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

Primary Purpose

Alcohol Drinking, Alcohol-Related Disorders

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intensive Case Management
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

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 Type

Experimental

Arm Label

Intensive Case Management Intervention

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.

Outcomes

Primary Outcome Measures

Change in number of Emergency Department Visits
Change compared to previous year
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.
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 descriptive system (5-digit number that describes the patient's health state)
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
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)
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
Need of inpatient care

Full Information

First Posted
June 4, 2021
Last Updated
September 25, 2023
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04938258
Brief 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
Acronym
MALUA_Freq_P
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual rate to achieve expected sample size.
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Case Management Intervention
Arm Type
Experimental
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive 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
Change in number of Emergency Department Visits
Description
Change compared to previous year
Time Frame
At 12 months after enrollment
Title
Change from baseline in the proportion of risky drinkers measured by AUDIT-C (Alcohol Use Disorders Identification Test-Consumption)
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. Minimum value: 0. Maximum value: 12. Higher scores indicate more severity of alcohol use.
Time Frame
At 12 months after enrollment
Title
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)
Description
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
Time Frame
At 12 months after enrollment
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
At 12 months after enrollment
Title
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
Description
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.
Time Frame
At 12 months after enrollment
Title
Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)
Description
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.
Time Frame
At 12 months after enrollment
Title
Change from previous year in number of hospital admissions
Description
Need of inpatient care
Time Frame
At 12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Gual, PhD, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Feasibility and Potential Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department: a Pilot Study

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