Predicting clinical aggression in mental health patients (#2716)

Creation
Draft
Initial
Detailed
Accepted
Adoption
Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
A predictive model for clinical aggression providing a daily ranked list of high, medium, and lower-risk patients - giving insight to clinical staff to develop a risk mitigation plan.
Overview of Innovation:
Traditional data in mental health is based on last episode, meds, structured questionnaire etc. However, nurses written observations provide valuable unstructured data (e.g. refused meds today, had no visitors, unresponsive etc.) for predictive analysis.
This solution uses Content Classification on historical data to correlate to aggression. The output file is fed into SPSS Modeller to create a predictive model. The model provides the most important factors (which can be confirmed by clinicians).
The model runs against the client’s data and provides reports identifying patients at risk of becoming aggressive – the nurses and clinicians can then take actions to prevent this. In a pilot client (in Canada) the model predicted the exact number and names of patients who became aggressive.
See: http://www.acumi.com/ontario-shores/
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
Similar Content3
Innovation 'Elevator Pitch':
Electronic wound imaging, 3D measurement, documentation, reporting, data sharing and informatics system.  An enabling technology to support objective wound assessment, quantitative outcomes monitoring and evidence-based treatment.
Overview of Innovation:
Silhouette is an easy-to-use wound imaging, 3D measurement & documentation system providing accurate wound information at the point of care to support effective clinical management of patients. Silhouette wound informatics are available as a wound assessment PDF report and on a secure web-enabled database and for easy access and sharing across the entire care team. 

The wound images and wound healing progress charts are highly visual and provide immediate and clear indication of a patient's response to treatment.

This award-winning system includes an imaging 3D camera that precisely and consistently measures the area, depth & volume of wounds to track and report healing progress. Silhouette enables wound assessment activity and wound outcomes to be monitored, providing wound information that is available instantly to key stakeholders, integrated with your EMR system. Silhouette is proven in both clinical research & clinical practice.

Silhouette supports pro-active management of wound-related risk & improves communication, helping practitioners to be more productive & effective in their delivery of wound care. Silhouette is suitable for all settings, including acute out-patient clinics, community-based care, home health & telehealth wound care.

The Silhouette system is made up of three main parts – a point of care wound camera, smart software for measuring wounds, & a wound information database:
  • The SilhouetteStar® specialized camera (pictured right) captures the wound image;
  • SilhouetteConnect® software for accurate 3D measurements of the wound based on the data acquired by SilhouetteStar (see below), together with healing progress charts & electronic wound assessment summary reports. 
  • SilhouetteCentral®, a secure Internet-accessible database that stores & consolidates the information obtained from the organisation’s SilhouetteStar + SilhouetteConnect devices, including integration with the EMR.
Unlike non-3D and traditional methods, which are imprecise & unreliable, Silhouette provides meaningful information for better clinical decisions. It is also extremely easy to use & is ready to integrate with EMR systems. Silhouette was first established in clinical research, which requires rigorous source documentation, & is now available for widespread use in clinical practice.

Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Digital health / Person centred care
Benefit to NHS:
Silhouette is an enabling technology to support safe, cost-effective care for patients with chronic and acute wounds such as diabetic foot ulcers, pressure ulcers and leg ulcers and complex wounds.
Currently, the burden of wound care on the NHS is estimated at £3billion per annum, with unacceptable variances reported in practice standards and outcomes achieved so that thousands of patients are not receiving the standard of care that should be possible.
Silhouette technology transforms how wound status is assessed, documented and reported. Better quality of wound information available in a connected and interoperable system means that clinicians are better supported for effective and timely clinical decisions and actions. Silhouette facilitates data sharing across an entire care pathway to reduce the risks of fragmented care across silos.
Silhouette equips, empowers and enables healthcare professionals and patients to collaborate for best practice to achieve optimal wound outcomes. 
There is significant potential for the NHS to drive for cost savings, greater efficiencies and clinical effectiveness with the adoption of the Silhouette wound informatics solution.
Online Discussion Rating
5.00 (3 ratings)
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
As well as assuring patients of best practice and quality of care, patients can actively engage in their care plan and outcomes due to the highly visual nature of Silhouette wound healing data and charts displayed on the software screens.

The benefits of rapid and effective wound healing for the patient should not be underestimated. The psychological consequences of living with a chronic wound are well documented. Upton and Hender (2012) suggest that patients with chronic wounds may experience negative emotions such as:
  • Stress
  • Concern about physical symptoms
  • Lack of self-worth
  • Despair
See featured Silhouette Patient Story which demonstrate the power of Silhouette informatics in motivating a patient with a debilitating pressure ulcer to recovery.  http://www.aranzmedical.com/patient-pressure-ulcer/
Current and planned activity: 
Entec Health is an appointed distributor to ARANZ Medical for the Silhouette solution in the UK. Our partnering goals are to inform & engage NHS stakeholders on the advantages of adopting digital wound assessment & wound informatics to address the “best practice, clinical excellence & cost-effectiveness gap” in wound management. Entec has supported 5 field Silhouette evaluations in acute & community care with considerable investment of time, expertise & resource. Entec has successfully established early adopters of Silhouette across the NHS:  
Clinical Practice: King’s College Hospital London Diabetic Foot Clinic, North Bristol Trust Enablement Centre
Clinical Research: 10 NHS centres of excellence in diabetes foot care are currently using Silhouette in a multi-centre clinical trial sponsored by EdixoMed  
Planned activity: A Diabetes Foot Pathway demonstrator project supported by EMAHSN to be announced & 2 further Silhouette collaborations are in progress, information to follow.
What is the intellectual property status of your innovation?:
Product family: Silhouette Mobile, Silhouette Connect
US patent: 8,755,053
Chinese patent: ZL 200680037626.3 

Product family: Silhouette Star, Silhouette Connect
US patents: 9,179,844, 8,755,053, D662,122
Chinese patent: ZL 200680037626.3
Other patent(s) pending

Regulatory Approvals: Silhouette has the following regulatory approvals:
  • FDA 510(k) approval
  • CE Mark
  • Health Canada – Therapeutic Products Directorate
  • TGA approval (Australia)
  • WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.

Health information protocols and privacy:  Silhouette supports a variety of protocols and functionality, including:
  • HL7 patient demographic information exchange or transfer
  • DICOM image transfer
  • DICOM Encapsulated PDF report creation and transfer
Silhouette is designed to support HIPAA and HITECH compliance.
 
 
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
2
Regulatory Approvals:
Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.
Commercial information:
The Silhouette wound imaging, assessment and information management system is a proven, established in-market solution used across world-wide markets. The Silhouette solution is supporting wound outcomes documentation, reporting and informatics for effective and efficient wound care service delivery. Silhouette is enabling transformation of wound care pathways in acute, community and integrated care settings. Early market for Silhouette is the US with UK, Europe and Asia as emerging markets.  
Investment activity:
Entec Health, as an appointed distributor of Silhouette in the UK, has invested considerable time, effort and funds to introduce the Silhouette to the NHS/UK market since 2011. ARANZ Medical, the developer and manufacturer of Silhouette has invested significant ,funds, effort and expertise in R&D and bringing the Silhouette solution to the global market. There is continued investment in partnering with the NHS and UK healthcare provider market by Entec Health. ARANZ Medical has a commitment to on-going investment in R&D for Silhouette to ensure that the solution meets the future needs of healthcare professionals.
Regional Scalability:
The Silhouette solution is highly and easily scalable across the West Midlands region for transformation of wound care services within the NHS sector. Silhouette can help to address delivery of greater clinical effectiveness and productivity in managing patients with chronic and acute wounds, including Diabetic Foot ulcers, Pressure Ulcers, Leg Ulcers and complex wounds. Silhouette is an enterprise system designed to be interoperable and connected within the NHS/Provider IT infrastructure to enable support of multi-disciplinary care of patients across a diverse range of care settings. Silhouette can be incorporated into telehealth/teleconsultation models of service delivery to support new models of care that improve patient experience, outcomes and cost-effectiveness. 
Measures:
The target outcomes of adoption of the Silhouette solution for the Healthcare Provider Organisation are:
Quality outcomes/measure
Organisation will demonstrate objective, evidenced-based practice to support timely and appropriate treatment planning and care for delivery of optimal wound outcomes.
Measure: Silhouette wound informatics available; quantifies and reports wound healing outcomes for individual patient, patient-population, clinical pathway and treatment type. 
 
Safety outcomes/measure
Organisation will have consistent standard of wound care practice and transparency on wound care outcomes to demonstrate accountable care provision to the required safety standards.
Measure: Silhouette wound informatics available; including digital wound images, wound healing data/charts and wound assessment reports available electronically for audit and management reporting.
Cost outcomes/measure
Organisation will have wound care outcomes data available to support assessment of cost-effectiveness of wound care treatments, service delivery and wound outcomes by treatment type.
Measure: Silhouette wound outcomes and assessment activity data available; to feed into cost-planning and cost-assessment of wound care service.
People outcomes/measure
Organisation will be supported to ensure high levels of staff and patient satisfaction of wound care services through equipping and empowering with quality clinical information on wound progress. The objective wound outcomes data generated with Silhouette will enable joint, evidence-based conversations on care plan and treatment goals with patients and the multi-disciplinary care team.  
Measure: Silhouette patient and population-level reporting available; combined with patient/staff surveys before and after deployment of Silhouette.
Adoption target:
Over next 2 years, we would like to aim to partner with 6 NHS Trusts/other healthcare providers in the West Midlands region for adoption of Silhouette.
Investment sought:
The Silhouette enterprise system is a modular system and investment level is dependent on scope of deployment. An enterprise level Silhouette system based on 5 Silhouette assessment devices and SilhouetteCentral database package starts from £45,000 (net, excluding VAT) for a capital purchase plan. Data integration, IT services, project management and annual software maintenance/support fees are additional costs, dependent on requirements. Silhouette pricing can be offered as an annual subscription model or a capital purchase model to suit different budgetary requirements. 
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Innovation 'Elevator Pitch':
Clinical CARPS improves patient care outcomes & staff experience through effective management, distribution & prioritisation of work
#Clear, consistent, flexible task allocation
#Real-time workload understanding
#Data for analysis & improvements
Overview of Innovation:
Clinical CARPS (C-CARPS) is a simple to use clinical task management system. Users have been delighted with the speed of implementation & the ability to fine tune the system to their needs
The system improves patient care outcomes & the experience of clinical staff in a very cost effective manner by saving time, optimising the deployment of staff resources & identifying areas for improvement. 
C-CARPS has been implemented with great success by the Hospital at Night team at The Alfred Hospital, Melbourne with our co-developer partners, InControl Australia. Alfred Health have cited many achievements facilitated or directly enabled by the system:
  • improved performance against patient care targets e.g. 8% increase in emergency patients admitted within 4 hours
  • increased overall productivity
  • improved staff attitude towards the overnight shift
Alfred Health won the “The Premier’s Award for Advancing Healthcare 2013”  & "The Metropolitan Health Workforce Initiative Award 2014" for their achievements, in which C-CARPS was instrumental.
C-CARPS replaces the existing method of task allocation, typically reliant on paging & phone calls between staff to clarify patient needs. In simple terms it is used as follows:
  • Nursing staff issue clinical task requests from ward PC’s or mobile devices
  • Team members carry a mobile device to track, manage & update allocated tasks
  • “Clinical Leads” have the ability to re-allocate work according to demand
  • Handovers are managed quickly & safely through the system
Task requests contain all the information required to immediately prioritise & complete the task. Geographic, nurse & patient identifiers provided by C-CARPS task requests optimise efficient task allocation, improve communication & help prevent errors
The ‘Clinical Lead’ can see all tasks in real time and redistribute them as appropriate. This allows free staff to ease the burden on others, preventing individuals from being overwhelmed & minimising delays. Clinical Leads now redistribute around 14% of the work on a nightly basis.
Data from C-CARPS is used to identify long trends & to understand the type of work carried out by specific staff at night. This has provided supporting evidence in cases of complaints or concerns from staff & enabled the implementation of organisational or procedural change to improve staff utilisation & patient care. In one instance, C-CARPS data was used to reduce the overnight drug chart re-writes average of 42 to 2.5
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption / Patient and medicines safety / Person centred care
Benefit to NHS:
  • Saves nursing and clinical staff time by communicating task information in a clear, complete and standardised way, giving staff more time to focus on the tasks themselves and to progress patient care and professional development
  • Clear visibility of entire workload means that teams can respond dynamically in busy periods by re-allocating work to optimise use of valuable resources in real-time
  • A more responsive and even workload distribution ultimately results in fewer delays and reduced risk of clinical errors due to unmanageable workloads, stress levels or ‘burn-out’
  • Improved handover between shifts, saving time and reducing the likelihood of errors
  • Transparency of the system promotes a team ethic and a shared workload mentality
  • The centralised, time-stamped and easily accessible data will save time reporting on:
    •  Performance, creating new opportunities for performance analysis, promote continuous improvement of working practices and monitor any changes.
    • Resolve any complaints or disputes easily by reviewing real time data evidence.
Additional Information
Please watch the presentation “Data to Transform: Electronic Task Management in the After Hours” by Alfred Health’s Benjamin Warren (Redesigning Care Project Officer at Alfred Health) and Dr Kyle Brooks (Senior ICU Registrar and overnight Clinical Lead at The Alfred), available through the InControl Australia YouTube Channel:

https://youtu.be/NmHE0Jg4DXU

Please view the presentation slides, including graphs, from a presentation delivered by Andrew Stripp, Deputy Chief Executive & Chief Operating Officer of Alfred Health, at the 2014 Emergency Department Management Conference in Melbourne, Australia, which demonstrate the instrumental role Clinical CARPS has played in the success of Alfred Health’s ambitious and award winning “Timely Quality Care” initiative:
http://www.slideshare.net/informaoz/andrew-stripp-alfred-health

InControl Australia have produced a short demonstration video entitled “CARPS Clinical Task Management Overview”, showing the basics of task allocation and distribution between the controller PC software and an Android smart device:
https://youtu.be/3a9yaZ1z8L0

 
Initial Review Rating
4.60 (1 ratings)
Benefit to WM population:
Clinical CARPS is a tool that enables safer, more efficient working practices and improved opportunities for performance analysis, facilitating the implementation of further improvements. This can reduce the costs associated with care delivery and dealing with errors and delays.
  • Saves nursing and clinical staff time
  • Allows staff to progress patient care and professional development
  • Provides clear visibility of entire workload to optimise use of valuable resources in real-time
  • A result of workload distribution  is fewer delays and reduced risk of clinical errors  by managing workloads and stress levels and avoiding ‘burn-out’
  • Reducing the likelihood of errors via Improved handover between shifts and saving time
  • Transparency of the system promotes a team ethic and a shared workload mentality
  • Time-stamped and easily accessible data reporting:
    •  new opportunities for performance analysis to promote continuous improvement of working practices whilst monitoring any changes.
    • Easily resolve any concerns, complaints or disputes by reviewing real time data evidence.
 
ROI
  • The potential exists for very high return on investment, depending on the relative efficiency of the hospital’s existing processes. A user of the original CARPS system cited recovering the original investment every four months! The non-clinical version of CARPS typically recovers initial investment within 18 months. We are awaiting analysis of data on installed versions of Clinical CARPS. We are expecting similar or even better results, due to potential cost savings within a clinical environment.

    Note: Our previous model is used successfully within 15 UK NHS trusts to mange non-clinical tasks
Current and planned activity: 
Currently ‘Clinical CARPS’, Clinical Task Management System is being used in Australia and seeking first adoption within the NHS in the UK. We are looking to NHS organisations within the West Midlands to discuss the possibility of adopting the clinical version on a trial-to-permanent basis.
 
We are seeking collaborations with West Midlands NHS trusts, clinical speciality services or an NHS region to experience our technology, understand the simplicity of installation and to witness the benefits that it can bring to managing the clinical workload, especially out of hours where resources may be limited or stretched and thus not immediately available unless the work flow is adjusted. 

Evaluation/Validation – We are seeking a trial centre to work with to gain additional evidence & validation of the benefits that our software delivers

We look forward to discussing with West Midlands Clinical Management teams how ‘Clinical CARPS’ can transform their task management processes.

.
What is the intellectual property status of your innovation?:
Clinical CARPS is the property of In Control Pty Ltd, co-developer partners of Purcell Radio Systems Ltd. Purcell Radio Systems Ltd have sole rights for the distibution of Clinical CARPS within the UK and Europe.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
3
Regional Scalability:

All of our solutions are highly scalable and an installation of CARPS software will typically lead to a future expansion of the system within that site or further installations at other sites within the region or company, usually by word of mouth promotion. Pricing for individual software licences will come down where larger systems are purchased within a single contract. Depending on the needs of the client we would expect to have a single installation up and running within 2 - 3 months.

Measures:

Quality: We expect Clinical CARPS to improve the quality of communication regarding clinical task allocation, for instance Clinical CARPS task requests can be configured for required minimum information to be mandatory. We would expect this to be measurable by a reduction in the amount of time spent on task allocation (phone calls, conversations, etc) and an increase in productivity in the undertaking of the clinical tasks themselves (delivering patient care). We would expect the enhanced analytical possibilities enabled by CARPS data capture to result in the identification of improved working processes, which should also be taken into account as measures of the system's success.
Safety: We expect patient care outcomes to improve based on the fact that Clinicians and nursing staff have more time available to deliver care as above and can re-allocate work according to demand, priority, availability and suitability. We expect to see measurable improvements against patient safety targets such as improved performance against the four hour admission target from emergencey and a reduction in errors and delays to patient care. As above, any improvements to patient safety made possible through CARPS enhanced data capture should also be counted.
Cost: Return on investment can be measured against increases in productivity on the front line and relating to time saved on performance analysis and the production of reports performed my clinical Management. We would expect complaints to be reduced and costs around the complaints process should also be factored in. A normal CARPS system would be expected to cover the cost of implementation within 18 months and we might cautiously expect even better results within the clinical environment, due to the increased value of the resources involved.
People: Feedback from users and stakeholders should give evidence of an improved attitude towards the way clinical tasks are managed compared with the preceeding system.

Adoption target:

Minimum viability would be the out-of hours clinical team at one hospital. After confirmation of the system's success, we would hope to expand use to 24/7 and to implement the system at other hospitals within the WM region.

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Innovation 'Elevator Pitch':
Electronic wound imaging, assessment & information management system.  An enabling technology to support objective wound assessment, monitoring & evidence-based treatment for patients with chronic & acute wounds such as diabetic foot ulcers.
Overview of Innovation:
Silhouette is an easy-to-use wound imaging, 3D measurement & documentation system providing accurate wound information at the point of care to support effective clinical management of patients. Silhouette wound informatics are available as a wound assessment PDF report and on a secure web-enabled database and for easy access and sharing across the entire care team. 

The wound images and wound healing progress charts are highly visual and provide immediate and clear indication of a patient's response to treatment.

This award-winning system includes an imaging 3D camera that precisely and consistently measures the area, depth & volume of wounds to track and report healing progress. Silhouette enables wound assessment activity and wound outcomes to be monitored, providing wound information that is available instantly to key stakeholders, integrated with your EMR system. Silhouette is proven in both clinical research & clinical practice.

Silhouette supports pro-active management of wound-related risk & improves communication, helping practitioners to be more productive & effective in their delivery of wound care. Silhouette is suitable for all settings, including acute out-patient clinics, community-based care, home health & telehealth wound care.

The Silhouette system is made up of three main parts – a point of care wound camera, smart software for measuring wounds, & a wound information database:
  • The SilhouetteStar® specialized camera (pictured right) captures the wound image;
  • SilhouetteConnect® software for accurate 3D measurements of the wound based on the data acquired by SilhouetteStar (see below), together with healing progress charts & electronic wound assessment summary reports. 
  • SilhouetteCentral®, a secure Internet-accessible database that stores & consolidates the information obtained from the organisation’s SilhouetteStar + SilhouetteConnect devices, including integration with the EMR.
Unlike non-3D and traditional methods, which are imprecise & unreliable, Silhouette provides meaningful information for better clinical decisions. It is also extremely easy to use & is ready to integrate with EMR systems. Silhouette was first established in clinical research, which requires rigorous source documentation, & is now available for widespread use in clinical practice.



Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Digital health / Person centred care
Benefit to NHS:
Silhouette is an enabling technology to support safe, cost-effective care for patients with chronic and acute wounds such as diabetic foot ulcers, pressure ulcers and leg ulcers and complex wounds.

Currently, the burden of wound care on the NHS is estimated at £3billion per annum, with unacceptable variances reported in practice standards and outcomes achieved so that thousands of patients are not receiving the standard of care that should be possible.

Silhouette technology transforms how wound status is assessed, documented and reported. Better quality of wound information available in a connected and interoperable system means that clinicians are better supported for effective and timely clinical decisions and actions. Silhouette facilitates data sharing across an entire care pathway to reduce the risks of fragmented care across silos.

Silhouette equips, empowers and enables healthcare professionals and patients to collaborate for best practice to achieve optimal wound outcomes. 

There is significant potential for the NHS to drive for cost savings, greater efficiencies and clinical effectiveness with the adoption of the Silhouette wound informatics solution.
Online Discussion Rating
5.00 (2 ratings)
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
As well as assuring patients of best practice and quality of care, patients can actively engage in their care plan and outcomes due to the highly visual nature of Silhouette wound healing data and charts displayed on the software screens.

The benefits of rapid and effective wound healing for the patient should not be underestimated. The psychological consequences of living with a chronic wound are well documented. Upton and Hender (2012) suggest that patients with chronic wounds may experience negative emotions such as:
  • Stress
  • Concern about physical symptoms
  • Lack of self-worth
  • Despair
See featured Silhouette Patient Story which demonstrate the power of Silhouette informatics in motivating a patient with a debilitating pressure ulcer to recovery.  http://www.aranzmedical.com/patient-pressure-ulcer/
Current and planned activity: 
Entec Health is an appointed distributor to ARANZ Medical for the Silhouette solution in the UK. Our partnering goals are to inform & engage NHS stakeholders on the advantages of adopting digital wound assessment & wound informatics to address the “best practice, clinical excellence & cost-effectiveness gap” in wound management. Entec has supported 5 field Silhouette evaluations in acute & community care with considerable investment of time, expertise & resource. Entec has successfully established early adopters of Silhouette across the NHS:  
Clinical Practice: King’s College Hospital London Diabetic Foot Clinic, North Bristol Trust Enablement Centre
Clinical Research: 10 NHS centres of excellence in diabetes foot care are currently using Silhouette in a multi-centre clinical trial sponsored by EdixoMed  
Planned activity: A Diabetes Foot Pathway demonstrator project supported by EMAHSN to be announced & 2 further Silhouette collaborations are in progress, information to follow.
What is the intellectual property status of your innovation?:
Product family: Silhouette Mobile, Silhouette Connect
US patent: 8,755,053
Chinese patent: ZL 200680037626.3 

Product family: Silhouette Star, Silhouette Connect
US patents: 9,179,844, 8,755,053, D662,122
Chinese patent: ZL 200680037626.3
Other patent(s) pending

Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.

Health information protocols and privacy:  Silhouette supports a variety of protocols and functionality, including:
·         HL7 patient demographic information exchange or transfer
·         DICOM image transfer
·         DICOM Encapsulated PDF report creation and transfer
Silhouette is designed to support HIPAA and HITECH compliance.
 
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
2
Regulatory Approvals:
Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.
Commercial information:
The Silhouette wound imaging, assessment and information management system is a proven, established in-market solution used across world-wide markets. The Silhouette solution is supporting wound outcomes documentation, reporting and informatics for effective and efficient wound care service delivery. Silhouette is enabling transformation of wound care pathways in acute, community and integrated care settings. Early market for Silhouette is the US with UK, Europe and Asia as emerging markets.  
Investment activity:
Entec Health, as an appointed distributor of Silhouette in the UK,  has invested considerable time, effort and funds to introduce the Silhouette to the NHS/UK market since 2011. ARANZ Medical, the developer and manufacturer of Silhouette has invested signficant funds, effort and expertise in R&D and bringing the Silhouette solution to the global market.

There is continued investment in partnering with the NHS and UK healthcare provider market by Entec Health. ARANZ Medical has a commitment to on-going investment in R&D for Silhouette to ensure that the solution meets the future needs of healthcare professionals.
 
Regional Scalability:
The Silhouette solution is highly and easily scalable across the West Midlands region for transformation of wound care services within the NHS sector. Silhouette can help to address delivery of greater clinical effectiveness and productivity in managing patients with chronic and acute wounds, including Diabetic Foot ulcers, Pressure Ulcers, Leg Ulcers and complex wounds. Silhouette is an enterprise system designed to be interoperable and connected within the NHS/Provider IT infrastructure to enable support of multi-disciplinary care of patients across a diverse range of care settings. Silhouette can be incorporated into telehealth/teleconsultation models of service delivery to support new models of care that improve patient experience, outcomes and cost-effectiveness. 
Measures:
The target outcomes of adoption of the Silhouette solution for the Healthcare Provider Organisation are:
Quality outcomes/measure
Organisation will demonstrate objective, evidenced-based practice to support timely and appropriate treatment planning and care for delivery of optimal wound outcomes.
Measure: Silhouette wound informatics available; quantifies and reports wound healing outcomes for individual patient, patient-population, clinical pathway and treatment type. 
 
Safety outcomes/measure
Organisation will have consistent standard of wound care practice and transparency on wound care outcomes to demonstrate accountable care provision to the required safety standards.
Measure: Silhouette wound informatics available; including digital wound images, wound healing data/charts and wound assessment reports available electronically for audit and management reporting.
Cost outcomes/measure
Organisation will have wound care outcomes data available to support assessment of cost-effectiveness of wound care treatments, service delivery and wound outcomes by treatment type.
Measure: Silhouette wound outcomes and assessment activity data available; to feed into cost-planning and cost-assessment of wound care service.
People outcomes/measure
Organisation will be supported to ensure high levels of staff and patient satisfaction of wound care services through equipping and empowering with quality clinical information on wound progress. The objective wound outcomes data generated with Silhouette will enable joint, evidence-based conversations on care plan and treatment goals with patients and the multi-disciplinary care team.  
Measure: Silhouette patient and population-level reporting available; combined with patient/staff surveys before and after deployment of Silhouette.
Adoption target:
Over next 2 years, we would like to aim to partner with 6 NHS Trusts/other healthcare providers in the West Midlands region for adoption of Silhouette.
Investment sought:
The Silhouette enterprise system is a modular system and investment level is dependent on scope of deployment. An enterprise level Silhouette system based on 5 Silhouette assessment devices and SilhouetteCentral database package starts from £45,000 (net, excluding VAT) for a capital purchase plan. Data integration, IT services, project management and annual software maintenance/support fees are additional costs, dependent on requirements. Silhouette pricing can be offered as an annual subscription model or a capital purchase model to suit different budgetary requirements. 
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