End of Life Care, Liver Cirrhosis, Nurse-Patient Relations, Quality of Life
Conditions
Brief summary
Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment. Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services. Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services. Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status. Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention. Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.
Interventions
BEHAVIORALAdvance Care Planning and the consequent actions
The palliative care intervention is based on the advance care planning process and the actions taken as a consequence of these conversations. The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems. Advance care actions These are the actions taken to fulfill the advance care plan and can include, but are not limited to: treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities
Sponsors
Herlev Hospital
Aarhus University Hospital
Hvidovre University Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness 2. 2 or more items checked on the Supportive and Palliative Care Indicators Tool (SPICT™, appendix) 3. Expressed desire for palliative support from the patient and relatives 4. Ability to give informed consent
Exclusion criteria
1. Inability to give informed consent 2. Age \< 18 years 3. Ongoing contact with specialized palliative care teams or hospice 4. Other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-subject change in patient burden | From date of inclusion until the date of death from any cause, assessed up to 100 months | Change in Hospital Anxiety and Depression Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-subject change in caregiver burden | From date of inclusion until the date of death from any cause, assessed up to 100 months | Change in Zarit Caregiver Burden Questionnaire |
| Inter-group difference in health care system burden | From date of inclusion until the date of death from any cause, assessed up to 100 months | The difference in the use of health care services between intervention and control groups from 2 non-participating hospitals. The difference will be assessed by a review of electronic patient files and sundhed.dk. |
Countries
Denmark
Outcome results
None listed