Back to results

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

Primary Purpose

Alcohol Drinking, Alcohol-Related Disorders

Status

Terminated

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Case Management

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring alcohol-related disorders, emergency department, frequent users, case management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Only treatment as usual in the Emergency Department (and in the Health and Social Services Network).

Outcomes

Primary Outcome Measures

Number of Emergency Department Visits

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.

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.

Secondary Outcome Measures

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).

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.

Change from baseline in number of hospital admissions

Need of inpatient care

Full Information

NCT ID

NCT04219748

First Posted

December 20, 2019

Last Updated

May 13, 2021

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT04219748

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Insufficient accrual rate to achieve expected sample size in the context of a global pandemic.

Study Start Date

January 20, 2020 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking, Alcohol-Related Disorders

Keywords

alcohol-related disorders, emergency department, frequent users, case management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Only treatment as usual in the Emergency Department (and in the Health and Social Services Network).

Intervention Type

Behavioral

Intervention Name(s)

Case Management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Emergency Department Visits

Time Frame

At 12 months after enrollment

Title

Change from baseline in the proportion of risky drinkers measured by AUDIT-C

Description

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.

Time Frame