Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Other: risk factors
* Other: self-care
* Other: nutrition
* Other: lifestyle
* Other: psychosocial needs
* Other: Nurse-led clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (CI)<br>Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors. | Other: risk factors<br>* monitoring risk factors due to deterioration of the liver disease<br>Other: lifestyle<br>* motivation of lifestyle changes essential for disease progress and<br>Other: Nurse-led clinic<br>* compensated disease once yearly, decompensated disease twice a month to every third month<br>|
| No Intervention: Control (CC)<br>Compensated Control (CC) | |
| Experimental: Intervention (DI)<br>Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs | Other: risk factors<br>* monitoring risk factors due to deterioration of the liver disease<br>Other: self-care<br>* information and motivation to adherence to self-care instructions and medical treatment<br>Other: nutrition<br>* nutritional assessment and activities to prevent malnutrition<br>Other: lifestyle<br>* motivation of lifestyle changes essential for disease progress and<br>Other: psychosocial needs<br>* psychosocial care.<br>Other: Nurse-led clinic<br>* compensated disease once yearly, decompensated disease twice a month to every third month<br>|
| No Intervention: Control (DC)<br>Decompensated Control (DC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health related quality of life | Patient survey using the instrument from Research and development, RAND 36-item heath survey | At baseline after 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination of presence of ascites | Severity of ascites is grouped as none, mild or severe | At baseline after 12 and 24 months | 
| Child-Pugh scale | Liver cirrhosis specific calculator to measure long time survival | At baseline after 12 and 24 months | 
| Presence of Hepatic encephalopathy | Paper and pencil test the psychometric hepatic encephalopathy score (PHES) | At baseline after 12 and 24 months | 
| Health literacy | Standardized interview of a table of contents using the instrument The newest vital sign (NVS) | 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 | 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. | At baseline after 12 and 24 months | 
| Changes in patients experienced Quality of care | Patient survey using the instrument Quality of care from the the patient's perspective (QPP) | At baseline after 12 and 24 months | 
| Health care consumption | Medical Review of inpatient and outpatient care | through study completion, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of care, Health related quality of life, Nurse-led clinic, Health economics