Project EmpatIA: Enabling Healthcare Transformation in Peru

A blog post by Michael Wilkinson, Founder and CEO of Inavya Ventures

Explore learnings from our pilot ‘EmpatIA — AI to enhance healthcare in remote areas of Peru'.

Between the end of 2023 and the start of 2024, Project EmpatIA focused on three key experiments essential to delivering the project aims:  1) Ethics Approval, 2) Technology Setup, and 3) Ecosystem Development.   We report on each experiment and key learning below. To read our previous blogs, see our site here.

1. ETHICS APPROVAL

Ethical principles protect research participants' dignity, rights, and welfare. An ethics committee should review all research involving human beings to ensure that the appropriate ethical standards are upheld.

Peru requires clinical trial approval from an institutional ethics committee (EC) accredited by the National Institute of Health’s National Registry of Accredited Institutional Ethics Committees.

Detecta Clinic selected the University of Peru Cayetano Heredia Ethics Committee due to its association with university-based research and the potential for future collaboration.

Detecta Clinic contacted the University of Peru Cayetano Heredia Ethics Committee at the start of the sprint to confirm what documents were required and had to be submitted by January 8, 2024.  The Inavya and Detecta Clinic project team scheduled weekly meetings to ensure the Ethics Approval process advanced appropriately.  Inavya’s role is related to the technical delivery of the EmpatIA system; and Detecta Clinic’s role is related to clinical delivery, including recruitment and engagement with patients.  Due to the demands of preparing documents for the Ethics Committee, the project team often had more than one weekly meeting. The project team also set up a WhatsApp group account, which was used regularly to communicate between meetings.  

The Detecta Clinic R&D lead met with the Ethics Committee members before the submission to review the study protocol and receive feedback.  The key recommendation was that the study should have two phases to manage better risks and opportunities arising from the research.  A small Phase 1 study would be limited in time, budget and number of participants. Phase 1 would finish by the end of March 2024 and be positioned as a prospective evaluation with a control and experimental group.  The Phase 1 study would provide insight and inform the design of a Phase 2 clinical trial, a larger multi-centre clinical study, with a control and experimental group.  As such, a Phase 2 study would be longer in duration, require more funding and time, and involve more participants.

Documents prepared by Inavya were further refined to meet the recommendations for a Phase 1 and Phase 2 process, and then the documents were translated into Spanish.  The full Ethics Application was then sent for initial review by the Ethics Committee before the formal submission.  The feedback noted a further strengthening of the literature review, which was then conducted.  Following this feedback and further refinement, the Ethics Application was submitted by Detecta Clinic at the end of December.

As planned, the Ethics Committee met on January 8, 2024, and the EmpatIA application was approved. Following this meeting, the Ethics Committee sent a letter of confirmation to Detecta Clinic with the Peru government study registration number. Detecta Clinic received the letter because it is the Project EmpatIA clinical study sponsor and made the submission to the Ethics Committee. Detecta Clinic then sent a letter to Dr Mendoza, the Project EmpatIA Principal Investigator, confirming that the study could commence without delay.

We identified and managed the main risks of ethics approval delays and rejections.  These risks were managed well during and between the meetings, with the process for gaining ethics approval involving proactive engagement and responsive work by the project team.

The project benefited from the leadership of a clinical R&D lead with extensive experience engaging with the Ethics Committee application process. The R&D lead has relevant advanced educational qualifications in clinical research methodology and extensive clinical work experience in designing and delivering clinical R&D projects.  The project also benefited from leadership at Detecta Clinic, which provided the R&D lead with time, resources, and encouragement to enable her to lead the R&D project successfully.

Our Learning

The project team needed to communicate more frequently than once per week so that we could respond on time to the Ethics Committee's requirements. We, therefore, had meetings more frequently than once per week, except during the Christmas holiday period, and this was supplemented by setting up the WhatsApp group account. 

We also identified the need to engage with the Ethics Committee early and often so that the committee members could provide feedback on the Project EmpatIA application and then the project team could respond accordingly.  This engagement and responsive work by the project team significantly reduced the risk of rejection or delay by the Ethics Committee. 

During this process, we learned about the focus of attention by the Ethics Committee for Project EmpatIA, which is primarily about ensuring patient safety and that the study protocol has an appropriate methodology to ensure that the study results will likely deliver valuable results from scientific, technical,  clinical and regulatory perspectives.  Ethics approval is not easy, and securing ethics approval is an essential milestone for health technology innovations.  To ensure that innovation projects advance on time, on budget, and to a high technical standard, it is important that clinical R&D project teams have all the necessary capacities and capabilities to engage Ethics Committees with confidence.  

2. TECHNOLOGY SETUP

During this phase, the Inavya team worked closely with the Detecta Clinic R&D lead to deliver the following technology customisations to ensure that the Avatr technology met the requirements of patients and clinicians from Peru.

EmpatIA is a specific instance of Avatr that has been customised to meet the specific needs of patients and clinicians in Peru. In Project EmpatIA, an ‘instance’ is an example of how the Avatr system can be configured and used to meet these needs. EmpatIA is accessible via Android and iOS systems.

Inavya set up this unique Project EmpatIA instance on a Microsoft Azure server based in Peru to meet regulatory requirements.

As the EmpatIA use case focuses on breast cancer, Detecta Clinic asked for a few adjustments to the EmpatIA instance.  The first request was to profile patient pain levels on the clinician’s high-level dashboard, with data generated from the patient through a standardised pain level question that is asked by Avatr to each patient in the morning and evening - Inavya completed this task.  The second request related to the introduction email text each patient received from Detecta Clinic.  The wording was simplified and translated into Spanish to ensure accurate reading.  Inavya completed this task, as requested. 

Patient information: Detecta Clinic created a set of patient information videos to support Project EmpatIA.  This was achieved by Detecta Clinic first asking clinicians the most common questions cancer patients ask. A short video was produced to answer each question from this list.  In making the video, the Detecta Clinic team drafted the question and answer with careful attention to wording so that the information presented was clear and accurate and had a tone that was appropriate for patients.  The team then trained clinicians to present and hired a production team to make each video.  The videos were then uploaded to the Avatr EmpatIA instance for patients and clinicians to use when needed.  Detecta Clinic also provided Inavya with a Peru government document on nutrition and healthy living.  This document is a large data file and will be rendered by Inavya during the next sprint.  To support patients in eating well, the current EmpatIA instance enables clinicians to list what foods the patient should avoid and eat. 

GenAI Enhancement:  Building on strong interest from Detecta Clinic, the Detecta Clinic team is providing Inavya with use case examples to inform the development of a novel GenerativeAI feature of Avatr, which is being developed with support from Microsoft. Benefits sought by Detecta Clinic include a GenAI enhancement to the EmpatIA instance to enable:

• Natural, human-like, real-time conversational interaction between the outpatient and the technology, reflecting evolving expectations from technology in an era of ChatGPT.

• Multi-lingual interaction with patients whereby information recorded in factsheets in one language can drive a chat interaction in another language, which is important as over 26% of the Peruvian population speaks a first language other than Spanish, and these non-Spanish speakers typically live in more remote areas where healthcare is, in any case, more difficult to access.

• Short-form video delivered in real-time which Detecta Clinic staff indicate will be a more effective way of delivering information, advice, and guidance in the Peru context, where there is widespread engagement with TikTok and similar formats, and patients who live in remote areas of Peru who find video content more accessible than text information.  This will initially be short video content provided by Detecta Clinic for the purpose but with a latent capacity to service a wide variety of personalised, generated videos.

• Providing advice and guidance that is soundly based on the treatment protocol particular to Detecta Clinic, as such protocols differ from one country to another, and to some extent even from one hospital to another.

• Making optimal and efficient use of clinical dark data, including scanned documents and other unstructured data, for a more data-driven approach to hospital treatment protocols.

• Delivering healthcare education and health literacy to patients about their condition and treatment plan in ways that do not put extra strain on the limited time of healthcare teams at hospitals such as Detecta Clinic.

These benefits represent a much-needed advance on current processes at hospitals in Peru, which typically involve handing out printed factsheets or sharing a limited range of videos in ways that are not customised or personalised and not given in real-time as needed by outpatients.   As such, these features are expected to deliver particular benefits to people living in remote areas who cannot access healthcare services in person.

Providing these benefits is anticipated to improve the outpatient's confidence in managing their healthcare condition, leading to better patient-physician concordance and increased adherence rates to the treatment plan.

Education and training materials for the Detecta Clinic team:  Inavya provided the Detecta Clinic R&D lead with several training sessions to use the Avatr system fully.  This was in a Train-the-Trainer format, designed to empower the R&D lead to use the toolset herself and train other clinicians on using the EmpatIA toolset.  The training was supported with written documents, such as a features deck, a clinician manual, and a patient manual.  A video was also made to provide additional support. The training was well received, and the R&D lead could test and use the system before starting patients on the Project EmpatIA study.  The most useful approach for the R&D lead was for her to watch the Inavya team use and explain the toolset features based on the patient’s journey - e.g. 1. Patient registration to Avatr, 2. setting up Care Plan, 3. requesting information from the patient.  Following this demonstration, the R&D lead would repeat the same process and demo back to the Inavya Team.  Throughout, Inavya provided technical support to the Detecta Clinic team, with prompt response times.  The training, support material, and technical support are all essential to successful knowledge transfer to Clinicians to empower them to provide the EmpatIA service to a high standard.

Meeting documentation: Regular meetings included developing, launching, and supporting the EmpatIA instance. This way of working enabled the team to focus on the important tasks that needed to be cleared, by whom, and when.

During this sprint, the project team became increasingly aware of the specific information requirements of cancer outpatients and responded with the creation of tailored videos, pain management systems, patient communications, and an informed approach to GenAI.  During Sprint 6, these digital health services' use, impact and benefits will become apparent during the study and patient engagement.

3. PERU ECOSYSTEM

The term "ecosystem" is commonly used in the global healthcare sector to refer to a network of stakeholders involved in healthcare. These ecosystems are typically informal and include various entities such as healthcare providers, hospitals, universities, pharmacies, pharmaceutical companies, insurance companies, medical technology companies, investors, and government policy-makers.

The current Peruvian healthcare ecosystem is characterised as a complex network of institutions and caregivers that strive to deliver quality healthcare to patients across diverse regions. From pharmacists to surgeons, various professionals provide services to enhance patient outcomes and elevate care quality.  Given this, there are significant opportunities for improvement.

Integrating health technology and AI across Peru's healthcare landscape has strong potential to transform healthcare delivery, making it more efficient, effective, and patient-centred.

After active engagement by Inavya, the British Embassy in Peru, Detecta Clinic, and wider stakeholders in Peru, a Peru Health Ecosystem Report will be published upon the completion of Project EmpatIA. The report will include an overview of the Peru health context and an overview of Project EmpatIA. 

The methodological approach to making the report will be based on a Review of the Literature, contributions from subject-matter experts, and engagement with stakeholders across the Peru Health Ecosystem.   Key stakeholders include public and private hospitals, universities, the Ministry of Health, pharma companies, and insurance companies.  Many of these stakeholders have already been engaged with the Project EmpatIA team and their contributions will be included in the report, as well as an invitation to participate in Phase 2 of the Project EmpatIA study and to attend the planned event at the British Embassy in Peru at the end of March 2024, when the report will be presented. 

Our Learning

The experiment achieved its objective of co-developing an approach to creating a project and ecosystem report that met the needs and aspirations of all key stakeholders. At the start of the experiment, the team aimed to produce a report that would present Project EmpatIA, including the approach used, early findings, and the next steps. A discussion with wider stakeholders in Peru helped to clarify how best to position the report to achieve maximum impact.

The approach to this experiment has been very helpful. The aim was precise, and enough flexibility enabled wider stakeholders from the Peru health ecosystem to contribute. This enables a sense of shared ownership and control, which is essential to the project's ongoing success.