Clinical trial NCT03047577: Brief Intervention for ICU Patients with Alcohol Use Disorders
Official title: Brief Intervention for ICU Patients with Alcohol Use Disorders- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Use Disorder
Critically Ill
Keywords: Brief intervention
Alcohol
Alcohol use disorder
Intensive care unit
Critically ill
Audit
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Turku University Hospital
First posted: 2017-02-09
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly assigned to a standard care or an intervention arm
Primary purpose: TREATMENT

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,


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)

Primary outcomes:
measure: Reported total amount of alcohol consumed during preceding week
timeFrame: 6 months after study enrollment
measure: Reported total amount of alcohol consumed during preceding week
timeFrame: 12 months after study enrollment
Secondary outcomes:
measure: Change in AUDIT score
timeFrame: 6 months after study enrollment
measure: Change in AUDIT score
timeFrame: 12 months after study enrollment
measure: Mortality
timeFrame: One year after study enrollment
measure: Quality of life
timeFrame: One year after study enrollment
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital Intensive Care Units 20 and M1
city: Tampere
country: Finland
facility: Tampere University Hospital ICU
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: