Liver Cirrhosis
Conditions
Keywords
Quality of care, Health related quality of life, Nurse-led clinic, Health economics
Brief summary
This study compare the effects of traditional follow-up by physician with a combined follow-up alternately by physician and nurse-led clinic. The main variable is; health related quality of Life. Participants are randomized into control group or intervention group.
Detailed description
The incidence of liver cirrhosis in Sweden increase mostly due to life style factors. A large need of care is common in the end stage of the disease. Nurse-led clinics for other groups of patients, e.g. coronary heart disease, have shown high quality which has resulted in an established part of the follow-up. This study is a randomized controlled study at six Swedish hospitals to study the effect of a changed follow-up process for liver cirrhotic patients by adding a nurse-led clinic to follow up by physician. The intervention implies a larger extend of nursing interventions at the outpatient clinic to increase the patient's quality of life, quality of care and reduce the need of inpatient care. A few hospitals in Sweden offers a nurse-led clinic for liver cirrhotic patients, the interest in other hospitals are raising. Though there is a lack of evidence in nursing intervention within this population and it is still unknown what the effects are for the individual or on the health economy.
Interventions
OTHERrisk factors
monitoring risk factors due to deterioration of the liver disease
OTHERself-care
information and motivation to adherence to self-care instructions and medical treatment
OTHERnutrition
nutritional assessment and activities to prevent malnutrition
OTHERlifestyle
motivation of lifestyle changes essential for disease progress and
OTHERpsychosocial needs
psychosocial care.
OTHERNurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month
Sponsors
Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden
Center for Clinical Research Dalarna, Sweden
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* within the last 24 months diagnosed liver cirrhosis based on clinical investigation, laboratory findings, histology, magnetic resonance imaging, computer tomography, ultrasound or elastography * followed at one of the six Gastroenterology departments
Exclusion criteria
* Insufficient knowledge of the Swedish language * Persistent hepatic ecephalopathy grades 2-4 * Comorbidity: Chronic obstructive pulmonary disease grade 3-4, Coronary heart disease New York Heart Association Functional Classification class 3-4, Dementia, Actual advanced cancer, Stroke with sequelae, Severe psychiatric disease, Renal failure requiring dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Health related quality of life | At baseline after 12 and 24 months | Patient survey using the instrument from Research and development, RAND 36-item heath survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child-Pugh scale | At baseline after 12 and 24 months | Liver cirrhosis specific calculator to measure long time survival |
| Presence of Hepatic encephalopathy | At baseline after 12 and 24 months | Paper and pencil test the psychometric hepatic encephalopathy score (PHES) |
| Health literacy | At baseline after 12 and 24 months | Standardized interview of a table of contents using the instrument The newest vital sign (NVS) |
| Clinical examination of presence of ascites | At baseline after 12 and 24 months | Severity of ascites is grouped as none, mild or severe |
| Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool | At baseline after 12 and 24 months | A liver cirrhosis specific instrument will be used to assess the risk of malnutrition. The risk is subdivided into low, moderate or high risk. |
| Changes in patients experienced Quality of care | At baseline after 12 and 24 months | Patient survey using the instrument Quality of care from the the patient's perspective (QPP) |
| Health care consumption | through study completion, 24 months | Medical Review of inpatient and outpatient care |
| Model of end stage liver disease (MELD-score) | At baseline after 12 and 24 months | A liver cirrhosis specific calculator to assess short time survival rate |
Countries
Sweden
Outcome results
None listed