Brief Intervention for ICU Patients With Alcohol Use Disorders (ICU-BI)
Primary Purpose
Alcohol Use Disorder, Critically Ill
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Brief intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit
Eligibility Criteria
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)
Sites / Locations
- Helsinki University Hospital Intensive Care Units 20 and M1
- Tampere University Hospital ICU
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Standard care arm
Intervention arm
Arm Description
Treatment as usual and discussion according to the treating clinicians in the hospital
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in AUDIT score
The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission
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
Mortality
Survival of the patients will be obtained from Statistics Finland
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
Full Information
NCT ID
NCT03047577
First Posted
February 7, 2017
Last Updated
November 11, 2022
Sponsor
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT03047577
Brief Title
Brief Intervention for ICU Patients With Alcohol Use Disorders
Acronym
ICU-BI
Official Title
Brief Intervention for ICU Patients With Alcohol Use Disorders- a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruiting stopped due to slow recruitment particularly due to COVID
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Critically Ill
Keywords
Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomly assigned to a standard care or an intervention arm
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care arm
Arm Type
No Intervention
Arm Description
Treatment as usual and discussion according to the treating clinicians in the hospital
Arm Title
Intervention arm
Arm Type
Other
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Other Intervention Name(s)
Mini-intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
Reported total amount of alcohol consumed during preceding week
Description
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
Title
Reported total amount of alcohol consumed during preceding week
Description
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 Outcome Measure Information:
Title
Change in AUDIT score
Description
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
Title
Change in AUDIT score
Description
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
Title
Mortality
Description
Survival of the patients will be obtained from Statistics Finland
Time Frame
One year after study enrollment
Title
Quality of life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Helsinki University Hospital Intensive Care Units 20 and M1
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Tampere University Hospital ICU
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Intervention for ICU Patients With Alcohol Use Disorders
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