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Recruiting stopped due to slow recruitment particularly due to COVID
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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital Intensive Care Units 20 and M1 | Helsinki | Helsinki | 00290 | Finland | ||
| Tampere University Hospital ICU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38689346 | Derived | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Patients are randomly assigned to a standard care or an intervention arm
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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.
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| 12 months after study enrollment |
| Mortality | Survival of the patients will be obtained from Statistics Finland | 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 | One year after study enrollment |
| Tampere |
| 33521 |
| Finland |
| Turku University Hospital | Turku | Finland |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |