Clinical trial NCT01207791: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments
Official title: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Keywords: drug abuse
emergency department
brief intervention
motivational interviewing
SBIRT
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-09-23
Enrollment: 1285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: days of use of the primary drug of abuse
timeFrame: 30 days preceding 3-month follow-up
Secondary outcomes:
measure: Days of use of the primary drug of abuse
timeFrame: 6 months, 12 months
measure: number days abstinent from all drugs
timeFrame: 3, 6, 12 months
measure: days of heavy drinking
timeFrame: 3, 6, 12 months
measure: total quantity of drug use
timeFrame: 3, 6, 12 months
measure: objective change in drug use based on analysis of hair samples
timeFrame: 3, 6, 12 months
measure: self-reported consequences of drug and alcohol use
timeFrame: 3, 6, 12 months
measure: percent entering treatment among those classified as having probable dependence
timeFrame: 3, 6, 12 months
measure: ED and other health care utilization
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: New York
country: United States
facility: Belleview Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Hospital
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: University of New Mexico
name: Michael P. Bogenschutz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.