • Comments

  • Relatives

  1. Click "Update" when you have finished updating the information.

The patient data has been updated.


Print patient information

  1. Click “master data” in the patient menu.

  2. Scroll down to the bottom of the page and click "Print."

This opens the print page.

  1. Make sure you select the correct printer / destination.

  2. Click "Print".

The document is printed.

Reset a patient's password

  1. Click "Basic data" in the patient menu

  2. Scroll to the bottom of the page and click "Reset password".

  3. "Are you sure you want to reset the password?" pop-up message appears. Click on "OK".

This will open a new page.

  1. A new temporary password is assigned to the patient. 

Communicate the temporary password to the patient.

Measurements

Addition of measurements is used when hospital staff add measurements to the patient, e.g. In a video conference or a personal meeting at the hospital.

  1. Click "Add Measurements" from the patient menu.

  2. Select / click on the measurement you want to add in the drop-down menu.

  3. Enter / enter the values ​​manually based on the information the patient has given you. Repeat steps 2-6 to add a measurement as needed.

  4. Click "Save" when you are done 

  5. The measurement will now appear in the completed questionnaire. Click on "Completed questionnaires" to see the added measurement (s)


Patient threshold values

Adding a threshold value to a patient through the patient menu creates a unique threshold value for the specific patient regardless of the assigned questionnaires.

  1. Click "Master Data" from the patient menu.

  2. Click "Edit".

  3. Scroll to the bottom of the page and click "Add Threshold" to create / add a threshold measurement.

  4. Select the preferred threshold value from the drop-down menu.

  5. Select threshold type

  6. Select oom it should aggregate

  7. Enter the threshold values ​​for the patient.

  8. Click "Create" Click to update existing threshold information as needed.







Ongoing monitoring

Manage completed questionnaires

Review and acknowledge completed questionnaires


  1. Click on the patient profile.


The "Measurements" page appears. This page is the default page when you click on a patient profile. Alternatively, you can click on "Completed questionnaires" in the patient menu to access the page.

  1. Period selection to view the time frame for the preferred completed questionnaires.

  2. Scroll down the "Select ..." mark to select a measurement / question to display in the top row.

  3. Column header indicating the date and time the questionnaire was completed along with various icons for which alarm limits have been exceeded.

  4. Each column shows the patient's answer to each question (one question per row) within the questionnaire


See questionnaire

  1. Click on “Show questionnaire.”

  2. The patient's questionnaire is displayed.

Review the questionnaire and add a closing note as needed.

  1. Write the closing note in this field.

  2. Click "Ignore" if you want to skip the measure over urement and exclude it from graphs / tables.

  3. Click "Receive" to acknowledge the questionnaire.


Confirm completed questionnaires

There are two ways to acknowledge the completed questionnaires directly from measurement ago:

  1. Acknowledge

  2. Acknowledge and send response authentication to the patient. Here it is possible to add closing notes and finish by pressing "Receipt".

Graphs and results

  1. Click "Graphs" in the patient menu.

  2. Each graph shows the date on the x-axis, the measurement on the y-axis, the title of the graph, the explanation and the data.

To change the date selection and

amount of data on the graph: 


  1. Click on the preferred period you want to see in the top navigation menu, or click on "Select period" to select your own.

Notes

General notes

  1. Click "Notes" from the patient menu 

  2. The notes are displayed. Each row shows:

  • Patient note

  • Type

  • Reminder date 

  • Seen by me? 

  • Seen by another user? 

To sort the notes by column: 

  1. Click on the title you want to sort by. 


Note

Text fields are sorted alphabetically, dates by most recent. 

You can also sort / move rows by clicking the up / down arrows.

View notes

  1. On the notes page. Click on the note you want to view.

The note appears in a new window.

  1. In addition to the note itself, it will also show:

  • The date of creation

  • Key edited 

  • Who it was created by.

  1. Click "Mark as read" to mark the read note. 


Note

Notes cannot be edited once they have been approved by a user.

Create a new note

  1. Click on "Create" from the note page.

The "Create Patient Note" page appears.

  1. Enter your patient note.

  2. Click / select the type in the drop-down menu.

  • Normal

  • Important

  1. Set the reminder date and time as needed.

  2. Click "Create".


Edit monitoring

schedule Monitoring schedule

  1. Click on "Monitoring schedule" in the patient menu. 

The monitoringplan for your patient is displayed. From the page you can fill in the following:

  1. Edit the start date of the patient to fill in questionnaires.

  2. View, edit and delete assigned questionnaires.

  3. Assign questionnaire.

  1. Edit assigned questionnaire groups.

Edit or delete monitoring schedule

  1. Click the "Edit " icon to open the monitoring schedule.

  2. Update the information you would like to update in the monitoring plan. 

  3. Click "Update".

  4. Click the "Delete Icon" to delete the monitoring plan. A small pop-up will appear asking if you are safe. 


  1. Communication with patients

Patient messages 

Messages and general layout

  1. Click on "Messages to / from the patient" in the patient menu.

  2. The message page for your patient is displayed. Here are a few navigation tips:

  • The latest messages appear at the top.

  • Messages from clinicians are gray and patient messages are blue.

  • Click Reply to respond to the patient.

  • Click Mark Unread / Read to mark patient messages as read or unread. 



Note The

heading “Messages” appears with a red number for the number of unread messages.

Replying, Sending, and Creating Messages

  1. To reply to a patient, click "Reply."

  2. To create a new message: Click "New message".

In both cases, a new window will open.

  1. Write your message to the patient

  2. Click Reply or Send.

You will be taken back to the message page and your message to the patient will be displayed.

Text messages

It is possible to define a set of standard text messages under the Administration menu: "Standard text messages".

The predefined messages can then be sent to individual patients using the patient menu: "Text Messages" and "Patient Group Messages".


Note

There is no guarantee that the patient will receive text messages, nor can the confidentiality of text messages be guaranteed. Therefore, critical or sensitive information should not be sent via the SMS messaging functionality.

CTG measurements 

The option to record continuous CTGs is presented to the patient as a separate menu. The menu is only displayed for patients who are in a patient group that has continuous CTGs activated (see screenshot).


Note

CTG measurements can be captured in two ways: as continuous CTGs or as questionnaire-based CTGs. Continuous CTG acts as a stream, the patient begins to record, and the CTG data is displayed in the external viewer after a short delay. The measurement continues until the patient stops the measurement. Questionnaire-based CTGs are discrete measurements. They are captured as part of a questionnaire result. The patient starts his questionnaire and registers a CTG as with any other measurement.


For continuous CTGs, the patient selects which setting of uterine activity sensitivity to use on the Monica AN24 device (see the user documentation for the AN24 device for the correct setting for use).

Once recording is started by the patient, a "Continuous CTG" column will appear below the "Completed Questionnaires" view below that patient. "Continuous CTG" cell shows which sensitivity setting the patient has selected.

Normally, the measurement continues until the patient stops it, but there may be circumstances where the system actively stops the measurement.

This can occur in two circumstances:

Slow network connection (or no connection) between the patient tablet and the server means that data delivery cannot keep up with measurement data.

Slow network connection (or no connection) between the server and the remote CTG viewer means that data delivery cannot keep up with measurement data. In either case, there is some leeway to prevent intermittent network problems from preventing a measurement from being performed. In both cases, the patient will be informed that the measurement has stopped due to network problems.

Questionnaire-based CTGCTG Questionnaire-based is collected

in the same way as all other measurements. A CTG-type measurement node is added to a questionnaire and that questionnaire is assigned to the patient. The patient will then be asked to perform a CTG measurement as part of this questionnaire.


Once the patient has completed the questionnaire, it becomes visible in the "Completed Questionnaires" view. The measurement is transferred to an external viewer. You can see the possible status of the transfer below:


Precautions

The information in this document is subject to change without notice.

Supplier

Levvel Health ApS

Savsvinget 7, 2970 Hørsholm

Denmark

Supplier responsibility

The supplier is only responsible for the software itself.



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