For patients and family members

For patients and family members

Here we provide essential information about the EPIC clinical trial, ensuring understanding of its objectives, implications and what to expect from your loved one’s participation.

Palliative care in ICU

The EPIC trial aims to improve the palliative care experience in ICUs across Europe by standardising established practices. Through standardization, EPIC wants to ensure early and high-quality access to palliative care for all patients who might benefit.

When palliative care practice is added to intensive care therapy early, this can reduce unwanted suffering, alleviate stress and ensure comfort for patients, families and the medical staff at this critical stage. Palliative care brings a strong patient-centred view to the table. Palliative care does not mean “letting the patient die” or “not doing everything that is possible”. On the contrary, by adding a patient-centred focus, the overall quality of care in ICU can be improved. Patients, families and medical staff are better supported in their decisions.

Palliative care is an integral part of intensive care. Basic palliative care is provided by ICU clinicians as part of regular practice. In addition, in complex clinical situations, it can be helpful to get the advice of a specialist palliative care physician. Specialist palliative care physicians can be asked to consult just like specialists from other medical fields like neurology or cardiology can be called for if needed.

What is the EPIC palliative care model?

The standardized practice is called the EPIC palliative care model. Clinicians are trained to understand when and why palliative care specialists can improve the care of their patients. Clinicians are aided by a checklist to identify patients who can benefit from specialist care. Palliative care specialists provide their consultation through telemedicine, thereby making it possible to advise physicians in ICUs without access to in-person specialist palliative care.

The specialist palliative care consultation is provided to the treating ICU physician. The ICU physician stays in charge of the care for the patient.

Telemedicine

Specialist palliative care consultations are provided by telemedicine using audio-visual technology. Telemedicine is simply a means of visual and auditory contact between the ICU physician and the palliative care specialist. No patient data will be gathered or stored. Telemedicine has become an accepted technology since the COVID pandemic. Use of telemedicine in EPIC clinical centers is approved by data security and ethical oversight required in each location.

How is the clinical trial set up?

The trial recruits ~2000 patients from 23 multi-disciplinary ICUs across 5 European countries. A cluster-randomized trial design is used to test the effectiveness of the EPIC palliative care model compared to the current standard of care. That means that ICUs, not individual patients are randomized, to enter into the intervention phase.

At the beginning of the trial, all ICUs provide usual care to their patients. After 3 months, ICUs begin to switch to the standard palliative care model in a step-wise manner at time points determined by the randomization procedure. After a crossover period, in which ICU staff is trained in the EPIC model, patients and one of their family members are invited to enter the trial if they fulfil certain criteria.

Three months after ICU discharge, patients and family members are contacted for a follow-up interview.

Who can participate in this study?

Patients and their families are invited to participate in this study based on certain criteria. All ICU patients must be at least 18 years old. Because of the funding rules, patients with cancer as the primary cause for ICU treatment are not accepted. However, if a patient had cancer in the past and is now treated in ICU for other reasons, he or she may participate.

If the patient lacks decision making capability, the legal surrogate will be asked to provide informed consent on behalf of the patient.

What should I consider before consenting my loved one’s participation in this study?

First, take time to fully understand the information about the EPIC study. Please do not hesitate to ask questions. The decision to participate in the trial is a personal one, and patients and their families are encouraged to discuss the potential risks and benefits amongst themselves and with their healthcare team before making a decision.

What if I or the patient change our mind and refuse further treatment?

You can withdraw consent at any time and without giving a reason. The patient will continue to receive treatment and best possible care.

What if I have any questions or concerns, now or later?

If you have any questions about the study, please do not hesitate to ask anyone of the medical or research team at your treatment centre or contact the study’s representatives (contact details found here).

If you have any questions about the storage of your data, you should contact the study’s representatives.

If you have any complaints about any aspect of the way you or your family member have been approached or treated during the course of this study, please feel free to discuss your concerns with the treatment team or contact the local hospital’s complain department.

How can I find out about the progress of the EPIC study?

After the end of the study, medical researchers have the responsibility to publish the results and make them widely known. Results are published in medical journals, presented at national and international conferences, and will also be reported on this website.

How can I become involved ?

The consortium has established a Patient and Family Support and Advisory Group. You can learn more here.