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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
167
monitoring risk factors due to deterioration of the liver disease
information and motivation to adherence to self-care instructions and medical treatment
nutritional assessment and activities to prevent malnutrition
Gastroenterology department
Falun, Sweden
Gastroenterology outpatientclinic, Sahlgrenska hospital
Gothenburg, Sweden
Gastroenterology outpatient department, Skane Universityhospital
Malmo, Sweden
Gastroenterology department, Örebro Universityhospital
Örebro, Sweden
Changes in Health related quality of life
Patient survey using the instrument from Research and development, RAND 36-item heath survey
Time frame: At baseline after 12 and 24 months
Clinical examination of presence of ascites
Severity of ascites is grouped as none, mild or severe
Time frame: At baseline after 12 and 24 months
Child-Pugh scale
Liver cirrhosis specific calculator to measure long time survival
Time frame: At baseline after 12 and 24 months
Presence of Hepatic encephalopathy
Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
Time frame: At baseline after 12 and 24 months
Health literacy
Standardized interview of a table of contents using the instrument The newest vital sign (NVS)
Time frame: At baseline after 12 and 24 months
Model of end stage liver disease (MELD-score)
A liver cirrhosis specific calculator to assess short time survival rate
Time frame: At baseline after 12 and 24 months
Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool
A liver cirrhosis specific instrument will be used to assess the risk of malnutrition. The risk is subdivided into low, moderate or high risk.
Time frame: At baseline after 12 and 24 months
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motivation of lifestyle changes essential for disease progress and
psychosocial care.
compensated disease once yearly, decompensated disease twice a month to every third month
Gastroenterology department, Danderyd hospital
Stockholm, Sweden
Gastroenterology department, Uppsala academical hospital
Uppsala, Sweden
Changes in patients experienced Quality of care
Patient survey using the instrument Quality of care from the the patient's perspective (QPP)
Time frame: At baseline after 12 and 24 months
Health care consumption
Medical Review of inpatient and outpatient care
Time frame: through study completion, 24 months