Clinical trial NCT04219748: Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department
Official title: "Case Management" de Problemes Per Ús d'Alcohol en Pacients Que Hiperfreqüenten el Servei d'Urgències
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Drinking
Alcohol-Related Disorders
Keywords: alcohol-related disorders
emergency department
frequent users
case management
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Emergency Department Visits
timeFrame: At 12 months after enrollment
measure: Change from baseline in the proportion of risky drinkers measured by AUDIT-C
timeFrame: At baseline and at 3, 6, 9 and 12 months after enrollment
measure: Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)
timeFrame: At baseline and at 3, 6, 9 and 12 months after enrollment
Secondary outcomes:
measure: Change from baseline in quality of life according to EQ-5D-5L questionnaire
timeFrame: At baseline and at 3, 6, 9 and 12 months after enrollment
measure: Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)
timeFrame: At baseline and at 3, 6, 9 and 12 months after enrollment
measure: Change from baseline in number of hospital admissions
timeFrame: At baseline and at 3, 6, 9 and 12 months after enrollment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antoni Gual, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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