Brief Intervention for ICU Patients With Alcohol Use Disorders

Study Overview
=================
Brief Summary
-----------------
Patients non-electively admitted to intensive care units (ICUs) will be screened for eligibility. The investigators will include adult patients with risk level alcohol use, defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained from the patient in the end or shortly after the ICU treatment, when they have regained sufficient cognitive function. 600 patients will be randomized to receive either routine treatment or a brief intervention (BI). The BI includes a 20 minute discussion with pre-educated study personnel, option to discussion with a social worker and written material. Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at 6 and 12 months after study entry. The information will be obtained 1)in an interview by a study team member blinded for the intervention arm at 6 months 2) A letter of a telephone interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded. An interim analysis by an external reviewer will be performed after the primary outcome has been recorded for 200 patients,

Official Title
-----------------
Brief Intervention for ICU Patients With Alcohol Use Disorders- a Randomized Controlled Trial

Conditions
-----------------
Alcohol Use Disorder, Critically Ill

Intervention / Treatment
-----------------
* Behavioral: Brief intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AUDIT-C score >5 (women) and >6 (men) Non-elective admission to the ICU Exclusion Criteria: Terminal illness (expected to survive less than 6 months), palliative care Diagnosed severe mental illness (psychos, severe depression, bipolar disorder, personality disorder) Cognitive disability Diagnosed dementia Impaired level of consciousness at discharge from the ICU (expected to remain unchanged >2 days Other substance abuse (excluding cigarette smoking) Ongoing treatment for alcohol dependency Insufficient language skills (finnish/swedish) Expected difficulty in getting contacted by mail or telephone (no permanent address or telephone in use)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomly assigned to a standard care or an intervention arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care arm<br>Treatment as usual and discussion according to the treating clinicians in the hospital | |
| Other: Intervention arm<br>Patients receive a brief intervention, including a short discussion, opportunity for an appointment with a social worker and written information about effects of alcohol on health and contact information for seeking additional support | Behavioral: Brief intervention<br>* A 15-20minute discussion about the patients alcohol use and its association with current health conditions, option for a discussion with social worker and written material (information about how alcohol affects health and contact details for seeking more support)<br>* Other names: Mini-intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported total amount of alcohol consumed during preceding week | The patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams | 6 months after study enrollment | 
| Reported total amount of alcohol consumed during preceding week | The patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams | 12 months after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AUDIT score | The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission | 6 months after study enrollment | 
| Change in AUDIT score | The AUDIT score will be filled in a telephone interview or by mailed questionnaire and compared with the initial score obtained on study admission | 12 months after study enrollment | 
| Mortality | Survival of the patients will be obtained from Statistics Finland | One year after study enrollment | 
| Quality of life | A structured questionnaire EQ-5D will be mailed or filled in a telephone interview and the EQ-5D will be compared between the groups | One year after study enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit