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

April 6, 2016 updated by: Frederic C. Blow, University of Michigan

Optimizing SBIRT for Drug-Using Patients in an Inner-City Emergency Department

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
878

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CBI in ED with AMET at 3 months
computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Behavioral: Computer-delivered Brief Intervention (CBI)
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.
Behavioral: Adapted Motivational Enhancement Therapy (AMET)
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.
Active Comparator: CBI in ED with EUC at 3 months
computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months
Behavioral: Computer-delivered Brief Intervention (CBI)
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.
Behavioral: Enhanced Usual Care (EUC)
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.
Active Comparator: IBI in ED with AMET at 3 months
intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Behavioral: Adapted Motivational Enhancement Therapy (AMET)
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.
Behavioral: Intervener-delivered Brief Intervention (IBI)
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.
Active Comparator: IBI in ED with EUC at 3 months
intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months
Behavioral: Enhanced Usual Care (EUC)
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.
Behavioral: Intervener-delivered Brief Intervention (IBI)
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.
Active Comparator: EUC in ED with AMET at 3 months
enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months
Behavioral: Adapted Motivational Enhancement Therapy (AMET)
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.
Behavioral: Enhanced Usual Care (EUC)
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.
Active Comparator: EUC in ED with EUC at 3 months
enhanced usual care (EUC) at baseline with EUC at 3 months
Behavioral: Enhanced Usual Care (EUC)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
drug use
Time Frame: change over time (3, 6 and 12 months post-baseline)
Drug use is measured using the NIDA-Modified ASSIST (Alcohol, Smoking and Substance Involvement Screening Test).
change over time (3, 6 and 12 months post-baseline)
drug use - number of days used
Time Frame: change over time (3, 6 and 12 months post-baseline)
change over time (3, 6 and 12 months post-baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV risk behaviors
Time Frame: change over time (3, 6 and 12 months post-baseline)
HIV risk behaviors are measured using the Health Related Behavior Survey (HRBS).
change over time (3, 6 and 12 months post-baseline)
health related outcomes (physical health)
Time Frame: change over time (3, 6 and 12 months post-baseline)
Physical health is measured using the Short Form Health Survey (SF-12).
change over time (3, 6 and 12 months post-baseline)
health related outcomes (mental health)
Time Frame: change over time (3, 6 and 12 months post-baseline)
Mental health is measured using the Brief Symptom Inventory (BSI-18).
change over time (3, 6 and 12 months post-baseline)
health related outcomes (mental health)
Time Frame: change over time (3, 6 and 12 months post-baseline)
Mental health is measured using the Patient Health Questionnaire (PHQ-9).
change over time (3, 6 and 12 months post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA026029
  • R01DA026029 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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