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

Primary Purpose

Cirrhosis, Liver

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Evidence-based standardized Cirrhosis order set
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Control

Intervention

Intervention + EMR

Arm Description

Current practice at baseline, routine cirrhosis care.

Use of a standardized cirrhosis order set.

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

Outcomes

Primary Outcome Measures

Cumulative hospital length of stay (LOS) per patient year
LOS

Secondary Outcome Measures

Hospital Readmission Rate
Readmission rate
Mean Length of Stay (LOS) (Ward, ICU, Total)
LOS
Readmission rate at 90 days
Readmission rate
Emergency Department (ED) Visit Rate
ED visit rate
Outpatient Visit rate
by provider type, location
Survival
Patient with cirrhosis survival
Disease severity
laboratory values, model for end-stage liver disease (MELD) score
Implementation fidelity
Adherence to cirrhosis order set

Full Information

First Posted
August 12, 2019
Last Updated
May 22, 2023
Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT04149223
Brief Title
Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial
Acronym
CCAB
Official Title
Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial Evaluating the Effectiveness of a Standardized Order Set
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
3975 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Current practice at baseline, routine cirrhosis care.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Use of a standardized cirrhosis order set.
Arm Title
Intervention + EMR
Arm Type
Active Comparator
Arm Description
Use of a standardized cirrhosis order set embedded within an electronic medical record.
Intervention Type
Other
Intervention Name(s)
Evidence-based standardized Cirrhosis order set
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cumulative hospital length of stay (LOS) per patient year
Description
LOS
Time Frame
Baseline, 1 year, 2 year
Secondary Outcome Measure Information:
Title
Hospital Readmission Rate
Description
Readmission rate
Time Frame
Baseline,through study completion, an average of 1 year
Title
Mean Length of Stay (LOS) (Ward, ICU, Total)
Description
LOS
Time Frame
Baseline,through study completion, an average of 1 year
Title
Readmission rate at 90 days
Description
Readmission rate
Time Frame
From commencement of the study (baseline), assessed quarterly until study completion.
Title
Emergency Department (ED) Visit Rate
Description
ED visit rate
Time Frame
Baseline,through study completion, an average of 1 year
Title
Outpatient Visit rate
Description
by provider type, location
Time Frame
Baseline,through study completion, an average of 1 year
Title
Survival
Description
Patient with cirrhosis survival
Time Frame
Baseline,through study completion, an average of 1 year
Title
Disease severity
Description
laboratory values, model for end-stage liver disease (MELD) score
Time Frame
Baseline,through study completion, an average of 1 year
Title
Implementation fidelity
Description
Adherence to cirrhosis order set
Time Frame
From commencement of the study (baseline), assessed quarterly until study completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Puneeta Tandon, MD
Phone
780-492-9844
Email
ptandon@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Carbonneau, MN, NP
Phone
780-492-9991
Email
michelle.carbonneau@albertahealthservices.ca
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puneeta Tandon, MD
Phone
780-492-9844
Email
ptandon@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Michelle C Carbonneau, MN NP
Phone
780-492-8856
Email
michelle.carbonneau@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32552833
Citation
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.
Results Reference
derived

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

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