CLM Hypertension | Amlodipine Dose Optimisation System
MedBrand OptiDose was a proof of concept product designed to show the feasibility of an automated medication dose optimisation system. The system was designed to meet regulatory requirements in the UK, EU and USA and be deployable through a single prescription and made available through a normal pharmacy supply chain. This example of the system was built to optimise Amlodipine, a first line treatment for hypertension. The work built on a successful clinical trial showing that patients could be optimised on lower than standard doses minimising the instance of side effects and optimising the likelihood of adherence to treatment increasing the likelihood of long term blood pressure control.
Note: As the product was pre-submission brand names where not developed for its constituent parts. Medbrand and Optidose where used as placeholder names for development.
The overall system was conceived as follows; the patient receives treatment by taking MedBrand and using the OptiDose App, the secure OptiDose Engine informs patients when to change dose within the MedBrand label, the OptiDose reports treatment outcomes to Clinicians and suggests changes including new prescriptions, refills or discontinuation, patients and Clinicians can contact support for help with any logistical or technical difficulties with the system.
My Role | Senior Product Design Director
As part of my role as Senior Product Design Director I led the product definition and design of the dose optimisation system. This involved developing the product vision, therapy experience, learning programme, design strategy, design direction, usability engineering file and managing the design team and design team deliverables. The front end interfaces were built on a reusable design system developed by the design team over a number of years. Another example of this design system can be seen in the CLM Insomnia product here.
Patient Set Up | Autonomous Patient Onboarding
The patient receives a titration starter pack at the beginning of treatment. To get started they follow a few simple steps: (1) Fulfil prescription and receive the titration starter pack. (2) Open the starter pack. (3) Follow the App download instructions. Open the App.
Once the App is downloaded it introduces the patient to the product, and educates them how to implement daily therapy. The patient: (1) Watches a welcome video. (2) Accepts terms and conditions. (3) Set up a Patient profile. (4) Starts their first lesson, which is the beginning of their treatment.
App Overview | Repeatable Therapy Implimentaion
Patients take MedBrand medication and receive therapy using the OptiDose App. The App was specifically designed to guide patients consistently through a consistent journey so that efficacy could be measured and repeated at scale. The App has three main components: (1) The therapy manager instructs patients on their daily MedBrand dose, helps them establish good medication-taking habits and structures their engagement with day-to-day therapy. (2) The log helps the Patient record dose optimisation input data, track their therapy progress and encourages them to stick with the programme. (3) The learning manager guides the Patient through a structured learning programme helping them learn how to sustainably control their blood pressure over time.
Therapy Manager | Supporting Habit Formation
The OptiDose App lowers the barrier to change by helping the patient manage therapeutic events, complete learning tasks and form healthy habits. The therapy manager helps to organise: Amlodipine timing and adherence Routine scheduling. Data log completion. New lesson completion.
In addition to the Therapy Manger patients also had the option to set reminder notifications for key therapy habits. The notifications manager provided a single place where patients can manage their reminder preferences. This includes: (1) MedBrand medication reminder. (2) Log reminder. (3) Lesson reminder. (4) Practice reminders (for additional features unlocked during the lesson programme.
Log | Date Entry
To enable the dose optimisation engine and tailor treatment, the patient had to consistently log data in the app each day. This log included: (1) Measuring blood pressure. (2) Reporting symptoms and side effects. (3) Logging daily Medbrand adherence.
Log History and Insights | Encouragement & Proper Implementation
The History feature allowed patients to see all the data they have entered, understand their progress and view insights to motivate continued engagement with treatment. This feature included; viewing past data including blood pressure measurements, medication adherence, dose changes and reported side effects. Viewing insights was designed to encourage adherence to the programme and link to relevant educational content, creating learning moments and reinforcing behavioural education.
Dose Changes | Autonomous Patient Dose Changes
When the OptiDose Engine calculates that a dose change is required this change is communicated and confirmed by the patient. Dose changes adopted a standard prescription format to remain consistent with existing practices. A dose change involved: (1) The system communicating a dose change to the patient through the OptiDose app. (2) The patient accepting the dose recommendation and confirming they understand their new dose. (3) Or the patient rejecting the dose recommendation and reporting their reasons for doing so.
Learning Programme | Therapy Implementation
To ensure that treatment was implemented correctly the OptiDose App included a learning programme to help Patients carry out tasks like data entry correctly and also learn about behaviours to support long term Hypertension management A Patient could complete the learning program in less than 4 weeks and continue using the App as long as needed. After the second day a new lesson can be unlocked every 3 days. Each lesson is chunked into digestible modules. Patients could complete a session every three days or choose to complete available modules at their own pace.
Lessons where delivered using a learning manager which organised all learning content on the App into accessible and digestible chunks. Patients can see all the lessons on the App so that completion is an understandable and attainable goal. As lessons are completed they are “ticked” so the Patient can track their progress in completing the program.
Each lesson is broken down into short 3min modules that can be completed at the Patient’s own pace. Most lessons were delivered using video content to make information as easily digestible and as literal as possible to aid implementation. As the patient progressed through the content new features where unlocked like meditation audio for stress management.
Dose Optimisation Report | PDF Available on EHR
After a period of 4 weeks a Patient dose optimisation report would be uploaded the patients health record and accessed by the clinician in the EMR. This report was designed to aid clinician decision making after MedBrand OptiDose treatment. The report included: (1) A recommended next prescription action. (2) A rationale for the prescription recommendation. (3) Access to the data on which dose changes and the prescription recommendation are based.
Product Efficacy | Product Commercialisation & Partnership
The proof of concept succeeded in showing a vision for a dose optimisation system and a feasible path for commercial implementation. This project contributed to CLM signing a co-development partnership with Pharmanovia to develop precision medicine combination products.