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

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.

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.