Health Explorer - Optimizing Alcohol Brief Interventions

Alcohol Abuse Clinical Trial

Official title:

Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370226
• Other study ID #: AA018659
• Secondary ID: R01AA018659
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: April 6, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Behavioral:
• CBI
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.
• TBI
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.

Locations

Country	Name	City	State
United States	University of Michigan Health System Emergency Department	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use - number of drinking days		change over time (3, 6 and 12-months post baseline)	No
Primary	Alcohol use - number of drinks per day		change over time (3, 6 and 12-months post baseline)	No
Primary	Alcohol use - number of binge drinking days		change over time (3, 6 and 12-months post baseline)	No
Primary	Alcohol use	Alcohol Use Disorders Identification Test (AUDIT-C)	change over time (3, 6 and 12-months post baseline)	No
Primary	Alcohol related consequences	Consequences are measured using the modified Short Inventory of Problems (SIP).	change over time (3, 6 and 12-months post baseline)	No
Primary	Alcohol related consequences	Consequences are measured using the Drinker Inventory of Consequences (DrInC)	change over time (3, 6 and 12-months post baseline)	No
Secondary	Consequences of Alcohol Use - injury	Injury is measured using the Revised Injury Behavior Checklist (RIBC).	change over time (3, 6 and 12-months post baseline)	No
Secondary	Consequences of Alcohol Use - health functioning	Health functioning is measured using the Brief Symptom Index (BSI-18).	change over time (3, 6 and 12-months post baseline)	No
Secondary	Consequences of Alcohol Use - health functioning - depression	Depression is measured using the Patient Health Questionnaire (PHQ-9).	change over time (3, 6 and 12-months post baseline)	No
Secondary	Consequences of Alcohol Use - HIV-risk behaviors	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)	No