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

NCT05375682 | Unknown

• 1 other identifier: HS24921
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol; Liver

Keywords

Collaborative care; Integrated care; alcohol use disorder; Addiction medicine; cirrhosis; Alcohol liver disease; Alcoholic hepatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.).

  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.

  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.

  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.

  6 months

• Change in number of hospital admissions at 6 months after enrollment compared to previous six months.

  One year

• Change in number of Emergency Department Visits at 6 months after enrollment compared to previous six months.

  One year

Study Arms (1)

Integrated care program

EXPERIMENTAL

ICP intervention consists of several core intervention components.

Other: Integrated care program

Interventions

Integrated care program OTHER

Core Component 1: Fostering Collaboration and Capacity Core Component 2: Streamlined communication process for referrals and care planning Core Component 3: Coordinated Care Conferences

Integrated care program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-morbid severe mental illness
• Medically unstable

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (28)

• 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.

  PMID: 33234583 BACKGROUND

• Osna 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.

  PMID: 28988570 BACKGROUND

• 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.

  PMID: 31314133 BACKGROUND

• 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.

  PMID: 28793133 BACKGROUND

• 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.

  PMID: 20385251 BACKGROUND

• 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.

  PMID: 29628280 BACKGROUND

• 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.

  PMID: 26124208 BACKGROUND

• 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.

  PMID: 34118717 BACKGROUND

• 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.

  PMID: 32033835 BACKGROUND

• 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.

  PMID: 19560604 BACKGROUND

• 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.

  PMID: 33229348 BACKGROUND

• 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.

  PMID: 32557350 BACKGROUND

• 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.

  PMID: 32990735 BACKGROUND

• 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.

  PMID: 25732712 BACKGROUND

• 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.

  PMID: 26039070 BACKGROUND

• 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.

  PMID: 30667521 BACKGROUND

• 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.

  PMID: 29910011 BACKGROUND

• 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.

  PMID: 24825640 BACKGROUND

• Goodwin N. Understanding Integrated Care. Int J Integr Care. 2016 Oct 28;16(4):6. doi: 10.5334/ijic.2530. No abstract available.

  PMID: 28316546 BACKGROUND

• 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.

  PMID: 26462820 BACKGROUND

• 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.

  PMID: 15626531 BACKGROUND

• 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.

  PMID: 12047729 BACKGROUND

• 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.

  PMID: 11594896 BACKGROUND

• 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.

  PMID: 16565634 BACKGROUND

• 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.

  PMID: 32021585 BACKGROUND

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 21506242 BACKGROUND

• 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.

  PMID: 9523497 BACKGROUND

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Alcoholism; Fibrosis; Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 17, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share