Brief Intervention for ICU Patients with Alcohol Use Disorders

Not Applicable

Terminated

• Conditions: Critically Ill; Alcohol Use Disorder
• Interventions: Behavioral: Brief intervention

• Registration Number: NCT03047577
• Lead Sponsor: University of Helsinki

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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Study Start: 2017-03-30
• Primary Completion: 2022-07-12
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 237

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Brief intervention	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

Primary Outcome Measures

Name	Time	Method
Reported total amount of alcohol consumed during preceding week	12 months after study enrollment	The patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital Intensive Care Units 20 and M1; 🇫🇮 Helsinki, Finland

Tampere University Hospital ICU; 🇫🇮 Tampere, Finland