Alcohol AbusePhase 3NCT00183183
Impact of a Brief Motivational Interview on Drinking Behaviors of At Risk Drinkers Screened in the Emergency Room
A Phase 3 study testing Screening and Brief Intervention in people with Alcohol Abuse, run by UConn Health at 15 sites in United States.
Trial summary
Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social costs to families and communities. The goal of this project is to translate motivational interventions successful in the primary care setting to the Emergency Department (ED) environment by implementing screening, brief… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Screening and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,137 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2004to Dec 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Communication in English or Spanish
- Met NIAAA criteria for "at-risk drinking":
- for Men: 15 or more drinks/week, or 5 or more drinks on a single occasion
- for Women: 8 or more drinks/week, or 4 or more drinks on a single occasion
- Age 65 or over: 8 or more drinks/week or more than 1 drink per day
Who cannot join
- Requests detox or already in alcohol treatment program
- Abnormal mental status
- Too ill to give consent
- Unable to provide consent for other reasons
- Suicidal
- Employee or student of site institution (where required)
- Prisoner
- Inability to follow up
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The University of New Mexico Hospital/Health Sciences Center
Albuquerque, New Mexico
University of Michigan Hospital and Health System / Department of Emergency Medicine
Ann Arbor, Michigan, 48109
Department of Emergency Medicine Emory University School of Medicine / Emergency Care Center of the Grady Memorial Hospital
Atlanta, Georgia
Boston University Medical Center
Boston, Massachusetts
Tufts-New England Medical Center Hospital/Tufts University
Boston, Massachusetts
Cooper Health/Department of Emergency Medicine at UMNDJ-RWJMS
Camden, New Jersey
University of Virginia Health System, University Hospital
Charlottesville, Virginia
University of Denver/Denver Health Medical Center
Denver, Colorado
University of Connecticut Health Center
Farmington, Connecticut, 06030
Charles R. Drew University of Medicine and Science/Matrin Luther King Hospital
Los Angeles, California
University of Southern California Keck School of Medicine / Los Angeles County+University of Southern California Medical Center
Los Angeles, California
Section of Emergency Medicine/Yale University School of Medicine
New Haven, Connecticut
Rhode Island Hospital / Brown University / Department of EM and Injury Prevention Center
Providence, Rhode Island
University of California San Diego Medical Center - Hillcrest
San Diego, California, 92103
Howard University/College of Medicine/Department of Pharmacology and Emergency Medicine
Washington D.C., District of Columbia
About this study
Official title: Alcohol Screening and Brief Intervention in the Emergency Department
Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social costs to families and communities. The goal of this project is to translate motivational interventions successful in the primary care setting to the Emergency Department (ED) environment by implementing screening, brief intervention and referral to treatment (SBIRT) in order to reduce at-risk drinking among ED patients.
Read the detailed description
To evaluate the effectiveness of SBIRT in the emergency room setting, ED patients meeting NIAAA criteria for high risk drinking were recruited from 14 sites nationwide (control group-Spring, 2004; intervention group-Summer, 2004). 26% of screened ED patients met inclusion criteria. All enrollees received a list of local referral resources. Intervention group patients also participated in a 15 minute negotiated interview and ED staff referred them directly for treatment if indicated. Enrollees completed 3-month follow-up surveys with a telephone Interactive Voice Response (IVR) system. A total of 1137 patients were enrolled across 14 sites (561 intervention, 576 control), with 62% male, 37% Black, and 38% White, and a mean age of 37. At baseline intervention-i and control-c groups were similar in demographic characteristics and number of drinks on a typical day (mean-i 5.00, mean-c 5.12) and maximum drinks on a given day in the past month (mean-i 7.51, mean-c 7.33). The 3 month follow-up rate was 62% (n=687); the 6 month follow-up rate was 52% (n=567). The 12 month follow up is currently underway.
- Conditions
- Alcohol Abuse
- Being tested
- Screening and Brief Intervention
- Keywords
- Alcohol Abuse, Harm Reduction, Motivational Interviewing, Emergency Department, Risky Drinking, Prevention
- Medical subject headings
- Alcoholism, Harm Reduction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and Brief InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of drinks per day
Frequency of drinking days per week
Secondary outcomes (2)
Completing alcohol related treatment
Reporting negative alcohol related events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Edward Bernstein, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183183
- Sponsor's protocol ID
- NIAAAASE15123
- Other IDs
- R21AA015123, NIH 5R21AA15123-02
- Status last verified
- May 2010
- First submitted
- 12 Sep 2005
- Last updated
- 24 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Screening and Brief Intervention in the Emergency Department
- ClinicalTrials.gov ID
- NCT00183183
- Acronym / sponsor ID
- NIAAAASE15123
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol Abuse, Harm Reduction, Motivational Interviewing, Emergency Department, Risky Drinking, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,137 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 16 Sep 2005 (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.
Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social costs to families and communities. The goal of this project is to translate motivational interventions successful in the primary care setting to the Emergency Department (ED) environment by implementing screening, brief intervention and referral to treatment (SBIRT) in order to reduce at-risk drinking among ED patients.
Detailed description
To evaluate the effectiveness of SBIRT in the emergency room setting, ED patients meeting NIAAA criteria for high risk drinking were recruited from 14 sites nationwide (control group-Spring, 2004; intervention group-Summer, 2004). 26% of screened ED patients met inclusion criteria. All enrollees received a list of local referral resources. Intervention group patients also participated in a 15 minute negotiated interview and ED staff referred them directly for treatment if indicated. Enrollees completed 3-month follow-up surveys with a telephone Interactive Voice Response (IVR) system. A total of 1137 patients were enrolled across 14 sites (561 intervention, 576 control), with 62% male, 37% Black, and 38% White, and a mean age of 37. At baseline intervention-i and control-c groups were similar in demographic characteristics and number of drinks on a typical day (mean-i 5.00, mean-c 5.12) and maximum drinks on a given day in the past month (mean-i 7.51, mean-c 7.33). The 3 month follow-up rate was 62% (n=687); the 6 month follow-up rate was 52% (n=567). The 12 month follow up is currently underway.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18+
- Communication in English or Spanish
- Met NIAAA criteria for "at-risk drinking":
Key exclusion criteria (8 listed)
- Requests detox or already in alcohol treatment program
- Abnormal mental status
- Too ill to give consent
- Unable to provide consent for other reasons
- Suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and Brief Intervention | Behavioural | – |
Primary outcome
Quantity of drinks per day
Frequency of drinking days per week
2 secondary outcomes
Completing alcohol related treatment
Reporting negative alcohol related events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
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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.
Edward Bernstein, MD principal investigator
Boston University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Screening and Brief Intervention in people with Alcohol Abuse, run by UConn Health at 15 sites 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of drinks per day. The study lists 2 primary outcomes in all. 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 24 May 2010.