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

Drug Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113190
• Other study ID #: DA026029
• Secondary ID: R01DA026029
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: April 6, 2016
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Drug Abuse

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Hurley Medical Center Emergency Department	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug use	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)	No
Primary	drug use - number of days used		change over time (3, 6 and 12 months post-baseline)	No
Secondary	HIV risk behaviors	HIV risk behaviors are measured using the Health Related Behavior Survey (HRBS).	change over time (3, 6 and 12 months post-baseline)	No
Secondary	health related outcomes (physical health)	Physical health is measured using the Short Form Health Survey (SF-12).	change over time (3, 6 and 12 months post-baseline)	No
Secondary	health related outcomes (mental health)	Mental health is measured using the Brief Symptom Inventory (BSI-18).	change over time (3, 6 and 12 months post-baseline)	No
Secondary	health related outcomes (mental health)	Mental health is measured using the Patient Health Questionnaire (PHQ-9).	change over time (3, 6 and 12 months post-baseline)	No