The EPIC trial aims to establish a European-wide standardized palliative care practice within ICUs, focussing on early and high-quality access to palliative care. By implementation of a novel telemedicine-using model, we seek to reduce the overall length of ICU stays while alleviating stress for patients, families and the medical staff. The trial is supported by an interdisciplinary consortium from 5 European and 4 non-European members to bring together expertise from diverse backgrounds and to ensure a comprehensive and inclusive approach to palliative care.
Trial Set Up
The trial encompasses 7 clinical centres and 23 multi-disciplinary ICUs across Europe. Each clinical centre is considered a “hub” which delivers specialist consultations to ICU clinicians in participating ICUs. It is estimated that at least 2001 patients can be recruited into the trial. A stepped-wedge, cluster-randomised trial design is used to test the effectiveness and cost-effectiveness of the EPIC palliative care model compared to the current standard of care.
At the start of the trial, all ICUs start in the control arm. Crossover to the interventional arm occurs at specified time points determined by the randomization procedure. The crossover period lasts for 1 month, after which the ICUs remain in the intervention arm for at least 6 months until the end of the trial.
Study flow (left) and stepped wedge design of the clinical trial (right). Control = grey, Cross-over = shaded, Intervention = dark blue, the last three months are only Follow-Up (= light blue). Upper line shows project month.
Inclusion and Exclusion Criteria
All patients are recruited directly by the ICU staff. All ICU patients over the age of 18 and without cancer as the primary cause for critical illness will be screened for the presence of eligibility criteria. If the patient lacks decision making capability, the legal surrogates will be asked to provide informed consent on behalf of the patient.
Study Endpoints
The primary outcome of this trial is the length of ICU stay, measured in days. A reduction of mean 2 days is expected. Several secondary outcomes at the patient-, family- and clinician level are being measured which complement the current understanding of palliative care practices and decision-making processes within ICUs.
In this context, the patient’s demographic, clinical data and 30-day survival are being captured. The patient- and family reported outcomes are being assessed during the follow-up period. These include satisfaction with care and communication, quality of dying in the ICU, and health-related quality of life. We expect that patients and families are able to contribute more meaningfully with the joint decision-making process integrated in the EPIC care model.
Clinicians are asked about burnout, intent to leave and their perception of end-of-life decision-making. Furthermore, ethical practices at the participating ICUs are being assessed. In this context, it is expected that clinicians will have access to and use improved clinical guidelines and policy with respect to pain and symptom management, psychological support and palliative care for patients.
To investigate the cost-effectiveness of the EPIC model, health economic data is being captured alongside the trial. Direct and indirect costs will be assessed using criteria such as medical resource use, unit costs, and amount of informal healthcare provided. Alongside the reduced ICU stay, we expect the healthcare cost to be reduced whilst maintaining the patient quality of life.
What are the Implications for Clinical Practice?
Evidence shows that palliative care consultations can directly improve physical and psychological symptoms such as pain or anxiety, reduce non-beneficial medical interventions, address holistic needs and reduce unnecessary hospital costs. In addition, clinician education can facilitate an understanding of when and why to call palliative care specialists, increase ethical awareness, educate about advance directives, legal framework, and communication opportunities and requirements to help to prepare the team for a “good” death in ICU. Taken together, these measurements contribute to relieve overall patient and family suffering, reduce decision delays, and thus shorten the length of ICU stays and mitigate clinician stress.
