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Palliative Care for Patients With Liver Cirrhosis (LiverCare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05431946
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Herlev Hospital
Hvidovre University Hospital
Aarhus University Hospital
Information provided by (Responsible Party):
Hospital of South West Jutland

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.


Condition or disease Intervention/treatment
End of Life Care Liver Cirrhosis Nurse-Patient Relations Quality of Life Behavioral: Advance Care Planning and the consequent actions

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Group/Cohort Intervention/treatment
Palliative Care arm

Intervention by Advance care planning (ACP) conversation: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

Behavioral: Advance 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

Other Name: Questionnaires

Non-participating arm
Will continue standard of care



Primary Outcome Measures :
  1. Intra-subject change in patient burden [ Time Frame: 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 Outcome Measures :
  1. Intra-subject change in caregiver burden [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 100 months ]
    Change in Zarit Caregiver Burden Questionnaire

  2. Inter-group difference in health care system burden [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with liver cirrhosis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431946


Locations
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Denmark
Hospital of South West Jutland
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Jutland
Herlev Hospital
Hvidovre University Hospital
Aarhus University Hospital
Investigators
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Principal Investigator: Mette M Lauridsen Head of Liver Research
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Responsible Party: Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT05431946    
Other Study ID Numbers: LiverCare
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Death
Pathologic Processes
Liver Diseases
Digestive System Diseases