Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis (NurseAID)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Behavioral: Nurse-driven post-discharge intervention

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre
    • Copenhagen, Hvidovre, Denmark, 2650
      • Copenhagen University Hospital, Amager Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard treatment; Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory.
Experimental: Nurse-driven post-discharge intervention; Participates in a nurse-driven post-discharge intervention program.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Number of readmissions	Number of readmissions within 2 years	Number of readmissions within 2 years.
Duration of readmissions	Duration of readmissions due to liver cirrhosis	Duration of readmissions due to liver cirrhosis in the 6 month trial time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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)
Mortality	Mortality after 6 months, 12 months and 2 years	The mortality rate after 6 months, 12 months and 2 years

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Investigators: Principal Investigator: Malene Barfod O'Connell, RN, MScPH, Amager Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: Splcirr2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No