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  • Periodic Reporting for period 1 - EmERGE (Evaluating mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care)

EmERGE Report Summary

Project ID: 643736
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - EmERGE (Evaluating mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care)

Reporting period: 2015-05-01 to 2016-04-30

Summary of the context and overall objectives of the project

With the advent of effective antiretroviral therapy (ART) HIV is now regarded as a chronic illness with a normal life expectancy in individuals who have access to testing, treatment and care such as those in the European Union. The vast majority of individuals have undetectable HIV viral loads (the aim of ART) on stable treatment and now seek to reduce the impact of HIV on their lives. Individuals living with HIV are currently seen by an HIV clinician every 3-6 months according to national and international guidelines. Given that the number of new diagnoses and onward transmissions are at best stable, if not increasing, in association with longevity, the number of patients requiring treatment and care continues to increase year on year. In the current era of austerity there is little or no additional resource to manage this increasing workload without a substantial increase in capacity which is unlikely to be forthcoming. Therefore, it is imperative that new models of service provision are explored and evaluated.
The EmERGE project aims to address both the desire of patients to reduce the impact of HIV on their lives and also the need to develop new models of healthcare provision - by developing and evaluating an innovative platform to enable self-management of HIV in patients with stable disease. The mHealth platform will provide users with a mobile device application which will interface securely with relevant medical data and facilitate remote access to key healthcare providers. The mHealth platform will be integrated with clinic ICT systems and will be used to reduce face-to-face appointments and in the future to complement appointments in those with more complex medical needs. The platform will be evaluated by the Model for ASsessment of Telemedicine applications (MAST) approach. MAST provides a framework for an evaluation especially developed for telemedicine, and suited to mHealth. This evaluation will look at a number of aspects including: empowerment, health economics, sociotechnical aspects, clinical outcomes, patient related outcomes and quality of life. EmERGE also aims to evaluate and develop the commercial potential of the platform. To achieve this, the consortium will consider potential markets, the quality aspects of the mHealth platform from a multi-stakeholder perspective (including national and regional factors), the relative importance and ranking of features and benefits and the competitive mHealth landscape. These analyses will inform the development of the product offering.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project was initiated by undertaking a background assessment and situational analysis. Details were gathered as to how people living with HIV are currently followed up in the five clinics which are participating in the study. To develop a software application, knowledge of the present information technology is equally crucial: for example, what kind of patient file is used, how data are stored, how does communication with other health workers happen. Detailed questionnaires were designed to capture this information, covering ICT infrastructure and security requirements, HIV-care organization, information governance and the ethical-legal frameworks. These questionnaires were completed and discussed by clinical leads at each site. This information is being used not only to develop the application but also for the economic and socio-technical evaluations. We have also organised ‘co-design’ workshops with both people living with HIV (PLWH) and clinicians where they have been able to express their views concerning the design and components of the proposed mHealth application The responses to the consultation on the development of the app were very constructive, informative, and on the whole positive. Many comments were made about the benefits that it could bring. The concerns raised were mostly related to the security of the app and the effect that it would have on the patients relationship with their clinics – in particular, the reduction in personal contact with the HIV doctor. Another clear message was that the app needed to look innocuous. The results from both the clinical questionnaires and the workshops have been fed into the design of the software for the platform and a design specification has been produced.
Arrangements for the clinical evaluation of the platform have begun. The data to be collected in order to carry out the economic, socio-technical and patient related evaluations have been defined and written up so the project can obtain ethical approval for the study at all five clinical sites. Systematic reviews of patient empowerment and quality of life measures in HIV have been carried out to determine the best method for evaluating these aspects. Work has also begun on developing a business model around the platform.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The EmERGE project will take HIV care, mHealth in HIV and the evaluation of mHealth platforms beyond the current state-of-the-art. Significant proportions of stable patients in HIV clinic cohorts (as the mHealth platform is adopted into normal practice this could reach over 30% of cohorts) will be managed remotely for most of the year without a reduction in the standard of their care. Within EmERGE adaptability of the mHealth platform to five clinical settings will be shown. The learning from the integration and implementation at different sites will be captured and used to inform a standardized process for approvals and integration at new sites. Barriers to implementation will be explored as part of the sociotechnical evaluation of this project and will be used to optimize the rate of success at new sites. The model of patient care within EmERGE offers choice with patients at the centre of their own care. Patients are able to choose with whom they share information empowering them to engage with and make decisions about their care. The detailed health economics assessment performed during this study, will be used to understand the impact of such a model on resources at clinical sites. This study has the potential to show true cost minimisation – the core intervention is simple and anticipated uptake is high (based on experience of partners). A detailed understanding of cost as part of the evaluation allows for discussion with commissioners and development of a reimbursable cost structure. An intervention that shows cost and patient benefit in a large validated study will be attractive to providers of HIV healthcare.
The expected potential impacts of the project are:
• Improved self-management of health. It is expected that developing an mhealth platform for patients will lead to greater empowerment of patients in their own care. This will be measured by questionnaire before and after the implementation of the mhealth platform.
• Indirect improvement of disease prevention. Although EmERGE will not address disease prevention directly, improving patient engagement in their own care may lead improved rates of virological suppression and/or retention in care which in turn may lead to a reduction in the onward transmission of HIV. Pre-frailty and adherence issues may also be more easily detected, thus further preventing disease.
• Improved cost-effectiveness of HIV healthcare. The cost and cost-effectiveness of the mHealth platform will be evaluated. If deemed as effective as anticipated this approach can then be implemented in other centres treating HIV patients and potentially also applied to other areas of healthcare, especially for the management of people living with chronic, non-communicable diseases.
• Strengthened evidence to inform policymakers. EmERGE is also expected to provide real world evidence to inform the development policies, medical guidelines, legal frameworks, medical standards etc. in HIV care and the use of mHealth technologies.

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