Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial

NCT04149223 | Recruiting

• 1 other identifier: Pro000089501
• Study Type: interventional
• Target: 3,975
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cumulative hospital length of stay (LOS) per patient year

  LOS

  Baseline, 1 year, 2 year

Secondary Outcomes (8)

• Hospital Readmission Rate

  Baseline,through study completion, an average of 1 year

• Mean Length of Stay (LOS) (Ward, ICU, Total)

  Baseline,through study completion, an average of 1 year

• Readmission rate at 90 days

  From commencement of the study (baseline), assessed quarterly until study completion.

• Emergency Department (ED) Visit Rate

  Baseline,through study completion, an average of 1 year

• Outpatient Visit rate

  Baseline,through study completion, an average of 1 year

Study Arms (3)

Control

NO INTERVENTION

Current practice at baseline, routine cirrhosis care.

Intervention

EXPERIMENTAL

Use of a standardized cirrhosis order set.

Other: Evidence-based standardized Cirrhosis order set

Intervention + EMR

ACTIVE COMPARATOR

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

Other: Evidence-based standardized Cirrhosis order set

Interventions

Evidence-based standardized Cirrhosis order set OTHER

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).

Intervention; Intervention + EMR

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• o Adult patients who do not have cirrhosis

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2S8, Canada

RECRUITING

Related Publications (1)

• Carbonneau M, Eboreime EA, Hyde A, Campbell-Scherer D, Faris P, Gramlich L, Tsuyuki RT, Congly SE, Shaheen AA, Sadler M, Zeman M, Spiers J, Abraldes JG, Sugars B, Sia W, Green L, Abdellatif D, Schaefer JP, Selvarajah V, Marr K, Ryan D, Westra Y, Bakshi N, Varghese JC, Tandon P. The cirrhosis care Alberta (CCAB) protocol: implementing an evidence-based best practice order set for the management of liver cirrhosis - a hybrid type I effectiveness-implementation trial. BMC Health Serv Res. 2020 Jun 18;20(1):558. doi: 10.1186/s12913-020-05427-8.

  PMID: 32552833 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Puneeta Tandon, MD

CONTACT

780-492-9844; ptandon@ualberta.ca

Michelle Carbonneau, MN, NP

CONTACT

780-492-9991; michelle.carbonneau@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental design is a stepped roll-out hybrid II effectiveness-implementation trial (Curran et al. 2012), which tests clinical intervention impact and rigorously evaluates implementation strategy in real time. Over three years, the investigators will implement the CCAB intervention across 8 Alberta hospital sites within Alberta Health Services (AHS). The overarching objective of this study is to demonstrate both effectiveness and implementation feasibility for routine patient care within AHS. Given the pragmatic approach to this study, the commencement and scale-up of the study will coincide with the phases of the planned roll-out of Connect Care (the new Alberta Electronic Medical Record (EMR) platform) across the province. The project allows for an incredibly interesting and unique opportunity to implement and evaluate a comprehensive provincial chronic disease intervention in a real-world context, both in current state and with EMR facilitation

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: November 4, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)