Alcohol AbuseNCT01370226
Health Explorer - Optimizing Alcohol Brief Interventions
A study testing CBI and TBI in people with Alcohol Abuse, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- CBI and TBI
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System Emergency Department
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Abuse
- Being tested
- CBI, TBI
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBIBehavioural
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.
TBIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBI | Active comparator | Computer delivered Brief Intervention Receives: Behavioral: CBI |
| TBI | Active comparator | Therapist delivered Brief Intervention Receives: Behavioral: TBI |
| EUC | No intervention | Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use - number of drinking days
Measured: change over time (3, 6 and 12-months post baseline)
Alcohol use - number of drinks per day
Measured: change over time (3, 6 and 12-months post baseline)
Alcohol use - number of binge drinking days
Measured: change over time (3, 6 and 12-months post baseline)
Alcohol use
Alcohol Use Disorders Identification Test (AUDIT-C)
Measured: change over time (3, 6 and 12-months post baseline)
Alcohol related consequences
Consequences are measured using the modified Short Inventory of Problems (SIP).
Measured: change over time (3, 6 and 12-months post baseline)
Alcohol related consequences
Consequences are measured using the Drinker Inventory of Consequences (DrInC)
Measured: change over time (3, 6 and 12-months post baseline)
Secondary outcomes (4)
Consequences of Alcohol Use - injury
Injury is measured using the Revised Injury Behavior Checklist (RIBC).
Measured: change over time (3, 6 and 12-months post baseline)
Consequences of Alcohol Use - health functioning
Health functioning is measured using the Brief Symptom Index (BSI-18).
Measured: change over time (3, 6 and 12-months post baseline)
Consequences of Alcohol Use - health functioning - depression
Depression is measured using the Patient Health Questionnaire (PHQ-9).
Measured: change over time (3, 6 and 12-months post baseline)
Consequences of Alcohol Use - HIV-risk behaviors
HIV-risk behaviors measures include questions about condom use, number of sexual partners, sex under the influence.
Measured: change over time (3, 6 and 12-months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionDec 2015
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.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370226
- Sponsor's protocol ID
- AA018659
- Other IDs
- R01AA018659
- Status last verified
- Apr 2016
- First submitted
- 1 Jun 2011
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery
- ClinicalTrials.gov ID
- NCT01370226
- Acronym / sponsor ID
- AA018659
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jun 2011 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBI | Active comparator | Behavioral: CBIComputer delivered Brief Intervention |
| TBI | Active comparator | Behavioral: TBITherapist delivered Brief Intervention |
| EUC | No intervention | –Enhanced Usual Care |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| CBIThe 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. | Behavioural | CBI |
| TBIParticipants 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. | Behavioural | TBI |
Primary outcome
Alcohol use - number of drinking days
Time frame: 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)
Alcohol use - number of binge drinking days
Time frame: 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)
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).
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)
4 secondary outcomes
Consequences of Alcohol Use - injury
Time frame: 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)
Consequences of Alcohol Use - health functioning - depression
Time frame: 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)
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 7 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Frederic C Blow, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI and TBI in people with Alcohol Abuse, run by University of Michigan 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 3 inclusion and 5 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 7 Apr 2016. 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?
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?
Alcohol use - number of drinking days (time frame: change over time (3, 6 and 12-months post baseline)). The study lists 6 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 7 Apr 2016.