Drug AbuseNCT01113190
Healthier You: Optimizing Screening, Brief Interventions, and Referral to Treatment (SBIRT) in the Emergency Department
A study testing Computer-delivered Brief Intervention (CBI), Intervener-delivered Brief Intervention (IBI) and Adapted Motivational Enhancement Therapy (AMET) in people with Drug Abuse, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Computer-delivered Brief Intervention (CBI), Intervener-delivered Brief Intervention (IBI) and Adapted Motivational Enhancement Therapy (AMET)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hurley Medical Center Emergency Department
Flint, Michigan, 48503
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Abuse
- Being tested
- Computer-delivered Brief Intervention (CBI), Intervener-delivered Brief Intervention (IBI), Adapted Motivational Enhancement Therapy (AMET), Enhanced Usual Care (EUC)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-delivered Brief Intervention (CBI)Behavioural
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.
Intervener-delivered Brief Intervention (IBI)Behavioural
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.
Adapted Motivational Enhancement Therapy (AMET)Behavioural
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.
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBI in ED with AMET at 3 months | Active comparator | computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months Receives: Behavioral: Computer-delivered Brief Intervention (CBI); Behavioral: Adapted Motivational Enhancement Therapy (AMET) |
| CBI in ED with EUC at 3 months | Active comparator | computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months Receives: Behavioral: Computer-delivered Brief Intervention (CBI); Behavioral: Enhanced Usual Care (EUC) |
| IBI in ED with AMET at 3 months | Active comparator | intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months Receives: Behavioral: Intervener-delivered Brief Intervention (IBI); Behavioral: Adapted Motivational Enhancement Therapy (AMET) |
| IBI in ED with EUC at 3 months | Active comparator | intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months Receives: Behavioral: Intervener-delivered Brief Intervention (IBI); Behavioral: Enhanced Usual Care (EUC) |
| EUC in ED with AMET at 3 months | Active comparator | enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months Receives: Behavioral: Adapted Motivational Enhancement Therapy (AMET); Behavioral: Enhanced Usual Care (EUC) |
| EUC in ED with EUC at 3 months | Active comparator | enhanced usual care (EUC) at baseline with EUC at 3 months Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug use
Drug use is measured using the NIDA-Modified ASSIST (Alcohol, Smoking and Substance Involvement Screening Test).
Measured: change over time (3, 6 and 12 months post-baseline)
drug use - number of days used
Measured: change over time (3, 6 and 12 months post-baseline)
Secondary outcomes (4)
HIV risk behaviors
HIV risk behaviors are measured using the Health Related Behavior Survey (HRBS).
Measured: change over time (3, 6 and 12 months post-baseline)
health related outcomes (physical health)
Physical health is measured using the Short Form Health Survey (SF-12).
Measured: change over time (3, 6 and 12 months post-baseline)
health related outcomes (mental health)
Mental health is measured using the Brief Symptom Inventory (BSI-18).
Measured: change over time (3, 6 and 12 months post-baseline)
health related outcomes (mental health)
Mental health is measured using the Patient Health Questionnaire (PHQ-9).
Measured: change over time (3, 6 and 12 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113190
- Sponsor's protocol ID
- DA026029
- Other IDs
- R01DA026029
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2010
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31400240
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing SBIRT for Drug-Using Patients in an Inner-City Emergency Department
- ClinicalTrials.gov ID
- NCT01113190
- Acronym / sponsor ID
- DA026029
- Conditions
- Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CBI in ED with AMET at 3 months | Active comparator | Behavioral: Computer-delivered Brief Intervention (CBI), Behavioral: Adapted Motivational Enhancement Therapy (AMET)computer-delivered brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months |
| CBI in ED with EUC at 3 months | Active comparator | Behavioral: Computer-delivered Brief Intervention (CBI), Behavioral: Enhanced Usual Care (EUC)computer-delivered brief intervention (CBI) at baseline with enhanced usual care-EUC at 3 months |
| IBI in ED with AMET at 3 months | Active comparator | Behavioral: Intervener-delivered Brief Intervention (IBI), Behavioral: Adapted Motivational Enhancement Therapy (AMET)intervener-delivered brief intervention (IBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months |
| IBI in ED with EUC at 3 months | Active comparator | Behavioral: Intervener-delivered Brief Intervention (IBI), Behavioral: Enhanced Usual Care (EUC)intervener-delivered brief intervention (IBI) at baseline with enhanced usual care-EUC at 3 months |
| EUC in ED with AMET at 3 months | Active comparator | Behavioral: Adapted Motivational Enhancement Therapy (AMET), Behavioral: Enhanced Usual Care (EUC)enhanced usual care (EUC) at baseline with adapted motivational enhancement therapy-AMET at 3 months |
| EUC in ED with EUC at 3 months | Active comparator | Behavioral: Enhanced Usual Care (EUC)enhanced usual care (EUC) at baseline with EUC at 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBI in ED with AMET at 3 months, CBI in ED with EUC at 3 months |
| 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. | Behavioural | IBI in ED with AMET at 3 months, IBI in ED with EUC at 3 months |
| 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. | Behavioural | CBI in ED with AMET at 3 months, EUC in ED with AMET at 3 months, IBI in ED with AMET at 3 months |
| 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. | Behavioural | CBI in ED with EUC at 3 months, EUC in ED with AMET at 3 months, EUC in ED with EUC at 3 months, IBI in ED with EUC at 3 months |
Primary outcome
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).
drug use - number of days used
Time frame: change over time (3, 6 and 12 months post-baseline)
4 secondary outcomes
HIV risk behaviors
Time frame: 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)
health related outcomes (mental health)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Derived from this study: PubMed 31400240Drislane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic C Blow, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-delivered Brief Intervention (CBI), Intervener-delivered Brief Intervention (IBI) and Adapted Motivational Enhancement Therapy (AMET) in people with Drug Abuse, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
drug use (time frame: change over time (3, 6 and 12 months post-baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.