Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Behavioral: Nurse-driven post-discharge intervention

• Registration Number: NCT04158986
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2019-12-01
• Primary Completion: 2021-10-13
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse-driven post-discharge intervention	Nurse-driven post-discharge intervention	Participates in a nurse-driven post-discharge intervention program.

Primary Outcome Measures

Name	Time	Method
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.	Time from discharge to first readmission.
Duration of readmissions	Duration of readmissions due to liver cirrhosis in the 6 month trial time.	Duration of readmissions due to liver cirrhosis
Number of readmissions	Number of readmissions within 2 years.	Number of readmissions within 2 years

Secondary Outcome Measures

Name	Time	Method
Self-perceived health before and after intervention	The change in self-perceived health before and after intervention (6 months trial time).	Measured by SF-12v2® Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.
Functional disability in work-, social-, and family life before and after intervention	The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)	Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.
Health related quality of life before and after intervention	The change in health related quality of life before and after intervention (6 months trial time).	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.
Mortality	The mortality rate after 6 months, 12 months and 2 years	Mortality after 6 months, 12 months and 2 years

Trial Locations

Locations (1)

Copenhagen University Hospital, Amager Hvidovre; 🇩🇰 Copenhagen, Hvidovre, Denmark