Brief Intervention for ICU Patients With Alcohol Use Disorders

Alcohol Use Disorder Clinical Trial

— ICU-BI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03047577
• Other study ID #: TYH2017105
• Status: Terminated
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 237
• Est. completion date: October 31, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Critical Illness
• Critically Ill
• Disease

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Finland	Helsinki University Hospital Intensive Care Units 20 and M1	Helsinki
Finland	Tampere University Hospital ICU	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in AUDIT score	The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission	6 months after study enrollment
Secondary	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	12 months after study enrollment
Secondary	Mortality	Survival of the patients will be obtained from Statistics Finland	One year after study enrollment
Secondary	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	One year after study enrollment