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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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 |
| 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. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malene Barfod O'Connell, RN, MScPH | Amager Hvidovre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Amager Hvidovre | Copenhagen | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38668732 | Derived | 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. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Allocation is blinded.
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|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |