Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT04149223

Conditions

Cirrhosis, Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evidence-based standardized Cirrhosis order set

Study Details

Brief summary:

Liver cirrhosis is the leading cause of morbidity and premature mortality in patients with digestive disease. There are many gaps in care which contribute to a high rate of hospital readmissions (44 percent at 90 days) and inadequate quality of care. Currently, there is a lack of structured processes to initiate best practice support for medical and broader health needs of high risk patients.

The cirrhosis care Alberta program (CCAB) is a 3 year multi-component quality improvement initiative which will aim to improve quality of care, reduce acute care utilization and be satisfactory to both patients and providers. Best practice support will be provided in the areas of: Evidence based management of cirrhosis, alcohol use support, frailty, advance care planning, home-hospital-home transitions including standardized outpatient monitoring and structured urgent access for rapid, on-demand outpatient assessment.

Conditions

Cirrhosis, Liver

Study ID

NCT04149223

Start date

Jun 1, 2019

Status verified date

Aug, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (great than 18 years of age) with a clinical diagnosis of cirrhosis (confirmed by compatible radiology, histology or fibroscan)
  • Admitted to a study hospital site

Exclusion Criteria

o Adult patients who do not have cirrhosis

Study Design

Enrollment

3975 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control

Current practice at baseline, routine cirrhosis care.

experimental: Intervention

Use of a standardized cirrhosis order set.

active comparator: Intervention + EMR

Use of a standardized cirrhosis order set embedded within an electronic medical record.

Interventions

Evidence-based standardized Cirrhosis order set

Standardized order sets for guidance in ascites, varices, hepatic encephalopathy, infections, and medication reconciliation (optimizing HE medication, medication prophylaxis, withdrawal of non-indicated proton pump inhibitors).

Primary outcome measure

  • Cumulative hospital length of stay (LOS) per patient year [ Time Frame: Baseline, 1 year, 2 year ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2S8

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-08-21.