Trials / Terminated
TerminatedNCT03047577
Brief Intervention for ICU Patients with Alcohol Use Disorders
Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 237 (actual)
- Sponsor
- University of Helsinki · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2017-03-30
- Primary completion
- 2022-07-12
- Completion
- 2022-10-31
- First posted
- 2017-02-09
- Last updated
- 2024-12-10
Locations
3 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT03047577. Inclusion in this directory is not an endorsement.