Clinical trial NCT01113190: 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
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-04-29
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: drug use
timeFrame: change over time (3, 6 and 12 months post-baseline)
measure: drug use - number of days used
timeFrame: change over time (3, 6 and 12 months post-baseline)
Secondary outcomes:
measure: HIV risk behaviors
timeFrame: change over time (3, 6 and 12 months post-baseline)
measure: health related outcomes (physical health)
timeFrame: change over time (3, 6 and 12 months post-baseline)
measure: health related outcomes (mental health)
timeFrame: change over time (3, 6 and 12 months post-baseline)
measure: health related outcomes (mental health)
timeFrame: change over time (3, 6 and 12 months post-baseline)
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center Emergency Department
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frederic C Blow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.