Randomised evaluation of myVirtualClinic (#2872)

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Idea Description
Supplementary Information
Detailed Submission Data
Innovation 'Elevator Pitch':
Liver transplant patients often travel long distances for outpatient appointments. A randomised study is being conducted to evaluate the impact of outpatient consultations administered through a video call on the myhealth@QEHB patient records portal
Overview of Innovation:

Virtual clinics, where patients can have a hospital appointment with their clinician from home, are emerging in practice, but their effectiveness is unclear. This study will evaluate whether a virtual clinic developed by University Hospitals Birmingham NHS Foundation Trust (UHB) called myVirtualClinic improves patient satisfaction compared to standard face-to-face appointments for liver transplant patients.

A parallel, two-arm, statistician-blinded, randomised evaluation is being undertaken to evaluate myVirtualClinic. Clinically stable liver patients 1 to 5 years post-transplant (n=180) will be randomised in equal numbers to virtual clinic appointments (intervention) or standard face-to-face appointments (control). The intervention group will have outpatient appointments from home via secure video link accessed through the UHB patient portal. All patients will complete baseline questionnaires before randomisation and electronic follow-up questionnaires after each appointment over 12 months. The primary outcome is the difference in scores between groups for three areas of satisfaction (modified Visit-Specific Satisfaction Instrument, VSQ-9). Secondary outcomes include quality of life (EQ-5D-5L), costs, clinical contacts and user experiences (patient, carer and health professional).

The study has been approved by the NHS Health Research Authority (HRA) and received a favourable ethical opinion from the West Midlands Solihull Research Ethics Committee on 24.10.17. Research governance approval was obtained from University Hospitals Birmingham NHS Foundation Trust in February 2018. The study is sponsored by University of Birmingham and is registered on ISRCTN (Ref: 14093266)

The study is a collaboration between NIHR CLAHRC West Midlands Chronic Disease Theme based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study principle investigator and clinical lead Dr James Ferguson (Consultant Hepatologist) developed the myVirtualClinic intervention with the University Hospitals Birmingham Informatics and myHealth@QEHB team.The lead University of Birmingham Research Fellow evaluating the intervention is Elaine O’Connell Francischetto and other members of the myVirtualClinic randomised evaluation steering group are Gill Combes, Sarah Damery, Eric Deeson, Janet Jones, Foyzal Miah, Pamela Nayyar, Aziz Sheikh and Katie Squire.
Stage of Development:
Evaluation stage - Representative model or prototype system developed and can be effectively evaluated
Similar Content3
Innovation 'Elevator Pitch':
LiverMultiScan is an FDA 510(k) cleared and CE marked MRI technology that provides a quantitative assessment of liver health, including fibroinflammatory disease, steatosis and iron, all in a non-contrast 5 minute scan.
Overview of Innovation:
Perspectum Diagnostics is a medical imaging company with an ISO 13485 compliant CoreLab. The company has developed novel imaging technology, LiverMultiScan, an MRI-based non-invasive tool that has attained CE-marking and FDA 510(k) clearance to aid the diagnosis of patients with chronic liver disease.
LiverMultiScan (and LiverMultiScan Discover for clinical trial use) can characterise liver tissue in three ways, providing accurate measurements of liver fat, hepatic iron content and fibro-inflammatory disease, using the proprietary Liver Inflammation and Fibrosis (LIF) score. The LIF score has been shown to stratify NAFLD and NASH patients (Pavlides, 2015), correlate with histological markers of inflammation and fibrosis (Banerjee, 2014), and most importantly, is the first imaging test to predict liver-related clinical outcomes (Pavlides, 2016). It is the only liver imaging technology included in the UK Biobank study, with 100,000 scans to be performed in the coming years (Kelly, 2015).
Available as a Quantitative Analysis Service (QAS), LiverMultiScan has been cleared as an imaging tool to aid the diagnosis of early liver disease. It offers a standardised and high-quality method for supporting Gastroenterology/Hepatology and Radiology departments in diagnosis and monitoring of the liver in clinical settings and studies, and has potential to streamline clinical management by compressing the diagnostic pathway. Perspectum is also supporting multiple international clinical trials with LiverMultiScan Discover.
  • Banerjee et al. (2014) Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 60:69-77.
  • Kelly et al. (2015) Predicted prevalence of NAFLD and NASH in a large population using non-invasive multiparametric MRI. AASLD 2015. Abstract ID: 931.
  • Pavlides et al. (2015) Multi-parametric magnetic resonance can accurately assess NAFLD histological disease severity; comparison with transient elastography. AASLD 2015. Abstract ID: 2190.
  • Pavlides et al. (2016) Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 64:308-315.
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 / Advanced diagnostics, genomics and precision medicine / Wealth creation / Clinical trials and evidence / Digital health / Patient and medicines safety
Benefit to NHS:
The utility of LiverMultiScan for assessing fibroinflammatory disease, steatosis and predicting clinical outcomes means it is well-positioned to reduce (and potentially remove) the need to perform invasive liver biopsies. It also facilitates longitudinal monitoring, which is near impossible with current sampling technology.
According to a recent NIHR HTA report, the cost of a liver biopsy is £956, but this can increase significantly with complications (clinically significant bleeding in 1.1 – 1.6%). For healthcare providers, liver biopsies are unappealing because of the attendant risk, financial cost, lack of reliability (as sampling only 0.002% of the liver volume), and uncertainty in interpretation. Nevertheless, primarily because there has not been a viable alternative, it is estimated that 650,000 liver biopsies are performed annually worldwide. 
There are substantial costs associated with managing patients with NAFLD, in particular for those patients progressing to NASH who are at significant risk of cirrhosis, HCC and liver failure. Although pharmacologic options are limited, there are numerous clinical trials ongoing.
Available treatment options increase (e.g., diet, surgery), outcomes improve and healthcare costs decrease the earlier those with, or at risk of, more advanced disease are identified. When combined with the rising incidence of NAFLD and NASH, the availability of a non-invasive test for accurately assessing fibroinflammatory disease, steatosis and predicting clinical outcomes, is vital.
A recent health economic study (submitted for publication) from the University of Birmingham concluded that LiverMultiScan is cost effective either as an adjunct to or replacement of Fibroscan in the diagnostic pathway of NAFLD. In addition, the utility of LiverMultiScan in reducing the proportion of patients with suspected NAFLD undergoing hospital consultations and/or liver biopsies is currently being evaluated in a large Europe-wide multicentre clinical trial (including the UK).
LiverMultiScan could allow:
  • A faster throughput and diagnostic analysis than conventional sampling – reducing patient lists and identifying those that need and do not need clinical intervention.
  • Regular monitoring of patients without painful invasive and potentially dangerous biopsies.
  • A less traumatic assessment of liver disease in children.
  • Assessment of liver health in other diseases (e.g., viral hepatitis, alcoholic liver disease)
Initial Review Rating
5.00 (2 ratings)
Benefit to WM population:
Liver disease is the fifth ‘big killer’ in England and Wales, after heart, cancer, stroke and respiratory disease (http://www.britishlivertrust.org.uk/about-us/media-centre/facts-about-liver-disease), with twice as many people dying from liver disease now compared to 1991.
In a European study, the healthcare costs for patients with NAFLD were 26% higher than for those without the disease (Baumeister, 2008). In the US, the direct costs of cirrhosis and chronic liver disease were estimated to by $2.5 billion, whereas indirect costs were estimated to be $10.6 billion (Ruhl, 2008).
Identifying those with, or at risk of, more advanced liver disease earlier increases treatment options available, reduces healthcare costs and improves outcomes. Benefitting both the NHS and wider West Midlands community.
This diagnostic test could also be used to aid the diagnosis and monitoring of liver disease in children, with a European clinical trial underway.
 
  • Baumeister et al. (2008) Impact of fatty liver disease on health care utilization and costs in a general population: A 5-year observation. Gastroenterology. 134:85.
  • Ruhl et al. (2008) Costs of digestive disease. In The Burden of Digestive Disease in the United States. NIH Publication. pp 137-143.
Current and planned activity: 
LiverMultiScan currently in use at University Hospitals in Birmingham, Edinburgh, Oxford Southampton & Kings College London (KCL). Discussions with other NHS sites

Recent completion of large Innovate UK funded 2.5 year study at University Hospitals Birmingham & Edinburgh to develop & validate against liver biopsy

KCL is UK site for large EU multi-centre clinical trial to evaluate cost-effectiveness of LiverMultiScan in primary care pathway.

Patient study - 100 patients with history of liver disease receive LiverMultiScan, nearing completion with extremely +ve feedback

LiverMultiScan is only liver imaging technology in UK Biobank - 100,000 subjects to be imaged

Planned activity
West Midlands location of choice as:
  • Build on relationship with University of Birmingham following 2.5 yr study
  • West Midland’s considerable expertise in liver disease
  • Large patient cohort and trials infrastructure
  • Involve Children’s Hospital in study
  • Dr Banerjee, founder & CEO, visiting Hon. Consultant Hepatologist at UHB
What is the intellectual property status of your innovation?:
Perspectum holds or exclusively licenses 7 patent applications in the UK and other territories. To date, one has been granted in the UK (GB2497668).
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Virtual Clinic is an innovative mobile app which securely sends real time patient data to the hospital database.  A web interface allows the consultant to review a patient’s condition online and give feedback to the patient.
Overview of Innovation:
Virtual Clinic enables patients to manage their conditions more effectively by communicating information about their condition on a daily basis, reducing the need to attend a clinic unless it’s absolutely necessary.



A collaboration between Imobisoft and Birmingham Children’s Hospital, the Virtual Clinic app enables patients to securely communicate information about their condition directly to a clinician while simultaneously updating the Trust’s electronic patient record system.

Currently, patients with long term conditions or requiring post-operative care regularly attend outpatient clinics. The majority of these appointments require no clinical intervention and may require several hours’ travel for what might be a very brief questionnaire-based session with a clinician.
 
If a patient’s condition changes between routine appointments, the app automatically alerts the clinician who can respond immediately and effectively, having been provided with details about the change. An intervention can be made earlier, potentially decreasing the risk of morbidity or the need for more complex interventions or hospital admission.
 
Providing patients with immediate feedback on how their lifestyle or treatment impacts on their symptoms provides immediate personalised education to help them manage their condition.
 
Virtual Clinic is a free app. Users download it onto their phone and enter their unique code to create their profile. Symptoms are recorded via slider bars and radio buttons and sent in real time to the server. Clinicians view the data received, either via an alert when abnormal data is received or by logging onto the web interface to see all data for a particular patient over a period of time. Clinicians can send a message via the web interface to the patient’s phone and run reports on patients, symptoms, etc. from the database.
 
The functionality of the app can be applied to the majority of long term conditions currently managed by regular Outpatient appointments.
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
Benefit to NHS:
Successful implementation of the Virtual Clinic app will support the health care community vision and aims by:
 
1. Adding to the communication channels between patient and consultant at the time that their chronic condition has worsened
2. Improving efficiency in clinical workflows via automatic two-way messaging between the patient’s app and the clinician
3. Providing real time clinical intelligence on a patient’s symptoms to highlight any clinical issues via alerts
4. Patients using Virtual Clinic will not have to attend regular Outpatient appointments if the condition has abated, thereby freeing up Outpatient appointment slots
5. Providing prospective data on patient outcomes, informing future patient management decisions and advances in practice.
 
The implementation of Virtual Clinic is expected to realise improvements in a number of areas:
 
• Redesigned processes associated with monitoring of chronic conditions
• Real-time monitoring when a patient’s condition worsens
• Ability to interact with a patient when their condition initially worsens, rather than at an outpatient appointment when the condition has continued to deteriorate
• Decreased Outpatient appointments
• Decreased A&E attendances and admissions with disease complications
• Improvements in information for reporting purposes via the collection of data regarding a patient’s condition
• Collection of validated prospective health status data
• Improved outcome data for audit and research
• Improved patient satisfaction.

Virtual Clinic can be customised for various metrics monitored via Outpatient appointments (e.g. incontinence, asthma, diabetes, etc.). Currently, Virtual Clinic is used for patients at Birmingham Children’s Hospital with anorectic malformations and chronic constipation.

“Virtual Clinic allows the clinician to communicate via the app with the patient and give feedback. It also allows the clinician to tailor the treatment of the patient more precisely based on his daily symptom recording and therefore adjust his follow-up in clinic according his clinical needs. By allowing the clinician to monitor a patient's condition in real time, the Virtual Clinic app has huge potential to improve patient care. I believe it will reduce the number of unnecessary Outpatient appointments, deliver significant cost savings, free up capacity and inform future advances in practice."    Mr Ingo Jester, Consultant Paediatric Surgeon, Birmingham Children’s Hospital
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
1. Imobisoft Ltd is a West Midlands based SME and adoption of the Virtual Clinic app within the region would allow the company to grow and take on additional specialist staff
2. Reduction in unnecessary Outpatient appointments
3. Improved health and wellbeing from the enablement of early intervention, potentially decreasing morbidity and preventing the need for more complex interventions or a hospital admission
4. Reduction in travel for patients (reduces pressure on the region’s transport infrastructure)
5. Reduction in the need for parents and/or carers to take time off work to escort the patient to and from hospital.
Current and planned activity: 
A pilot study is currently in progress at Birmingham Children's Hospital NHS Foundation Trust. The ROI will be available when this completed.

Other NHS engagements include:

University Hospitals of North Midlands NHS Trust
Heart of England NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
What is the intellectual property status of your innovation?:
The intellectual property in the Virtual Clinic app is owned by Imobisoft Ltd.
Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
4
Regulatory Approvals:
Not applicable.
Investment sought:
Not applicable.
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Innovation 'Elevator Pitch':
Virtual Clinic is an innovative mobile app which securely sends real time patient data to the hospital database.  A web interface allows the consultant to review a patient’s condition online and give feedback to the patient.
Overview of Innovation:
Virtual Clinic enables patients to manage their conditions more effectively by communicating information about their condition on a daily basis, reducing the need to attend a clinic unless it’s absolutely necessary.

A collaboration between Imobisoft and Birmingham Children’s Hospital, the Virtual Clinic app enables patients to securely communicate information about their condition directly to a clinician while simultaneously updating the Trust’s electronic patient record system.

Currently, patients with long term conditions or requiring post-operative care regularly attend outpatient clinics. The majority of these appointments require no clinical intervention and may require several hours’ travel for what might be a very brief questionnaire-based session with a clinician.
 
If a patient’s condition changes between routine appointments, the app automatically alerts the clinician who can respond immediately and effectively, having been provided with details about the change. An intervention can be made earlier, potentially decreasing the risk of morbidity or the need for more complex interventions or hospital admission.
 
Providing patients with immediate feedback on how their lifestyle or treatment impacts on their symptoms provides immediate personalised education to help them manage their condition.
 
Virtual Clinic is a free app. Users download it onto their phone and enter their unique code to create their profile. Symptoms are recorded via slider bars and radio buttons and sent in real time to the server. Clinicians view the data received, either via an alert when abnormal data is received or by logging onto the web interface to see all data for a particular patient over a period of time. Clinicians can send a message via the web interface to the patient’s phone and run reports on patients, symptoms, etc. from the database.
 
The functionality of the app can be applied to the majority of long term conditions currently managed by regular Outpatient appointments.
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
Benefit to NHS:
Successful implementation of the Virtual Clinic app will support the health care community vision and aims by:
 
1. Adding to the communication channels between patient and consultant at the time that their chronic condition has worsened
2. Improving efficiency in clinical workflows via automatic two-way messaging between the patient’s app and the clinician
3. Providing real time clinical intelligence on a patient’s symptoms to highlight any clinical issues via alerts
4. Patients using Virtual Clinic will not have to attend regular Outpatient appointments if the condition has abated, thereby freeing up Outpatient appointment slots
5. Providing prospective data on patient outcomes, informing future patient management decisions and advances in practice.
 
The implementation of Virtual Clinic is expected to realise improvements in a number of areas:
 
• Redesigned processes associated with monitoring of chronic conditions
• Real-time monitoring when a patient’s condition worsens
• Ability to interact with a patient when their condition initially worsens, rather than at an outpatient appointment when the condition has continued to deteriorate
• Decreased Outpatient appointments
• Decreased A&E attendances and admissions with disease complications
• Improvements in information for reporting purposes via the collection of data regarding a patient’s condition
• Collection of validated prospective health status data
• Improved outcome data for audit and research
• Improved patient satisfaction.

Virtual Clinic can be customised for various metrics monitored via Outpatient appointments (e.g. incontinence, asthma, diabetes, etc.). Currently, Virtual Clinic is used for patients at Birmingham Children’s Hospital with anorectic malformations and chronic constipation.

“Virtual Clinic allows the clinician to communicate via the app with the patient and give feedback. It also allows the clinician to tailor the treatment of the patient more precisely based on his daily symptom recording and therefore adjust his follow-up in clinic according his clinical needs. By allowing the clinician to monitor a patient's condition in real time, the Virtual Clinic app has huge potential to improve patient care. I believe it will reduce the number of unnecessary Outpatient appointments, deliver significant cost savings, free up capacity and inform future advances in practice."    Mr Ingo Jester, Consultant Paediatric Surgeon, Birmingham Children’s Hospital
Initial Review Rating
5.00 (1 ratings)
Online Discussion Rating
3.00 (3 ratings)
Benefit to WM population:
1. Imobisoft Ltd is a West Midlands based SME and adoption of the Virtual Clinic app within the region would allow the company to grow and take on additional specialist staff
2. Reduction in unnecessary Outpatient appointments
3. Improved health and wellbeing from the enablement of early intervention, potentially decreasing morbidity and preventing the need for more complex interventions or a hospital admission
4. Reduction in travel for patients (reduces pressure on the region’s transport infrastructure)
5. Reduction in the need for parents and/or carers to take time off work to escort the patient to and from hospital.
Current and planned activity: 
A pilot study is currently in progress at Birmingham Children's Hospital NHS Foundation Trust. The ROI will be available when this completed.

Other NHS engagements include:

University Hospitals of North Midlands NHS Trust
Heart of England NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
What is the intellectual property status of your innovation?:
The intellectual property in the Virtual Clinic app is owned by Imobisoft Ltd.
Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
4
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