Standardized Care for Liver Cirrhosis

(CCAB Trial)

Overseen By Michelle Carbonneau, MN, NP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: No cirrhosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

3975 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve liver cirrhosis management by testing a new, structured care plan. It examines different care methods, including a standardized treatment plan called the Evidence-based Standardized Cirrhosis Order Set, integrated with electronic medical records. The goal is to enhance care quality, reduce hospital visits, and increase satisfaction for both patients and healthcare providers. Suitable participants have been diagnosed with cirrhosis and are admitted to a participating hospital. As an unphased trial, this study offers patients the chance to contribute to innovative care strategies that could enhance future cirrhosis treatment.

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 prior data suggests that this protocol is safe for liver cirrhosis patients?

Research has shown that using a set of standard steps to manage liver cirrhosis can improve patient care. By following the same procedures, doctors and nurses can achieve better outcomes. Safety information from other studies indicates that this method is generally safe, with no reports of major issues or side effects.

The plan involves integrating these guidelines into an electronic medical record system, enabling healthcare providers to easily follow best practices. While no specific safety concerns have been identified, discussing any worries with a healthcare team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to standardize and possibly improve care for liver cirrhosis using a structured order set. Unlike traditional care, which varies and depends heavily on individual clinician practices, this standardized approach aims to ensure consistency and adherence to evidence-based guidelines. Additionally, embedding this order set within an electronic medical record could enhance efficiency and reduce human error, potentially leading to better patient outcomes. By comparing this method to current routine care, researchers hope to find out if standardization can make a significant difference in managing cirrhosis.

What evidence suggests that the Evidence-based standardized Cirrhosis order set is effective for improving care in liver cirrhosis?

This trial will compare different approaches to standardized care for liver cirrhosis. Research has shown that a standardized treatment plan can improve patient care. Studies have found that this approach helps reduce the high rate of hospital readmissions, currently 44% within 90 days. The plan provides clear steps for managing cirrhosis, leading to better health outcomes. In this trial, one group will use the standardized cirrhosis order set alone, while another group will use it embedded within electronic medical records (EMR). Early evidence suggests that both methods can effectively enhance the quality of care for people with liver cirrhosis. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Evidence-based standardized Cirrhosis order set

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.

How Is the Trial Designed?

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+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

A study of 242 patients with cirrhosis across three different hepatology clinics revealed significant variations in adherence to quality care indicators, with the safety-net hospital showing the highest rates for hepatitis vaccinations and cancer surveillance.

The Faculty Practice excelled in documenting liver transplant discussions, indicating that different specialty settings have distinct strengths and weaknesses in cirrhosis care, highlighting the need for strategies to improve overall quality across all sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Care Provided by Hepatologists to Patients with Cirrhosis at Three Parallel Health Systems. Sclair, SN., Carrasquillo, O., Czul, F., et al.[2021]

Implementing a standardized electronic order set for treating patients with cirrhosis and upper gastrointestinal hemorrhage significantly improved adherence to administering antibiotics (100% vs 89%) and reduced the time to administration (3 hours 28 minutes vs 10 hours 4 minutes).

The order set also reduced the time to administration of octreotide (2 hours 16 minutes vs 6 hours 21 minutes), demonstrating that structured protocols can enhance the efficiency of critical treatments in emergency settings.

NCBI (Pubmed)

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. Mayorga, CA., Rockey, DC.[2019]

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]

Patients with cirrhosis receiving care from the multidisciplinary Cirrhosis Care Clinic (CCC) had significantly lower acute care utilization, with a 3-day shorter hospital stay and 9% fewer days spent in the hospital compared to those receiving standard care.

Despite having more advanced liver disease, CCC patients showed a 53% reduction in the risk of death or liver transplant within one year, along with a cost savings of $2,280 per patient-month of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of specialized multidisciplinary care on cirrhosis outcomes and acute care utilization. Carbonneau, M., Davyduke, T., Congly, SE., 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]

The Cirrhosis Care Alberta (CCAB) trial aims to reduce hospital readmission rates and length of stay for patients with liver cirrhosis by implementing a structured clinical information system that delivers evidence-based best practices during hospitalization.

This 4-year trial will evaluate the effectiveness and feasibility of the intervention across eight hospitals in Alberta, focusing on various outcomes including readmission rates, quality of care, and cost-effectiveness, guided by established implementation frameworks.

NCBI (Pubmed)

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. Carbonneau, M., Eboreime, EA., Hyde, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7301349/

The cirrhosis care Alberta (CCAB) protocol - PubMed Central In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04149223

Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32552833/

The cirrhosis care Alberta (CCAB) protocol: implementing ... The overarching objective of the CCAB trial is to demonstrate effectiveness and implementation feasibility for use of the order set in routine patient care.

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09632-z

Implementing a cirrhosis order set in a tertiary healthcare system Key findings revealed that participants recognized the value of the cirrhosis order set and its potential to improve the quality of care.

5. researchgate.net researchgate.net/figure/Overview-of-Cirrhosis-Care-Alberta-CCAB-Order-Set-Domains_fig3_342280666

Overview of Cirrhosis Care Alberta (CCAB) Order Set ... In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, multiple care ...

6. researchgate.net researchgate.net/publication/342280666_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

The cirrhosis care Alberta (CCAB) protocol: implementing ... In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days.