Feasibility and Potential Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department: a Pilot Study

NCT04938258 | Terminated

• 1 other identifier: HCB/2019/0717 ER-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 feasibility and potential effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital.

Conditions

Alcohol Drinking; Alcohol-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Change in number of Emergency Department Visits

  Change compared to previous year

  At 12 months after enrollment

• Change from baseline in the proportion of risky drinkers measured by AUDIT-C (Alcohol Use Disorders Identification Test-Consumption)

  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. Minimum value: 0. Maximum value: 12. Higher scores indicate more severity of alcohol use.

  At 12 months after enrollment

• 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 12 months after enrollment

Secondary Outcomes (4)

• 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 12 months after enrollment

• 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 12 months after enrollment

• Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)

  At 12 months after enrollment

• Change from previous year in number of hospital admissions

  At 12 months after enrollment

Study Arms (1)

Intensive Case Management Intervention

EXPERIMENTAL

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.

Behavioral: Intensive Case Management

Interventions

Intensive Case Management BEHAVIORAL

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.

Intensive Case Management Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Alcohol Drinking; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Antoni Gual, PhD, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, IDIBAPS Grup de Recerca en Addiccions Clinic Emeritus Researcher

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 24, 2021
• Study Start: June 23, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)