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Healthier You: Optimizing Screening, Brief Interventions, and Referral to Treatment (SBIRT) in the Emergency Department

Primary Purpose

Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-delivered Brief Intervention (CBI)
Intervener-delivered Brief Intervention (IBI)
Adapted Motivational Enhancement Therapy (AMET)
Enhanced Usual Care (EUC)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Drug Abuse

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients age 18-60 years presenting to the HMC for medical care (except exclusions as noted below)
  • ability to provide informed consent. Additional inclusion criteria for intervention: past 3-month use of illicit drugs or misuse of psychoactive prescription drugs

Exclusion Criteria:

  • patients who do not understand English (less than 1% in our prior work) -
  • 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

  • Hurley Medical Center Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

CBI in ED with AMET at 3 months

CBI in ED with EUC at 3 months

IBI in ED with AMET at 3 months

IBI in ED with EUC at 3 months

EUC in ED with AMET at 3 months

EUC in ED with EUC at 3 months

Arm Description

computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months

intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months

enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months

enhanced usual care (EUC) at baseline with EUC at 3 months

Outcomes

Primary Outcome Measures

drug use
Drug use is measured using the NIDA-Modified ASSIST (Alcohol, Smoking and Substance Involvement Screening Test).
drug use - number of days used

Secondary Outcome Measures

HIV risk behaviors
HIV risk behaviors are measured using the Health Related Behavior Survey (HRBS).
health related outcomes (physical health)
Physical health is measured using the Short Form Health Survey (SF-12).
health related outcomes (mental health)
Mental health is measured using the Brief Symptom Inventory (BSI-18).
health related outcomes (mental health)
Mental health is measured using the Patient Health Questionnaire (PHQ-9).

Full Information

First Posted
April 20, 2010
Last Updated
April 6, 2016
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01113190
Brief Title
Healthier You: Optimizing Screening, Brief Interventions, and Referral to Treatment (SBIRT) in the Emergency Department
Official Title
Optimizing SBIRT for Drug-Using Patients in an Inner-City Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Screening, brief interventions, and referral to treatment (SBIRT) for drug use/abuse offers opportunities for early detection, brief intervention/treatment, and substance use treatment referrals for patients in medical settings. Although SBIRT components, particularly screening and brief interventions, have been shown to be effective strategies for addressing alcohol misuse in primary care, data are limited on using all of the components of SBIRT for drug-using patients, particularly in the Emergency Department (ED). Further, because of the often chaotic environment of EDs, many logistical and practical impediments exist for the adoption of the entire SBIRT model in this setting.
Detailed Description
The proposed study will use computerized screening using touch screen computer tablets with audio (~4,900 patients) and will test intervention strategies in a two-factorial design (3x2). Specifically, 900 patients aged 18-60 in an inner-city ED who screen positive for drug use in the past 3 months will be randomized to the combinations of three ED-based conditions (computer brief intervention-CBI; intervener brief intervention-IBI; enhanced usual care-EUC), and two follow-up conditions (adapted motivational enhancement therapy-AMET; enhanced usual care-EUC) that will take place 3 months post-ED. All individuals who meet criteria for a drug use disorder will additionally receive the "referral to treatment" or "RT" component of SBIRT. Stratified random assignment [by gender and diagnosis of a drug use disorder (yes/no)] will take place at baseline for all ED based and follow-up conditions. All participants will receive written information including substance abuse and other community resources, and HIV prevention materials. Recognizing that brief interventions are important, but not necessarily sufficient, for change in all patients who use drugs, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ED-based brief intervention conditions, 3-month followup brief treatment conditions, and combinations of conditions, for decreasing drug use and improving health-related outcomes (including physical and mental health, and HIV risk behavior) at 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug 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
878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBI in ED with AMET at 3 months
Arm Type
Active Comparator
Arm Description
computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Arm Title
CBI in ED with EUC at 3 months
Arm Type
Active Comparator
Arm Description
computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months
Arm Title
IBI in ED with AMET at 3 months
Arm Type
Active Comparator
Arm Description
intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Arm Title
IBI in ED with EUC at 3 months
Arm Type
Active Comparator
Arm Description
intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months
Arm Title
EUC in ED with AMET at 3 months
Arm Type
Active Comparator
Arm Description
enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Arm Title
EUC in ED with EUC at 3 months
Arm Type
Active Comparator
Arm Description
enhanced usual care (EUC) at baseline with EUC at 3 months
Intervention Type
Behavioral
Intervention Name(s)
Computer-delivered Brief Intervention (CBI)
Intervention Description
The multimedia, interactive Computer BI (CBI) condition will be delivered using tablet computers. The content and format will be easily negotiated by participants. The proposed CBI condition will use actors with 'green screen' to deliver scripted therapist content that will be highly tailored to individual responses. 'Green screens' are standard recording formats that allow for inserting engaging background and other overlays onto recorded material. This program will be viewed on a touch screen tablet computer with audio delivered via headphones. The CBI will be designed in a therapist video-delivered interactive style, that provides tailoring options for reviewing patient goals, providing feedback regarding substance use patterns and consequences, completing a "decisional balance" exercise, and formulating a change plan. It requires active participation and is not a passive video that is merely viewed.
Intervention Type
Behavioral
Intervention Name(s)
Intervener-delivered Brief Intervention (IBI)
Intervention Description
IBI is a 30-minute intervention session with a master's-level clinician. The interventions will include FRAMES (Miller & Rollnick, 2002): personalized Feedback (regarding substance use, risk factors), emphasis on Responsibility for change, Advice, Menu of options, Empathic clinical behaviors, and support of Self-Efficacy regarding making changes. The interventions are designed to address the primary target behavior of drug use, and will include a tailored review of participants' goals/values, feedback regarding their present substance use patterns and consequences, developing a discrepancy between their substance use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant. IBI will be highly individualized to participants' goals, values and substance use, and will will follow similar session outlines and length of delivery as the CBI sessions.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Motivational Enhancement Therapy (AMET)
Intervention Description
This session will have a similar general outline to the sessions conducted in the ED, including a review of participants' goals and values, and a review of their substance use and consequences, use of decisional balance exercises as indicated, and review and modification of their change plan. For the AMET intervention, the intervener (at least master's level) will conduct a single session (~30-45 minutes) in the community (HMC ED or our community research office). The therapist will be able to tailor their approach to each individual's needs and motivational state.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
The EUC group will receive brief advice to change their drug use, as well as a booklet including information on community support groups, location of substance use treatment centers, mental health services, suicide prevention hotlines, risk of injecting drugs including HIV and hepatitis and HIV prevention and testing information.
Primary Outcome Measure Information:
Title
drug use
Description
Drug use is measured using the NIDA-Modified ASSIST (Alcohol, Smoking and Substance Involvement Screening Test).
Time Frame
change over time (3, 6 and 12 months post-baseline)
Title
drug use - number of days used
Time Frame
change over time (3, 6 and 12 months post-baseline)
Secondary Outcome Measure Information:
Title
HIV risk behaviors
Description
HIV risk behaviors are measured using the Health Related Behavior Survey (HRBS).
Time Frame
change over time (3, 6 and 12 months post-baseline)
Title
health related outcomes (physical health)
Description
Physical health is measured using the Short Form Health Survey (SF-12).
Time Frame
change over time (3, 6 and 12 months post-baseline)
Title
health related outcomes (mental health)
Description
Mental health is measured using the Brief Symptom Inventory (BSI-18).
Time Frame
change over time (3, 6 and 12 months post-baseline)
Title
health related outcomes (mental health)
Description
Mental health is measured using the Patient Health Questionnaire (PHQ-9).
Time Frame
change over time (3, 6 and 12 months post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients age 18-60 years presenting to the HMC for medical care (except exclusions as noted below) ability to provide informed consent. Additional inclusion criteria for intervention: past 3-month use of illicit drugs or misuse of psychoactive prescription drugs Exclusion Criteria: patients who do not understand English (less than 1% in our prior work) - 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
Hurley Medical Center Emergency Department
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31400240
Citation
Drislane LE, Waller R, Martz ME, Bonar EE, Walton MA, Chermack ST, Blow FC. Therapist and computer-based brief interventions for drug use within a randomized controlled trial: effects on parallel trajectories of alcohol use, cannabis use and anxiety symptoms. Addiction. 2020 Jan;115(1):158-169. doi: 10.1111/add.14781. Epub 2019 Oct 24.
Results Reference
derived

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Healthier You: Optimizing Screening, Brief Interventions, and Referral to Treatment (SBIRT) in the Emergency Department

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