Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders

May 10, 2022 updated by: Nabiha Faisal, University of Manitoba

Integrating Care for Patients With Alcohol Liver Disease and Mental Health and Alcohol Use Disorders: A Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. To examine the feasibility of implementing several key strategies to initiate an integrated care pathway.
  2. To explore the providers' and patients' perspectives regarding the acceptability of the integrated care pathway and seek their recommendations for improvement.
  3. To explore the preliminary effects of the intervention based on changes over 6 months in health outcomes and use of health services.
  4. 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated care program
ICP intervention consists of several core intervention components.
Other: Integrated care program
Core Component 1: Fostering Collaboration and Capacity Core Component 2: Streamlined communication process for referrals and care planning Core Component 3: Coordinated Care Conferences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the ICP
Time Frame: One year
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.
One year
Retention to the ICP
Time Frame: One year
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.).
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score at 6 months after enrollment.
Time Frame: 6 months
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
6 months
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.
Time Frame: 6 months
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.
6 months
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.
Time Frame: 6 months
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.
6 months
Change in number of hospital admissions at 6 months after enrollment compared to previous six months.
Time Frame: One year
Use of Health services
One year
Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.
Time Frame: One year
Use of Health services
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS24921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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