Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01207791
First received: September 21, 2010
Last updated: May 22, 2013
Last verified: May 2013
  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

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1285
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: June 2012 (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

  Hide Detailed Description

Detailed Description:

2. STUDY SYNPOSIS AND SCHEMA

STUDY OBJECTIVES:

The study will contrast substance use and substance-related outcomes among patients endorsing problematic drug use during an emergency department (ED) visit who are randomly assigned to one of three treatment conditions: 1) minimal screening only (MSO); 2) screening, assessment, and referral to treatment (if indicated) (SAR); and 3) screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster sessions (BI-B).

STUDY DESIGN:

The proposed project is a 3-group randomized, prospective trial with blinded assessments. Individuals presenting in the ED endorsing problematic drug use on screening will be randomized in 1:1:1 ratio to MSO vs. SAR vs. BI-B. Randomization will occur after screening, and those randomized to MSO will not receive further assessment until follow-up. The other two groups will receive baseline assessment, and assignment to SAR vs. BI-B will not be revealed until after the baseline assessment is complete. Those in the SAR group will then receive referral if indicated or requested, and those assigned to the BI-B group will be receive a brief intervention consisting of motivational enhancement therapy (MET) adapted for use in the ED, followed by referral if indicated or requested. The BI-B group will also receive two booster telephone calls, ideally within one week of the ED visit. Follow-up assessments of all three groups will be conducted face-to-face at 3 months, 6 months, and 12 months post-enrollment.

STUDY POPULATION:

A total of 1285 patients with probable drug abuse or dependence (approximately 429 per group) seeking medical treatment in the ED, recruited from 6 EDs, will be randomized to MSO, SAR, or BI-B. Each ED will enroll approximately 215 participants.

ELIGIBILITY CRITERIA:

Participants will be men and women 18 years of age or older who are seeking medical treatment at the ED, have adequate English proficiency, are able to provide informed consent, endorse current (past 30 days) problematic use of one or more drugs, are willing to participate in the protocol (e.g., be randomized to treatment, participate in follow-up assessment), and have access to a telephone. Individuals will be excluded if they are incapable of informed consent, are prisoners or in police custody, are currently engaged in addiction treatment, reside more than 50 miles from the site where follow-ups are conducted, are unable to provide sufficient contact information, or have already participated in the study.

TREATMENTS:

The MSO group will not receive further assessment or treatment following randomization, but will be given an informational pamphlet about drug use and its potential consequences.

The SAR group will be provided with the same information pamphlet as the MSO group. In addition, following assessment, SAR participants with "probable dependence" on one or more substances (based on ASSIST score ≥ 27) will also be provided a referral to treatment, consisting of a positive recommendation to seek treatment and a standardized list of available treatment options. Participants who request a referral will also receive one, regardless of ASSIST score. Referrals will be made to CTN-affiliated CTPs as well as other community programs in the normal clinical referral networks of the participating EDs.

Individuals randomized to the BI+Booster (BI-B) condition will receive the same information and referral as those in SAR. In addition, while in the ED the BI-B group will receive a manual-guided brief intervention based on motivational interviewing principles, including feedback based on screening information, the FRAMES heuristic, and development of a change plan if indicated. The brief intervention will focus primarily on the most problematic drug of abuse identified by the participant. The BI will be provided in person in the ED while the participant is still there. In addition, participants in the BI-B group will receive up to 2 phone "booster" sessions that will check to see whether they have engaged in treatment, review change plans, and seek a commitment from them (Mello, Longabaugh et al. 2008). The content of these boosters is patterned after sessions in Motivational Enhancement Therapy (MET). The initial phone booster call will occur within 3 days of discharge from the ED if possible, and the second within 7 days. Booster calls will be made using a centralized, study-wide intervention booster call center.

SAFETY ASSESSMENT:

Adverse Events (AEs) including Serious Adverse Events (SAEs) will be monitored and reported throughout the study. These events will be subject to ongoing monitoring by the study executive committee (including representatives of the lead nodes, NIDA, and the Clinical Coordinating Center), and will be presented for DSMB review.

OUTCOME ASSESSMENTS:

The primary outcome is days of use of the patient-defined primary problem drug, assessed by the Time-Line Follow-Back for the 30-day period preceding the 3-month follow-up. Secondary outcomes include change from baseline in days of use of the primary substance, the number days abstinent from all drugs, days of heavy drinking, total quantity of drug use, objective change in drug use based on analysis of hair samples, self-reported consequences of drug and alcohol use, percent entering treatment among those classified as having probable dependence, and ED and other health care utilization.

PRIMARY OUTCOME ANALYSIS:

The primary analysis will contrast MSO, SAR and BI-B groups with respect to the primary outcome variable (days of use of the primary drug of abuse in the 30 days preceding 3-month follow-up) using a linear mixed model with a random site effect and fixed treatment effect and intercept. Three pairwise contrasts will be made with an overall type 1 error rate of α = 0.05.

REGULATORY ISSUES:

The trial will be conducted in compliance with protocol, ICH Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Registration as patient in the ED during study screening hours
  2. Positive screen (≥3) for problematic use of a non-alcohol, non-nicotine drug based on the Drug Abuse Screening Test (DAST)
  3. At least one day of problematic drug use (excluding alcohol and nicotine) in the past 30 days
  4. Age 18 years or older
  5. Adequate English proficiency
  6. Ability to provide informed consent
  7. Access to phone (for booster sessions)

Exclusion Criteria:

  1. Inability to participate due to emergency treatment
  2. Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication)
  3. Status as a prisoner or in police custody at the time of treatment.
  4. Current engagement in addiction treatment
  5. Residence more than 50 miles from the location of follow-up visits
  6. Inability to provide sufficient contact information (must provide at least 2 reliable locators).
  7. Prior participation in the current study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207791

Locations
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
United States, New York
Belleview Hospital
New York, New York, United States
United States, Ohio
University of Cincinnati Hospital
Cincinnati, Ohio, United States
United States, Washington
University of Washington
Seattle, Washington, United States
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States
Sponsors and Collaborators
University of New Mexico
Investigators
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: May 22, 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:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014