- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219748
Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department
"Case Management" de Problemes Per Ús d'Alcohol en Pacients Que Hiperfreqüenten el Servei d'Urgències
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. Alcohol consumption is associated with a decrease in primary care services utilization, thus Emergency Departments (EDs) are a primary gateway to healthcare services in this group.
Depending on the investigative method and the mixture of the target population, an estimated 0.6-40% of all ED visits are due to alcohol-related problems. Given this, EDs offer a unique window of opportunity to address alcohol problems.
The threshold most commonly used to define frequent use of EDs is more than 4 visits per year. Frequent users comprise 0.3% to 10% of all ED patients and account for 3.5% to 28% of ED visits in developed countries. Addictive and other psychiatric disorders, and also social vulnerability are more common in frequent ED users than in non-frequent users. Although case management interventions seem promising to reduce ED attendance among frequent users, currently there is mixed evidence on the effects of such interventions on ED use.
Considering all this, a broader understanding of interventions to reduce frequent visits is needed, specially focusing on local frequent ED populations and identified highly vulnerable subgroups, such as hazardous drinkers.
The investigators aim to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods:
Randomized controlled trial to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital in Barcelona. All patients between 18 and 65 years old that frequently attended Hospital Clínic of Barcelona emergency department during the previous year that reattend the ED during the recruitment period will be eligible to follow-up. Those of them presenting risky alcohol use according to AUDIT-C score will be randomized to either case management intervention or treatment as usual. Main outcomes will be the number of visits to the ED and proportion of risky drinkers measured by AUDIT-C at 3, 6, 9 and 12 months follow-up.
Case management (CM) can be defined as a collaborative process of assessment, planning, facilitation, and advocacy for options and services to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. Case managers identify appropriate providers and services for individual patients while simultaneously ensuring that available resources are being used in a timely and cost-effective manner. It is a model of continuous, integrated medical and psychosocial care, which is markedly different from the episodic and often fragmented care that occurs in the ED setting. Close partnerships with healthcare providers and community services resources are key factors of CM interventions, that should target patients with the greatest needs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 5 or more attendances during the previous 12 months at the Emergency Department of Hospital Clínic de Barcelona
- an AUDIT-C score higher than 5 points for men and 4 for women
- Patients who accept to participate in the study and give informed consent
- Exists valid contact information to reach patient in the future.
Exclusion Criteria:
- There is psychopathology that prevents study comprehension and/or future participation (i.e. cognitive impairment, acutely psychotic, acutely confused, intoxicated...)
- Patients who present medical conditions that predict that will not be able to participate in follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team during 2 months. They will attend weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes and will be conducted based on Motivational Interviewing techniques in order to explore values and needs and to enhance motivation to reduce alcohol use and self-efficacy. Receiving the CM intervention doesn't exclude treatment as usual. |
Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team (Psychiatry, Social Work, Nursing) during 2 months. The intervention will encompass attending weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes. This CM intervention will include referral to Hospital Clínic de Barcelona Addiction Outpatient Clinic and a personalised assessment of the medical, psychiatric and social situation of each individual by the CM team. An individualised care plan will be established and periodically reviewed by the multidisciplinary team in response to a better understanding of patient needs or to a change in patient health condition. The intervention will offer motivational interviewing psychotherapy to enhance motivation to reduce or to quit alcohol use, in crisis intervention, coordination of care, patient education and self-management support, and assistance to navigate in the healthcare system. |
No Intervention: Control
Only treatment as usual in the Emergency Department (and in the Health and Social Services Network).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Emergency Department Visits
Time Frame: At 12 months after enrollment
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At 12 months after enrollment
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Change from baseline in the proportion of risky drinkers measured by AUDIT-C
Time Frame: At baseline and at 3, 6, 9 and 12 months after enrollment
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Participants will be assessed with AUDIT-C (a tool to assess alcohol consumption).
Main outcome 2 is the proportion of patients who score more than 5 in men and more than 4 in women in this scale.
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At baseline and at 3, 6, 9 and 12 months after enrollment
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Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)
Time Frame: At baseline and at 3, 6, 9 and 12 months after enrollment
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Minimum value: 0. Maximum value: 40.
Higher scores indicate more severity of alcohol use.
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At baseline and at 3, 6, 9 and 12 months after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in quality of life according to EQ-5D-5L questionnaire
Time Frame: At baseline and at 3, 6, 9 and 12 months after enrollment
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The EQ-5D-5L 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) and a general evaluation of health status by a Visual Analogue Scale (VAS).
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At baseline and at 3, 6, 9 and 12 months after enrollment
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Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)
Time Frame: At baseline and at 3, 6, 9 and 12 months after enrollment
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BPRS is a clinician rating scale that provides an assessment of common psychopathology symptoms.
Minimum value: 18. Maximum value: 126.
Higher scores indicate more severity of psychiatric symptoms.
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At baseline and at 3, 6, 9 and 12 months after enrollment
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Change from baseline in number of hospital admissions
Time Frame: At baseline and at 3, 6, 9 and 12 months after enrollment
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Need of inpatient care
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At baseline and at 3, 6, 9 and 12 months after enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antoni Gual, PhD, MD, Hospital Clinic of Barcelona
Publications and helpful links
General Publications
- Williams S, Brown A, Patton R, Crawford MJ, Touquet R. The half-life of the 'teachable moment' for alcohol misusing patients in the emergency department. Drug Alcohol Depend. 2005 Feb 14;77(2):205-8. doi: 10.1016/j.drugalcdep.2004.07.011.
- Vu F, Daeppen JB, Hugli O, Iglesias K, Stucki S, Paroz S, Canepa Allen M, Bodenmann P. Screening of mental health and substance users in frequent users of a general Swiss emergency department. BMC Emerg Med. 2015 Oct 9;15:27. doi: 10.1186/s12873-015-0053-2.
- Simioni N, Rolland B, Cottencin O. Interventions for Increasing Alcohol Treatment Utilization Among Patients with Alcohol Use Disorders from Emergency Departments: A Systematic Review. J Subst Abuse Treat. 2015 Nov;58:6-15. doi: 10.1016/j.jsat.2015.06.003. Epub 2015 Jun 23.
- Klein LR, Driver BE, Miner JR, Martel ML, Cole JB. Emergency department length of stay for ethanol intoxication encounters. Am J Emerg Med. 2018 Jul;36(7):1209-1214. doi: 10.1016/j.ajem.2017.12.017. Epub 2017 Dec 8.
- Klein LR, Martel ML, Driver BE, Reing M, Cole JB. Emergency Department Frequent Users for Acute Alcohol Intoxication. West J Emerg Med. 2018 Mar;19(2):398-402. doi: 10.5811/westjem.2017.10.35052. Epub 2018 Feb 26.
- Urbanoski K, Cheng J, Rehm J, Kurdyak P. Frequent use of emergency departments for mental and substance use disorders. Emerg Med J. 2018 Apr;35(4):220-225. doi: 10.1136/emermed-2015-205554. Epub 2018 Jan 8.
- Verelst S, Moonen PJ, Desruelles D, Gillet JB. Emergency department visits due to alcohol intoxication: characteristics of patients and impact on the emergency room. Alcohol Alcohol. 2012 Jul-Aug;47(4):433-8. doi: 10.1093/alcalc/ags035. Epub 2012 Apr 5.
- Anderson P, Berridge V, Conrod P, Dudley R, Hellman M, Lachenmeier D, Lingford-Hughes A, Miller D, Rehm J, Room R, Schmidt L, Sullivan R, Ysa T, Gual A. Reframing the science and policy of nicotine, illegal drugs and alcohol - conclusions of the ALICE RAP Project. F1000Res. 2017 Mar 17;6:289. doi: 10.12688/f1000research.10860.1. eCollection 2017.
- Bruguera P, Barrio P, Oliveras C, Braddick F, Gavotti C, Bruguera C, Lopez-Pelayo H, Miquel L, Segura L, Colom J, Ortega L, Vieta E, Gual A. Effectiveness of a Specialized Brief Intervention for At-risk Drinkers in an Emergency Department: Short-term Results of a Randomized Controlled Trial. Acad Emerg Med. 2018 May;25(5):517-525. doi: 10.1111/acem.13384. Epub 2018 Apr 2.
- Locker TE, Baston S, Mason SM, Nicholl J. Defining frequent use of an urban emergency department. Emerg Med J. 2007 Jun;24(6):398-401. doi: 10.1136/emj.2006.043844.
- Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
- LaCalle E, Rabin E. Frequent users of emergency departments: the myths, the data, and the policy implications. Ann Emerg Med. 2010 Jul;56(1):42-8. doi: 10.1016/j.annemergmed.2010.01.032. Epub 2010 Mar 26.
- Meng X, Muggli T, Baetz M, D'Arcy C. Disordered lives: Life circumstances and clinical characteristics of very frequent users of emergency departments for primary mental health complaints. Psychiatry Res. 2017 Jun;252:9-15. doi: 10.1016/j.psychres.2017.02.044. Epub 2017 Feb 21.
- Moschetti K, Iglesias K, Baggio S, Velonaki V, Hugli O, Burnand B, Daeppen JB, Wasserfallen JB, Bodenmann P. Health care costs of case management for frequent users of the emergency department: Hospital and insurance perspectives. PLoS One. 2018 Sep 24;13(9):e0199691. doi: 10.1371/journal.pone.0199691. eCollection 2018.
- Moe J, Kirkland S, Ospina MB, Campbell S, Long R, Davidson A, Duke P, Tamura T, Trahan L, Rowe BH. Mortality, admission rates and outpatient use among frequent users of emergency departments: a systematic review. Emerg Med J. 2016 Mar;33(3):230-6. doi: 10.1136/emermed-2014-204496. Epub 2015 May 7.
- Giannouchos TV, Kum HC, Foster MJ, Ohsfeldt RL. Characteristics and predictors of adult frequent emergency department users in the United States: A systematic literature review. J Eval Clin Pract. 2019 Jun;25(3):420-433. doi: 10.1111/jep.13137. Epub 2019 May 2.
- Shumway M, Boccellari A, O'Brien K, Okin RL. Cost-effectiveness of clinical case management for ED frequent users: results of a randomized trial. Am J Emerg Med. 2008 Feb;26(2):155-64. doi: 10.1016/j.ajem.2007.04.021.
- Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
- Kumar GS, Klein R. Effectiveness of case management strategies in reducing emergency department visits in frequent user patient populations: a systematic review. J Emerg Med. 2013 Mar;44(3):717-29. doi: 10.1016/j.jemermed.2012.08.035. Epub 2012 Nov 29.
- Moe J, Kirkland SW, Rawe E, Ospina MB, Vandermeer B, Campbell S, Rowe BH. Effectiveness of Interventions to Decrease Emergency Department Visits by Adult Frequent Users: A Systematic Review. Acad Emerg Med. 2017 Jan;24(1):40-52. doi: 10.1111/acem.13060.
- Hudon C, Chouinard MC, Lambert M, Diadiou F, Bouliane D, Beaudin J. Key factors of case management interventions for frequent users of healthcare services: a thematic analysis review. BMJ Open. 2017 Oct 22;7(10):e017762. doi: 10.1136/bmjopen-2017-017762.
- Kahan D, Poremski D, Wise-Harris D, Pauly D, Leszcz M, Wasylenki D, Stergiopoulos V. Perceived Case Management Needs and Service Preferences of Frequent Emergency Department Users: Lessons Learned in a Large Urban Centre. PLoS One. 2016 Dec 21;11(12):e0168782. doi: 10.1371/journal.pone.0168782. eCollection 2016.
- Parkman T, Neale J, Day E, Drummond C. How Do People Who Frequently Attend Emergency Departments for Alcohol-Related Reasons Use, View, and Experience Specialist Addiction Services? Subst Use Misuse. 2017 Sep 19;52(11):1460-1468. doi: 10.1080/10826084.2017.1285314. Epub 2017 May 3.
- Irving A, Goodacre S, Blake J, Allen D, Moore SC. Managing alcohol-related attendances in emergency care: can diversion to bespoke services lessen the burden? Emerg Med J. 2018 Feb;35(2):79-82. doi: 10.1136/emermed-2016-206451. Epub 2017 Nov 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MALUA_Freq
- HCB/2019/0717 (Other Identifier: Hospital Clínic de Barcelona Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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