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Brief Intervention for ICU Patients with Alcohol Use Disorders

NCT ID: NCT03047577

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Alcohol Use Disorder Critically Ill

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Standard care arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Brief intervention

Intervention Type BEHAVIORAL

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)

Interventions

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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)

Intervention Type BEHAVIORAL

Other Intervention Names

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Mini-intervention

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Johanna Hastbacka

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Hospital Intensive Care Units 20 and M1

Helsinki, Helsinki, Finland

Site Status

Tampere University Hospital ICU

Tampere, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 38689346 (View on PubMed)

Other Identifiers

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TYH2017105

Identifier Type: -

Identifier Source: org_study_id