Living Well, Dying Well. A Research Programme to Support Living Until the End
Living Well, Dying Well. A Research Programme to Support Living Until the End
The iLIVE project involves a cohort study in which patients with an estimated life expectancy
 of six months or less are followed until they die. In total, the investigators will include
 2200 patients in 11 countries, i.e. 200 per country. The primary outcome for the cohort study
 is a descriptive assessment of the concerns, expectations and preferences around dying and
 end-of-life care of patients and their relatives, in different settings and cultures..
Rationale: In the EU about 4 million people yearly die from a chronic illness. Many of these
 people die in pain or distress. Care for dying patients and their close relatives is often
 suboptimal.

 Objective: To contribute to high-quality personalized care at the end of life by:

 1. Providing in-depth understanding of the concerns, expectations and preferences of
 patients in the last phase of life and their relatives

 2. Understanding the cultural, gender, age, healthcare -related and socio-economic variance
 in these concerns expectations and preferences Study design: The iLIVE project involves
 a cohort study in which patients with an estimated life expectancy of six months or less
 are followed until they die. In total, the investigators will include 2200 patients in
 11 countries, i.e. 200 per country. Participants are requested to also involve a close
 relative. Both patients and relatives are asked to fill in a questionnaire, at baseline
 and after four weeks. If patients die during the study, the relative is asked to fill in
 a post-bereavement questionnaire. Medical files are studied to assess health care use in
 the last days of life.

 Main study endpoints: The primary outcome for the cohort study is a descriptive assessment of
 patients' concerns, expectations and preferences around dying and end-of-life care, at
 baseline and after one month of follow-up.

 Potential risks and benefits associated with participation: The study population concerns
 vulnerable people who may experience fluctuating symptoms and levels of suffering across
 their disease trajectory. The investigators acknowledge the risk of overburdening or
 stigmatizing participants. If patients feel burdened by participating in the study, they are
 encouraged to indicate that. The investigators will develop a protocol for researchers and
 interviewers to address such situations.
Inclusion Criteria patients:

 -  The patient is aware that recovering from his/her disease is unlikely, to be assessed
 by the attending physician

 -  The attending physician would not be surprised if the patient were to die within 6
 months

 -  If the physician is uncertain about the surprise question, the patient is eligible if
 presenting with at least one SPICT indicator:

 General SPICT indicators:

 -  Unplanned hospital admission

 -  Performance status is poor or deteriorating, with limited reversibility (eg stays in
 bed or in a chair for more than half the day)

 -  Depends on others for care due to increasing physical and/or mental health problems;
 person's carer needs more help and support

 -  Progressive weight loss; remains underweight; low muscle mass

 -  Persistent symptoms despite optimal treatment of underlying condition(s)

 -  Person (or family) asks for palliative care; chooses to reduce, stop or not have
 treatment; or wishes to focus on quality of life

 Disease-specific SPICT indicators:

 Cancer:

 -  Functional ability deteriorating due to progressive cancer

 -  Too frail for cancer treatment or treatment is for symptom control

 Neurological disease:

 -  Progressive deterioration in physical and/or cognitive function despite optimal
 therapy

 -  Speech problems with increasing difficulty communicating and/or progressive difficulty
 with swallowing

 -  Recurrent aspiration pneumonia; breathless or respiratory failure

 -  Persistent paralysis after stroke with significant loss of function and ongoing
 disability

 Heart/vascular disease:

 -  Heart failure or extensive, untreatable coronary artery disease; with breathlessness
 or chest pain at rest or on minimal effort

 -  Severe, inoperable peripheral vascular disease

 Respiratory disease:

 -  Severe, chronic lung disease; with breathlessness at rest or on minimal effort between
 exacerbations

 -  Persistent hypoxia needing long term oxygen therapy

 -  Has needed ventilation for respiratory failure or ventilation is contraindicated

 Kidney disease:

 -  Stage 4 or 5 chronic kidney disease (eGFR < 30ml/min) with deteriorating health

 -  Kidney failure complicating other life limiting conditions or treatments

 -  Stopping or not starting dialysis

 Liver disease:

 -  Cirrhosis with one or more complications in the past year: diuretic resistant ascites;
 hepatic encephalopathy; hepatorenal syndrome; bacterial peritonitis; or recurrent
 variceal bleeds

 -  Liver transplant is not possible

 Dementia/ frailty:

 -  Unable to dress, walk or eat without help

 -  Eating and drinking less, difficulty with swallowing

 -  Urinary and faecal incontinence

 -  Not able to communicate by speaking; little social interaction

 -  Frequent falls; fractured femur

 -  Recurrent febrile episodes or infections, aspiration pneumonia

 Other conditions:

 o Deteriorating and at risk of dying with other conditions or complications that are not
 reversible; any treatment available will have a poor outcome

 Exclusion Criteria patients:

 -  The patient is incapable of filling in a questionnaire in the country's main language
 or in English (patients may be supported by relatives when filling in the
 questionnaire)

 -  The patient is incapable of providing informed consent to participate in the study, to
 be assessed by the attending physician

 Inclusion Criteria relatives:

 -  Family, friend or other close relative of the patient

 -  18 years or older

 -  The relative is aware that it is unlikely that that patient will recover from his/her
 disease

 Exclusion Criteria relatives:

 -  The relative is incapable of filling in a questionnaire in the country's main language
 or in English

 -  The relative is incapable of providing informed consent to participate in the study