Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments

NCT01207791 | Completed DMC

• 3 other identifiers: NIDA CTN Protocol 0047U10DA015833U10DA013732
• Study Type: interventional
• Target: 1,285
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Drug Abuse

Keywords

drug abuse; emergency department; brief intervention; motivational interviewing; SBIRT

Outcome Measures

Primary Outcomes (1)

• days of use of the primary drug of abuse

  Assessed by Time-line Follow-back method

  30 days preceding 3-month follow-up

Secondary Outcomes (8)

• Days of use of the primary drug of abuse

  6 months, 12 months

• number days abstinent from all drugs

  3, 6, 12 months

• days of heavy drinking

  3, 6, 12 months

• total quantity of drug use

  3, 6, 12 months

• objective change in drug use based on analysis of hair samples

  3, 6, 12 months

Study Arms (3)

Minimal screening only (MSO)

OTHER

Minimal screening

Behavioral: screening

Screening, assessment, and referral (SAR)

ACTIVE COMPARATOR

Behavioral: screening; Behavioral: assessment; Behavioral: referral

Brief intervention plus telephone boosters (BI-B)

EXPERIMENTAL

Behavioral: screening; Behavioral: assessment; Behavioral: referral; Behavioral: Brief intervention; Behavioral: booster sessions

Interventions

screening BEHAVIORAL

Brief screening to assess eligibility and collect minimal baseline data

Brief intervention plus telephone boosters (BI-B); Minimal screening only (MSO); Screening, assessment, and referral (SAR)

assessment BEHAVIORAL

comprehensive substance use assessment

Brief intervention plus telephone boosters (BI-B); Screening, assessment, and referral (SAR)

referral BEHAVIORAL

referral to treatment if indicated or requested

Brief intervention plus telephone boosters (BI-B); Screening, assessment, and referral (SAR)

Brief intervention BEHAVIORAL

30-minute brief intervention session in ED

Brief intervention plus telephone boosters (BI-B)

booster sessions BEHAVIORAL

two 15-minute booster counseling sessions conducted by telephone

Brief intervention plus telephone boosters (BI-B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (7)

Jackson Memorial Hospital

Miami, Florida, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

Belleview Hospital

New York, New York, United States

Location

University of Cincinnati Hospital

Cincinnati, Ohio, United States

Location

University of Washington

Seattle, Washington, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, United States

Location

Related Publications (2)

• Bogenschutz MP, Donovan DM, Mandler RN, Perl HI, Forcehimes AA, Crandall C, Lindblad R, Oden NL, Sharma G, Metsch L, Lyons MS, McCormack R, Macias-Konstantopoulos W, Douaihy A. Brief intervention for patients with problematic drug use presenting in emergency departments: a randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1736-45. doi: 10.1001/jamainternmed.2014.4052.

  PMID: 25179753 DERIVED

• Donovan DM, Bogenschutz MP, Perl H, Forcehimes A, Adinoff B, Mandler R, Oden N, Walker R. Study design to examine the potential role of assessment reactivity in the Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED) protocol. Addict Sci Clin Pract. 2012 Aug 28;7(1):16. doi: 10.1186/1940-0640-7-16.

  PMID: 23186329 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Emergencies

Interventions

Mass Screening; Restraint, Physical; Referral and Consultation; Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Behavior Control; Therapeutics; Immobilization; Professional Practice; Organization and Administration; Health Services Administration; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael P. Bogenschutz, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (7)