Brief Intervention for Drug Misuse in the Emergency Department (BIDMED)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population.

The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.

Condition or disease	Intervention/treatment	Phase
Substance Abuse Detection; HIV; Hepatitis B; Hepatitis C; Brief Intervention; HIV Infections	Behavioral: Brief motivational intervention	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1030 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
Study Start Date :	June 2010
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Treatment; Assessment and brief intervention	Behavioral: Brief motivational intervention; two session delivered two weeks apart

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Reduction in past 30 day drug misuse [ Time Frame: 12 months post-randomization ]
2. Reduction in behaviors associated with drug misuse [ Time Frame: 12 months post-randomization ]
3. Reduction negative physical health, psychosocial health, and socioeconomic consequences [ Time Frame: 12 months post-randomization ]

Secondary Outcome Measures :

1. Uptake of HIV and hepatitis B/C screening [ Time Frame: 3 months post randomization ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Self-report of illicit and/or prescription drug misuse in the past three-months. Presenting at the emergency department for medical care.

Exclusion Criteria:

Not age appropriate, in custody, medically unstable, actively psychotic, suicidal

Contacts and Locations

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Locations

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Rhode Island Hospital

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Roland C Merchant, MD; ScD	Rhode Island Hospital
Principal Investigator:	Ted Nirenberg, PhD	Rhode Island Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Merchant RC, Zhang Z, Zhang Z, Liu T, Baird JR. Lack of efficacy in a randomised trial of a brief intervention to reduce drug use and increase drug treatment services utilisation among adult emergency department patients over a 12-month period. Emerg Med J. 2018 Feb 2. pii: emermed-2016-206540. doi: 10.1136/emermed-2016-206540. [Epub ahead of print]

Guan W, Liu T, Baird JR, Merchant RC. Evaluation of a brief intervention to reduce the negative consequences of drug misuse among adult emergency department patients. Drug Alcohol Depend. 2015 Dec 1;157:44-53. doi: 10.1016/j.drugalcdep.2015.10.007. Epub 2015 Oct 13.

Merchant RC, Baird JR, Liu T. Short-term Efficacy of a Brief Intervention to Reduce Drug Misuse and Increase Drug Treatment Utilization Among Adult Emergency Department Patients. Acad Emerg Med. 2015 Oct;22(10):1172-80. doi: 10.1111/acem.12767. Epub 2015 Sep 16.

Merchant RC, Baird JR, Liu T, Taylor LE. HCV among The Miriam Hospital and Rhode Island Hospital Adult ED Patients. R I Med J (2013). 2014 Jul 1;97(7):35-9.

Bernardino VL, Baird JR, Liu T, Merchant RC. Comparison of substance-use prevalence among Rhode Island and The Miriam Hospital Emergency Department patients to state and national general population prevalence estimates. R I Med J (2013). 2014 Apr 1;98(4):30-4.

Responsible Party:	Roland C. Merchant, MD. MPH, ScD, Attending Physician, Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT01124591 History of Changes
Other Study ID Numbers:	0113-09
First Posted:	May 17, 2010
Last Update Posted:	June 10, 2015
Last Verified:	June 2015

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; HIV Infections; Emergencies; Hepatitis B; Substance-Related Disorders; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections	Flaviviridae Infections; Lentivirus Infections; Retroviridae Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Hepadnaviridae Infections; DNA Virus Infections; Chemically-Induced Disorders; Mental Disorders