- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370226
Health Explorer - Optimizing Alcohol Brief Interventions
April 6, 2016 updated by: Frederic C. Blow, University of Michigan
Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery
The aims of the study are to develop and refine tailored motivational brief interventions that are parallel in structure but have varied delivery modalities (computer vs. therapist) for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent alcohol consumption and alcohol consequences, including alcohol-related injury, mental and physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.
Study Overview
Detailed Description
Although a high proportion of patients seen in Emergency Departments (EDs) have at-risk or problem alcohol use, few are screened and receive services such as brief interventions (BI) designed to help them cut-back or stop drinking.
EDs do not routinely provide BIs, perhaps due to feasibility challenges such as training of staff, monitoring fidelity, and maintaining a system to ensure longer-term implementation.
Alcohol BIs have been found to be efficacious and effective in a variety of health care settings.
However, the evidence for their use in the ED has been mixed.
There is a pressing need to develop efficacious strategies to screen and optimally deliver alcohol BIs in this fast-paced and widely-used setting.
Existing clinician-delivered BI strategies need to be modified so that they can be standardized and administered with high fidelity and minimal demands on ED staff time and resources.
Computer-delivered BIs are one method to address the challenges inherent in delivering interventions in this and other healthcare settings.
The proposed study will use computerized screening via touch-screen computer tablets with audio to recruit inner-city ED patients screening positive for at-risk or problem alcohol use.
Participants age 21-65 will be randomized to one of three conditions: 1) Computer-delivered brief intervention (CBI); 2) Therapist-delivered brief intervention (TBI); or 3) Enhanced usual care (EUC).
All participants will receive written information regarding community resources; individuals who meet alcohol abuse/dependence criteria will also receive alcohol treatment referrals.
Stratified random assignment [by gender; meeting criteria for an alcohol use disorder] will take place at baseline for all conditions.
The rigorous examination of the efficacy of therapist- vs. computer-delivered BIs, including potential moderators and mediators, will address the key limitations raised by previous trials and will determine the optimal modality for wide implementation of brief alcohol interventions in this venue.
Because the ED is such an important portal for entry into the medical care system, particularly for inner-city patients, the delivery of efficacious alcohol BIs that emphasize key motivational interviewing components and minimize staff resources could have a major public health impact.
Study Type
Interventional
Enrollment (Actual)
750
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System Emergency Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients age 21-65 years presenting to the ED for medical care (except exclusions as noted below)
- ability to provide informed consent
- Additional criteria for intervention: past 3-month at-risk alcohol use
Exclusion Criteria:
- patients who do not understand English
- prisoners
- patients classified by medical staff as "Level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery)
- patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence)
- patients treated in the ED for suicide attempts or sexual assault
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBI
Computer delivered Brief Intervention
|
The multimedia, interactive Computer Brief Intervention (CBI) condition will be delivered using tablet computers.
The content and format will be easily negotiated by participants.
The 30-minute interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.
|
Active Comparator: TBI
Therapist delivered Brief Intervention
|
Participants receive a 30-minute intervention session with a Master's-level clinician.
The interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.
|
No Intervention: EUC
Enhanced Usual Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use - number of drinking days
Time Frame: change over time (3, 6 and 12-months post baseline)
|
change over time (3, 6 and 12-months post baseline)
|
|
Alcohol use - number of drinks per day
Time Frame: change over time (3, 6 and 12-months post baseline)
|
change over time (3, 6 and 12-months post baseline)
|
|
Alcohol use - number of binge drinking days
Time Frame: change over time (3, 6 and 12-months post baseline)
|
change over time (3, 6 and 12-months post baseline)
|
|
Alcohol use
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Alcohol Use Disorders Identification Test (AUDIT-C)
|
change over time (3, 6 and 12-months post baseline)
|
Alcohol related consequences
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Consequences are measured using the modified Short Inventory of Problems (SIP).
|
change over time (3, 6 and 12-months post baseline)
|
Alcohol related consequences
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Consequences are measured using the Drinker Inventory of Consequences (DrInC)
|
change over time (3, 6 and 12-months post baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consequences of Alcohol Use - injury
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Injury is measured using the Revised Injury Behavior Checklist (RIBC).
|
change over time (3, 6 and 12-months post baseline)
|
Consequences of Alcohol Use - health functioning
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Health functioning is measured using the Brief Symptom Index (BSI-18).
|
change over time (3, 6 and 12-months post baseline)
|
Consequences of Alcohol Use - health functioning - depression
Time Frame: change over time (3, 6 and 12-months post baseline)
|
Depression is measured using the Patient Health Questionnaire (PHQ-9).
|
change over time (3, 6 and 12-months post baseline)
|
Consequences of Alcohol Use - HIV-risk behaviors
Time Frame: change over time (3, 6 and 12-months post baseline)
|
HIV-risk behaviors measures include questions about condom use, number of sexual partners, sex under the influence.
|
change over time (3, 6 and 12-months post baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 8, 2011
First Posted (Estimate)
June 9, 2011
Study Record Updates
Last Update Posted (Estimate)
April 7, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA018659
- R01AA018659 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Polaris Health DirectionsUniversity of Massachusetts, WorcesterCompletedAlcohol Abuse, Alcohol DependenceUnited States
-
Australian National UniversityUniversity of Peradeniya; Department of Foregin Affairs and Trade, AustraliaCompletedIntimate Partner Violence | Domestic Abuse | Drug and Alcohol AbuseAustralia
-
Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Queen Mary University of LondonBarts & The London NHS Trust; University of HertfordshireRecruitingAlcohol Use Disorder | Alcohol Abuse or DependenceUnited Kingdom
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Drug Abuse | Alcohol AbuseUnited States
-
Baylor College of MedicineCompletedAlcohol Dependence | Substance Abuse | Alcohol AbuseUnited States
-
Fundació Sant Joan de DéuInstituto de Salud Carlos III; European Union; University of Barcelona; Red Salud...UnknownAlcohol Abuse in PregnancySpain
Clinical Trials on CBI
-
Case Comprehensive Cancer CenterWithdrawnNon-muscle Invasive Bladder Cancer (NMIBC) | Bladder Tumor (TURBT)United States
-
Hospital Civil de GuadalajaraUniversity of GuadalajaraUnknownEnd-Stage Renal DiseaseMexico
-
VA Office of Research and DevelopmentCompleted
-
Beijing Normal UniversityCompleted
-
VA Office of Research and DevelopmentCompleted
-
Koç UniversityCompletedPsychological Distress | Well-beingTurkey
-
Johns Hopkins UniversityCompletedTobacco SmokingUnited States
-
California State University, Long BeachCompletedPhysical Inactivity
-
The University of Texas at San AntonioNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedObesity | Physical Activity | Health Knowledge, Attitudes, Practice | Healthy Eating | Gross Motor DevelopmentUnited States
-
Apollomics Inc.RecruitingGastric Cancer | Pancreatic Cancer | NSCLC | Lung Cancer | Brain Tumor | Glioblastoma Multiforme | Advanced Cancer | Colon Cancer | Solid Tumors | Thyroid Cancer | Renal Cancer | Gastroesophageal Junction Adenocarcinoma | EGFR Gene Mutation | MET Amplification | HGF | MET Alteration | MET Fusion | Exon 14 SkippingUnited States, Spain, France, United Kingdom, Taiwan, Australia, Finland, Italy, Singapore, Hungary, Canada, Puerto Rico, Russian Federation