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TerminatedNCT03047577ICU-BIUpdated Dec 10, 2024

Brief Intervention for ICU Patients with Alcohol Use Disorders

An interventional study of Brief intervention in Alcohol Use Disorder and Critically Ill, sponsored by University of Helsinki. Terminated at 3 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruiting stopped due to slow recruitment particularly due to COVID
Phase
Not applicable
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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,

02

Conditions studied

  • Alcohol Use Disorder
  • Critically Ill

Keywords

  • Brief intervention
  • Alcohol
  • Alcohol use disorder
  • Intensive care unit
  • Critically ill
  • Audit
03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 237 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of Helsinki is the lead sponsor of 132 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • AUDIT-C score >5 (women) and >6 (men)
  • Non-elective admission to the ICU

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
237 participants (actual)

Study arms

  • 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

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)

    Also known as: Mini-intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months after study enrollment

  2. 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

    Time frame: 12 months after study enrollment

Secondary outcomes

  1. Change in AUDIT score

    The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission

    Time frame: 6 months after study enrollment

  2. 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

    Time frame: 12 months after study enrollment

  3. Mortality

    Survival of the patients will be obtained from Statistics Finland

    Time frame: One year after study enrollment

  4. 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

    Time frame: One year after study enrollment

07

Study locations

3 sites
  • Helsinki University Hospital Intensive Care Units 20 and M1
    Helsinki, Helsinki 00290, Finland
  • Tampere University Hospital ICU
    Tampere, 33521, Finland
  • Turku University Hospital
    Turku, Finland
08

References and documents

Publications

  • Nissila E, Hynninen M, Jalkanen V, Kuitunen A, Backlund M, Inkinen O, Hastbacka J. The effectiveness of a brief intervention for intensive care unit patients with hazardous alcohol use: a randomized controlled trial. Crit Care. 2024 Apr 30;28(1):145. doi: 10.1186/s13054-024-04925-z. PubMed 38689346 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03047577
Responsible party
Johanna Hastbacka (Dr, University of Helsinki) — Principal investigator
First posted
Feb 9, 2017
Start date
Mar 30, 2017
Primary completion
Jul 12, 2022
Completion
Oct 31, 2022
Last update
Dec 10, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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