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

University of Helsinki

Status: Terminated

Conditions: Critically Ill; Alcohol Use Disorder

Treatments: Behavioral: Brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03047577

TYH2017105

Details and patient eligibility

About

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,

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

237 participants in 2 patient groups

Standard care arm

No Intervention group

Description:

Treatment as usual and discussion according to the treating clinicians in the hospital

Intervention arm

Other group

Description:

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

Treatment:

Behavioral: Brief intervention