Unhealthy Alcohol UseNCT02465177
Tailoring Screening, Brief Intervention, and Referral to Treatment for Medical ICU Survivors
An observational study of Unhealthy Alcohol Use and Alcohol Use Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Unhealthy Alcohol Use, Alcohol Use Disorders
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to one of 3 medical intensive care units in the Denver metropolitan area
Who may be able to join
- 18 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
Who cannot join
- unable to provide informed consent
- prisoner
- Unable to speak or write in English
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Diandra Reed, BS, 303-724-6079, kathryne.reed@ucdenver.edu
About this study
Official title: Tailoring Screening, Brief Intervention, and Referral to Treatment for Medical Intensive Care Unit Survivors
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
- Conditions
- Unhealthy Alcohol Use, Alcohol Use Disorders
- Keywords
- Unhealthy alcohol use, ICU survivors, Alcohol use disorder, SBIRT, Screening, brief intervention, and referral to treatment
- Medical subject headings
- Alcoholism
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol use
Change in alcohol use as assessed using a Semi-structured qualitative interview
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unhealthy Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465177
- Sponsor's protocol ID
- 13-3159
- Other IDs
- UL1TR001082
- Status last verified
- Feb 2021
- First submitted
- 26 May 2015
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Screening, Brief Intervention, and Referral to Treatment for Medical Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT02465177
- Acronym / sponsor ID
- 13-3159
- Conditions
- Unhealthy Alcohol Use, Alcohol Use Disorders
- Keywords
- Unhealthy alcohol use, ICU survivors, Alcohol use disorder, SBIRT, Screening, brief intervention, and referral to treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to one of 3 medical intensive care units in the Denver metropolitan area
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (4 listed)
- unable to provide informed consent
- prisoner
- Unable to speak or write in English
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in alcohol use
Time frame: 3 months
Change in alcohol use as assessed using a Semi-structured qualitative interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unhealthy Alcohol Use and Alcohol Use Disorders, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diandra Reed, BS (3037246079, kathryne.reed@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.