- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149223
Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial (CCAB)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Puneeta Tandon, MD
- Phone Number: 780-492-9844
- Email: ptandon@ualberta.ca
Study Contact Backup
- Name: Michelle Carbonneau, MN, NP
- Phone Number: 780-492-9991
- Email: michelle.carbonneau@albertahealthservices.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2S8
- Recruiting
- University of Alberta
-
Contact:
- Puneeta Tandon, MD
- Phone Number: 780-492-9844
- Email: ptandon@ualberta.ca
-
Contact:
- Michelle C Carbonneau, MN NP
- Phone Number: 780-492-8856
- Email: michelle.carbonneau@ahs.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Current practice at baseline, routine cirrhosis care.
|
|
Experimental: Intervention
Use of a 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).
|
Active Comparator: Intervention + EMR
Use of a standardized cirrhosis order set embedded within an electronic medical record.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative hospital length of stay (LOS) per patient year
Time Frame: Baseline, 1 year, 2 year
|
LOS
|
Baseline, 1 year, 2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Readmission Rate
Time Frame: Baseline,through study completion, an average of 1 year
|
Readmission rate
|
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
|
LOS
|
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.
|
Readmission rate
|
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
|
ED visit rate
|
Baseline,through study completion, an average of 1 year
|
Outpatient Visit rate
Time Frame: Baseline,through study completion, an average of 1 year
|
by provider type, location
|
Baseline,through study completion, an average of 1 year
|
Survival
Time Frame: Baseline,through study completion, an average of 1 year
|
Patient with cirrhosis survival
|
Baseline,through study completion, an average of 1 year
|
Disease severity
Time Frame: Baseline,through study completion, an average of 1 year
|
laboratory values, model for end-stage liver disease (MELD) score
|
Baseline,through study completion, an average of 1 year
|
Implementation fidelity
Time Frame: From commencement of the study (baseline), assessed quarterly until study completion.
|
Adherence to cirrhosis order set
|
From commencement of the study (baseline), assessed quarterly until study completion.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro000089501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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