SERENITY will be organised through 6 work packages over a five-year timescale

WP1: UNDERSTANDING CURRENT PRACTICE AND THE COMPLEXITY OF DECISION-MAKING IN END-OF-LIFE CARE

The problem
Current patterns of deprescribing in European countries are unknown, as are the rationale and preferences behind ATT management decisions in cancer patients at the end of life.

The contribution of SERENITY
In SERENITY, we will perform an extensive realist review to identify and describe best available evidence. Moreover, we will perform a flash mob research (FMR), including a discrete choice experiment (DCE) to evaluate current practice patterns with the specific aim to describe differences in preferences of medical professionals from different specialties and from various European countries.

WP 2: Epidemiological studies

The problem
The clinical consequences of (dis)continuing ATT are largely unknown. Moreover, it is completely unknown what patient profiles are associated with an increased risk of bleeding on ATT or, similarly, what patient profiles  are  associated  with  a  risk  of  cardiovascular  complications  whilst  stopping  ATT.  The  lack  of  evidence surrounding this clinical conundrum is one of the most important barriers to informed decision making and for widespread implementation of deprescribing ATT. Providing evidence from a variety of sources and perspectives is at the heart of this proposal.

The  contribution of SERENITY
The problem: The clinical consequences of (dis)continuing ATT are largely unknown. Moreover, it is completely unknown what patient profiles are associated with an increased risk of bleeding on ATT or, similarly, what patient profiles are associated with a risk of cardiovascular complications whilst stopping ATT. The lack of evidence surrounding this clinical conundrum is one of the most important barriers to informed decision making and for widespread implementation of deprescribing ATT. Providing evidence from a variety of sources and perspectives is at the heart of this proposal.
The contribution of SERENITY: This epidemiological study in Danish, Dutch, and UK national routine healthcare databases will answer important questions as to the actual current practice of deprescribing ATT in end-of-life care of cancer patients, as well as the clinical consequences of doing so in terms of the incidence of bleeding events and cardiovascular complications. Moreover, using these routine healthcare data sources, we aim to identify patient profiles for these highly burdening complications that occur still too often in end-stage palliative cancer care. The
information acquired in this study will have a key and pivotal role in the development of the SERENITY intervention.epidemiological study  in Danish, Dutch,  and  UK  national  routine  healthcare databases will answer important questions as to the actual current practice of deprescribing ATT in end-of-life care of cancer patients, as well as the clinical consequences of doing so in terms of the incidence of bleeding events and cardiovascular complications. Moreover, using these routine healthcare data sources, we aim to identify patient profiles for these highly burdening complications that occur still too often in end-stage palliative cancer care. The

information acquired in this study will have a key and pivotal role in the development of the SERENITY intervention.

WP3: Qualitative research

The problem
The decision whether to continue ATT in patients with advanced cancer is not clear since both options bring with them competing risks and advantages. A key factor in decision making will be the views of patients, their carers, and healthcare professionals. Currently, the opinions and the factors informing their stance are unknown.

Contribution of SERENITY
WP3 will inform the SERENITY intervention by exploring and categorising the experiences and perspectives of patients, their carers, and healthcare professionals who may be involved in such decisions. Specifically, it will identify which clinical outcomes are important to these stakeholders, and what differences would be considered clinically relevant. It will identify barriers to discussing rationalisation of ATT as well as suggesting the optimal timing to use the SDST in different health system contexts. It will recognise and capture data specific to three main clinical categories of patients: those anticoagulated for atrial fibrillation; those anticoagulated for VTE; and those on antiplatelets for cerebrovascular, cardiovascular, and peripheral vascular disease. It will capture views on the best way to communicate important issues with patients and carers with specific consideration of SDST development and format. It will also inform of the most valued primary outcome of the planned RCT in WP6

WP4: Delphi process

The problem
No consensus exists on the optimal content and interface of a SDST for determining the optimal use of ATT at the end of life of cancer patients, let alone on the complex clinical decision making itself. Achieving broad consensus will be key for the successful implementation of the concrete intervention SERENITY aims to provide.

The contribution of SERENITY
In SERENITY, we will develop a consensus agreement on the optimal interface, content of the decision tool under development, and likely ‘fit’ into the clinical care pathways of palliative care across European countries, taking the findings from WP 1-3 into account. Moreover, the primary outcome of the RCT in WP6 will be determined.

WP5: Development and testing of the Shared Decision Support Tool

The problem
After completing the first 4 WPs, the criteria for the SDST are clear, but the SDST still needs to take shape. We will design, develop, and test the alpha version of the SDST by combining state-of-the-art software development with clinical expertise.

The contribution of SERENITY
The SDST will be designed and developed in close relation with patients and physicians to ensure the utility, usability, and acceptability in everyday practice.

WP6: Cluster-randomized controlled trial

The problem
We do not know whether the SERENITY intervention improves the care and experience of patients with cancer in the final year of life who are receiving ATT.

The contribution of SERENITY
The SERENITY intervention will be trialed in five EU countries (FR, ES, IT, NL and UK) to evaluate its utility across different healthcare settings and cultures. This will be achieved by a network of clinicians, nurses, patients, and researchers with experience in conducting large pragmatic complex intervention studies in patients where overall survival as an outcome has limited relevance.

Timeline serenity project (duration 60 months)

month 0

month 60

  • FAIR data management and stewardship
  • Phase 1 | WP1: Realist review and Flash mob study
  • Phase 1 | WP2: Epidemiologic studies
  • Phase 1 | WP3: Qualitative studies
  • Phase 2 | WP4: Delphi
  • Phase 2 | WP5: Tool development, design and testing
  • Phase 3 | WP6: RCT
  • Phase 3 | WP7: Dissemination
  • WP8: Project Management
  • Public engagement