Standardized Care for Liver Cirrhosis

(CCAB Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: No cirrhosis

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Evidence-based standardized Cirrhosis order set, Cirrhosis Care Alberta (CCAB) Protocol?

The CCAB protocol aims to improve care for liver cirrhosis by using a structured approach to address care gaps, and similar standardized order sets have shown improved adherence to guidelines in other studies, such as increased use of recommended treatments for gastrointestinal bleeding in cirrhosis patients. ^{1 2 3 4 5}

Is the standardized care for liver cirrhosis safe for humans?

The available research does not specifically address the safety of the standardized care for liver cirrhosis, but it focuses on improving adherence to treatment guidelines and managing complications effectively. ^{1 2 3 5 6}

How is the Cirrhosis Care Alberta (CCAB) Protocol treatment different from other treatments for liver cirrhosis?

The Cirrhosis Care Alberta (CCAB) Protocol is unique because it uses a standardized electronic order set to ensure that patients receive evidence-based best practices for managing liver cirrhosis, addressing care gaps and improving transitions from hospital to community care. ^{1 3 5 6 7}

Research Team

Eligibility Criteria

This trial is for adults over 18 with a clinical diagnosis of cirrhosis, confirmed by radiology, histology or fibroscan, who are admitted to a study hospital site. It's not open to those without cirrhosis.

Inclusion Criteria

Admitted to a study hospital site

I am over 18 and have been diagnosed with cirrhosis.

Exclusion Criteria

I do not have cirrhosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a standardized integrated strategy for delivering evidence-based best practices to address hospital readmission and length of stay in patients with cirrhosis.

3 years

Follow-up

Participants are monitored for safety and effectiveness after implementation of the care strategies.

1 year

Treatment Details

Interventions

• Evidence-based standardized Cirrhosis order set (Other)

Trial Overview The CCAB program aims to improve care quality and reduce hospital visits for liver cirrhosis patients through evidence-based management practices including support for alcohol use, frailty assessment, advance care planning and structured transitions from home to hospital and back.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Use of a standardized cirrhosis order set.

Group II: Control Active Control 1 Intervention

Current practice at baseline, routine cirrhosis care.

Group III: Intervention + EMR Active Control 1 Intervention

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

Evidence-based standardized Cirrhosis order set is already approved in Canada for the following indications:

Approved in Canada as Cirrhosis Care Alberta (CCAB) Protocol for:

• Liver cirrhosis management
• Alcohol use support
• Frailty management
• Advance care planning
• Home-hospital-home transitions

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Dr. Verna Yiu

Alberta Health services

Chief Medical Officer

MD

Andre Tremblay

Alberta Health services

Chief Executive Officer

Bachelor's degree in a relevant field

Findings from Research

From 2002 to 2010, inpatient mortality rates for patients with cirrhosis significantly decreased from 9.1% to 5.4%, indicating improved outcomes for this patient group, which may be linked to better care practices.

Despite the increasing age and complexity of patients with cirrhosis, the independent mortality risk ratio improved to 0.50 by 2010, suggesting that advancements in cirrhosis management have positively impacted survival rates, although sepsis remains a critical area needing further attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Schmidt, ML., Barritt, AS., Orman, ES., et al.[2022]

After implementing standardized order sets for managing gastrointestinal bleeding in patients with suspected cirrhosis, the use of prophylactic antibiotics and octreotide increased to 76%, and upper endoscopy was performed in 94% of cases within 24 hours.

This improvement in adherence to AASLD guidelines suggests that standardized protocols can enhance treatment practices, but further research with larger sample sizes is necessary to assess the long-term clinical outcomes and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utilization of standardized order sets using AASLD guidelines for patients with suspected cirrhosis and acute gastrointestinal bleeding. Kijsirichareanchai, K., Ngamruengphong, S., Rakvit, A., et al.[2018]

Primary care providers (PCPs) often feel overwhelmed by the complexity of managing cirrhosis patients due to their multiple medical and psychosocial issues, leading them to prefer deferring major management decisions to specialists.

Barriers to effective cirrhosis care identified by PCPs include patient behaviors, access to care, and conflicts with specialists, highlighting the need for educational efforts to empower PCPs in managing these patients more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Providers Report Challenges to Cirrhosis Management and Specialty Care Coordination. Beste, LA., Harp, BK., Blais, RK., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quality of Care Provided by Hepatologists to Patients with Cirrhosis at Three Parallel Health Systems. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The utilization of standardized order sets using AASLD guidelines for patients with suspected cirrhosis and acute gastrointestinal bleeding. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

Impact of specialized multidisciplinary care on cirrhosis outcomes and acute care utilization. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical utility of a standardized electronic order set for the management of acute upper gastrointestinal hemorrhage in patients with cirrhosis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Primary Care Providers Report Challenges to Cirrhosis Management and Specialty Care Coordination. [2018]