NCT01113190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

April 20, 2010

Last Update Submit

April 6, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • drug use - number of days used

    change over time (3, 6 and 12 months post-baseline)

Secondary Outcomes (4)

  • HIV risk behaviors

    change over time (3, 6 and 12 months post-baseline)

  • health related outcomes (physical health)

    change over time (3, 6 and 12 months post-baseline)

  • health related outcomes (mental health)

    change over time (3, 6 and 12 months post-baseline)

  • health related outcomes (mental health)

    change over time (3, 6 and 12 months post-baseline)

Study Arms (6)

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

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

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

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

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

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

Behavioral: Enhanced Usual Care (EUC)

Interventions

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.

CBI in ED with AMET at 3 monthsCBI in ED with EUC at 3 months

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.

IBI in ED with AMET at 3 monthsIBI in ED with EUC at 3 months

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.

CBI in ED with AMET at 3 monthsEUC in ED with AMET at 3 monthsIBI in ED with AMET at 3 months

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.

CBI in ED with EUC at 3 monthsEUC in ED with AMET at 3 monthsEUC in ED with EUC at 3 monthsIBI in ED with EUC at 3 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center Emergency Department

Flint, Michigan, 48503, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Frederic C Blow, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 29, 2010

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations