search
Back to results

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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 3, 2022
    Last Updated
    May 10, 2022
    Sponsor
    University of Manitoba
    search

    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
    Citations:
    PubMed Identifier
    33234583
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28988570
    Citation
    Osna NA, Donohue TM Jr, Kharbanda KK. Alcoholic Liver Disease: Pathogenesis and Current Management. Alcohol Res. 2017;38(2):147-161.
    Results Reference
    background
    PubMed Identifier
    31314133
    Citation
    Crabb 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.
    Results Reference
    background
    PubMed Identifier
    28793133
    Citation
    Grant 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.
    Results Reference
    background
    PubMed Identifier
    20385251
    Citation
    Kanwal 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.
    Results Reference
    background
    PubMed Identifier
    29628280
    Citation
    European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European 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.
    Results Reference
    background
    PubMed Identifier
    26124208
    Citation
    Erim 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.
    Results Reference
    background
    PubMed Identifier
    34118717
    Citation
    Mellinger 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.
    Results Reference
    background
    PubMed Identifier
    32033835
    Citation
    Winder 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.
    Results Reference
    background
    PubMed Identifier
    19560604
    Citation
    Rehm 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.
    Results Reference
    background
    PubMed Identifier
    33229348
    Citation
    Hulme 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.
    Results Reference
    background
    PubMed Identifier
    32557350
    Citation
    Hobin 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.
    Results Reference
    background
    PubMed Identifier
    32990735
    Citation
    Pollard 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.
    Results Reference
    background
    PubMed Identifier
    25732712
    Citation
    Beste 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.
    Results Reference
    background
    PubMed Identifier
    26039070
    Citation
    Grant 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.
    Results Reference
    background
    PubMed Identifier
    30667521
    Citation
    Mellinger JL, Fernandez A, Shedden K, Winder GS, Fontana RJ, Volk ML, Blow FC, Lok ASF. Gender Disparities in Alcohol Use Disorder Treatment Among Privately Insured Patients with Alcohol-Associated Cirrhosis. Alcohol Clin Exp Res. 2019 Feb;43(2):334-341. doi: 10.1111/acer.13944. Epub 2019 Jan 22.
    Results Reference
    background
    PubMed Identifier
    29910011
    Citation
    Mellinger JL, Scott Winder G, DeJonckheere M, Fontana RJ, Volk ML, Lok ASF, Blow FC. Misconceptions, preferences and barriers to alcohol use disorder treatment in alcohol-related cirrhosis. J Subst Abuse Treat. 2018 Aug;91:20-27. doi: 10.1016/j.jsat.2018.05.003. Epub 2018 May 18.
    Results Reference
    background
    PubMed Identifier
    24825640
    Citation
    Bradley KA, Kivlahan DR. Bringing patient-centered care to patients with alcohol use disorders. JAMA. 2014 May 14;311(18):1861-2. doi: 10.1001/jama.2014.3629. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28316546
    Citation
    Goodwin N. Understanding Integrated Care. Int J Integr Care. 2016 Oct 28;16(4):6. doi: 10.5334/ijic.2530. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26462820
    Citation
    Moffat K, Mercer SW. Challenges of managing people with multimorbidity in today's healthcare systems. BMC Fam Pract. 2015 Oct 14;16:129. doi: 10.1186/s12875-015-0344-4.
    Results Reference
    background
    PubMed Identifier
    15626531
    Citation
    Donald M, Dower J, Kavanagh D. Integrated versus non-integrated management and care for clients with co-occurring mental health and substance use disorders: a qualitative systematic review of randomised controlled trials. Soc Sci Med. 2005 Mar;60(6):1371-83. doi: 10.1016/j.socscimed.2004.06.052.
    Results Reference
    background
    PubMed Identifier
    12047729
    Citation
    O'Toole TP, Strain EC, Wand G, McCaul ME, Barnhart M. Outpatient treatment entry and health care utilization after a combined medical/substance abuse intervention for hospitalized medical patients. J Gen Intern Med. 2002 May;17(5):334-40. doi: 10.1046/j.1525-1497.2002.10638.x.
    Results Reference
    background
    PubMed Identifier
    11594896
    Citation
    Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating primary medical care with addiction treatment: a randomized controlled trial. JAMA. 2001 Oct 10;286(14):1715-23. doi: 10.1001/jama.286.14.1715.
    Results Reference
    background
    PubMed Identifier
    16565634
    Citation
    Saxon AJ, Malte CA, Sloan KL, Baer JS, Calsyn DA, Nichol P, Chapko MK, Kivlahan DR. Randomized trial of onsite versus referral primary medical care for veterans in addictions treatment. Med Care. 2006 Apr;44(4):334-42. doi: 10.1097/01.mlr.0000204052.95507.5c.
    Results Reference
    background
    PubMed Identifier
    32021585
    Citation
    Reus VI, Fochtmann LJ, Bukstein O, Eyler AE, Hilty DM, Horvitz-Lennon M, Mahoney J, Pasic J, Weaver M, Wills CD, McIntyre J, Kidd J, Yager J, Hong SH. The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. Focus (Am Psychiatr Publ). 2019 Apr;17(2):158-162. doi: 10.1176/appi.focus.17205. Epub 2019 Apr 10.
    Results Reference
    background
    PubMed Identifier
    19664226
    Citation
    Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
    Results Reference
    background
    PubMed Identifier
    21506242
    Citation
    Weinrieb RM, Van Horn DH, Lynch KG, Lucey MR. A randomized, controlled study of treatment for alcohol dependence in patients awaiting liver transplantation. Liver Transpl. 2011 May;17(5):539-47. doi: 10.1002/lt.22259.
    Results Reference
    background
    PubMed Identifier
    9523497
    Citation
    Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs