Brief Intervention for ICU Patients with Alcohol Use Disorders (ICU-BI)

Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial

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,

Study Overview

• Status: Terminated
• Conditions: Critically Ill; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Brief intervention

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Hospital Intensive Care Units 20 and M1
  • Tampere, Finland, 33521
    • Tampere University Hospital ICU
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care arm; Treatment as usual and discussion according to the treating clinicians in the hospital
Other: Intervention arm; 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; 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); 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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Turku University Hospital; Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Estimated): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care unit; Alcohol; Brief intervention; Alcohol use disorder; Critically ill; Audit
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking; Critical Illness
• Other Study ID Numbers: TYH2017105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No