Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

NCT ID: NCT04158986

Last Updated: 2022-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-10-01

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nurse-driven post-discharge intervention

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

Group Type: EXPERIMENTAL

Nurse-driven post-discharge intervention

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Malene Barfod O'Connell

RN, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malene Barfod O'Connell, RN, MScPH

Role: PRINCIPAL_INVESTIGATOR

Amager Hvidovre Hospital

Locations

Copenhagen University Hospital, Amager Hvidovre

Copenhagen, Hvidovre, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 38668732 (View on PubMed)

Other Identifiers

Splcirr2019

Identifier Type: -

Identifier Source: org_study_id