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Brief Intervention for ICU Patients with Alcohol Use Disorders

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03047577
Acronym
ICU-BI
Enrollment
237
Registered
2017-02-09
Start date
2017-03-30
Completion date
2022-10-31
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Critically Ill

Keywords

Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit

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,

Interventions

BEHAVIORALBrief 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)

Sponsors

Tampere University Hospital
CollaboratorOTHER
Turku University Hospital
CollaboratorOTHER_GOV
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Unlike other team members, the investigator interviewing the patients will be unaware of the treatment group. The patient will be encouraged not to reveal the treatment group to the investigator.

Intervention model description

Patients are randomly assigned to a standard care or an intervention arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Reported total amount of alcohol consumed during preceding week6 months after study enrollmentThe patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams

Secondary

MeasureTime frameDescription
Change in AUDIT score6 months after study enrollmentThe AUDIT score will be filled in an interview and compared with the initial score obtained on study admission
MortalityOne year after study enrollmentSurvival of the patients will be obtained from Statistics Finland
Quality of lifeOne year after study enrollmentA structured questionnaire EQ-5D will be mailed or filled in a telephone interview and the EQ-5D will be compared between the groups

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026