NCT02465177

Brief Summary

Unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an American intensive care unit (ICU) each year in the US. Despite the high prevalence of unhealthy alcohol use in ICU survivors, routine interventions targeted at reducing alcohol consumption, alcohol-related consequences, and illness related to alcohol are not currently part of the multidisciplinary approach to critical care. Although screening, brief intervention, and referral to treatment (SBIRT) has been described in several healthcare settings, it fails to address common characteristics of medical ICU survivors including high rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and intimate involvement of friends and family. This study uses a qualitative approach to further understand the needs of medical ICU survivors with unhealthy alcohol use. The investigators hypothesize that there are common, modifiable barriers to improving alcohol-related outcomes

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

7.3 years

First QC Date

May 26, 2015

Last Update Submit

February 17, 2021

Conditions

Keywords

Unhealthy alcohol useICU survivorsAlcohol use disorderSBIRTScreening, brief intervention, and referral to treatment

Outcome Measures

Primary Outcomes (1)

  • Change in alcohol use

    Change in alcohol use as assessed using a Semi-structured qualitative interview

    3 months

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to one of 3 medical intensive care units in the Denver metropolitan area

You may qualify if:

  • years or older
  • admitted to the medical ICU
  • resolution of critical illness
  • resolution of delirium/agitation
  • AUDIT score 8 or greater for men, 5 or greater for women

You may not qualify if:

  • unable to provide informed consent
  • prisoner
  • Unable to speak or write in English
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Brendan J Clark, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 8, 2015

Study Start

July 1, 2014

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations