Cirrhosis, LiverCCABNCT04149223
Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial
A study testing Evidence-based standardized Cirrhosis order set in people with Cirrhosis, Liver, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Evidence-based standardized Cirrhosis order set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,975 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- o Adult patients who do not have cirrhosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2S8
Puneeta Tandon, MD, 780-492-9844, ptandon@ualberta.ca
Michelle C Carbonneau, MN NP, 780-492-8856, michelle.carbonneau@ahs.ca
About this study
Official title: Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial Evaluating the Effectiveness of a Standardized Order Set
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.
Read the detailed 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:
- Comprehensive Care Bundle (development underway):
- 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
- 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.
- 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)).
- Community Care Pathways
- 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.
- 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.
- Conditions
- Cirrhosis, Liver
- Being tested
- Evidence-based standardized Cirrhosis order set
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based standardized Cirrhosis order setOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Current practice at baseline, routine cirrhosis care. |
| Intervention | Experimental | Use of a standardized cirrhosis order set. Receives: Other: Evidence-based standardized Cirrhosis order set |
| Intervention + EMR | Active comparator | Use of a standardized cirrhosis order set embedded within an electronic medical record. Receives: Other: Evidence-based standardized Cirrhosis order set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative hospital length of stay (LOS) per patient year
LOS
Measured: Baseline, 1 year, 2 year
Secondary outcomes (8)
Hospital Readmission Rate
Readmission rate
Measured: Baseline,through study completion, an average of 1 year
Mean Length of Stay (LOS) (Ward, ICU, Total)
LOS
Measured: Baseline,through study completion, an average of 1 year
Readmission rate at 90 days
Readmission rate
Measured: From commencement of the study (baseline), assessed quarterly until study completion.
Emergency Department (ED) Visit Rate
ED visit rate
Measured: Baseline,through study completion, an average of 1 year
Outpatient Visit rate
by provider type, location
Measured: Baseline,through study completion, an average of 1 year
Survival
Patient with cirrhosis survival
Measured: Baseline,through study completion, an average of 1 year
Disease severity
laboratory values, model for end-stage liver disease (MELD) score
Measured: Baseline,through study completion, an average of 1 year
Implementation fidelity
Adherence to cirrhosis order set
Measured: From commencement of the study (baseline), assessed quarterly until study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 3,975 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149223
- Sponsor's protocol ID
- Pro000089501
- Acronym
- CCAB
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2019
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32552833
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial Evaluating the Effectiveness of a Standardized Order Set
- ClinicalTrials.gov ID
- NCT04149223
- Acronym / sponsor ID
- CCAB / Pro000089501
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,975 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health services
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Comprehensive Care Bundle (development underway):
- 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
- 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.
- 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)).
- Community Care Pathways
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Current practice at baseline, routine cirrhosis care. |
| Intervention | Experimental | Other: Evidence-based standardized Cirrhosis order setUse of a standardized cirrhosis order set. |
| Intervention + EMR | Active comparator | Other: Evidence-based standardized Cirrhosis order setUse of a standardized cirrhosis order set embedded within an electronic medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- o Adult patients who do not have cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-based standardized Cirrhosis order setStandardized 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). | Other | Intervention, Intervention + EMR |
Primary outcome
Cumulative hospital length of stay (LOS) per patient year
Time frame: Baseline, 1 year, 2 year
LOS
8 secondary outcomes
Hospital Readmission Rate
Time frame: Baseline,through study completion, an average of 1 year
Mean Length of Stay (LOS) (Ward, ICU, Total)
Time frame: Baseline,through study completion, an average of 1 year
Readmission rate at 90 days
Time frame: From commencement of the study (baseline), assessed quarterly until study completion.
Emergency Department (ED) Visit Rate
Time frame: Baseline,through study completion, an average of 1 year
Outpatient Visit rate
Time frame: Baseline,through study completion, an average of 1 year
Survival
Time frame: Baseline,through study completion, an average of 1 year
Disease severity
Time frame: Baseline,through study completion, an average of 1 year
Implementation fidelity
Time frame: From commencement of the study (baseline), assessed quarterly until study completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 32552833Carbonneau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based standardized Cirrhosis order set in people with Cirrhosis, Liver, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Puneeta Tandon, MD (780-492-9844, ptandon@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative hospital length of stay (LOS) per patient year (time frame: Baseline, 1 year, 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.