Clinical trial NCT01370226: Health Explorer - Optimizing Alcohol Brief Interventions
Official title: Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2011-06-09
Enrollment: 750
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol use - number of drinking days
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Alcohol use - number of drinks per day
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Alcohol use - number of binge drinking days
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Alcohol use
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Alcohol related consequences
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Alcohol related consequences
timeFrame: change over time (3, 6 and 12-months post baseline)
Secondary outcomes:
measure: Consequences of Alcohol Use - injury
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Consequences of Alcohol Use - health functioning
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Consequences of Alcohol Use - health functioning - depression
timeFrame: change over time (3, 6 and 12-months post baseline)
measure: Consequences of Alcohol Use - HIV-risk behaviors
timeFrame: change over time (3, 6 and 12-months post baseline)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System Emergency Department
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frederic C Blow, PhD
role: PRINCIPAL_INVESTIGATOR
References: