Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

Liver Cirrhosis Clinical Trial

— NurseAID  

Official title:

Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158986
• Other study ID #: Splcirr2019
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

Description:

Since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. Grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. These patients have a higher 90-day mortality rate than those who avoid readmission. Re-admissions have great personal-, societal- and economic consequences.

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated.

The intervention, based on concepts from Family Nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. After 12 weeks the participants will be followed-up by telephone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 1, 2022
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding.

• Patients must read and understand Danish.

• Adults >18 years.

Exclusion Criteria:

• When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.

• Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc.

• Patients diagnosed with an active and invasive malignant disease.

• Residency outside the catchment area of Amager Hvidovre Hospital.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Nurse-driven post-discharge intervention
Home visits based on the concepts of Family Nursing: The participants will receive three home visits by a nurse who is trained in the Family Nursing principles during the first 12 weeks after discharge. The home visits will comprise of: Filling in the Chronic Liver Disease Questionnaire. Therapeutic conversations including drawing and review of genogram and eco-map. Information about- and help to initiate contact to relevant municipal offers. Evidence-based information based on the patient's current problems or symptoms, base-line knowledge and receptiveness. Follow-up telephone calls: • After the first 12 weeks participants will be followed-up by telephone monthly during the following 12 weeks. Pamphlet: • All participants will receive a pamphlet with brief information regarding preventive measures and early signs of decompensation as well as relevant contact details. The pamphlet will be handed out before discharge

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Amager Hvidovre	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from discharge to first readmission.	Time from discharge to first readmission.	Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.
Primary	Number of readmissions	Number of readmissions within 2 years	Number of readmissions within 2 years.
Primary	Duration of readmissions	Duration of readmissions due to liver cirrhosis	Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Secondary	Health related quality of life before and after intervention	Measured by the Chronic Liver Disease Questionnaire (CLDQ), which comprises 29 questions split into six domains. Domain scores and an overall score are presented on a 1-7 scale. Higher scores represents better HRQOL.	The change in health related quality of life before and after intervention (6 months trial time).
Secondary	Self-perceived health before and after intervention	Measured by SF-12v2® Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.	The change in self-perceived health before and after intervention (6 months trial time).
Secondary	Functional disability in work-, social-, and family life before and after intervention	Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.	The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
Secondary	Mortality	Mortality after 6 months, 12 months and 2 years	The mortality rate after 6 months, 12 months and 2 years