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Completed

NCT Number: NCT01370226

Health Explorer - Optimizing Alcohol Brief Interventions

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System Emergency Department

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBI

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Alcohol use - number of drinking days

    Time frame: change over time (3, 6 and 12-months post baseline)

  2. Alcohol use - number of drinks per day

    Time frame: change over time (3, 6 and 12-months post baseline)

  3. Alcohol use - number of binge drinking days

    Time frame: change over time (3, 6 and 12-months post baseline)

  4. Alcohol use

    Time frame: change over time (3, 6 and 12-months post baseline)

    Alcohol Use Disorders Identification Test (AUDIT-C)

  5. 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).

  6. 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)

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2011
Registry last updated
Apr 7, 2016

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.

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