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

Cirrhosis, Liver Clinical Trial

— CCAB  

Official title:

Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial Evaluating the Effectiveness of a Standardized Order Set

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149223
• Other study ID #: Pro000089501
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: Puneeta Tandon, MD
• Phone: 780-492-9844
• Email: ptandon[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cirrhosis Care Alberta (CCAB) is a 3 year multi-component system-wide quality improvement trial which aims to improve quality of care, reduce acute care utilization and meet the needs of both patients and providers throughout Alberta. Instead of addressing just a single contributor to acute care utilization, this ambitious intervention will be the first in the world to bring together care providers across the province to tackle the complex multilevel problem with a multilevel solution. The intervention includes implementation of our standardized integrated strategy for delivering evidence-based best practices under real-world conditions to address the key determinants of hospital readmission and length of stay (LOS) in patients admitted with cirrhosis.

The CCAB project intervention includes:

1. Comprehensive Care Bundle (development underway):

1. Admission and Discharge/Transition order set focused on the screening and management of:

• Cirrhosis complications

• Frailty and malnutrition

• Alcohol use disorder and

• Transition to community

2. Patient and caregiver education

• A major theme that came up in focus group work with patients and in the literature is the lack of useful information that is available to them. This is a top priority for patients. Education will include guidelines and tools for patients to improve self-management as well as support for caregivers.

3. Provider education

• Nursing education focused on providing teaching to patients with cirrhosis and initiating alcohol screening and performing a brief intervention to promote abstinence is done in the minority of patients at discharge.

• Physician education focused on cirrhosis complications and broader health needs such as prescribing pharmacological therapies for alcohol use disorder (currently done in <5% of patients even though the number needed to treat is 12 (i.e. need to do it in 12 patients to result in a benefit)).

2. Community Care Pathways

1. Hepatic Encephalopathy (HE) Pathway: HE is the most common reason for admission to hospital and is a significant burden on patients and families. In collaboration with Health Link, this project aims to develop a call pathway so that patients and families can receive best practice support by nurses in the community and avoid needing to access emergency departments when HE can safely be managed in the community. The patient education surrounding HE is being developed as part of the Care Bundle, but developing a care pathway will ensure the education is translated and reinforced.

2. Ascites Pathway: Ascites (abdominal fluid build-up) is the most common cirrhosis related complication and is extremely uncomfortable for patients. When diuretics are not tolerated or ineffective, this population typically requires frequent draining of the ascites fluid (paracentesis) to treat symptoms such as shortness of breath, pain and inability to eat. Paracentesis is usually performed in hospital based day procedure areas, but when patients can not access a scheduled paracentesis in a timely manner, they are left with no option other than going to emergency rooms. Through process mapping and identifying current barriers and facilitators with each site, the project team aims to develop effective pathways for linking patients in with timely paracentesis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3975
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services, Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative hospital length of stay (LOS) per patient year	LOS	Baseline, 1 year, 2 year
Secondary	Hospital Readmission Rate	Readmission rate	Baseline,through study completion, an average of 1 year
Secondary	Mean Length of Stay (LOS) (Ward, ICU, Total)	LOS	Baseline,through study completion, an average of 1 year
Secondary	Readmission rate at 90 days	Readmission rate	From commencement of the study (baseline), assessed quarterly until study completion.
Secondary	Emergency Department (ED) Visit Rate	ED visit rate	Baseline,through study completion, an average of 1 year
Secondary	Outpatient Visit rate	by provider type, location	Baseline,through study completion, an average of 1 year
Secondary	Survival	Patient with cirrhosis survival	Baseline,through study completion, an average of 1 year
Secondary	Disease severity	laboratory values, model for end-stage liver disease (MELD) score	Baseline,through study completion, an average of 1 year
Secondary	Implementation fidelity	Adherence to cirrhosis order set	From commencement of the study (baseline), assessed quarterly until study completion.