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Brief Intervention for ICU Patients With Alcohol Use Disorders (ICU-BI)

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ClinicalTrials.gov Identifier: NCT03047577
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Johanna Hastbacka, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Critically Ill Behavioral: Brief intervention Not Applicable

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Study Type : Interventional
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomly assigned to a standard care or an intervention arm
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Brief Intervention for ICU Patients With Alcohol Use Disorders- a Randomized Controlled Trial
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
No Intervention: Standard care arm
Treatment as usual and discussion according to the treating clinicians in the hospital
Intervention arm
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
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)
Other Name: Mini-intervention




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in AUDIT score [ Time Frame: 6 months after study enrollment ]
    The AUDIT score will be filled in an interview and compared with the initial score obtained on study admission

  2. Change in AUDIT score [ Time Frame: 12 months after study enrollment ]
    The AUDIT score will be filled in a telephone interview or by mailed questionnaire and compared with the initial score obtained on study admission

  3. Mortality [ Time Frame: One year after study enrollment ]
    Survival of the patients will be obtained from Statistics Finland

  4. Quality of life [ Time Frame: One year after study enrollment ]
    A structured questionnaire EQ-5D will be mailed or filled in a telephone interview and the EQ-5D will be compared between the groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047577


Contacts
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Contact: Johanna Hästbacka, MD, PhD +358504286701 johanna.hastbacka@hus.fi

Locations
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Finland
Helsinki University Hospital Intensive Care Units 20 and M1 Recruiting
Helsinki, Finland, 00290
Contact: Johanna Hästbacka, MD, PhD    +358504286701    johanna.hastbacka@hus.fi   
Contact: Marja Hynninen, MD, PhD    +358504271731    marja.hynninen@hus.fi   
Sub-Investigator: Anna-Maija Korhonen, MD, PhD         
Sub-Investigator: Eliisa Uljas, MD         
Tampere University Hospital ICU Recruiting
Tampere, Finland, 33521
Contact: Sari Karlsson, MD, PhD    +3583 311 66428    sari.karlsson@pshp.fi   
Contact: Anne Kuitunen, MD, PhD       anne.kuitunen@pshp.fi   
Turku University Hospital Recruiting
Turku, Finland
Contact: Outi Inkinen, MD       outi.inkinen@tyks.fi   
Contact: Ruut Laitio, MD, PhD       ruut.laitio@tyks.fi   
Sponsors and Collaborators
Helsinki University

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Responsible Party: Johanna Hastbacka, Dr, Helsinki University
ClinicalTrials.gov Identifier: NCT03047577     History of Changes
Other Study ID Numbers: TYH2017105
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johanna Hastbacka, Helsinki University:
Brief intervention
Alcohol
Alcohol use disorder
Intensive care unit
Critically ill
Audit

Additional relevant MeSH terms:
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Disease
Critical Illness
Alcohol Drinking
Alcoholism
Pathologic Processes
Disease Attributes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs