Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

NCT04158986 | Completed DMC

• 1 other identifier: Splcirr2019
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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).

• Self-perceived health before and after intervention

  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

  The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)

• Mortality

  The mortality rate after 6 months, 12 months and 2 years

Study Arms (2)

Standard treatment

NO INTERVENTION

Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory.

Nurse-driven post-discharge intervention

EXPERIMENTAL

Participates in a nurse-driven post-discharge intervention program.

Behavioral: Nurse-driven post-discharge intervention

Interventions

Nurse-driven post-discharge intervention BEHAVIORAL

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

Nurse-driven post-discharge intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital, Amager Hvidovre

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Barfod O'Connell M, Brodsgaard A, Matthe M, Hobolth L, Wullum L, Bendtsen F, Kimer N. A randomized controlled trial of a postdischarge nursing intervention for patients with decompensated cirrhosis. Hepatol Commun. 2024 Apr 26;8(5):e0418. doi: 10.1097/HC9.0000000000000418. eCollection 2024 May 1.

  PMID: 38668732 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malene Barfod O'Connell, RN, MScPH

  Amager Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Allocation is blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD student

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 12, 2019
• Study Start: December 1, 2019
• Primary Completion: October 13, 2021
• Study Completion: October 1, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

DK (1)