Alcohol; LiverNCT05375682
Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders
A study testing Integrated care program in people with Alcohol; Liver, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol; Liver
- What is being tested?
- Integrated care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting all inclusion criteria
- Co-morbid severe mental illness
- Medically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol; Liver
- Being tested
- Integrated care program
- Keywords
- Collaborative care, Integrated care, alcohol use disorder, Addiction medicine, cirrhosis, Alcohol liver disease, Alcoholic hepatitis
- Medical subject headings
- Liver Diseases, Alcoholic, Alcoholism, Fibrosis, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care programOther
Core Component 1: Fostering Collaboration and Capacity Core Component 2: Streamlined communication process for referrals and care planning Core Component 3: Coordinated Care Conferences
| Study group | Role | What they receive |
|---|---|---|
| Integrated care program | Experimental | ICP intervention consists of several core intervention components. Receives: Other: Integrated care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
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.).
Measured: One year
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 6 months
Change in number of hospital admissions at 6 months after enrollment compared to previous six months.
Use of Health services
Measured: One year
Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.
Use of Health services
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Apr 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Alcohol; LiverStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabiha Faisal, University of Manitoba
- Investigators
- Nabiha Faisal, MD, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375682
- Sponsor's protocol ID
- HS24921
- Status last verified
- Jul 2026
- First submitted
- 3 May 2022
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolton JM, Leong C, Ekuma O, Prior HJ, Konrad G, Enns J, Singal D, Nepon J, Paille MT, Finlayson G, Nickel NC. Health service use among Manitobans with alcohol use disorder: a population-based matched cohort study. CMAJ Open. 2020 Nov 24;8(4):E762-E771. doi: 10.9778/cmajo.20200124. Print 2020 Oct-Dec.
PubMed 33234583Osna NA, Donohue TM Jr, Kharbanda KK. Alcoholic Liver Disease: Pathogenesis and Current Management. Alcohol Res. 2017;38(2):147-161. doi: 10.35946/arcr.v38.2.01.
PubMed 28988570Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
PubMed 31314133Grant BF, Chou SP, Saha TD, Pickering RP, Kerridge BT, Ruan WJ, Huang B, Jung J, Zhang H, Fan A, Hasin DS. Prevalence of 12-Month Alcohol Use, High-Risk Drinking, and DSM-IV Alcohol Use Disorder in the United States, 2001-2002 to 2012-2013: Results From the National Epidemiologic Survey on Alcohol and Related Conditions. JAMA Psychiatry. 2017 Sep 1;74(9):911-923. doi: 10.1001/jamapsychiatry.2017.2161.
PubMed 28793133Kanwal F, Kramer J, Asch SM, El-Serag H, Spiegel BM, Edmundowicz S, Sanyal AJ, Dominitz JA, McQuaid KR, Martin P, Keeffe EB, Friedman LS, Ho SB, Durazo F, Bacon BR. An explicit quality indicator set for measurement of quality of care in patients with cirrhosis. Clin Gastroenterol Hepatol. 2010 Aug;8(8):709-17. doi: 10.1016/j.cgh.2010.03.028. Epub 2010 Apr 10.
PubMed 20385251European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.
PubMed 29628280Erim Y, Bottcher M, Schieber K, Lindner M, Klein C, Paul A, Beckebaum S, Mayr A, Helander A. Feasibility and Acceptability of an Alcohol Addiction Therapy Integrated in a Transplant Center for Patients Awaiting Liver Transplantation. Alcohol Alcohol. 2016 Jan;51(1):40-6. doi: 10.1093/alcalc/agv075. Epub 2015 Jun 28.
PubMed 26124208Mellinger JL, Winder GS, Fernandez AC, Klevering K, Johnson A, Asefah H, Figueroa M, Buchanan J, Blow F, Lok ASF. Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. J Subst Abuse Treat. 2021 Nov;130:108396. doi: 10.1016/j.jsat.2021.108396. Epub 2021 Apr 9.
PubMed 34118717Winder GS, Fernandez AC, Klevering K, Mellinger JL. Confronting the Crisis of Comorbid Alcohol Use Disorder and Alcohol-Related Liver Disease With a Novel Multidisciplinary Clinic. Psychosomatics. 2020 May-Jun;61(3):238-253. doi: 10.1016/j.psym.2019.12.004. Epub 2019 Dec 19.
PubMed 32033835Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009 Jun 27;373(9682):2223-33. doi: 10.1016/S0140-6736(09)60746-7.
PubMed 19560604Hulme J, Sheikh H, Xie E, Gatov E, Nagamuthu C, Kurdyak P. Mortality among patients with frequent emergency department use for alcohol-related reasons in Ontario: a population-based cohort study. CMAJ. 2020 Nov 23;192(47):E1522-E1531. doi: 10.1503/cmaj.191730.
PubMed 33229348Hobin E, Smith B. Is another public health crisis brewing beneath the COVID-19 pandemic? Can J Public Health. 2020 Jun;111(3):392-396. doi: 10.17269/s41997-020-00360-z. Epub 2020 Jun 18.
PubMed 32557350Pollard MS, Tucker JS, Green HD Jr. Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US. JAMA Netw Open. 2020 Sep 1;3(9):e2022942. doi: 10.1001/jamanetworkopen.2020.22942.
PubMed 32990735Beste LA, Harp BK, Blais RK, Evans GA, Zickmund SL. Primary Care Providers Report Challenges to Cirrhosis Management and Specialty Care Coordination. Dig Dis Sci. 2015 Sep;60(9):2628-35. doi: 10.1007/s10620-015-3592-1. Epub 2015 Mar 3.
PubMed 25732712Grant BF, Goldstein RB, Saha TD, Chou SP, Jung J, Zhang H, Pickering RP, Ruan WJ, Smith SM, Huang B, Hasin DS. Epidemiology of DSM-5 Alcohol Use Disorder: Results From the National Epidemiologic Survey on Alcohol and Related Conditions III. JAMA Psychiatry. 2015 Aug;72(8):757-66. doi: 10.1001/jamapsychiatry.2015.0584.
PubMed 26039070
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Care for Patients With Alcohol Liver Disease and Mental Health and Alcohol Use Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT05375682
- Acronym / sponsor ID
- HS24921
- Conditions
- Alcohol; Liver
- Keywords
- Collaborative care, Integrated care, alcohol use disorder, Addiction medicine, cirrhosis, Alcohol liver disease, Alcoholic hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 17 May 2022 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated care program | Experimental | Other: Integrated care programICP intervention consists of several core intervention components. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Not meeting all inclusion criteria
- Co-morbid severe mental illness
- Medically unstable
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 |
|---|---|---|
| Integrated care programCore Component 1: Fostering Collaboration and Capacity Core Component 2: Streamlined communication process for referrals and care planning Core Component 3: Coordinated Care Conferences | Other | Integrated care program |
Primary outcome
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.
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.).
5 secondary outcomes
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
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
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
Change in number of hospital admissions at 6 months after enrollment compared to previous six months.
Time frame: One year
Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 33234583Bolton JM, Leong C, Ekuma O, Prior HJ, Konrad G, Enns J, Singal D, Nepon J, Paille MT, Finlayson G, Nickel NC. Health service use among Manitobans with alcohol use disorder: a population-based matched cohort study. CMAJ Open. 2020 Nov 24;8(4):E762-E771. doi: 10.9778/cmajo.20200124. Print 2020 Oct-Dec.
- Background: PubMed 28988570Osna NA, Donohue TM Jr, Kharbanda KK. Alcoholic Liver Disease: Pathogenesis and Current Management. Alcohol Res. 2017;38(2):147-161. doi: 10.35946/arcr.v38.2.01.
- Background: PubMed 31314133Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
- Background: PubMed 28793133Grant BF, Chou SP, Saha TD, Pickering RP, Kerridge BT, Ruan WJ, Huang B, Jung J, Zhang H, Fan A, Hasin DS. Prevalence of 12-Month Alcohol Use, High-Risk Drinking, and DSM-IV Alcohol Use Disorder in the United States, 2001-2002 to 2012-2013: Results From the National Epidemiologic Survey on Alcohol and Related Conditions. JAMA Psychiatry. 2017 Sep 1;74(9):911-923. doi: 10.1001/jamapsychiatry.2017.2161.
- Background: PubMed 20385251Kanwal F, Kramer J, Asch SM, El-Serag H, Spiegel BM, Edmundowicz S, Sanyal AJ, Dominitz JA, McQuaid KR, Martin P, Keeffe EB, Friedman LS, Ho SB, Durazo F, Bacon BR. An explicit quality indicator set for measurement of quality of care in patients with cirrhosis. Clin Gastroenterol Hepatol. 2010 Aug;8(8):709-17. doi: 10.1016/j.cgh.2010.03.028. Epub 2010 Apr 10.
- Background: PubMed 29628280European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.
- Background: PubMed 26124208Erim Y, Bottcher M, Schieber K, Lindner M, Klein C, Paul A, Beckebaum S, Mayr A, Helander A. Feasibility and Acceptability of an Alcohol Addiction Therapy Integrated in a Transplant Center for Patients Awaiting Liver Transplantation. Alcohol Alcohol. 2016 Jan;51(1):40-6. doi: 10.1093/alcalc/agv075. Epub 2015 Jun 28.
- Background: PubMed 34118717Mellinger JL, Winder GS, Fernandez AC, Klevering K, Johnson A, Asefah H, Figueroa M, Buchanan J, Blow F, Lok ASF. Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. J Subst Abuse Treat. 2021 Nov;130:108396. doi: 10.1016/j.jsat.2021.108396. Epub 2021 Apr 9.
- Background: PubMed 32033835Winder GS, Fernandez AC, Klevering K, Mellinger JL. Confronting the Crisis of Comorbid Alcohol Use Disorder and Alcohol-Related Liver Disease With a Novel Multidisciplinary Clinic. Psychosomatics. 2020 May-Jun;61(3):238-253. doi: 10.1016/j.psym.2019.12.004. Epub 2019 Dec 19.
- Background: PubMed 19560604Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009 Jun 27;373(9682):2223-33. doi: 10.1016/S0140-6736(09)60746-7.
- Background: PubMed 33229348Hulme J, Sheikh H, Xie E, Gatov E, Nagamuthu C, Kurdyak P. Mortality among patients with frequent emergency department use for alcohol-related reasons in Ontario: a population-based cohort study. CMAJ. 2020 Nov 23;192(47):E1522-E1531. doi: 10.1503/cmaj.191730.
- Background: PubMed 32557350Hobin E, Smith B. Is another public health crisis brewing beneath the COVID-19 pandemic? Can J Public Health. 2020 Jun;111(3):392-396. doi: 10.17269/s41997-020-00360-z. Epub 2020 Jun 18.
- 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. This study is not recruiting at the moment.
Nabiha Faisal, MD, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care program in people with Alcohol; Liver, run by University of Manitoba 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the ICP (time frame: One year). The study lists 2 primary outcomes in all. 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 NCT05375682, which also lists 28 linked publications.
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 4 Aug 2026.