University of Michigan Health System Emergency Department
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT01370226
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.
Looking for future studies?
Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: change over time (3, 6 and 12-months post baseline)
Time frame: change over time (3, 6 and 12-months post baseline)
Time frame: change over time (3, 6 and 12-months post baseline)
Time frame: change over time (3, 6 and 12-months post baseline)
Alcohol Use Disorders Identification Test (AUDIT-C)
Time frame: change over time (3, 6 and 12-months post baseline)
Consequences are measured using the modified Short Inventory of Problems (SIP).
Time frame: change over time (3, 6 and 12-months post baseline)
Consequences are measured using the Drinker Inventory of Consequences (DrInC)
Time frame: change over time (3, 6 and 12-months post baseline)
Injury is measured using the Revised Injury Behavior Checklist (RIBC).
Time frame: change over time (3, 6 and 12-months post baseline)
Health functioning is measured using the Brief Symptom Index (BSI-18).
Time frame: change over time (3, 6 and 12-months post baseline)
Depression is measured using the Patient Health Questionnaire (PHQ-9).
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.
University of Michigan
Other
Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06607562
Alcohol Abuse, Alcohol-Related Disorders
Luoyang, Henan, China
View Trial DetailsNCT04154111
Alcohol Abuse, Alcohol Dependence
Winston-Salem, North Carolina, United States
View Trial DetailsNCT03952429
Alcohol Abuse, Alcohol Dependence
Lindow, Brandenburg, Germany
View Trial DetailsNCT05427734
Alcohol Abuse, Alcohol Use Disorder
Seattle, Washington, United States
View Trial Details