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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT04938258

Collaborator

(none)

Enrollment

Location

Arm

23.3

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Alcohol-Related Disorders	Behavioral: Intensive Case Management	N/A

Detailed Description

Methods:

Unicentric, national, open, non-controlled pre-post pilot study 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 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 that consent to participate will receive a case management intervention as well as treatment as usual. Main outcomes will be change in the number of visits to the ED and change in proportion of risky drinkers measured by AUDIT-C at 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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 23, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive Case Management 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.	Behavioral: Intensive 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.

Arm

Intervention/Treatment

Experimental: Intensive Case Management 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.

Behavioral: Intensive 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.

Outcome Measures

Primary Outcome Measures

Change in number of Emergency Department Visits [At 12 months after enrollment]
Change compared to previous year
Change from baseline in the proportion of risky drinkers measured by AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) [At 12 months after enrollment]
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.
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable) [At 12 months after enrollment]
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 descriptive system (5-digit number that describes the patient's health state) [At 12 months after enrollment]
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) 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) as a description of the patient's health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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]
The EQ-5D-5L (5-level EQ-5D version (EQ-5D-5L) by the EuroQol Group) is a generic test to assess quality of life related to health. It includes the EQ VAS, which records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from score 100 ('The best health you can imagine') to 0 ('The worst health you can imagine'). The VAS can be used as a quantitative measure of health outcome.
Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS) [At 12 months after enrollment]
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 previous year in number of hospital admissions [At 12 months after enrollment]
Need of inpatient care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic de Barcelona	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Antoni Gual, PhD, MD, Hospital Clinic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Antoni Gual, MD, PhD, IDIBAPS Grup de Recerca en Addiccions Clinic Emeritus Researcher, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT04938258

Other Study ID Numbers:

HCB/2019/0717 ER-01
HCB/2019/0717 ER-01

First Posted:

Jun 24, 2021

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Alcohol-Related Disorders

Alcohol Drinking

Study Results

No Results Posted as of Mar 17, 2022