Clinical trial NCT04158986: Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis
Official title: Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from discharge to first readmission.
timeFrame: Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.
measure: Number of readmissions
timeFrame: Number of readmissions within 2 years.
measure: Duration of readmissions
timeFrame: Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Secondary outcomes:
measure: Health related quality of life before and after intervention
timeFrame: The change in health related quality of life before and after intervention (6 months trial time).
measure: Self-perceived health before and after intervention
timeFrame: The change in self-perceived health before and after intervention (6 months trial time).
measure: Functional disability in work-, social-, and family life before and after intervention
timeFrame: The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
measure: Mortality
timeFrame: The mortality rate after 6 months, 12 months and 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Amager Hvidovre
state: Hvidovre
Study officials:
affiliation: Amager Hvidovre Hospital
name: Malene Barfod O'Connell, RN, MScPH
role: PRINCIPAL_INVESTIGATOR
References: