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Living well, dying well. A research programme to support living until the end

Periodic Reporting for period 1 - iLIVE (Living well, dying well. A research programme to support living until the end)

Reporting period: 2019-01-01 to 2020-06-30

An excess of 5 million people die in the EU each year, with 77% of deaths resulting from chronic disease and illness. Dying from chronic illness typically involves a period of declining health, deteriorating functioning and increasing symptom load. The imminence of death is often not recognized or acknowledged in patients with an advancing chronic illness, due to an omnipresent focus on diagnosis, therapy and cure. As a result of a lack of acknowledgement of the needs of the imminently dying, many patients die in distress, with unresolved issues and insufficiently controlled symptoms, and with family often feeling unsupported at this vulnerable time in their lives.

The overall objectives of iLIVE are:
I. To develop and evaluate a digital clinical tool to guide clinicians in optimizing individualized medication management for patients who are in the last months of life, i.e. in the prescription of medication to relieve symptoms and suffering, and in the de-prescription of medication that has no benefits and may involve side effects
II. To develop and evaluate an international volunteer training programme to support patients dying in the hospital and their families
III. To assess the cost-effectiveness of the medication tool and the volunteer training programme
IV. To contribute to high-quality personalized care at the end of life by:
a. Providing in-depth understanding of the concerns, expectations and preferences of dying patients and their formal and informal caregivers
b. Understanding the cultural, gender, age and socio-economic variance in these concerns, expectations and preferences
V. To enhance the awareness and engagement of the community at large with the reality of death and dying
VI. To establish a Core Outcome Set (COS) for care of dying patients and develop methods for international benchmarking

To realise these objectives, an 11-country prospective cohort study of 2200 patients with a life expectancy of six months or less, across different settings, diagnoses, ages, genders, socio-economic and religious groups is set up. Embedded in this cohort study, we will develop and evaluate two innovative interventions in end-of-life care:
• a digital clinical tool to optimize medication management to relieve symptoms that occur at the end of life
• an international volunteer programme to support patients and their families, dying in the hospital
During the first 18 months of the project we have prepared protocols, questionnaires, interview guides and the infrastructure for the cohort study and the embedded trials. The protocol for the cohort study includes detailed descriptions of the inclusion and exclusion criteria for patients and relatives, recruitment and follow-up procedures, procedures to pilot test the study, data collection instruments, a data analysis plan, and ethical safeguards. The design of a complementary qualitative interview study is described in an additional study protocol. The protocol has been submitted for approval by ethical review boards in all participating countries and approval has been granted in nearly all countries. The study was planned to start in March 2020, but this was impossible due to the worldwide COVID-19 pandemic. We now hope to start recruitment for the study in September 2020.

The embedded medication study involved the development of a digital tool to provide individually tailored advice on medication use. The content of the tool was based on published literature and an international Delphi rstudy. The tool will be implemented and evaluated in three out of the 11 participating counties.

The embedded volunteer study involved the development of an international volunteer train-the-trainer programme. The content of this programme was based on a consensus procedure and carried out in January 2020. Trained volunteer trainers will educate volunteers in the five countries that participate in this part of the project. The volunteer study also includes a digital 'learning lab', where volunteers can share and discuss experiences.

The costeffectiveness of both interventions will be evaluated based on a number of tools that were added to the data collection instruments. We also performed a literature review on costeffectiveness analysis methods in palliative care.

We developed a framework of important cultural and ethical values, that will serve as a background for the interpretation of the outcomes of the cohort and embedded studies.

We developed an international datamanagement system for secure and safe data collection that is compliant with international legal standards.

We performed a literature review on outcome measures for care in the last days of life and added items to the data collection for the cohort study to support the development of the COS.

We launched a project website, several newsletters, a template for presentations on the project (that were delivered at several occasions) and a publication and dissemination plan.
The iLIVE project will deliver an internationally evaluated digital clinical tool to optimize medication management in the last phase of life. The tool provides an automated advice for each individual patient, that is grounded in a broad set of clinical decision rules. The tool also represents an opportunity for physicians to engage in conversations about the end of life with patients and their families.

The iLIVE project will deliver an internationally evaluated compassion-based volunteer training programme for dying patients and their family within the hospital setting. Research on the involvement of volunteers in palliative care is a new and developing field. Evaluations of impact and effects are largely lacking.

A comparative analysis of different interventions in the area of palliative care can help us understand what their broader impact on patients and families are, what their cost impact is, whether the available resources are used efficiently, and whether the interventions provide relevant options within the currently proposed value frameworks for end-of-life care.

In the iLIVE project, we will develop the first internationally validated COS for care of dying patients, independent of their diagnosis. The protocol for the COS development has been posted on the COMET website.

The LIVE project aims to contribute to the engagement with death and dying of the community, formal and informal caregivers, and other stakeholders. It does so by supporting clinicians, by addressing the role of volunteers, by linking directly to patients and families through assessing their concerns, expectations and preferences around dying and end-of-life care; and by informing all stakeholders and policymakers about 21st century experiences of dying and end-of-life care.