Alcohol Use DisorderICU-BINCT03047577
Brief Intervention for ICU Patients with Alcohol Use Disorders
A study testing Brief intervention in people with Alcohol Use Disorder and Critically Ill, run by University of Helsinki at 3 sites in Finland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Critically Ill
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 3 sitesFinland
- Study dates
- 30 Mar 2017to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AUDIT-C score >5 (women) and >6 (men)
- Non-elective admission to the ICU
Who cannot join
- 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)
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- 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)
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital Intensive Care Units 20 and M1
Helsinki, Helsinki, 00290
Tampere University Hospital ICU
Tampere, 33521
Turku University Hospital
Turku
About this study
Official title: Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial
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
- Being tested
- Brief intervention
- Keywords
- Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit
- Medical subject headings
- Alcoholism, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
Also called Mini-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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months after study enrollment
Secondary outcomes (4)
Change in AUDIT score
The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission
Measured: 6 months after study enrollment
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
Measured: 12 months after study enrollment
Mortality
Survival of the patients will be obtained from Statistics Finland
Measured: One year after study enrollment
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
Measured: One year after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start30 Mar 2017
- Primary completion12 Jul 2022
- Study completion31 Oct 2022
Why it stopped: Recruiting stopped due to slow recruitment particularly due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to a standard care or an intervention arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital
- Responsible party
- Principal investigator, Johanna Hastbacka, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047577
- Sponsor's protocol ID
- TYH2017105
- Acronym
- ICU-BI
- Status last verified
- Nov 2022
- First submitted
- 7 Feb 2017
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03047577
- Acronym / sponsor ID
- ICU-BI / TYH2017105
- Conditions
- Alcohol Use Disorder, Critically Ill
- Keywords
- Brief intervention, Alcohol, Alcohol use disorder, Intensive care unit, Critically ill, Audit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting stopped due to slow recruitment particularly due to COVID
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to a standard care or an intervention arm
| Arm | Type | Receives |
|---|---|---|
| Standard care arm | No intervention | –Treatment as usual and discussion according to the treating clinicians in the hospital |
| Intervention arm | Other | Behavioral: Brief interventionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AUDIT-C score >5 (women) and >6 (men)
- Non-elective admission to the ICU
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionAlso: Mini-interventionA 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) | Behavioural | Intervention arm |
Primary outcome
Reported total amount of alcohol consumed during preceding week
Time frame: 6 months after study enrollment
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
Time frame: 12 months after study enrollment
The patients are interviewed and the amount of alcohol consumed during the last week is recorded and converted in grams
4 secondary outcomes
Change in AUDIT score
Time frame: 6 months after study enrollment
Change in AUDIT score
Time frame: 12 months after study enrollment
Mortality
Time frame: One year after study enrollment
Quality of life
Time frame: One year after study enrollment
Results and safety
The study was stopped early (reason given: Recruiting stopped due to slow recruitment particularly due to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 38689346Nissila 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention in people with Alcohol Use Disorder and Critically Ill, run by University of Helsinki at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting stopped due to slow recruitment particularly due to COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported total amount of alcohol consumed during preceding week (time frame: 6 months after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.