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Health Explorer - Optimizing Alcohol Brief Interventions

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBI
TBI
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Abuse

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan Health System Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

CBI

TBI

EUC

Arm Description

Computer delivered Brief Intervention

Therapist delivered Brief Intervention

Enhanced Usual Care

Outcomes

Primary Outcome Measures

Alcohol use - number of drinking days
Alcohol use - number of drinks per day
Alcohol use - number of binge drinking days
Alcohol use
Alcohol Use Disorders Identification Test (AUDIT-C)
Alcohol related consequences
Consequences are measured using the modified Short Inventory of Problems (SIP).
Alcohol related consequences
Consequences are measured using the Drinker Inventory of Consequences (DrInC)

Secondary Outcome Measures

Consequences of Alcohol Use - injury
Injury is measured using the Revised Injury Behavior Checklist (RIBC).
Consequences of Alcohol Use - health functioning
Health functioning is measured using the Brief Symptom Index (BSI-18).
Consequences of Alcohol Use - health functioning - depression
Depression is measured using the Patient Health Questionnaire (PHQ-9).
Consequences of Alcohol Use - HIV-risk behaviors
HIV-risk behaviors measures include questions about condom use, number of sexual partners, sex under the influence.

Full Information

First Posted
June 1, 2011
Last Updated
April 6, 2016
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01370226
Brief Title
Health Explorer - Optimizing Alcohol Brief Interventions
Official Title
Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBI
Arm Type
Active Comparator
Arm Description
Computer delivered Brief Intervention
Arm Title
TBI
Arm Type
Active Comparator
Arm Description
Therapist delivered Brief Intervention
Arm Title
EUC
Arm Type
No Intervention
Arm Description
Enhanced Usual Care
Intervention Type
Behavioral
Intervention Name(s)
CBI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TBI
Intervention Description
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 Outcome Measure Information:
Title
Alcohol use - number of drinking days
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Alcohol use - number of drinks per day
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Alcohol use - number of binge drinking days
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Alcohol use
Description
Alcohol Use Disorders Identification Test (AUDIT-C)
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Alcohol related consequences
Description
Consequences are measured using the modified Short Inventory of Problems (SIP).
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Alcohol related consequences
Description
Consequences are measured using the Drinker Inventory of Consequences (DrInC)
Time Frame
change over time (3, 6 and 12-months post baseline)
Secondary Outcome Measure Information:
Title
Consequences of Alcohol Use - injury
Description
Injury is measured using the Revised Injury Behavior Checklist (RIBC).
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Consequences of Alcohol Use - health functioning
Description
Health functioning is measured using the Brief Symptom Index (BSI-18).
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Consequences of Alcohol Use - health functioning - depression
Description
Depression is measured using the Patient Health Questionnaire (PHQ-9).
Time Frame
change over time (3, 6 and 12-months post baseline)
Title
Consequences of Alcohol Use - HIV-risk behaviors
Description
HIV-risk behaviors measures include questions about condom use, number of sexual partners, sex under the influence.
Time Frame
change over time (3, 6 and 12-months post baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic C Blow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System Emergency Department
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Explorer - Optimizing Alcohol Brief Interventions

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