Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)
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Purpose
Misuse of drugs and alcohol has a tremendous impact on individual health and on society, in terms of both human suffering and economic cost. Most substance abusers never seek specialty addiction treatment, but a large percentage of them receives some form of medical care, frequently in emergency room settings. There is considerable evidence showing that Screening, Brief Intervention, Referral, and Treatment (SBIRT) interventions in medical settings result in decreased drinking and alcohol-related problems among those with alcohol abuse or dependence. However, there are few studies using these models focusing on drug users. Although drug users are seen in large numbers in emergency departments, there have been no randomized controlled trials of SBIRT models for drug users presenting in Emergency Departments (EDs).
This study is designed to assess the effects of Assessment, Referral, and a Brief Intervention on substance use of individuals screening positive for drug use during a medical ED visit. The Southwest Node of the NIDA Clinical Trials Network, located at UNM CASAA, is taking the lead on this study. Six sites across the country will participate in this study, including the ED of UNM Hospital. A total of 1285 ED patients who screen positive for current drug use problems will be randomly assigned to receive 1) minimal screening only, 2) assessment of substance use and referral to treatment, or 3) assessment and referral combined with a 30-minute counseling session (Brief Intervention) and two follow-up telephone counseling sessions. Outcomes will be assessed at 3, 6, and 12 months after the ED visit. We hypothesize that those who receive the Brief Intervention will have the least drug use at follow-up, that those who receive minimal screening only (the usual current practice) will have the most drug use, and that those receiving assessment and referral without the Brief intervention will have intermediate outcomes.
| Condition | Intervention |
|---|---|
|
Drug Abuse |
Behavioral: screening Behavioral: assessment Behavioral: referral Behavioral: Brief intervention Behavioral: booster sessions |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments |
- days of use of the primary drug of abuse [ Time Frame: 30 days preceding 3-month follow-up ] [ Designated as safety issue: No ]Assessed by Time-line Follow-back method
- Days of use of the primary drug of abuse [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
- number days abstinent from all drugs [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- days of heavy drinking [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- total quantity of drug use [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- objective change in drug use based on analysis of hair samples [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- self-reported consequences of drug and alcohol use [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- percent entering treatment among those classified as having probable dependence [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
- ED and other health care utilization [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1285 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Minimal screening only (MSO)
Minimal screening
|
Behavioral: screening
Brief screening to assess eligibility and collect minimal baseline data
|
| Active Comparator: Screening, assessment, and referral (SAR) |
Behavioral: screening
Brief screening to assess eligibility and collect minimal baseline data
Behavioral: assessment
comprehensive substance use assessment
Behavioral: referral
referral to treatment if indicated or requested
|
| Experimental: Brief intervention plus telephone boosters (BI-B) |
Behavioral: screening
Brief screening to assess eligibility and collect minimal baseline data
Behavioral: assessment
comprehensive substance use assessment
Behavioral: referral
referral to treatment if indicated or requested
Behavioral: Brief intervention
30-minute brief intervention session in ED
Behavioral: booster sessions
two 15-minute booster counseling sessions conducted by telephone
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Registration as patient in the ED during study screening hours
- Positive screen (≥3) for problematic use of a non-alcohol, non-nicotine drug based on the Drug Abuse Screening Test (DAST)
- At least one day of problematic drug use (excluding alcohol and nicotine) in the past 30 days
- Age 18 years or older
- Adequate English proficiency
- Ability to provide informed consent
- Access to phone (for booster sessions)
Exclusion Criteria:
- Inability to participate due to emergency treatment
- Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication)
- Status as a prisoner or in police custody at the time of treatment.
- Current engagement in addiction treatment
- Residence more than 50 miles from the location of follow-up visits
- Inability to provide sufficient contact information (must provide at least 2 reliable locators).
- Prior participation in the current study.
Contacts and Locations| Contact: Alyssa A Forcehimes, Ph.D. | 505-925-2399 | aforcehimes@comcast.net |
| United States, Florida | |
| Jackson Memorial Hospital | Not yet recruiting |
| Miami, Florida, United States | |
| Contact: Paco Castellon | |
| Principal Investigator: Lisa Metsch, Ph.D. | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States | |
| Contact: Jessica Dreifuss, Ph.D. | |
| Principal Investigator: Roger Weiss, M.D. | |
| United States, New Mexico | |
| University of New Mexico Hospital | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Robert Kushner, M.D. | |
| Principal Investigator: Cameron Crandall, M.D. | |
| United States, New York | |
| Belleview Hospital | Not yet recruiting |
| New York, New York, United States | |
| Contact: Agatha Kulaga, MSW | |
| Principal Investigator: John Rotrosen, M.D. | |
| United States, Ohio | |
| University of Cincinnati Hospital | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Emily Dorer | |
| Principal Investigator: Theresa Winhusen, Ph.D. | |
| United States, Washington | |
| University of Washington | Active, not recruiting |
| Seattle, Washington, United States | |
| United States, West Virginia | |
| West Virginia University Hospital | Not yet recruiting |
| Morgantown, West Virginia, United States | |
| Contact: Dorothy Sandstrom | |
| Principal Investigator: Dennis Daley, Ph.D. | |
| Principal Investigator: | Michael P. Bogenschutz, M.D. | University of New Mexico |
More Information
No publications provided by University of New Mexico
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Bogenschutz, PI, University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT01207791 History of Changes |
| Other Study ID Numbers: | NIDA CTN Protocol 0047, U10DA015833, U10DA013732 |
| Study First Received: | September 21, 2010 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of New Mexico:
|
drug abuse emergency department brief intervention motivational interviewing SBIRT |
Additional relevant MeSH terms:
|
Substance-Related Disorders Emergencies Mental Disorders Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013