Brief Intervention for ICU Patients with Alcohol Use Disorders

NCT03047577 | Terminated

• 1 other identifier: TYH2017105
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 3

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,

Conditions

Alcohol Use Disorder; Critically Ill

Keywords

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (4)

• Change in AUDIT score

  6 months after study enrollment

• Change in AUDIT score

  12 months after study enrollment

• Mortality

  One year after study enrollment

• Quality of life

  One year after study enrollment

Study Arms (2)

Standard care arm

NO INTERVENTION

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

Intervention arm

OTHER

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

Brief intervention 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)

Also known as: Mini-intervention

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Helsinki: lead
• Tampere University Hospital: collaborator
• Turku University Hospital: collaborator

Study Sites (3)

Helsinki University Hospital Intensive Care Units 20 and M1

Helsinki, Helsinki, 00290, Finland

Location

Tampere University Hospital ICU

Tampere, 33521, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 38689346 DERIVED

MeSH Terms

Conditions

Alcoholism; Critical Illness

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

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

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: March 30, 2017
• Primary Completion: July 12, 2022
• Study Completion: October 31, 2022
• Last Updated: December 10, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)