Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders
Primary Purpose
Alcohol; Liver
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated care program
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol; Liver focused on measuring Collaborative care, Integrated care, alcohol use disorder, Addiction medicine, cirrhosis, Alcohol liver disease, Alcoholic hepatitis
Eligibility Criteria
Inclusion Criteria:
- Clinical or biopsy-proven alcohol-associated cirrhosis or acute alcoholic hepatitis,
- Active drinking of any amount within the last 6 months,
- Willingness to speak with Addiction Medicine physicians
Exclusion Criteria:
- Not meeting all inclusion criteria
- Co-morbid severe mental illness
- Medically unstable
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrated care program
Arm Description
ICP intervention consists of several core intervention components.
Outcomes
Primary Outcome Measures
Acceptability of the ICP
Acceptability is a key element based on patients' and providers' perceptions/ experiences with the ICP and an overall evaluation of whether the intervention is agreeable and satisfactory. From patient participant interviews, conducted at the end of the study, investigators will explore perceptions and experiences in accessing and obtaining addiction service, perceived impact, benefit, and convenience. Investigators will conduct focus group discussions to seek health care providers' perspectives and experiences with AUD management challenges, the acceptability and use of the ICP, as well as where further support or improvements are needed.
Retention to the ICP
Retention will be determined with the (interventionist's) logs use to record visits with patients' and intervention uptake rates (use of pharmacotherapy, CBT/behavioral therapy, peer support group etc.).
Secondary Outcome Measures
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score at 6 months after enrollment.
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
Change from baseline in quality of life according to EQ-5D-5L questionnaire descriptive system (5-digit number that describes the patient's health state) at 6 months after enrollment.
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) (43) is a generic test to assess quality of life related to health. It includes 5 dimensions of quality of life (mobility, self-care, daily activities, pain, anxiety/depression) as a description of the patient's health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change from baseline in quality of life according to EQ-5D-5L questionnaire visual analogue scale (EQ VAS): patient's self-rated health from 0 to 100 at 6 months after enrollment.
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) is a generic test to assess quality of life related to health. It includes the EQ VAS, which records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from score 100 ('The best health you can imagine') to 0 ('The worst health you can imagine'). The VAS can be used as a quantitative measure of health outcome.
Change in number of hospital admissions at 6 months after enrollment compared to previous six months.
Use of Health services
Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.
Use of Health services
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05375682
Brief Title
Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders
Official Title
Integrating Care for Patients With Alcohol Liver Disease and Mental Health and Alcohol Use Disorders: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
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
Alcohol related liver disease (ALD) contributes to 50% cases of cirrhosis worldwide and is the leading indication for liver transplant in North America. The treatment for ALD is achieving total alcohol abstinence and preventing relapse as medical and surgical options are limited when drinking continues. Patient care has been hindered by the isolation of Addiction Medical Services from Internal Medicine, Family Medicine, and Hepatology. Patients with ALD would benefit from multidisciplinary approach as it combines medical care of liver disease and management of addiction and mental health. The investigators aim to develop a patient-centered integrated care pathway supported by expertise from Hepatology, Addiction Medicine and Psychiatry to improve access to addiction services for patients with ALD. By participating in the services, patients will experience decreased substance use, psychological symptoms, and improved health-related quality of life, with greater patient and provider satisfaction.
Detailed Description
Introduction: Alcohol Use Disorder (AUD) elevates the risk of a number of health conditions, with social, economic and clinical consequences. The effects of AUD are particular evident among individuals with ALD. The persistence of alcohol consumption is the main risk factor for progression of liver damage and complications. Despite this disease burden the resources devoted to either research or treatment of ALD have lagged compared with liver diseases from other etiologies. Progress has been hindered by the isolation of key specialites, which leads to late recognition of ALD. Patients with ALD would benefit from a multidisciplinary approach as it combines several domains including medical and psychiatric care; however, there is little research describing an integrated care alcohol use disorder (AUD) model for patients with ALD within Canada. Our multidisciplinary team, encompassing Hepatologists, Addiction Medicine and Psychiatry has been co-developing a patient-centered integrated care pathway to enhance collaborative practice among these specialities and meet the needs of our patients with ALD and AUD. The goal of this study is to carry out collaborative participatory research with health care providers and patients to co-develop and refine a responsive integrated care pathway (ICP) that addresses alcohol use disorders for patients with ALD at a large urban based hospital setting. Specifically, this study aims to:
To examine the feasibility of implementing several key strategies to initiate an integrated care pathway.
To explore the providers' and patients' perspectives regarding the acceptability of the integrated care pathway and seek their recommendations for improvement.
To explore the preliminary effects of the intervention based on changes over 6 months in health outcomes and use of health services.
To make recommendations that will inform spread and scale to other sites and for other conditions related to AUD.
Study design: This demonstration project will use a multi-method design to co-develop an integrated care pathway (ICP) for AUD and ALD, and to acquire the most comprehensive understanding of processes and outcomes. This will be a single site pragmatic pilot study evaluating feasibility, acceptability and preliminary effects of the ICP.
Participants: Investigators will use a convenience sample of consecutive ALD patients who are referred to the outpatient advanced liver clinic.
The intervention protocol: The 6-month ICP intervention consists of several core intervention components, building upon the available resources and usual care practices at Health Sciences Centre and based on an AUD/ALD model of care implemented elsewhere.
Data: Over the intervention period of the study, data on ICP implementation will be collected through monthly research team meetings with the interventionists, and through semi-structured interviews with patients and focus groups with health care providers. Multiple questionnaires and clinical data will be used to examine feasibility measures and preliminary clinical outcomes. Impact: The impact of this research is two-fold: 1) the combination of psychosocial interventions, pharmacological therapy and medical management offers the most effective strategy for addressing AUD among patients with ALD; 2) the collaboration and cooperation fostered through a participatory approach will tailor high quality care and enable our team to expand our model and develop community partnerships for spread and scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Liver
Keywords
Collaborative care, Integrated care, alcohol use disorder, Addiction medicine, cirrhosis, Alcohol liver disease, Alcoholic hepatitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrated care program
Arm Type
Experimental
Arm Description
ICP intervention consists of several core intervention components.
Intervention Type
Other
Intervention Name(s)
Integrated care program
Intervention Description
Core Component 1: Fostering Collaboration and Capacity Core Component 2: Streamlined communication process for referrals and care planning Core Component 3: Coordinated Care Conferences
Primary Outcome Measure Information:
Title
Acceptability of the ICP
Description
Acceptability is a key element based on patients' and providers' perceptions/ experiences with the ICP and an overall evaluation of whether the intervention is agreeable and satisfactory. From patient participant interviews, conducted at the end of the study, investigators will explore perceptions and experiences in accessing and obtaining addiction service, perceived impact, benefit, and convenience. Investigators will conduct focus group discussions to seek health care providers' perspectives and experiences with AUD management challenges, the acceptability and use of the ICP, as well as where further support or improvements are needed.
Time Frame
One year
Title
Retention to the ICP
Description
Retention will be determined with the (interventionist's) logs use to record visits with patients' and intervention uptake rates (use of pharmacotherapy, CBT/behavioral therapy, peer support group etc.).
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score at 6 months after enrollment.
Description
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
Time Frame
6 months
Title
Change from baseline in quality of life according to EQ-5D-5L questionnaire descriptive system (5-digit number that describes the patient's health state) at 6 months after enrollment.
Description
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) (43) is a generic test to assess quality of life related to health. It includes 5 dimensions of quality of life (mobility, self-care, daily activities, pain, anxiety/depression) as a description of the patient's health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
6 months
Title
Change from baseline in quality of life according to EQ-5D-5L questionnaire visual analogue scale (EQ VAS): patient's self-rated health from 0 to 100 at 6 months after enrollment.
Description
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) is a generic test to assess quality of life related to health. It includes the EQ VAS, which records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from score 100 ('The best health you can imagine') to 0 ('The worst health you can imagine'). The VAS can be used as a quantitative measure of health outcome.
Time Frame
6 months
Title
Change in number of hospital admissions at 6 months after enrollment compared to previous six months.
Description
Use of Health services
Time Frame
One year
Title
Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.
Description
Use of Health services
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical or biopsy-proven alcohol-associated cirrhosis or acute alcoholic hepatitis,
Active drinking of any amount within the last 6 months,
Willingness to speak with Addiction Medicine physicians
Exclusion Criteria:
Not meeting all inclusion criteria
Co-morbid severe mental illness
Medically unstable
12. IPD Sharing Statement
Plan to Share IPD
No
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Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders
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