Guidance AMS

A responsive cloud based application for antimicrobial approvals management and review used in major hospitals and healthcare facilities across Australia.

Challenge

To help doctors quickly and easily obtain appropriate antimicrobial approvals, and AMS teams to review and audit prescribing practices, to ensure appropriate drug use and improved patient outcome.

Users

Pharmacists, doctors, nurses, infectious disease specialists, antimicrobial stewards and healthcare facility administrators.

Role

Sole designer responsible for UX, UI design, rebranding and compliance with ISO 62344 (Usability Engineering Standard for Medical Devices)

National Centre for Antimicrobial Stewardship

Antimicrobial resistance is one of the top ten threats to global health.
 
Antimicrobial Stewardship (AMS) is the systematic effort to educate and guide prescribers to follow evidence-based prescribing to minimise the adverse effects of inappropriate antibiotic use, which include resistance, toxicity and costs.
 
I was privileged to work with world experts in this field at the National Centre for Antimicrobial Stewardship, part of Melbourne Health and situated in the world renowned Peter Doherty Institute for Infection and Immunity, on a complete redesign of their existing antimicrobial stewardship application, Guidance MS.
 
Our working team included pharmacists using Guidance MS in Royal Melbourne Hospital, clinical content writers and developers.  We reported to clinical and commercial directors. 

National Centre for Antimicrobial Stewardship

Antimicrobial resistance is one of the top ten threats to global health identified by the World Health Organisation.
 
Antimicrobial Stewardship (AMS) is the systematic effort to educate and guide prescribers to follow evidence-based prescribing to minimise the adverse effects of inappropriate antibiotic use, including resistance, toxicity and costs.
 
I was privileged to work with world experts in this field at the National Centre for Antimicrobial Stewardship, part of Melbourne Health and situated in the world renowned Peter Doherty Institute for Infection and Immunity, on a complete redesign of their existing antimicrobial stewardship application, Guidance MS.
 
Our working team included infectious disease specialists, pharmacists actively using the existing product in Royal Melbourne Hospital, clinical content writers, developers, a Product Manager, a QA Manager and the Commercial Director.

The Challenge

Guidance MS was an integral tool in antimicrobial stewardship in major medical facilities Australia-wide, but the UI and technology were old, usability was problematic, more competitors were entering the market, and users had voiced the need for new and improved features to support their clinical workflows.
 
Additionally, its partner application, Guidance Management Tool (GM Tool), a clinical workflow builder also produced by NCAS, had been rebuilt and improvements to its capabilities offered opportunity and responsibility to enhance the approvals engine for Guidance MS.
 
Our challenges involved directing doctors towards appropriate prescribing practices without compromising their busy schedules or being seen to usurp their expertise, and providing antimicrobial stewardship teams with tools powerful enough to give them measurable insights and influence when advising hospital administration.
 
Significantly, it was also determined the product would need to be registered as a medical device with the Therapeutic Goods Administration, and so the entire research, design and development process would have to be restructured to ensure compliance.

Medical Device Compliance

As Guidance AMS is used for approvals for drugs which have the potential to cause patients serious harm if inappropriately issued, and it was determined there was a risk of this happening, the software would need to be registered as a medical device and comply with the international regulatory standard ISO 13485.  
 
I was tasked with responsibility for the Usability Engineering Standard (ISO 62366) – understanding its requirements, advising and educating the team as to how to integrate it with our processes, and developing our Usability Engineering Plan to ensure we identified potentially hazardous use scenarios in the UI, designed controls to eliminate or mitigate them to an acceptable degree, and verified and validated them across formative and summative evaluations, to feed back into the overall risk management process.
 
I was also a member of the selection committee that chose our QA software, and responsible for UI related documentation to prepare for auditing.
 
 

Medical Device Compliance

As Guidance AMS is used for approvals for drugs which have the potential to cause patients serious harm if inappropriately issued, and it was determined there was a risk of this happening, the software would need to be registered as a medical device and comply with the international regulatory standard ISO 13485.  
 
I was tasked with responsibility for the Usability Engineering Standard (ISO 62366) – understanding its requirements, advising and educating the team as to how to integrate it with our processes, and developing our Usability Engineering Plan to ensure we identified potentially hazardous use scenarios in the UI, designed controls to eliminate or mitigate them to an acceptable degree, and verified and validated them across formative and summative evaluations, to feed back into the overall risk management process.
 
I was also a member of the selection committee that chose our QA software, and responsible for UI related documentation to prepare for auditing.
 
 

Research

When I joined the project, a considerable amount of research (focus groups, workshops, user interviews) had already been conducted by the clinical team.  From this, along with commercial and technical requirements, and support team analysis of user feedback, they had prepared a preliminary set of requirements for the new product.
 
I led workshops with the team to understand the users – their backgrounds, roles, needs and goals, the use environments, and technology, and accompanied AMS teams on ward rounds in the Royal Melbourne Hospital and Peter MacCallum Cancer Centre to observe real use cases and better understand user behaviour, requirements and limitations.
 
We then created personas and created use scenarios to assess and flesh out the requirements, and identified known hazards and characteristics of the UI which could affect safety.
 
 
 
 

UX Design

After refinement and aggregation of requirements, I clarified the product architecture and dove deep in cycles into the UX for each feature, creating task flows and wireframe prototypes.
 
Each feature design cycle involved weekly evaluation workshops to review, verify and refine the prototypes, ensuring user goals were being met, hazard related use scenarios were removed or reduced to the lowest possible residual risk, and designs were technically and commercially achievable.
 
There were some extraordinarily complex clinical workflows to be addressed and the process took many iterations to resolve, but as the clinical team were users of the product, we were able to evaluate them against legitimate user concerns.
 
We also ran regular stage-gate meetings with the company directors to ensure we were satisfying larger stakeholder concerns.
 
 

UX Design

After refinement and aggregation of requirements, I clarified the product architecture and dove deep in cycles into the UX for each feature, creating task flows and wireframe prototypes.
 
Each feature design cycle involved weekly evaluation workshops to review, verify and refine the prototypes, ensuring user goals were being met, hazard related use scenarios were removed or reduced to the lowest possible residual risk, and designs were technically and commercially achievable.
 
There were some extraordinarily complex clinical workflows to be addressed and the process took many iterations to resolve, but as the clinical team were users of the product, we were able to evaluate them against legitimate user concerns.
 
We also ran regular stage-gate meetings with the company directors to ensure we were satisfying larger stakeholder concerns.
 
 

Rebrand

A brand overhaul was needed to establish a powerful new expression of the product in the marketplace.  It needed to clearly belong to its parent brand, the Guidance Group, but establish its own presence.
 
I consulted with the directors to clarify its values and personality.  (Female professor, smart, approachable, expert, mentor, professional, clinical, mature, reliable, trustworthy.) 
 
I researched competitors and other medical applications and products to explore the landscape, and developed some logos, which we narrowed down to settle on the final one, which represents the four pillars of antimicrobial stewardship and the concept of guidance itself (the red pointer/magnifying lens).
 
 
 

Setting the Style

For the UI design, we returned to the iterative cycle of design, review, risk analysis, verification and stage gates we followed for the UX. 
 
Added consideration was on accessibility – ensuring readability, clarity and compliance with usability principles.
 
I prepared a style guide which included standards for templates and responsive views, components (buttons, forms, tables, alerts, etc), typography, iconography, colour, logo, data formats and messaging.  This provided clear guidelines and controls for the offshore development team, to ensure usability was adhered to and design controls were protected.
 
 

Setting the Style

For the UI design, we returned to the iterative cycle of design, review, risk analysis, verification and stage gates we followed for the UX. 
 
Added consideration was on accessibility – ensuring readability, clarity and compliance with usability principles.
 
I prepared a style guide which included standards for templates and responsive views, components (buttons, forms, tables, alerts, etc), typography, iconography, colour, logo, data formats and messaging.  This provided clear guidelines and controls for the offshore development team, to ensure usability was adhered to and design controls were protected.
 
 

Approvals & Guidelines

Core to Guidance AMS is the approvals workflow, which allows doctors to obtain approvals for antimicrobial prescriptions, whilst guiding them towards appropriate therapies for their patients as a great concern in hospitals is inappropriate prescribing, which can lead to patient harm (toxicity or ineffective therapy), and a blowout in costs.  
 
A problem identified from use of the existing Guidance MS application was that doctors could easily ‘game’ the system to obtain approvals for drugs which might not be ideal for their patient. Doctors are time poor and often already convinced they have appropriate therapy, and a convoluted approvals process deterred them from due diligence with regard to AMS.
 
We designed a clear, simple guided flow flexible to their entry point (approval by drug or indication), that seamlessly leads them through decision points and resources to a recommendation or appropriateness assessment, designed controls around approval durations and oversight from ID physicians to reduce the potential for non-compliance and limit the potential for harm.  
 
The approvals flow offers either decision support or appropriateness assessment, and provides varying approval types (standard – meets criteria, non-standard – doesn’t meet criteria, highly restricted – needs ID approval, and authorised approvals) depending on a hospital’s drug restriction categories.
 
It was also critical that doctors in particular were able to access the flow on tablets and mobile phones, so they could attend to their approvals by the patient bedside and move on quickly, so I had to ensure the responsive view retained the integrity of the design and satisfied user goals.
 

Worklists

We created Worklists to give users a curated view of the patients under their care, as there are an enormous number of patients in most facilities, and clinicians are typically assigned to particular units and wards, so filtering through all patients is unwieldy and time consuming
 
For doctors and pharmacists, this meant lists filtered to location, whilst AMS Teams needed more filters to identify the patients that needed their review.
 
Worklists are data heavy – patient data, approvals and their history, flags and alerts (eg. alert indications and drugs, review requests, follow ups) and there are numerous activities to conduct against a patient (obtaining approvals and extensions, discontinuing approvals, marking under ID review, etc), so we designed a tiered, expandable view of patient information that provides a hierarchy of most important first, built in filters for easy searching, and special notifications tailored to the role to give a quick ‘for your attention’ view.
 
We also designed tools for integration with hospital EMMs.
 
 

Worklists

We created Worklists to give users a curated view of the patients under their care, as there are an enormous number of patients in most facilities, and clinicians are typically assigned to particular units and wards, so filtering through all patients is unwieldy and time consuming
 
For doctors and pharmacists, this meant lists filtered to location, whilst AMS Teams needed more filters to identify the patients that needed their review.
 
Worklists are data heavy – patient data, approvals and their history, flags and alerts (eg. alert indications and drugs, review requests, follow ups) and there are numerous activities to conduct against a patient (obtaining approvals and extensions, discontinuing approvals, marking under ID review, etc), so we designed a tiered, expandable view of patient information that provides a hierarchy of most important first, built in filters for easy searching, and special notifications tailored to the role to give a quick ‘for your attention’ view.
 
We also designed tools for integration with hospital EMMs.
 
 

Alerts Management

Often, pharmacists on their rounds will discover patients on drugs without approvals.  We created a pharmacy alert for recording a drug the patient has been prescribed but has no approval for, and issues an alert for doctors to create one.
 
The Review Request enables doctors to request AMS review if they’re concerned about appropriateness of the patient’s current antimicrobial prescriptions and need professional assessment.
 
As well as the standard alerts, one of the most complex pieces of UX we worked on was the approvals management alerts system, which is critical to ensuring clinicians have oversight into their patient’s current approval status and recent history.  
 
When an approval is being requested, these alerts identify whether there is an existing approval or a pharmacy alert for that drug already, or a recent course that might be connected to the new request, which would indicate the need for an extension instead.  This also helps the AMS teams monitoring and auditing drug therapies – essential for effective antimicrobial review and hospital audits.
 
 

Post Prescription Review Tool

The other core tool in Guidance AMS, the PPR, is designed for AMS teams, whose job it is to review patients and their antimicrobial prescriptions for appropriateness and provide professional advisement to doctors as to any adjustments needed to improve their therapies – such as changing route, dose, frequency, ceasing an antimicrobial or changing to another entirely.
 
The existing flow was disjointed and confusing, so I remade the architecture and UI to create clear, dedicated spaces for their primary tasks – Ward Round Spaces (shareable with other team members) where they manage their different rounds (eg. Haem patients or Plastics patients), and prepare their ward round lists (adding/removing patients for review).  They also provide visibility of and access to outstanding rounds which need to be completed, giving the teams a quick view of outstanding patient reviews and audits.
 
The ward round itself provides an overview of finalised vs outstanding reviews, enabling AMS teams to register the patient’s review status and access the review record itself. This helps the clinicians clearly see their remaining tasks.
 
The review record is where the AMS clinician record their assessment and recommendations, provide feedback to doctors and provide data for auditing and reporting, which itself allows them to advise primary hospital stakeholders on current antimicrobial prescribing practices in their facility and make recommendations for improvement or adjustment to drug policies hospital wide.
 
 

Post Prescription Review Tool

The other core tool in Guidance AMS, the PPR, is designed for AMS teams, whose job it is to review patients and their antimicrobial prescriptions for appropriateness and provide professional advisement to doctors as to any adjustments needed to improve their therapies – such as changing route, dose, frequency, ceasing an antimicrobial or changing to another entirely.
 
The existing flow was disjointed and confusing, so I remade the architecture and UI to create clear, dedicated spaces for their primary tasks – Ward Round Spaces (shareable with other team members) where they manage their different rounds (eg. Haem patients or Plastics patients), and prepare their ward round lists (adding/removing patients for review).  They also provide visibility of and access to outstanding rounds which need to be completed, giving the teams a quick view of outstanding patient reviews and audits.
 
The ward round itself provides an overview of finalised vs outstanding reviews, enabling AMS teams to register the patient’s review status and access the review record itself. This helps the clinicians clearly see their remaining tasks.
 
The review record is where the AMS clinician record their assessment and recommendations, provide feedback to doctors and provide data for auditing and reporting, which itself allows them to advise primary hospital stakeholders on current antimicrobial prescribing practices in their facility and make recommendations for improvement or adjustment to drug policies hospital wide.