Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department

Alcohol Drinking Clinical Trial

Official title:

"Case Management" de Problemes Per Ús d'Alcohol en Pacients Que Hiperfreqüenten el Servei d'Urgències

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04219748
• Other study ID #: MALUA_Freq
• Secondary ID: HCB/2019/0717
• Status: Terminated
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Related Disorders

Intervention

Behavioral:
• Case Management
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.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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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. — View Citation

Bruguera P, Barrio P, Oliveras C, Braddick F, Gavotti C, Bruguera C, López-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. — View Citation

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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. Review. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. Review. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Emergency Department Visits		At 12 months after enrollment
Primary	Change from baseline in the proportion of risky drinkers measured by AUDIT-C	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.	At baseline and at 3, 6, 9 and 12 months after enrollment
Primary	Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)	Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.	At baseline and at 3, 6, 9 and 12 months after enrollment
Secondary	Change from baseline in quality of life according to EQ-5D-5L questionnaire	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).	At baseline and at 3, 6, 9 and 12 months after enrollment
Secondary	Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)	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.	At baseline and at 3, 6, 9 and 12 months after enrollment
Secondary	Change from baseline in number of hospital admissions	Need of inpatient care	At baseline and at 3, 6, 9 and 12 months after enrollment