Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05592769 |
| Other study ID # |
HBMODENA001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 10, 2022 |
| Est. completion date |
November 2023 |
Study information
| Verified date |
November 2022 |
| Source |
HealthBeacon Plc |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This goal of this study is to assess the suitability of the HealthBeacon Injection Care
Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) device for patients on
injectable medications in the home-setting, for the management of respiratory disorders.
The HealthBeacon ICMS is composed of the Smart Sharps Bin, Companion App and Care Team
support. The Smart Sharps Bin a digitally connected sharps container and is pre-programmed
with a patient's injection schedule. It creates a time-stamped record of each used injection
deposited into it to calculate a patients' adherence to treatment. Following disposal, the
next date of injection and rotating injection site is updated without requiring any extra
work on behalf of the patient. The system also proactively supports enhanced compliance
through a series of smart dose reminders and intervention calls, to help patients stay on
track. Clinical teams can then review patient adherence data remotely via an online platform.
The main aims of this study include the following:
- To demonstrate the suitability of the HealthBeacon ICMS as an RTM device for respiratory
patients through successful billing and reimbursement for physicians
- To provide data to support the reimbursement of the HealthBeacon ICMS by Private Payors
in the future
Participants prescribed injectable medication for the treatment of a diagnosed respiratory
condition will be enrolled by the Principal Investigator (PI) and referred to HealthBeacon.
Participants will then be provided with access to the HealthBeacon ICMS to remotely track and
support their adherence to treatment in the home-setting. Participants will use the system
for 6 months and their adherence data during this time will be collected, which the PI and
clinical team involved will be able to remotely access and review.
At various stages of the study, the applicable RTM codes will be billed for, for each
participant. These stages include when providing each participant with access to the
HealthBeacon system, including the Smart Sharps Bin, when providing each participant with
education on how to use the device, and when the clinical team monitors each individual
patients' adherence data collected by the HealthBeacon system on a monthly basis.
Description:
The HealthBeacon ICMS is an adherence support platform for patients on injectable medications
in the home-setting. The Smart Sharps Bin electronically records each time a used injection
device is deposited into it by means of an infra-red sensor and camera. This data is compared
to an individuals' treatment schedule pre-programmed to the unit, to determine the patient's
adherence to therapy. The bin also issues reminders to patients when doses are due by means
of a blue light on its upper surface. Smart Short Message Service (SMS) dose reminders are
also provided to help patients stay on track. The bin displays patients personal adherence
score, date of their next injection and at which rotating injection site on a small screen on
its upper surface. When a used injection is deposited into the Smart Sharps Bin, patients'
adherence automatically updates as does the date of their next injection. This information is
also visible for patients to review in the HealthBeacon Companion App (the "App"). Within the
App, patients can also tailor their dose reminder preferences, see a log of all doses taken,
access educational materials and view their injection schedule details. They may also
remotely self-report a dose as taken in the App, if they were away from their Smart Sharps
Bin at the time of injection. Patients' adherence data, as collected by the HealthBeacon
ICMS, is then available for referring physicians and clinical teams to remotely review,
providing teams with greater insight and more accurate information regarding patient
compliance. HealthBeacon also remotely monitor the capacity of the Smart Sharps Bins, and
provide patients with replacement bins when they reach full capacity whilst arranging
collection of full bins through HealthBeacon's mail-back program.
The Centres for Medicare and Medicaid Services (CMS) released the Remote Therapeutic
Monitoring (RTM) codes in January 2021 to enable enhanced reimbursement of remote monitoring
services. Unlike existing Remote Physiological Monitoring (RPM) codes which required
collection of physiological data points, the RTM codes enable reimbursement of devices which
monitor therapy adherence, in particular for respiratory and/or musculoskeletal system
conditions.
As a remote device to track and support adherence to medications, the HealthBeacon ICMS is
well positioned to fulfil the definition of an RTM device. Key steps in the patient referral
and usage pathway, including providing access to the HealthBeacon system, initial set up and
education on how to use it, and its remote adherence monitoring capabilities, correspond to
separate billing events under the RTM codes. Therefore, HealthBeacon believe the system can
be successfully implemented as an RTM device with reimbursement for physicians. This study
aims to demonstrate this by providing real-world data on patient usage of the system,
implementation into clinical practice and primarily by assessing the outcome of the billing
process under the RTM codes.
